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Sample records for 12-week randomized intervention

  1. Exercise and quality of life in patients with cystic fibrosis: A 12-week intervention study

    DEFF Research Database (Denmark)

    Schmidt, Anne Mette; Jacobsen, Ulla; Bregnballe, Vibeke;

    2011-01-01

    It was hypothesised that increased exercise capacity is related to improved quality of life (QoL) in patients with cystic fibrosis (CF). A 12-week individually tailored unsupervised aerobic exercise programme was offered to 42 patients with CF. At the start and at the end of the exercise programme...

  2. Bifidogenic effect of whole-grain wheat during a 12-week energy-restricted dietary intervention in postmenopausal women

    DEFF Research Database (Denmark)

    Christensen, Ellen Gerd; Licht, Tine Rask; Kristensen, M.;

    2013-01-01

    Background/Objectives:Consumption of whole-grain products is known to have beneficial effects on human health. The effects of whole-grain products on the intestinal microbiota and intestinal integrity have, however, only been studied limitedly. We investigate changes of the human gut microbiota...... composition after consumption of whole-grain (WW) or refined wheat (RW) and further study effects on gut wall integrity.Subjects/Methods:Quantitative PCR was used to determine changes in the gut bacterial composition in postmenopausal women following a 12-week energy-restricted dietary intervention with WW (N......=38) or RW (N=34). Intestinal integrity was determined by measuring trans-epithelial resistance (TER) across a Caco-2 cell monolayer, following exposure to faecal water.Results:No significant differences in microbiota composition were observed between the two dietary groups; however, the whole...

  3. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Alessandra S. Braz

    2013-03-01

    Full Text Available The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng (100 mg/d with amitriptyline (25 mg/d and placebo in 38 patients with fibromyalgia: 13 in Group I (amitriptyline, 13 in Group II (placebo, and 12 in Group III (P. ginseng. Ratings on the Visual Analogue Scale (VAS revealed a reduction in pain in the P. ginseng group (p < .0001, an improvement in fatigue (p < .0001 and an improvement in sleep (p < .001, with respect to baseline characteristics, but there were no differences between the three groups. With respect to anxiety, improvements occurred in the P. ginseng group compared to baseline (p < .0001; however, amitriptyline treatment resulted in significantly greater improvements (p < .05. P. ginseng reduced the number of tender points and improved patients' quality of life (using the Fibromyalgia Impact Questionnaire - FIQ; however, there were no differences between groups. The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia.

  4. The outcomes of a 12-week Internet intervention aimed at improving fitness and health-related quality of life in overweight adolescents: the Young & Active controlled trial.

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    Kirsti Riiser

    Full Text Available Overweight and obesity among adolescents may have consequences, with potentially lasting effects on health and health-related quality of life (HRQoL. Excess weight is also associated with decreases in physical activity and cardiorespiratory fitness. The aim of the current study was to investigate the short-term effects of a 12-week Internet intervention in a primary care setting intended to increase cardiorespiratory fitness and HRQoL among overweight and obese adolescents.In this controlled trial, participants (13-15 years were non-randomly allocated to an intervention- or a control group. The intervention group received 12-weeks access to an online program providing tailored physical activity counseling based on principles from Self-determination Theory and Motivational Interviewing. The control group received standard follow-up by the school nurses. The primary outcome measure of cardiorespiratory fitness was determined using a shuttle run test. The secondary outcomes: HRQoL, leisure time exercise, body image and self-determined motivation for physical activity and exercise, were assessed by self-report measures. Age- and gender-adjusted body mass index (BMI was calculated based on measurements of height and weight. To compare pre-to post intervention differences within groups, a paired samples t-test was used while crude differences between groups were analyzed with an independent samples t-test.Of the 120 participants, 108 completed the study, 75 in the intervention group and 33 in the control group. Exposure to the intervention had a small effect on cardiorespiratory fitness (0.14; 95% CI [0.01;0.28]; P = 0.04, and a moderate effect on HRQoL (5.22; 95% CI [0.90; 9.53]; P = 0.02. Moreover, the control group increased significantly in BMI, yielding a moderate preventive effect on BMI (-0.39; 95% CI [-0.74;-0.03]; P = 0.03 for the intervention group.The results suggest that the Internet intervention with tailored physical activity counseling

  5. Postural correction for kyphosis improves the dyspnea index and pulmonary functions in patients with chronic obstructive pulmonary disease: A randomized trial over 12 weeks

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    Gajanan S Gaude

    2014-01-01

    Full Text Available Background: Patients with chronic obstructive pulmonary disease (COPD tend to attain forward shoulder posture and kyphosis and this affects their respiratory functions. Correcting this posture leads to straightening of the spine leading to improvement in the lung functions. The present study was carried out to evaluate the additional effect of correction of kyphosis in COPD patients. Objectives: The objective of the following study is to evaluate the effect of postural correction with respiratory muscle training in patients with COPD. Settings and Study Design: A randomized controlled prospective study in a tertiary care hospital in out-patients for 12 weeks. Materials and Methods: Confirmed cases of COPD were randomly divided into two groups by computer generated randomization: Study and control group. Study group patients received combination of respiratory muscle training and postural correction by a brace, whereas the control group received only respiratory muscle training exercises. The outcome measures evaluated were maximal inspiratory pressure, spirometry values, dyspnea scores and 6-min walk distance (MWD. Statistical Analysis: Statistical analysis was performed using Statistical Package for the Social Sciences version 16. Descriptive statistics are reported as means and standard deviation. Results: A total of 120 patients were included in the study with 60 in each group. Both groups showed a significant improvement in the inspiratory muscle strength, lung functions, dyspnea index and functional capacity at 8 weeks and 12 weeks of intervention. However, the interscapular distance, percentage of kyphotic index (KI and grades of a plumb line (PL measurement reduced significantly in the study group when compared to the control group (P < 0.01. There was also significant improvement in the 6-MWD and reduction of Borg scale of dyspnea when compared to the control group (P < 0.01. The pulmonary functions improvement was better in the study

  6. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    Science.gov (United States)

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

  7. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Yu-Mi Lee

    Full Text Available Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D; however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals.Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46 or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47 for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks.The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017. When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%. The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks.Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms.CRiS KCT0001771.

  8. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome.

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    Caren Lau

    Full Text Available To determine the efficacy of a 12-week Hatha yoga intervention to improve metabolic risk profiles and health-related quality of life (HRQoL in Chinese adults with and without metabolic syndrome (MetS.We conducted a controlled trial within an university-affiliated hospital. 173 Chinese men and women aged 18 or above were assigned to either the yoga intervention group (n = 87 or the control group (n = 86. Primary outcomes included 12-week change in metabolic risk factors and MetS z score. Secondary outcome was HRQoL (Medical Outcomes Short Form Survey at 12 weeks.The mean age of participants was 52.0 (SD 7.4, range 31-71 years. Analysis involving the entire study population revealed that the yoga group achieved greater decline in waist circumference (p0.05. There were no significant differences in the intervention effects on waist circumference and MetS z score between the MetS subgroups (both p>0.05.A 12-week Hatha yoga intervention improves metabolic risk profiles and HRQoL in Chinese adults with and without MetS.Australian New Zealand Clinical Trials Registry ACTRN12613000816752.

  9. Behavioural pattern of training-adherence in a 12 weeks home-based IMT intervention for individuals with COPD

    DEFF Research Database (Denmark)

    Sørensen, Dorthe; Christensen, Marie Ernst

    2016-01-01

    . Data were collected by semi-structured face-to-face and telephone interviews with participants after completion of the 12 weeks IMT program. Maintaining self-esteem resulted from the participants' behavioural patterns, through which they resolved their main concern: avoiding to disappoint themselves...... of Maintaining Self-esteem provides knowledge of participant's variation in their need for professional support, and should be targeted specifically at participants in the Misgiving Mode....

  10. Oral Microbiota Shift after 12-Week Supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289; A Randomized Control Trial.

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    Nelly Romani Vestman

    Full Text Available Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear.Oral microbiota was characterized via 454-pyrosequencing of the 16S rDNA hypervariable region V3-V4 after 12 weeks of daily Lactobacillus reuteri DSM 17938 and PTA 5289 consumption. Forty-four adults were assigned to a test group (n = 22 that received lactobacilli lozenges (108 CFU of each strain/lozenge or a control group that received placebo (n = 22. Presence of L. reuteri was confirmed by cultivation and species specific PCR. Tooth biofilm samples from 16 adults before, during, and after exposure were analyzed by pyrosequencing. A total of 1,310,292 sequences were quality filtered. After removing single reads, 257 species or phylotypes were identified at 98.5% identity in the Human Oral Microbiome Database. Firmicutes, Bacteroidetes, Fusobacteria, Proteobacteria, and Actinobacteria were the most abundant phyla. Streptococcus was the most common genus and the S. oralis/S. mitis/S. mitis bv2/S. infantis group comprised the dominant species. The number of observed species was unaffected by L. reuteri exposure. However, subjects who had consumed L. reuteri were clustered in a principal coordinates analysis relative to scattering at baseline, and multivariate modeling of pyrosequencing microbiota, and culture and PCR detected L. reuteri separated baseline from 12-week samples in test subjects. L. reuteri intake correlated with increased S. oralis/S. mitis/S. mitis bv2/S. infantis group and Campylobacter concisus, Granulicatella adiacens, Bergeyella sp. HOT322, Neisseria subflava, and SR1 [G-1] sp. HOT874 detection and reduced S. mutans, S. anginosus, N. mucosa, Fusobacterium periodicum, F. nucleatum ss vincentii, and Prevotella maculosa detection. This effect had disappeared 1 month after exposure was terminated.L. reuteri consumption did not affect species richness but induced a shift in

  11. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

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    Myers JS

    2014-03-01

    Full Text Available Jonathan S Myers,1 Steven Vold,2 Fiaz Zaman,3 Julia M Williams,4 David A Hollander41Wills Eye Hospital, Philadelphia, PA, USA; 2Vold Vision, PLLC, Bentonville, AR, USA; 3Houston Eye Associates, Houston, TX, USA; 4Allergan, Inc., Irvine, CA, USABackground: The purpose of this study was to evaluate the intraocular pressure (IOP-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma.Methods: Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily. Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03% are presented.Results: Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957. In both treatment arms, mean (± standard error of the mean reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001, ranging from 3.7±0.4 (17.0% mmHg to 4.4±0.4 (19.9% mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8% mmHg to 3.9±0.5 (16.7% mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival

  12. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    OpenAIRE

    Yu-Mi Lee; Se-A Kim; In-Kyu Lee; Jung-Guk Kim; Keun-Gyu Park; Ji-Yun Jeong; Jae-Han Jeon; Ji-Yeon Shin; Duk-Hee Lee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods P...

  13. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    Science.gov (United States)

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  14. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis

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    Nathalie Deckx

    2016-01-01

    Full Text Available Previously, we reported that patients with multiple sclerosis (MS demonstrate improved muscle strength, exercise tolerance, and lean tissue mass following a combined endurance and resistance exercise program. However, the effect of exercise on the underlying disease pathogenesis remains elusive. Since recent evidence supports a crucial role of dendritic cells (DC in the pathogenesis of MS, we investigated the effect of a 12-week combined exercise program in MS patients on the number and function of DC. We demonstrate an increased number of plasmacytoid DC (pDC following the exercise program. These pDC display an activated phenotype, as evidenced by increased numbers of circulating CD62L+ and CD80+ pDC. Interestingly, the number of CD80+ pDC positively correlates with the presence of IL-10-producing regulatory type 1 cells (Tr1, an important cell type for maintaining peripheral tolerance to self-antigens. In addition, decreased production of the inflammatory mediators, TNF-α and MMP-9, upon Toll-like receptor (TLR stimulation was found at the end of the exercise program. Overall, our findings suggest that the 12-week exercise program reduces the secretion of inflammatory mediators upon TLR stimulation and promotes the immunoregulatory function of circulating pDC, suggestive for a favorable impact of exercise on the underlying immunopathogenesis of MS.

  15. Comparison of the latanoprost 0.005%/timolol 0.5% + brinzolamide 1% versus dorzolamide 1%/timolol 0.5% + latanoprost 0.005%: a 12-week, randomized open-label trial

    Directory of Open Access Journals (Sweden)

    Kanamoto T

    2012-03-01

    Full Text Available Shunsuke Nakakura1, Hitoshi Tabuchi1, Yukio Baba2, Futoshi Maruiwa2, Nobuko Ando2, Takashi Kanamoto3, Yoshiaki Kiuchi31Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, Hyogo Prefecture, Japan; 2Department of Ophthalmology, Baba Eye Clinic, Hiroshima, Japan, 3Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima City, JapanObjective: To compare the safety and effectiveness of fixed-combination regimes (latanoprost–timolol and brinzolamide 1% compared to dorzolamide 1%/timolol and latanoprost in open-angle glaucoma patients after switching from a combination of three topical antiglaucoma eye drops.Methods: We conducted an open, randomized 12-week multicenter prospective study. We randomly allocated 39 patients who had been treated with three antiglaucoma eye drops (prostaglandin F2α analogues plus beta-blockers and carbonic anhydrase inhibitors into two groups. Group A (n = 20 were treated with latanoprost–timolol and brinzolamide 1% therapy and Group B (n = 16 were treated with dorzolamide 1%/timolol and latanoprost. Thirty-six patients completed all 12 weeks of this study. The major clinical parameters measured were intraocular pressure (IOP, conjunctive hyperemia, superficial punctate keratopathy and hyperpigmentation of eyelid at baseline, 4, and 12 weeks. Additionally noted were adverse events and patient preferences, measured using a questionnaire at study initiation and at 12 weeks.Results: At baseline, IOPs were (Group A: 14.1 ± 2.9 mmHg, B: 14.5 ± 2.9 mmHg; P = 0.658, (Group A: 13.8 ± 2.6 mmHg, B: 14.3 ± 2.8 mmHg; P = 0.715 at 4 weeks, and (Group A: 14.1 ± 2.7 mmHg, B: 14.2 ± 2.7 mmHg; P = 0.538 at 12 weeks. Among the groups, there was no significant difference at any time point after baseline (P = 0.923, 0.951, respectively. All adverse events were not remarkably different after therapy. In regards to patient preference before and after

  16. Implementation of a 12-week disease management program improved clinical outcomes and quality of life in adults with asthma in a rural district hospital: pre- and post-intervention study.

    Science.gov (United States)

    Chamnan, Parinya; Boonlert, Kittipa; Pasi, Wanit; Yodsiri, Songkran; Pong-on, Sirinya; Khansa, Bhoonsab; Yongkulwanitchanan, Pichapat

    2010-03-01

    Despite the availability of effective medical treatment and disease management guidelines, asthma remains a poorly controlled disease in developing countries. There is little evidence of the effectiveness of disease management guidelines in rural clinical practice. The effect of disease management guidelines on clinical outcomes and quality of life in asthmatic patients in a rural community hospital was examined. Fifty-seven patients aged > or = 16 years with physician-diagnosed asthma from a hospital outpatient clinic in Ubon-ratchathani, Thailand, were recruited. Asthma diagnosis was confirmed by reviewing clinical records. We implemented a 12-week disease management program, including the use of written asthma treatment plan and asthma action plan tailored to individual patients. Using one-group pre- and post-intervention design, we compared the average number of emergency visits and hospitalizations from acute asthmatic attacks before and after the implementation of interventions using the Wilcoxon matched-pairs signed-rank test. We also compared patient's asthma quality of life (AQL) scores, measured using the 7-point scaled Mini Asthma Quality of Life Questionnaire. It was found that among the 57 patients, 38 (67%) were women, and the mean age (SD) of the patients was 47.6 (17.0) years. Sixteen patients (28%) had a family history of asthma. Emergency visits decreased from 0.48 (SD = 0.83) per patient before implementation of interventions to 0.11 (0.37) per patient after implementation of interventions (p = 0.003). Hospitalizations with acute asthma attacks reduced from 0.14 (0.35) per patient to 0.04 (0.27) per patient (p = 0.034). Overall AQL scores increased significantly from 3.7 to 5.4 (p management program could reduce emergency visits and hospitalizations, and improve patients' quality of life in a rural practice setting.

  17. Web-based Intervention to Promote Physical Activity by Sedentary Older Adults: Randomized Controlled Trial

    OpenAIRE

    Irvine, A. Blair; Gelatt, Vicky A; John R. Seeley; Macfarlane, Pamela; Gau, Jeff M

    2013-01-01

    Background Physical activity (PA) for older adults has well-documented physical and cognitive benefits, but most seniors do not meet recommended guidelines for PA, and interventions are lacking. Objectives This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen. Methods A total of 368 sedentary men and women (M=60.3; SD 4.9) were recruited, screened, and assessed online. They were randomize...

  18. Effect of 12-Week Pilates Trainning on EDSS in Women Suffering fromMultiple Sclerosis

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    Z Shanazari

    2013-04-01

    Full Text Available Abstract Background & aim: Multiple sclerosis is a debilitating disease that strikes the immune system. Multiple sclerosis is a chronic disease which debilitates the nervous system. The study was evaluated the effects of Pilates exercise on women with physical disabilities suffering from multiple sclerosis for 12 weeks .The aim of this study was to investigating the effects of Pilates trainning on EDSS of women suffering from Multiple Sclerosis (MS for 12 weeks. Methods: In the present clinical trial study, 38 patients age 20-40 years (mean disease duration of 8±2 years with multiple sclerosis grade 0-4.5 were selected. The Patients were randomly divided into two groups: experimental and control groups. The training program for pilates, 12 weeks, three sessions a week, with each session consisting of 60 minutes. Patients' physical disability was measured using Krutzke Expanded Disability Status Scale, before and after exercise. Data were analyzed by ANCOVA test. Results: Physical disability scores before and after the exercise in intervention was 47.1 and 37 and in the control group, was 93.1 and 43.1 respectively, which was significantly different in the intervention group before and after training (p<0.05. Conclusion: Pilates training improves the physical disability of MS patients. Therefore, this exercise can be used as a complementary treatment alongside drug treatments. Key Words: Multiple Sclerosis, Women, Pilates, EDSS

  19. Efficacy and safety of combination therapy with latanoprost after a change in therapeutic regimen from timolol to brinzolamide in Japanese adult patients with primary open-angle glaucoma and ocular hypertension: open, non-randomized 12-week study

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    Shusaku Ishikawa

    2008-09-01

    Full Text Available Shusaku Ishikawa1, Yoshimi Nakamura1, Yuko Nakamura1, Hiroshi Sakai1, Shoichi Sawaguchi1, Kazuo Terashima2, Makoto Kanno2, Hidetoshi Yamashita21Department of Ophthalmology, University of the Ryukyus Faculty of Medicine, Okinawa, Japan; 2Department of Ophthalmology and Visual Science, Yamagata University Faculty of Medicine, Yamagata, JapanPurpose: To compare the efficacy of brinzolamide in Japanese patients with primary open-angle glaucoma (POAG or ocular hypertension (OH after a change from timolol in combination therapy with latanoprost.Methods: A 12-week, prospective, open-label, comparative study was performed in 20 patients [11 males and 9 females, mean age of 64.5 ± 11.0 (SDy] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol. Intraocular pressure (IOP was measured at baseline, 4, 8, and 12 weeks. Blood pressure (BP, pulse rate (PR, and adverse events were also recorded.Results: IOPs at baseline, 4, 8, and 12 weeks were 18.6 ± 2.1 mmHg, 17.8 ± 2.6 mmHg, 17.4 ± 2.5 mmHg, and 17.3 ± 3.5 mmHg, respectively. IOP reduction at 4 and 8 weeks was statistically significant (p < 0.05. The PR was significantly increased at 12 weeks (p < 0.01, but BP was not significantly affected. Four ocular adverse events were noted, but all were mild and transient.Conclusions: Substituting brinzolamide 1% for timolol 0.5% in combination therapy with latanoprost 0.005% demonstrated significant IOP reduction with improvement in PR with POAG or OH. Combination therapy using latanoprost and brinzolamide may be recommended for better IOP control with fewer systemic adverse events.Keywords: open-angle glaucoma, brinzolamide/latanprost combination therapy, timolol/latanoprost combination therapy, intraocular pressure

  20. Randomized Trial of a Literacy-Sensitive, Culturally Tailored Diabetes Self-Management Intervention for Low-Income Latinos

    OpenAIRE

    Rosal, Milagros C.; Ockene, Ira S; Restrepo, Angela; White, Mary Jo; Borg, Amy; Olendzki, Barbara; Scavron, Jeffrey; Candib, Lucy; Welch, Garry; Reed, George

    2011-01-01

    OBJECTIVE To test whether a theory-based, literacy, and culturally tailored self-management intervention, Latinos en Control, improves glycemic control among low-income Latinos with type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were randomized to the Latinos en Control intervention or to usual care. The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge, attitudes, and self-mana...

  1. Efficacy and safety of combination therapy with latanoprost after a change in therapeutic regimen from timolol to brinzolamide in Japanese adult patients with primary open-angle glaucoma and ocular hypertension: open, non-randomized 12-week study

    OpenAIRE

    Ishikawa, Shusaku; Nakamura, Yoshimi; Nakamura, Yuko; Sakai, Hiroshi; Sawaguchi, Shoichi; Terashima, Kazuo; Kanno, Makoto; Yamashita, Hidetoshi

    2008-01-01

    Purpose To compare the efficacy of brinzolamide in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) after a change from timolol in combination therapy with latanoprost. Methods A 12-week, prospective, open-label, comparative study was performed in 20 patients [11 males and 9 females, mean age of 64.5 ± 11.0 (SD)y] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol...

  2. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind, placeb

  3. The effect of whole-grain compared to refined wheat on the gut microbial composition and integrity in a colonic epithelial cell model following a 12-week energy-restricted dietary intervention in postmenopausal women

    DEFF Research Database (Denmark)

    Christensen, Ellen Gerd; Licht, Tine Rask; Kristensen, M.;

    Intake of whole-grain products are considered to decrease the risk of cardiovascular disease (CVD). This effect could potentially be linked to a prebiotic effect, hence positive modulation of the gut microbial composition or activity. Kristensen and coworkers recently conducted a study...... groups (Kristensen, et al, 2012). We used fecal samples from the same study to examine effects of WW and RW on the bacterial composition by quantitative PCR targeting the phylums Bacteroidetes and Firmicutes, and the genera Bifidobacteria, Lactobacillus, Bacteroides, and Prevotella, as well...... as the Enterobacteriaceae family. Potential bifidogenic effects were examined in depth by determining the levels of B. bifidum, B. adolescentis, B. catenulatum, and B. longum. The ratios of both Bifidobacteria and Lactobacillus increased following the WW intervention. The composition of the gut microbiota may affect...

  4. Diabetes NetPLAY: A physical activity website and linked email counselling randomized intervention for individuals with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Courneya Kerry S

    2009-03-01

    Full Text Available Abstract Background - This pilot study evaluated the feasibility (recruitment, retention, adherence and satisfaction and preliminary efficacy of a 12-week website and email-linked counselling intervention on physical activity behaviour change in individuals with type 2 diabetes. Methods - A total of 49 individuals with type 2 diabetes (59% female, average age 54.1 years were randomized to the Diabetes NetPLAY intervention or control condition. The intervention condition received information grounded in the Social Cognitive Theory (SCT, personalized weekly emails, an on-line logbook and message board. Key outcomes included physical activity behaviour and related cognition changes. The control condition was provided links to the Canadian Diabetes Association's Clinical Practice Guidelines for Physical Activity and Canada's Guide to Physical Activity. Results - Intervention participants indicated high levels of satisfaction for this mode of delivery and study results demonstrated the feasibility of web-based mediums for the delivery of physical activity information in this population. The intervention group demonstrated a significant improvement in total vigorous and moderate minutes of physical activity (p = 0.05 compared to the control group over the 12-week study. Among the SCT variables, behavioural capacity, showed a significant increase (p Conclusion - Web-based interventions for individuals with type 2 diabetes are feasible and show promise for improving positive physical activity outcomes.

  5. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes

    DEFF Research Database (Denmark)

    Kilen, Anders; Larsson, Tanja Hultengren; Jørgensen, Majke;

    2014-01-01

    It was investigated if high-intensity interval training (HIT) at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON) or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT c...

  6. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes.

    Directory of Open Access Journals (Sweden)

    Anders Kilen

    Full Text Available It was investigated if high-intensity interval training (HIT at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT comprised ∼5 h vs. 1 h and total distance was ∼17 km vs. 35 km per week for HIT and CON, respectively. HIT was performed as 6-10×10-30 s maximal effort interspersed by 2-4 minutes of rest. Performance of 100 m all-out freestyle and 200 m freestyle was similar before and after the intervention in both HIT (60.4±4.0 vs. 60.3±4.0 s; n = 13 and 133.2±6.4 vs. 132.6±7.7 s; n = 14 and CON (60.2±3.7 vs. 60.6±3.8 s; n = 15 and 133.5±7.0 vs. 133.3±7.6 s; n = 15. Maximal oxygen uptake during swimming was similar before and after the intervention in both the HIT (4.0±0.9 vs. 3.8±1.0 l O2×min-1; n = 14 and CON (3.8±0.7 vs. 3.8±0.7 l O2×min-1; n = 11 group. Oxygen uptake determined at fixed submaximal speed was not significantly affected in either group by the intervention. Body fat % tended to increase (P = 0.09 in the HIT group (15.4±1.6% vs. 16.3±1.6%; P = 0.09; n = 16 and increased (P<0.05 in the CON group (13.9±1.5% vs. 14.9±1.5%; n = 17. A distance reduction of 50% and a more than doubled HIT amount for 12 weeks did neither improve nor compromise performance or physiological capacity in elite swimmers.

  7. Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong.

    Science.gov (United States)

    Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

    2016-01-01

    Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

  8. Effect of individualized worksite exercise training on aerobic capacity and muscle strength among construction workers - a randomized controlled intervention study

    DEFF Research Database (Denmark)

    Gram, Bibi; Holtermann, Andreas; Søgaard, Karen;

    2012-01-01

    tailored exercise programs on their physical fitness and muscular capacity. METHOD: The study was a randomized controlled trial of male constructions workers allocated to either an exercise or control group. The intervention lasted 12 weeks, and the exercise group trained 3 x 20 minutes a week......) of 28.3 (SD 4.7). Compared to representative data on employees in Denmark (N=78), this study population (N=67) had significantly lower relative aerobic capacity [difference in z-score -1.13 (SE 0.1), P...

  9. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  10. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  11. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  12. The efficacy of 12 weeks supervised exercise in obesity management.

    Science.gov (United States)

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) . PMID

  13. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas;

    2004-01-01

    .45, 0.60, or 0.75 mg), placebo, or open-label sulfonylurea (glimepiride, 1-4 mg). The primary end point was HbA(1c) after 12 weeks; secondary end points were fasting serum glucose, fasting C-peptide, fasting glucagon, fasting insulin, beta-cell function, body weight, adverse events, and hypoglycemic....... Patients treated with glimepiride had decreased HbA(1c) and fasting glucose, but slightly increased body weight. No safety issues were raised for liraglutide; observed adverse events were mild and transient. CONCLUSIONS: A once-daily dose of liraglutide provides efficacious glycemic control...

  14. Feasibility of web-based protocol in a 12 weeks home-based IMT program for individuals with COPD

    DEFF Research Database (Denmark)

    Svenningsen, Helle; Sørensen, Dorthe

    2016-01-01

    of a web-based protocol with feedback function using mechanical threshold loading (MTL) as a home-based IMT in individuals with COPD. Thirty-six individuals with inspiratory muscle weakness were randomly selected from a pulmonary rehabilitation program to perform 12 weeks of MTL with either a web...

  15. Positive performance and health effects of a football training program over 12 weeks can be maintained over a 1-year period with reduced training frequency

    DEFF Research Database (Denmark)

    Randers, Morten Bredsgaard; Nielsen, Jens Jung; Krustrup, Birgitte Rejkjær;

    2010-01-01

    unaltered for CG. In conclusion, positive adaptations in cardiovascular fitness obtained over 12 weeks of regular recreational football training can be maintained over a 1-year period with a reduced training frequency, with further development in musculo-skeletal fitness.......We examined whether improvements in the performance and health profile of an intensive 12-week football intervention could be maintained with a reduced training frequency. Seventeen healthy untrained males completed the study. Ten subjects trained 2.4 times/week for 12 weeks and another 52 weeks...... (Pmuscle mass (11%), mean fiber area (10%) and citrate synthase activity (18%) were higher (P

  16. A Web-Based Intervention to Encourage Walking (StepWise): Pilot Randomized Controlled Trial

    OpenAIRE

    Hargreaves, Elaine Anne; Mutrie, Nanette; Fleming, Jade Dallas

    2016-01-01

    Background Despite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change. Objective The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined wi...

  17. Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    John O Younge

    Full Text Available Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease.The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male with heart disease in a 2:1 ratio (n = 215 versus n = 109 to a 12-week online mindfulness training in addition to usual care (UC compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT. Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP, subjective health status (SF-36, perceived stress (PSS, psychological well-being (HADS, social support (PSSS12 and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention. Linear mixed models were used to evaluate differences between groups on the repeated outcome measures.Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 26.4, p = 0.050. There was also a significant lower heart rate in favor of the mindfulness group (effect size, beats per minute: -2.8, 95%CI: -5.4;-0.2, p = 0.033. No significant differences were seen on other outcomes.Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease.Dutch Trial Register 3453.

  18. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  19. Pilot randomized controlled trial of an integrative intervention with methamphetamine-using men who have sex with men.

    Science.gov (United States)

    Carrico, Adam W; Gómez, Walter; Siever, Michael D; Discepola, Michael V; Dilworth, Samantha E; Moskowitz, Judith T

    2015-10-01

    Contingency management (CM) is an evidence-based intervention that provides tangible rewards as positive reinforcement for biologically confirmed abstinence from substance use. Integrative approaches targeting positive affect regulation could boost the effectiveness of CM by sensitizing individuals to non-drug-related sources of reward and assisting them with effectively managing symptoms of withdrawal. This pilot randomized controlled trial with 21 methamphetamine-using men who have sex with men (MSM) examined the feasibility and acceptability of a 5-session, positive affect intervention delivered during CM-Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). After completing 4 weeks of a 12-week CM program, participants were randomized to receive ARTEMIS+CM (n = 12) or CM-only (n = 9). Those randomized to receive the ARTEMIS positive affect intervention completed 98 % of sessions and reported marginally significant increases in positive affect over the five sessions. In exit interviews with ARTEMIS+CM participants, individuals noted that the positive affect regulation skills increased self-awareness and led to greater engagement in the recovery process. ARTEMIS+CM participants reported significant increases in positive affect and CM-only participants reported significant reductions in negative affect over a 2-month follow-up. These affective changes were not maintained, and no concurrent effects on stimulant use or sexual risk taking were observed over the 6-month follow-up. More definitive clinical research is necessary to examine the efficacy of ARTEMIS+CM with methamphetamine-using MSM. PMID:26123068

  20. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes.

    Directory of Open Access Journals (Sweden)

    Brian Suffoletto

    Full Text Available Binge drinking is associated with numerous negative consequences. The prevalence and intensity of binge drinking is highest among young adults. This randomized trial tested the efficacy of a 12-week interactive text message intervention to reduce binge drinking up to 6 months after intervention completion among young adults.Young adult participants (18-25 y; n = 765 drinking above the low-risk limits (AUDIT-C score >3/4 women/men, but not seeking alcohol treatment, were enrolled from 4 Emergency Departments (EDs in Pittsburgh, PA. Participants were randomized to one of three conditions in a 2:1:1 allocation ratio: SMS Assessments + Feedback (SA+F, SMS Assessments (SA, or control. For 12 weeks, SA+F participants received texts each Thursday querying weekend drinking plans and prompting drinking limit goal commitment and each Sunday querying weekend drinking quantity. SA+F participants received tailored feedback based on their text responses. To contrast the effects of SA+F with self-monitoring, SA participants received texts on Sundays querying drinking quantity, but did not receive alcohol-specific feedback. The control arm received standard care. Follow-up outcome data collected through web-based surveys were provided by 78% of participants at 3- months, 63% at 6-months and 55% at 9-months. Multiple imputation-derived, intent-to-treat models were used for primary analysis. At 9-months, participants in the SA+F group reported greater reductions in the number of binge drinking days than participants in the control group (incident rate ratio [IRR] 0.69; 95% CI .59 to.79, lower binge drinking prevalence (odds ratio [OR] 0.52; 95% CI 0.26 to 0.98], less drinks per drinking day (beta -.62; 95% CI -1.10 to -0.15 and lower alcohol-related injury prevalence (OR 0.42; 95% CI 0.21 to 0.88. Participants in the SA group did not reduce drinking or alcohol-related injury relative to controls. Findings were similar using complete case analyses.An interactive

  1. Effects of 12-week high-intensity interval training on plasma visfatin concentration and insulin resistance in overweight men

    Directory of Open Access Journals (Sweden)

    Hasan Matinhomaee

    2014-06-01

    Full Text Available The purpose of this study was to determine the effects of 12 weeks of high-intensity interval training (HIIT on visfatin and insulin resistance (IR in overweight adult men during a weight-loss program. Eighteen overweight men (age = 31.8 ± 9.2 years; body mass index = 28.6 ± 1.4 kg/m2 were randomly recruited into one of the two groups, namely, HIIT (3 days/week, 20 minutes/day; 85–95% peak oxygen uptake and diet-induced weight-loss combined (DHIIT; n = 10 and diet-induced weight loss only (DIO; n = 8. The DHIIT and DIO groups undertook a 12-week weight-loss intervention using a moderate isocaloric energy-deficit diet. Both DHIIT and DIO groups demonstrated a significant reduction in body weight (p < 0.01. Total fat mass (p < 0.05 and lean body mass (p < 0.05 were decreased in the DIO group with no significant changes in abdominal fat mass, plasma insulin concentration, homeostasis model assessment-estimated IR (HOMA-IR, blood glucose level, and plasma visfatin. In the DHIIT group, total fat mass (p < 0.01, abdominal fat mass (p < 0.05, plasma insulin concentration (p < 0.05, plasma visfatin (p < 0.01, and HOMA-IR (p < 0.05 were reduced and lean body mass remained unchanged. In conclusion, adding a low-volume 20-minute HIIT (three times/week to an energy-deficit diet not only can improve the efficiency of weight-loss program in the reduction of body fat, plasma visfatin levels, and HOMA-IR, but also has a reservation effect on lean body mass.

  2. A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions

    Directory of Open Access Journals (Sweden)

    Holger Cramer

    2016-01-01

    Full Text Available A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs. Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73% in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98; p=0.03. For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%. The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants’ sociodemographic and health condition.

  3. A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions

    Science.gov (United States)

    Haller, Heidemarie; Dobos, Gustav; Lauche, Romy

    2016-01-01

    A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs). Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73%) in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98; p = 0.03). For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%). The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants' sociodemographic and health condition. PMID:27413387

  4. Smoking cessation via the internet: a randomized clinical trial of an internet intervention as adjuvant treatment in a smoking cessation intervention.

    Science.gov (United States)

    Japuntich, Sandra J; Zehner, Mark E; Smith, Stevens S; Jorenby, Douglas E; Valdez, José A; Fiore, Michael C; Baker, Timothy B; Gustafson, David H

    2006-12-01

    Internet interventions for smoking cessation are ubiquitous. Yet, to date, there are few randomized clinical trials that gauge their efficacy. This study is a randomized clinical trial (N= 284, n= 140 in the treatment group, n= 144 in the control group) of an Internet smoking cessation intervention. Smokers were randomly assigned to receive either bupropion plus counseling alone, or bupropion and counseling in addition to 12 weeks of access to the Comprehensive Health Enhancement Support System for Smoking Cessation and Relapse Prevention (CHESS SCRP; a Web site which provided information on smoking cessation as well as support). We found that access to CHESS SCRP was not significantly related to abstinence at the end of the treatment period (OR= 1.13, 95% CI 0.66-2.62) or at 6 months postquit (OR= 1.48, 95% CI 0.66-2.62). However, the number of times participants used CHESS SCRP per week was related to abstinence at both end of treatment (OR= 1.79, 95% CI 1.25-2.56) and at the 6-month follow-up (OR= 1.59, 95% CI 1.06-2.38). Participants with access to CHESS SCRP logged in an average of 33.64 times (SD=30.76) over the 90-day period of access. Rates of CHESS SCRP use did not differ by ethnicity, level of education or gender (all p>.05). In sum, results suggest that participants used CHESS SCRP frequently, CHESS SCRP use was related to success, but the effects in general did not yield intergroup effects. PMID:17491172

  5. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Smith Sunyata

    2011-04-01

    Full Text Available Abstract Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH. High intakes of the omega-6 (n-6 polyunsaturated fatty acids (PUFAs, linoleic acid (LA and arachidonic acid (AA may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration ClinicalTrials.gov (NCT01157208

  6. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    Science.gov (United States)

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  7. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  8. Randomized interventions for needle procedures in children with cancer.

    Science.gov (United States)

    Hedén, L; VON Essen, L; Ljungman, G

    2009-07-01

    The aim of this study was to examine whether children experience less fear, distress and pain connected to a routine needle insertion in an intravenous port when subjected to an intervention: blowing soap bubbles or having a heated pillow vs. standard care. Twenty-eight children, 2-7 years, cared for at a paediatric oncology unit, undergoing a routine needle insertion in an intravenous port were included consecutively. All children were subjected to two needle insertions; at the first they received standard care, and at the second standard care + a randomized intervention. Parents and nurses assessed children's fear, distress and pain on 0-100 mm visual analogue scales. According to parents' report, children experienced less fear when subjected to intervention vs. standard care reported by parents (P soap bubbles vs. standard care (n = 14), and less fear when subjected to standard care + heated pillow vs. standard care (P soap bubbles or having a heated pillow is more effective than standard care in reducing children's fear and distress in needle procedures, according to parents' report. PMID:19040458

  9. The effect of a cognitive-motor intervention on voluntary step execution under single and dual task conditions in older adults: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Pichierri G

    2012-07-01

    Full Text Available Giuseppe Pichierri,1 Amos Coppe,1 Silvio Lorenzetti,2 Kurt Murer,1 Eling D de Bruin11Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Switzerland; 2Institute for Biomechanics, Department of Health Sciences and Technology, ETH Zurich, SwitzerlandBackground: This randomized controlled pilot study aimed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention demanding dual task conditions.Methods: Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks (intervention group. The control group received no specific intervention. Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention (Week 12.Results: After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions (U = 9, P = 0.034, r = 0.55 and backward steps under dual task conditions (U = 10, P = 0.045, r = 0.52 in favor of the intervention group, showing altered stepping levels in the intervention group compared to the control group.Conclusion: A cognitive-motor intervention based on strength and balance exercises with additional dance video gaming is able to improve voluntary step execution under both single and dual task conditions in older adults.Keywords: fall prevention, exercise, dance, video game

  10. Lifestyle intervention using an internet-based curriculum with cell phone reminders for obese Chinese teens: a randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Anisha A Abraham

    Full Text Available Obesity is an increasing public health problem affecting young people. The causes of obesity are multi-factorial among Chinese youth including lack of physical activity and poor eating habits. The use of an internet curriculum and cell phone reminders and texting may be an innovative means of increasing follow up and compliance with obese teens. The objectives of this study were to determine the feasibility of using an adapted internet curriculum and existing nutritional program along with cell phone follow up for obese Chinese teens.This was a randomized controlled study involving obese teens receiving care at a paediatric obesity clinic of a tertiary care hospital in Hong Kong. Forty-eight subjects aged 12 to 18 years were randomized into three groups. The control group received usual care visits with a physician in the obesity clinic every three months. The first intervention (IT group received usual care visits every three months plus a 12-week internet-based curriculum with cell phone calls/texts reminders. The second intervention group received usual care visits every three months plus four nutritional counselling sessions.The use of the internet-based curriculum was shown to be feasible as evidenced by the high recruitment rate, internet log-in rate, compliance with completing the curriculum and responses to phone reminders. No significant differences in weight were found between IT, sLMP and control groups.An internet-based curriculum with cell phone reminders as a supplement to usual care of obesity is feasible. Further study is required to determine whether an internet plus text intervention can be both an effective and a cost-effective adjunct to changing weight in obese youth.Chinese Clinical Trial Registry ChiCTR-TRC-12002624.

  11. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    Science.gov (United States)

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  12. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients

    Science.gov (United States)

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-01-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  13. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    Science.gov (United States)

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  14. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  15. Using ecological momentary assessment in testing the effectiveness of an alcohol intervention: a two-arm parallel group randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Carmen V Voogt

    Full Text Available BACKGROUND: Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. METHODS: Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention and control condition (n = 451: no intervention. Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. RESULTS: According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c heavy drinking status at 1, 2, 7, and 16 weeks follow-up. CONCLUSIONS: This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. TRIAL REGISTRATION: Netherlands Trial Register NTR2665.

  16. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    Science.gov (United States)

    Thorup, Anne Cathrine; Lambert, Max Norman; Kahr, Henriette Strøm; Bjerre, Mette; Jeppesen, Per Bendix

    2015-01-01

    Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed. PMID:26265926

  17. A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial

    Science.gov (United States)

    Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-01-01

    Background Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. PMID:27341852

  18. Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS – a randomized controlled trial protocol for a stationary cycling intervention

    Directory of Open Access Journals (Sweden)

    Simms Victoria

    2007-03-01

    Full Text Available Abstract Background In the past, effortful exercises were considered inappropriate for children with spastic cerebral palsy (CP due to concern that they would escalate abnormalities including spasticity and abnormal movement patterns. Current scientific evidence indicates that these concerns were unfounded and that therapeutic interventions focused on muscle strengthening can lead to improved functional ability. However, few studies have examined the potential benefits of cardiorespiratory fitness exercises in this patient population. Methods/design The rationale and design of a randomized controlled trial examining the effects of a stationary cycling intervention for children with CP are outlined here. Sixty children with spastic diplegic CP between the ages of 7 and 18 years and Gross Motor Function Classification System (GMFCS levels of I, II, or III will be recruited for this study. Participants will be randomly assigned to either an intervention (cycling or a control (no cycling group. The cycling intervention will be divided into strengthening and cardiorespiratory endurance exercise phases. During the strengthening phase, the resistance to lower extremity cycling will be progressively increased using a uniquely designed limb-loaded mechanism. The cardiorespiratory endurance phase will focus on increasing the intensity and duration of cycling. Children will be encouraged to exercise within a target heart rate (HR range (70 – 80% maximum HR. Thirty sessions will take place over a 10–12 week period. All children will be evaluated before (baseline and after (follow-up the intervention period. Primary outcome measures are: knee joint extensor and flexor moments, or torque; the Gross Motor Function Measure (GMFM; the 600 Yard Walk-Run test and the Thirty-Second Walk test (30 sec WT. Discussion This paper presents the rationale, design and protocol for Pediatric Endurance and Limb Strengthening (PEDALS; a Phase I randomized controlled trial

  19. Discourse-based intervention for modifying supervisory communication as leverage for safety climate and performance improvement: a randomized field study.

    Science.gov (United States)

    Zohar, Dov; Polachek, Tal

    2014-01-01

    The article presents a randomized field study designed to improve safety climate and resultant safety performance by modifying daily messages in supervisor-member communications. Supervisors in the experimental group received 2 individualized feedback sessions regarding the extent to which they integrated safety and productivity-related issues in daily verbal exchanges with their members; those in the control group received no feedback. Feedback data originated from 7-9 workers for each supervisor, reporting about received supervisory messages during the most recent verbal exchange. Questionnaire data collected 8 weeks before and after the 12-week intervention phase revealed significant changes for safety climate, safety behavior, subjective workload, teamwork, and (independently measured) safety audit scores for the experimental group. Data for the control group (except for safety behavior) remained unchanged. These results are explained by corresponding changes (or lack thereof in the control group) in perceived discourse messages during the 6-week period between the 1st and 2nd feedback sessions. Theoretical and practical implications for climate improvement and organizational discourse research are discussed.

  20. Histological changes in the bone structure induced at 12 weeks by experimental administration of bisphosphonates

    OpenAIRE

    ALMAŞAN, Horea Artimoniu; BACIUT, MIHAELA; ALMAŞAN, Oana Cristina; Bran, Simion; BACIUT, GRIGORE

    2013-01-01

    Histological changes in bone structure were induced at 12 weeks by experimental administration of bisphosphonates, which have been associated with osteonecrosis of the jaws. The purpose of this study was to determine the effect of local administration of bisphosphonate on bone formation in rats. Surgically created bone defects were evaluated at 12 weeks by histological examination after bisphosphonate administration. Fifteen Wistar rats that underwent surgery to create a bone defect at the ri...

  1. Effect of 12-Week Pilates Trainning on EDSS in Women Suffering fromMultiple Sclerosis

    OpenAIRE

    Z Shanazari; SM Marandi; S Samie

    2013-01-01

    Abstract Background & aim: Multiple sclerosis is a debilitating disease that strikes the immune system. Multiple sclerosis is a chronic disease which debilitates the nervous system. The study was evaluated the effects of Pilates exercise on women with physical disabilities suffering from multiple sclerosis for 12 weeks .The aim of this study was to investigating the effects of Pilates trainning on EDSS of women suffering from Multiple Sclerosis (MS) for 12 weeks. Methods: In the pres...

  2. The effect of 12-week Pilates exercises on wellness in the elderly

    OpenAIRE

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P

  3. A written language intervention for at-risk second grade students: a randomized controlled trial of the process assessment of the learner lesson plans in a tier 2 response-to-intervention (RtI) model.

    Science.gov (United States)

    Hooper, Stephen R; Costa, Lara-Jeane C; McBee, Matthew; Anderson, Kathleen L; Yerby, Donna Carlson; Childress, Amy; Knuth, Sean B

    2013-04-01

    In a randomized controlled trial, 205 students were followed from grades 1 to 3 with a focus on changes in their writing trajectories following an evidence-based intervention during the spring of second grade. Students were identified as being at-risk (n=138), and then randomized into treatment (n=68) versus business-as-usual conditions (n=70). A typical group also was included (n=67). The writing intervention comprised Lesson Sets 4 and 7 from the Process Assessment of the Learner (PAL), and was conducted via small groups (three to six students) twice a week for 12 weeks in accordance with a response-to-intervention Tier 2 model. The primary outcome was the Wechsler Individual Achievement Test-II Written Expression Scale. Results indicated modest support for the PAL lesson plans, with an accelerated rate of growth in writing skills following treatment. There were no significant moderator effects, although there was evidence that the most globally impaired students demonstrated a more rapid rate of growth following treatment. These findings suggest the need for ongoing examination of evidence-based treatments in writing for young elementary students.

  4. Exercise as an Intervention to Reduce Study-Related Fatigue among University Students: A Two-Arm Parallel Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Juriena D de Vries

    Full Text Available Many university students experience high levels of study-related fatigue. This high prevalence, and the negative impact of fatigue on health and academic performance, call for prevention and reduction of these symptoms. The primary aim of the current study was to investigate to what extent an exercise intervention is effective in reducing three indicators of study-related fatigue (emotional exhaustion, overall fatigue, and need for recovery. Effects of exercise on secondary outcomes (sleep quality, self-efficacy, physical fitness, and cognitive functioning were also investigated.Participants were students with high levels of study-related fatigue, currently not exercising or receiving other psychological or pharmacological treatments, and with no medical cause of fatigue. They were randomly assigned to either a six-week exercise intervention (low-intensity running three times a week, n = 49 or wait list (no intervention, n = 48. All participants were measured before the intervention (T0, and immediately after the intervention (T1. Exercisers were also investigated 4 weeks (T2 and 12 weeks (T3 after the intervention.Participants in the exercise condition showed a larger decrease in two of the three indicators of study-related fatigue (i.e., overall fatigue and need for recovery as compared to controls. Additionally, sleep quality and some indicators of cognitive functioning improved more among exercisers than among controls. No effects were found for self-efficacy, and physical fitness. The initial effects of the exercise intervention lasted at follow-up (T2 and T3. At 12-week follow up (T3, 80% of participants in the exercise condition still engaged in regular exercise, and further enhancements were seen for emotional exhaustion, overall fatigue, and sleep quality.These results underline the value of low-intensity exercise for university students with high levels of study-related fatigue. The follow-up effects that were found in this study imply

  5. Randomized Impact Evaluation of Education Interventions: Experiences and Lessons from a Reading to Learn Intervention in East Africa

    Science.gov (United States)

    Ngware, Moses Waithanji; Abuya, Benta; Oketch, Moses; Admassu, Kassahun; Mutisya, Maurice; Musyoka, Peter

    2015-01-01

    This paper presents the experiences and lessons learnt during the design and implementation of the randomized impact evaluation (IE) of a reading to learn (RtL) intervention in early primary grades. The study was to assess the impact of RtL on literacy and numeracy among pupils in low-performing districts in East Africa. The intervention was…

  6. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  7. Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

    Science.gov (United States)

    Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

    2005-01-01

    This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

  8. Efficacy of nonsurgical interventions for anterior knee pain: systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Collins, Natalie J; Bisset, Leanne M; Crossley, Kay M; Vicenzino, Bill

    2012-01-01

    Anterior knee pain is a chronic condition that presents frequently to sports medicine clinics, and can have a long-term impact on participation in physical activity. Conceivably, effective early management may prevent chronicity and facilitate physical activity. Although a variety of nonsurgical interventions have been advocated, previous systematic reviews have consistently been unable to reach conclusions to support their use. Considering a decade has lapsed since publication of the most recent data in these reviews, it is timely to provide an updated synthesis of the literature to assist sports medicine practitioners in making informed, evidence-based decisions. A systematic review and meta-analysis was conducted to evaluate the evidence for nonsurgical interventions for anterior knee pain. A comprehensive search strategy was used to search MEDLINE, EMBASE, CINAHL and Pre-CINAHL, PEDro, PubMed, SportDiscus, Web of Science, BIOSIS Previews, and the full Cochrane Library, while reference lists of included papers and previous systematic reviews were hand searched. Studies were eligible for inclusion if they were randomized clinical trials that used a measure of pain to evaluate at least one nonsurgical intervention over at least 2 weeks in participants with anterior knee pain. A modified version of the PEDro scale was used to rate methodological quality and risk of bias. Effect size calculation and meta-analyses were based on random effects models. Of 48 suitable studies, 27 studies with low-to-moderate risk of bias were included. There was minimal opportunity for meta-analysis because of heterogeneity of interventions, comparators and follow-up times. Meta-analysis of high-quality clinical trials supports the use of a 6-week multimodal physiotherapy programme (standardized mean difference [SMD] 1.08, 95% CI 0.73, 1.43), but does not support the addition of electromyography biofeedback to an exercise programme in the short-term (4 weeks: SMD -0.21, 95% CI -0.64, 0

  9. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    Science.gov (United States)

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  10. A Body Image and Disordered Eating Intervention for Women in Midlife: A Randomized Controlled Trial

    Science.gov (United States)

    McLean, Sian A.; Paxton, Susan J.; Wertheim, Eleanor H.

    2011-01-01

    Objective: This study examined the outcome of a body image and disordered eating intervention for midlife women. The intervention was specifically designed to address risk factors that are pertinent in midlife. Method: Participants were 61 women aged 30 to 60 years (M = 43.92, SD = 8.22) randomly assigned to intervention (n = 32) or (delayed…

  11. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Directory of Open Access Journals (Sweden)

    Dale Jeremy

    2006-07-01

    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  12. Features Predicting Weight Loss in Overweight or Obese Participants in a Web-Based Intervention: Randomized Trial

    OpenAIRE

    Brindal, Emily; Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny

    2012-01-01

    Background Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. Objective To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and we...

  13. Design of the Resistance and Endurance exercise After ChemoTherapy (REACT study: A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue

    Directory of Open Access Journals (Sweden)

    van Mechelen Willem

    2010-11-01

    Full Text Available Abstract Background Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. Methods After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group. After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to. Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities. Measurements will be performed at baseline (t = 0, 12 weeks after randomization (t = 1, and 64 weeks after randomization (t = 2. The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance

  14. Effects of cognitive and skilled rehabilitative training on deficiencies of theory of mind in patients with traumatic brain injury: A 12-week random, single-blind clinical trial%脑外伤患者心理推理能力缺陷的认知性和技巧性干预:一项12周随机单盲对照试验

    Institute of Scientific and Technical Information of China (English)

    张登科; 徐水琴; 苏巧荣; 潘一楠; 沈雪艳; 陈三妹; 葛建荣; 单兴尧

    2012-01-01

    cognitive and skilled rehabilitative training on theory of mind and social function deficiencies in traumatic brain injury patients. Methods: Totally 90 brain injury patients who were injured six or more months ago and whose condition was stable were selected. They were randomly assigned into cognitive intervention group (n = 30), skilled intervention group (n = 30) and control group ( n = 30). The cognitive intervention group received the cognitive orientated training focused on their real life behaviors, including life events discussing, contextual play and home works. The skill intervention group received the training focused on their examination skills, including the theory of mind stories comprehension, graph comprehension. The control group received normal outpatient follow-up health services. The classic Theory of Mind Tasks, Family Member Evaluated Scale of Theory of Mind in Traumatic Brain Injuries and Social Disability Screening Schedule (SDSS) were used to access the subjects' theory of mind and social function before and after intervention, and 3 months after intervention. Results: Before intervention, there was no significant difference between the three groups on all scores. After intervention, both intervention groups had higher scores of theory of mind classic tasks [ (14. 7 ±1. 3), (15. 2 ± 1. 7) vs. (12. 5 ± 1. 6), P 0. 05). Three months after the intervention, both intervention groups had higher scores of theory of mind classic tasks [ (16. 5 ± 1. 4), (15. 9 ± 1. 2) vs. (13. 3 ± 1. 5), P <0. 05] and family evaluated scale [ (146. 6 ± 15. 7), (134. 5 ± 14. 6) vs. (115. 8 ± 21. 2), P < 0. 05] than the control group, and their SDSS scores were lower than control group [(7. 1 ± 1. 2), (8. 0 ±0. 9) vs. (11.4 ±0. 8), P <0.05]. The scores of family evaluated scale was higher in the cognitive intervention group than in the skill intervention group [(146. 6 ± 15. 7) vs. (134. 5 ± 14. 6), P <0.05], the SDSS scores was lower in the cognitive

  15. Perspectives on randomization and readiness for change in a workplace intervention study

    DEFF Research Database (Denmark)

    Nabe-Nielsen, Kirsten; Persson, Roger; Nielsen, Karina;

    2015-01-01

    , it is important to investigate differences between study groups in readiness for change. To meet this aim, we used data from an intervention study of the effects of work-time control. The study design entailed both self-selection (i.e. non-random) and random allocation into intervention and control groups. Some...... team leaders rejected randomization because they considered it to be fairest to increase work-time control among employees in most need. Others accepted randomization arguing that it was fairer to allocate a potential benefi t by random. We found no difference in readiness for changes when comparing...

  16. EFFECTS OF 12 WEEKS OF COMBINED EXERCISE TRAINING ON VISFATIN AND METABOLIC SYNDROME FACTORS IN OBESE MIDDLE-AGED WOMEN

    Directory of Open Access Journals (Sweden)

    Dong-il Seo

    2011-03-01

    Full Text Available Visfatin is a highly expressed protein with insulin-like functions located predominantly in visceral adipose tissue and has been linked to obesity and increased health risks. The purpose of this study was to examine the effects of 12 weeks of combined exercise training on visfatin and metabolic syndrome factors in obese middle-aged women. Subjects were randomly assigned to either a training (n = 10 or control (n = 10 group. The training group exercised for 1 hour, 3 days per week during the 12 week supervised training program. The training program included 3 sets of 10 repetition maximum (10RM resistance exercise as well as aerobic exercise at an intensity of 60-70% of their heart rate reserve (HRR. The control group was asked to maintain their normal daily activities. Two-way (group X time repeated measured analysis of variance revealed no significant main effects, but there was a significant group X time interaction for the following variables: body weight (p < 0.01, percent body fat (% fat (p < 0.01, waist hip ratio (WHR (p < 0.01, diastolic blood pressure (DBP (p < 0.05, fasting glucose level (p < 0.01, triglyceride levels (TG (p < 0.01, high density lipoprotein cholesterol levels (HDL-C (p < 0.05, and visfatin (p < 0.01. In conclusion, the 12 week combined resistance and aerobic training program used in this study was very effective for producing significant benefits to body composition and metabolic syndrome factors, as well as lowering visfatin levels in these obese middle-aged women.

  17. Effects of 12-Week Bacopa monnieri Consumption on Attention, Cognitive Processing, Working Memory, and Functions of Both Cholinergic and Monoaminergic Systems in Healthy Elderly Volunteers

    Directory of Open Access Journals (Sweden)

    Tatimah Peth-Nui

    2012-01-01

    Full Text Available At present, the scientific evidence concerning the effect of Bacopa monnieri on brain activity together with working memory is less available. Therefore, we aimed to determine the effect of B. monnieri on attention, cognitive processing, working memory, and cholinergic and monoaminergic functions in healthy elderly. A randomized double-blind placebo-controlled design was utilized. Sixty healthy elderly subjects (mean age 62.62 years; SD 6.46, consisting of 23 males and 37 females, received either a standardized extract of B. monnieri (300 and 600 mg or placebo once daily for 12 weeks. The cholinergic and monoaminergic systems functions were determined using AChE and MAO activities. Working memory was assessed using percent accuracy and reaction time of various memory tests as indices, whereas attention and cognitive processing were assessed using latencies and amplitude of N100 and P300 components of event-related potential. All assessments were performed before treatment, every four weeks throughout study period, and at four weeks after the cessation of intervention. B. monnieri-treated group showed improved working memory together with a decrease in both N100 and P300 latencies. The suppression of plasma AChE activity was also observed. These results suggest that B. monnieri can improve attention, cognitive processing, and working memory partly via the suppression of AChE activity.

  18. Improvement in Patient Performance of Skin Self-examinations After Intervention With Interactive Education and Telecommunication Reminders: A Randomized Controlled Study.

    Science.gov (United States)

    Aneja, Savina; Brimhall, Angela K; Kast, Douglas R; Aneja, Sanjay; Carlson, Diana; Cooper, Kevin D; Bordeaux, Jeremy S

    2012-11-01

    OBJECTIVE To determine if interactive computerized patient education, skin self-examination (SSE) tutorials, and telecommunication reminders could be combined to increase patient performance of SSEs, increase confidence in ability to identify melanoma, and influence individual melanoma risk perception. DESIGN A total of 132 adult participants from our dermatology clinics were enrolled in an interventional study and randomized to a control group or an intervention group. Survey data were collected from all participants on the day of enrollment and 3 months after enrollment. SETTING University Hospitals Case Medical Center outpatient dermatology clinics. PARTICIPANTS English speakers older than 18 years. INTERVENTIONS The intervention group (1) participated in a computer-assisted learning tutorial, (2) took part in a hands-on SSE tutorial, (3) received monthly telecommunication reminders to perform SSEs for 12 weeks, and (4) received a brochure on melanoma detection. The control group received only the brochure on melanoma detection. MAIN OUTCOME MEASURES Self-report of performance of SSEs. Melanoma risk perception and confidence in ability to identify melanoma were secondary considerations. Logistic regressions, controlling for race, age, sex, education, and family history of melanoma, were used to assess the effectiveness of the intervention. RESULTS At the 3-month follow-up, those in the intervention group were more likely to perform SSEs (odds ratio [OR], 2.36; P ≤ .05). In addition, those who participated in the intervention were more likely to report being confident in their ability to identify melanoma during an SSE (OR, 2.72; P ≤ .05). CONCLUSION Computer-assisted patient education used in conjunction with a hands-on SSE tutorial and telecommunication reminders can increase patient performance of SSEs and confidence in the ability to identify melanoma.

  19. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks.

    Science.gov (United States)

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 weeks later. Additionally, his adrenals showed no evidence of metastasis. Hence his adrenal insufficiency had been a paraneoplastic manifestation of the lung cancer, and it had also preceded the primary by 12 weeks.

  20. The effect of 12-week Pilates exercises on wellness in the elderly.

    Science.gov (United States)

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, PPilates exercises helped improve wellness of the elderly. PMID:27162774

  1. Experiencing flow in different types of physical activity intervention programs: three randomized studies

    DEFF Research Database (Denmark)

    Elbe, Anne-Marie; Strahler, K.; Krustrup, Peter;

    2010-01-01

    This study explores whether inactive individuals can experience flow, a rewarding, psychological state, during an exercise intervention and if there are differences according to the type of intervention they perform. Furthermore, the study investigates if experiencing flow is connected to physiol...... have on experiencing flow, worry and perceived exertion. Furthermore, it should be investigated whether experiencing flow is linked to the long-term compliance of regular physical activity.......This study explores whether inactive individuals can experience flow, a rewarding, psychological state, during an exercise intervention and if there are differences according to the type of intervention they perform. Furthermore, the study investigates if experiencing flow is connected...... to physiological improvements attained during the exercise intervention. The 12- to 16-week interventions included six randomized intervention groups, two female and four male groups performing continuous running, football, interval running and strength training. The results indicate that all six randomized...

  2. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    Science.gov (United States)

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  3. The response of the lactate minimum test to a 12-week swimming training

    DEFF Research Database (Denmark)

    Campos, Eduardo Zapaterra; Nordsborg, Nikolai Baastrup; Da Silva, Adelino Sanchez Ramos;

    2014-01-01

    Despite the utilization of lactate minimum test (LMT) in training, its intensity response to training remains controversial. The aim of the present study was to verify alterations of LMT intensity in swimmers during a 12-week training protocol. Eight swimmers were submitted to three LMT assessmen...

  4. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

    Directory of Open Access Journals (Sweden)

    Lemon Stephenie C

    2009-12-01

    Full Text Available Abstract Background US Latinos have greater prevalence of type 2 diabetes (diabetes, uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. Methods and design This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control on glycemic control among low-income Latinos with diabetes, compared to usual care (control. Participants were recruited from five community health centers (CHCs in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c. Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. Discussion Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need. Trial registration http://www.clinicaltrials.gov # NCT00848315

  5. The effects of 12 weeks of step aerobics training on functional fitness of elderly women.

    Science.gov (United States)

    Hallage, Tatiane; Krause, Maressa P; Haile, Luke; Miculis, Cristiane P; Nagle, Elizabeth F; Reis, Rodrigo S; Da Silva, Sergio G

    2010-08-01

    The purpose of this study was to determine the effects of 12 weeks of step aerobics (SA) training on the functional fitness of apparently healthy older women. Thirteen previously sedentary elderly women (mean age 63.14 years) participated in this study. Subjects performed 3 training sessions per week for 30-60 minutes per session. All measurements were assessed at baseline, after 12 weeks of training (posttest), and after 1 month of detraining. Assessments included the evaluation of body mass index (BMI), waist circumference (WC), strength of the upper (arm-curl [AC] test) and lower body (30-second chair-stand test [CS]), dynamic balance and agility (8 foot up and go [8 ft]), flexibility (chair sit-and-reach [CSR]), and cardiorespiratory fitness (6-minute walk test [6MW]). Step aerobics significantly improved all functional fitness components except for BMI. The 12 weeks of SA promoted a large effect size in the following measurements: WC (d = 1.6); CSR (d = 1.51); CS (d = 1.49); AC (d = 1.41); 8 ft (d = 1.32); and 6MW (d = 1.06) (p < 0.05). These results indicate that 12 weeks of SA had a positive effect on the functional fitness components of these older women. Furthermore, these findings were confirmed by the reverse effect observed after 1 month of detraining, except for upper body strength (AC test). In conclusion, 12 weeks of SA training can promote improvements in the functional fitness of apparently healthy older women. Therefore, SA can be considered an effective exercise modality to prevent the loss of functional fitness and its associated consequences. PMID:20634751

  6. Promoting First Relationships: Randomized Trial of a Relationship-Based Intervention for Toddlers in Child Welfare

    OpenAIRE

    Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.

    2012-01-01

    We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational rati...

  7. Smoking Cessation Intervention After Ischemic Stroke or Transient Ischemic Attack. A Randomized Controlled Pilot Trial

    DEFF Research Database (Denmark)

    Brunner Frandsen, Nicole; Sørensen, Margit; Hyldahl, Tanja Kirstine;

    2012-01-01

    BACKGROUND: Smoking cessation is widely recommended for secondary stroke prevention. However, little is known about the efficacy of smoking cessation intervention after stroke or transient ischemic attack (TIA). METHODS: Ninety-four smokers under age 76, admitted with ischemic stroke or TIA were......-report and verified by measurement of exhaled carbon monoxide (CO). Fewer patients than expected were recruited, which renders this report a pilot study. RESULTS: The 6-month self-reported smoking cessation rate was 37.8% in the minimal intervention group and 42.9% in the intensive intervention group. Smoking...... randomized to minimal smoking cessation intervention or intensive smoking cessation intervention. All patients attended a 30-min individual counseling by the study nurse. Patients randomized to intensive smoking cessation intervention also participated in a 5-session outpatient smoking cessation program...

  8. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  9. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    Science.gov (United States)

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  10. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    Science.gov (United States)

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2009-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at post-intervention (2 months), after completion of 4 monthly booster sessions (6…

  11. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-01-01

    BACKGROUND: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. AIM: To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAI

  12. Randomized Controlled Trial of Brief Interventions to Reduce College Students’ Drinking and Risky Sex

    OpenAIRE

    Dermen, Kurt H.; Thomas, Sherilyn N.

    2011-01-01

    The present study tested the proposition that an intervention to reduce alcohol use among college students will also reduce their risky sexual behavior. In a randomized, controlled trial, 154 heavy-drinking, predominantly White, heterosexual college students at behavioral risk for infection with HIV and other STDs were assigned to receive no intervention or a two-session, in-person, motivational interviewing-based intervention focused on either: (a) reducing alcohol risk behavior, (b) reducin...

  13. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    OpenAIRE

    Tadjerbashi, Kamelia; Rosales, Roberto S; Atroshi, Isam

    2014-01-01

    Background: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arth...

  14. Coping Mediates Outcome Following a Randomized Group Intervention for HIV-Positive Bereaved Individuals

    OpenAIRE

    Smith, Nathan Grant; Tarakeshwar, Nalini; Hansen, Nathan B.; Kochman, Arlene; Sikkema, Kathleen J.

    2009-01-01

    The purpose of this study was to examine the mechanisms responsible for the beneficial psychological effects of a coping-focused group intervention for HIV-positive individuals who had lost loved ones to AIDS. Data from 235 HIV-positive men and women enrolled in a randomized controlled clinical trial testing a coping-focused group intervention were analyzed using a multiple-indicator-multiple-cause (MIMIC) structural equation model. Results revealed that the effects of the intervention on dec...

  15. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  16. LA Sprouts Randomized Controlled Nutrition, Cooking and Gardening Program Reduces Obesity and Metabolic Risk in Latino Youth

    OpenAIRE

    Gatto, Nicole M.; Martinez, Lauren C.; Spruijt-Metz, Donna; Davis, Jaimie N.

    2015-01-01

    Objective To assess the effects of a 12-week gardening, nutrition, and cooking intervention (“LA Sprouts”) on dietary intake, obesity parameters and metabolic disease risk among low-income, primarily Hispanic/Latino youth in Los Angeles. Methods Randomized control trial involving four elementary schools [2 schools randomized to intervention (172, 3rd–5th grade students); 2 schools randomized to control (147, 3rd–5th grade students)]. Classes were taught in 90-minute sessions once a week to ea...

  17. Guidelines for Developing Yoga Interventions for Randomized Trials

    Directory of Open Access Journals (Sweden)

    Karen J. Sherman

    2012-01-01

    Full Text Available Little guidance is available to assist researchers in developing treatment protocols for research on yoga for health concerns. Because yoga is a complex multifactorial mind-body discipline historically developed for nonmedical purposes, numerous decisions must be made in order to thoughtfully develop such protocols. In this paper, a systematic approach is proposed to assist researchers in selecting an intervention that is appropriate for the condition under consideration and explicitly developed. Researchers need to consider the type or “style” of yoga, the components to include (e.g., breathing exercises, postures as well as the specific protocol for each component, the dose to be delivered (frequency, duration of practice, and the total duration of practice, and issues related to selection of instructors and monitoring the fidelity to the intervention. Each of these domains and the key issues for the development of protocols is discussed. Finally, some areas for further research related to protocol development are recommended.

  18. Partner randomized controlled trial: study protocol and coaching intervention

    OpenAIRE

    Garbutt Jane M; Highstein Gabrielle; Yan Yan; Strunk Robert C

    2012-01-01

    Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes ...

  19. Lateralization of infant holding by mothers: A longitudinal evaluation of variations over the first 12 weeks.

    Science.gov (United States)

    Todd, Brenda K; Banerjee, Robin

    2016-01-01

    The maternal preference to hold infants on the left rather than right side of the body was examined longitudinally, with attention to 4 explanations: maternal monitoring of infant state, maternal handedness, infant proximity to the mother's heartbeat, and preferred infant head position. The side and site of holding were measured over the first 12 weeks of the lives of 24 infants. Information about group and individual consistency in holding side allowed novel evaluation of the theories. A strong bias to hold on the left dropped below significance when the infants were aged 12 weeks and was limited to specific holding positions. Findings were generally consistent with the monitoring hypothesis, and little support was found for the 3 alternative explanations.

  20. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training

    Directory of Open Access Journals (Sweden)

    Abdessalem Koubaa

    2015-02-01

    Full Text Available Introduction: Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. Aim: To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Methods: Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (VO2max. Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. Results: As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved VO2max (4.4 and 4.7%, respectively, v VO2max (6.7 and 5.6%, respectively, and the recovery index (7.9 and 10.5%, respectively. Conclusions: After 12 weeks of interval training program, the increase of VO2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only

  1. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM? Findings from a Randomized Control Mixed Methods Trial

    Directory of Open Access Journals (Sweden)

    Angela O’Dea

    2015-01-01

    Full Text Available Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM. Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n=24 or wait control (n=26 and postintervention qualitative interviews with participants. Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG from study entry to one-year follow-up. Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

  2. Randomized controlled trial of a family problem-solving intervention.

    Science.gov (United States)

    Drummond, Jane; Fleming, Darcy; McDonald, Linda; Kysela, Gerard M

    2005-02-01

    Adaptive problem solving contributes to individual and family health and development. In this article, the effect of the cooperative family learning approach (CFLA) on group family problem solving and on cooperative parenting communication is described. A pretest or posttest experimental design was used. Participant families were recruited from Head Start programs and exhibited two or more risk factors. Participant preschool children were screened to have two or more developmental delays. Direct behavioral observation measures were used to determine group family problem solving and cooperative parenting communication outcomes. Few group family problem-solving behaviors were coded, and they displayed little variability. However, intervention parents increased the length of time they played and extended the cooperative parent-child interactions. The evidence shows that CFLA has the potential to enhance parental-modeling of cooperative behavior while engaged in play activities with preschoolers. Direct measurement of group family problem solving was difficult. Solutions are suggested. PMID:15604228

  3. The working mechanisms of an environmentally tailored physical activity intervention for older adults: a randomized controlled trial

    OpenAIRE

    Mudde Aart N; de Vries Hein; van Stralen Maartje M; Bolman Catherine; Lechner Lilian

    2009-01-01

    Abstract Background The aim of this study was to explore the working mechanisms of a computer tailored physical activity intervention for older adults with environmental information compared to a basic tailored intervention without environmental information. Method A clustered randomized controlled trial with two computer tailored interventions and a no-intervention control group was conducted among 1971 adults aged ≥ 50. The two tailored interventions were developed using Intervention Mappin...

  4. The Effect of 12 Weeks Dance Education on Physical Fitness Values At Mentally Retarded Children

    Directory of Open Access Journals (Sweden)

    Asena DORSAN

    2014-08-01

    Full Text Available The purpose of the study was to examine the effect of 12 weeks of dance education on the values of physical fitness at children with mental retarded. 22 educable mentally retarded children from Dr. Günseli - Dr. Bülent Akınsal Secondary School and Working Sc hool participated in this study. Mentally Disabled children who participated voluntarily were grouped as the average age of 16.27± 1.00 year with11 people (9 males, 2females of the experimental group and the average age of 15.90± 0.83 year to 11people(7 males, 4 females as the control group. Participants in the experimental group was implemented 12 - weekdance education program including 2 days a week, 2 hours a day. Program contents included the basic posture correction, flexibility, ability to maintain a rhythm, motion diversity and self - expression skills, pair work and group work. Physical fitness values of experimental and control group were measured in before and after studies. After the 12 - week dance education, It was determined that there was st atistically significant differences in vertical jump, flexibility, sprint and balance parameters between the experimental and control groups.(p<0.05. In the study of comparing the experimental group in itself, statistically significant differences were fo und of the specified physical fitness parameters (p<0.01. As a result; physical fitness levels of the educable mentally retarded individuals who regularly participated in dance activities showed significant improvements. The results of this study, it was observed that after 12 - week education program there was more development of many physical fitness parameters in the experimental group than the control group and this revealed that the importance of dance education on educable mentally retarded children.

  5. A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

    OpenAIRE

    Salazar, Laura F.; Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-01-01

    Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743...

  6. Effekt of a two-stage nursing assesment and intervention - a randomized intervention study

    DEFF Research Database (Denmark)

    Rosted, Elizabeth Emilie; Poulsen, Ingrid; Hendriksen, Carsten;

    ; health related quality of life; and hours of help received from the community. Conclusion: Results collected at one and six months follow-up, will show if a two-stage intervention consisting of screening with the ISAR 1 tool followed by structured nursing assessment and intervention in the ED could......Background: Geriatric patients recently discharged from hospital are at risk of unplanned readmissions and admission to nursing home. When discharged directly from Emergency Department (ED) the risk increases, as time pressure often requires focus on the presenting problem, although 80...... % of geriatric patients have complex and often unresolved caring needs. The objective was to examine the effect of a two-stage nursing assessment and intervention to address the patients uncompensated problems given just after discharge from ED and one and six months after. Method: We conducted a prospective...

  7. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    Science.gov (United States)

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  8. Preventing College Women's Sexual Victimization Through Parent Based Intervention: A Randomized Controlled Trial

    OpenAIRE

    Testa, Maria; Hoffman, Joseph H.; Livingston, Jennifer A.; Turrisi, Rob

    2010-01-01

    A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n=305), Enhanced Alco...

  9. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  10. Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

    OpenAIRE

    Quinn, Charlene C.; Shardell, Michelle D; Terrin, Michael L.; Barr, Erik A.; Ballew, Shoshana H.; Gruber-Baldini, Ann L.

    2011-01-01

    OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled...

  11. Effects of an emotional literacy intervention for students identified with bullying behaviour

    OpenAIRE

    Knowler, C.; Frederickson, N.

    2013-01-01

    The effectiveness of a 12-week, small group emotional literacy (EL) intervention in reducing bullying behaviour in school was evaluated. Participants were 50 primary school pupils identified through peer nomination as engaging in bullying behaviours. The intervention was implemented in schools already engaged with a universal social and emotional learning initiative, including an anti-bullying component. Within schools, participants were randomly assigned to an intervention or a wait-list com...

  12. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    Science.gov (United States)

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  13. A randomized controlled trial of the efficacy of a stigma reduction intervention for HIV-infected women in the Deep South.

    Science.gov (United States)

    Barroso, Julie; Relf, Michael V; Williams, Megan Scull; Arscott, Joyell; Moore, Elizabeth D; Caiola, Courtney; Silva, Susan G

    2014-09-01

    The aim of this study was to compare outcomes (self-esteem, coping self-efficacy, and internalized stigma) across time in HIV-infected women living in the Deep South who received a stigma reduction intervention (n=51) with those of a control group (n=49) who received the usual care at baseline, and at 30 and 90 days. We recruited 99 women from clinics and an AIDS service organization; they were randomized by recruitment site. A video developed from the results of a qualitative metasynthesis study of women with HIV infection was loaded onto iPod Touch devices. Participants were asked to watch the video weekly for 4 weeks, and to record the number of times they viewed it over a 12-week period. We examined the trajectory model results for efficacy outcomes for the intent-to-treat and the supplemental completers groups. There was a treatment-by-time effect for improved self-esteem (intent-to-treat: p=0.0308; completers: p=0.0284) and decreases in internalized stigma (intent-to-treat: p=0.0036; completers: p=0.0060), and a treatment-by-time-by-time effect for improved coping self-efficacy (intent-to-treat: p=0.0414; completers: p=0.0321). A medium effect of the intervention in terms of improving self-esteem was observed when compared with the control condition in those who completed the study. The magnitude of the intervention effect, however, was large with regard to reducing overall stigma, improving social relationships, and decreasing stereotypes in both groups.

  14. A randomized controlled trial of the efficacy of a stigma reduction intervention for HIV-infected women in the Deep South.

    Science.gov (United States)

    Barroso, Julie; Relf, Michael V; Williams, Megan Scull; Arscott, Joyell; Moore, Elizabeth D; Caiola, Courtney; Silva, Susan G

    2014-09-01

    The aim of this study was to compare outcomes (self-esteem, coping self-efficacy, and internalized stigma) across time in HIV-infected women living in the Deep South who received a stigma reduction intervention (n=51) with those of a control group (n=49) who received the usual care at baseline, and at 30 and 90 days. We recruited 99 women from clinics and an AIDS service organization; they were randomized by recruitment site. A video developed from the results of a qualitative metasynthesis study of women with HIV infection was loaded onto iPod Touch devices. Participants were asked to watch the video weekly for 4 weeks, and to record the number of times they viewed it over a 12-week period. We examined the trajectory model results for efficacy outcomes for the intent-to-treat and the supplemental completers groups. There was a treatment-by-time effect for improved self-esteem (intent-to-treat: p=0.0308; completers: p=0.0284) and decreases in internalized stigma (intent-to-treat: p=0.0036; completers: p=0.0060), and a treatment-by-time-by-time effect for improved coping self-efficacy (intent-to-treat: p=0.0414; completers: p=0.0321). A medium effect of the intervention in terms of improving self-esteem was observed when compared with the control condition in those who completed the study. The magnitude of the intervention effect, however, was large with regard to reducing overall stigma, improving social relationships, and decreasing stereotypes in both groups. PMID:25084499

  15. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    DEFF Research Database (Denmark)

    Korshøj, Mette; Krustrup, Peter; Jørgensen, Marie Birk;

    2012-01-01

    . The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I) a reference group, receiving lectures concerning healthy living, or II) an intervention group, performing worksite aerobic exercise. Data collection...

  16. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    Science.gov (United States)

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  17. Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

    Science.gov (United States)

    Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

    2013-01-01

    The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

  18. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    International Nuclear Information System (INIS)

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

  19. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    Science.gov (United States)

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  20. A Mood Management Intervention in an Internet Stop Smoking Randomized Controlled Trial Does Not Prevent Depression: A Cautionary Tale

    OpenAIRE

    Schueller, Stephen M; Pérez-Stable, Eliseo J.; Muñoz, Ricardo F.

    2013-01-01

    Smoking and depression are related, and mood management interventions included in smoking cessation interventions can increase smoking abstinence rates. Could a mood management intervention embedded in an Internet-based smoking cessation intervention prevent major depressive episodes? Spanish- and English-speaking smokers (N = 17,430) from 191 countries were randomized to one of four online self-help intervention conditions (two with mood management). We analyzed preventive effects among thos...

  1. Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

    Science.gov (United States)

    Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

    2016-01-01

    OBJECTIVE To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). METHODS Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. RESULTS Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD:15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of grow thin adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. CONCLUSIONS This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism. PMID:19948568

  2. Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned

    Science.gov (United States)

    Steel, Jennifer; Geller, David A; Tsung, Allan; Marsh, J Wallis; Dew, Mary Amanda; Spring, Michael; Grady, Jonathan; Likumahuwa, Sonja; Dunlavy, Andrea; Youssef, Michael; Antoni, Michael; Butterfield, Lisa H; Schulz, Richard; Day, Richard; Helgeson, Vicki; Kim, Kevin H; Gamblin, T Clark

    2012-01-01

    Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression. Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial. Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum. Results and Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters

  3. EFFECTS OF A 12 WEEK SAQ TRAINING PROGRAMME ON AGILITY WITH AND WITHOUT THE BALL AMONG YOUNG SOCCER PLAYERS

    Directory of Open Access Journals (Sweden)

    Zoran Milanovic

    2013-03-01

    Full Text Available The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m. Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p < 0.05 between pre and post training were evident for almost all measures of agility, with and without the ball, with the exception being the Sprint with backward and forward running. This suggests that SAQ training is an effective way of improving agility, with and without the ball, for young soccer players and can be included in physical conditioning programmes

  4. Myogenic response of human skeletal muscle to 12 weeks of resistance training at light loading intensity

    DEFF Research Database (Denmark)

    Mackey, Abigail; Holm, L; Reitelseder, S;

    2011-01-01

    There is strong evidence for enhanced numbers of satellite cells with heavy resistance training. The satellite cell response to very light muscle loading is, however, unknown. We, therefore, designed a 12-week training protocol where volunteers trained one leg with a high load (H) and the other leg...... with a light load (L). Twelve young healthy men [mean age 25 ± 3 standard deviation (SD) years] volunteered for the study. Muscle biopsies were collected from the m. vastus lateralis of both legs before and after the training period and satellite cells were visualized by CD56 immunohistochemistry....... A significant main effect of time was observed (Ptraining skeletal muscle even with very light loads can induce an increase in the number of satellite...

  5. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  6. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique

    2016-01-01

    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  7. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    Science.gov (United States)

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress. PMID:23969994

  8. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    Science.gov (United States)

    Fuller, Daniel; Potvin, Louise

    2012-06-01

    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  9. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  10. Short-term effects of an educational intervention on physical restraint use: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Gulpers Math JM

    2006-10-01

    Full Text Available Abstract Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster randomized trial was applied to 5 psycho-geriatric nursing home wards (n = 167 residents with dementia. The wards were assigned at random to either educational intervention (3 wards or control status (2 wards. The restraint status was observed and residents' characteristics, such as cognitive status, were determined by using the Minimum Data Set (MDS at baseline and 1 month after intervention. Results Restraint use did not change significantly over time in the experimental group (55%–56%, compared to a significant increased use (P Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term. However, the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group. Whether the intervention will reduce restraint use in the long term could not be inferred from these results. Further research is necessary to gain insight into the long-term effects of this educational intervention.

  11. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. PMID:26121535

  12. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    Science.gov (United States)

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety. PMID:23362335

  13. A randomized controlled trial on a multicomponent intervention for overweight school-aged children - Copenhagen, Denmark

    DEFF Research Database (Denmark)

    Harder-Lauridsen, Nina Majlund; Birk, Nina Marie; Ried-Larsen, Mathias;

    2014-01-01

    BACKGROUND: Obesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance...... intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group. METHODS: School children from Copenhagen were randomly...

  14. Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

    Directory of Open Access Journals (Sweden)

    van Balkom Anton

    2008-11-01

    Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

  15. Factors influencing childhood cancer patients to participate in a combined physical and psychosocial intervention program : Quality of Life in Motion

    NARCIS (Netherlands)

    Van Dijk-Lokkart, Elisabeth M.; Braam, Katja I.; Huisman, Jaap; Kaspers, Gertjan Jl; Takken, Tim; Veening, Margreet A.; Bierings, MB; Merks, Hans; Grootenhuis, Martha A.; Eibrink, Marry; Streng, Isabelle C.; Van Dulmen-Den Broeder, Eline

    2015-01-01

    Background For a multi-center randomized trial investigating the effects of a 12-week physical and psychosocial intervention program for children with cancer, we invited 174 patients (8-18 years old) on treatment or within 1 year after treatment; about 40% participated. Reasons for non-participation

  16. Early psychological intervention in accidentally injured children ages 2–16: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Didier N. Kramer

    2014-06-01

    Full Text Available Background: Road traffic accidents (RTA and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children. Objectives: To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and burns. Methods: Children assessed at risk for the development of posttraumatic stress disorder (PTSD were randomly assigned to either a control group offered treatment as usual or an intervention group. Primary outcomes were PTSD, behavioral problems, and depression symptoms. Baseline and blinded 3- and 6-month follow-up assessments were conducted. Results: In pre-school children, no intervention effects were found. School-age children in the intervention group exhibited significantly fewer internalizing problems at 3-month follow-up relative to controls and a borderline significant time-by-group effect for PTSD intrusion symptoms was found (p=0.06. Conclusions: This is the first study examining the efficacy of an indicated, early psychological intervention among both school-age and pre-school-age children. Because the intervention was ineffective for young children, no evidence-based practice can currently be suggested. Given that parents of pre-school children perceived the intervention as helpful, brief counseling of parents in terms of psychoeducation and training in coping skills still should be provided by clinicians, despite the current lack of evidence. To prevent trauma-related disorders in school-age children, the intervention might be used in a step-wise manner, where only children at risk for long-term psychological maladjustment are provided with psychological support.

  17. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    DEFF Research Database (Denmark)

    Korshøj, Mette; Krustrup, Peter; Jørgensen, Marie Birk;

    2012-01-01

    fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria......: Geographical work location, gender, age and seniority. Cleaners are randomized to either I) a reference group, receiving lectures concerning healthy living, or II) an intervention group, performing worksite aerobic exercise "60 min per week". Data collection will be conducted at baseline, four months and 12...

  18. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    Science.gov (United States)

    Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas

    2016-01-01

    Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women.

  19. An adaptive physical activity intervention for overweight adults: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Marc A Adams

    Full Text Available BACKGROUND: Physical activity (PA interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible. OBJECTIVE: To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention. METHODS: Participants (N = 20 were randomized to one of two 6-month treatments: 1 static intervention (SI or 2 adaptive intervention (AI. Inactive overweight adults (85% women, M = 36.9 ± 9.2 years, 35% non-white in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data. RESULTS: A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001 and a group by study phase interaction was observed (p  .017. The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74. CONCLUSIONS: The adaptive

  20. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

    OpenAIRE

    Paul Ratanasiripong; Nop Ratanasiripong; Duangrat Kathalae

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on h...

  1. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    OpenAIRE

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2013-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was hig...

  2. Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial

    OpenAIRE

    Rost, Kathryn M.; Marshall, Donna; Xu, Stanley

    2014-01-01

    Background Employers can purchase high quality depression products that provide the type, intensity and duration of depression care management shown to improve work outcomes sufficiently for many employers to achieve a return on investment. The purpose of this randomized controlled trial was to test an intervention to encourage employers to purchase a high quality depression product for their workforce. Methods Twenty nine organizations recruited senior health benefit professional members rep...

  3. The Effect of Educational and Modifying Intervention on Asthma Control among Adolescents: a Randomized Clinical Trial

    OpenAIRE

    Zarei, Soheila; Valizadeh, Leila; BILAN, Nemat

    2013-01-01

    Introduction: Controlling over allergens and environmental irritants is one of the essential elements of controlling asthma. Asthma control in adolescents is a challenge. The current study was performed with the goal of investigating the effect of an educational and modifying intervention about asthma triggers on asthma control among adolescents. Methods: The current study was a randomized clinical trial. 60 adolescents of 12-18 years of age participated in this study. The p...

  4. An Eight Month Randomized Controlled Exercise Intervention Alters Resting State Synchrony in Overweight Children

    OpenAIRE

    Krafft, Cynthia E.; Pierce, Jordan E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Rodrigue, Amanda L.; Camchong, Jazmin; Allison, Jerry D.; Yanasak, Nathan E.; Liu, Tianming; Davis, Catherine L.; McDowell, Jennifer E.

    2013-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥ 85th percentile) children 8–11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional...

  5. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    OpenAIRE

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; HARDCASTLE, EMILY; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole

    2009-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; ...

  6. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2016-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  7. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John F. Emerson

    2015-12-01

    Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention

  8. Early rehabilitation of cancer patients – a randomized controlled intervention study

    Directory of Open Access Journals (Sweden)

    Arving Cecilia

    2013-01-01

    Full Text Available Abstract Background Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. Method Patients (≥ 18 years with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be

  9. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Science.gov (United States)

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.

  10. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    DEFF Research Database (Denmark)

    Andersen, Lars; Jørgensen, Marie Birk; Blangsted, Anne;

    2008-01-01

    PURPOSE:: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS:: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS:: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively......, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P

  11. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Science.gov (United States)

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone. PMID:27268572

  12. Randomized controlled trial of a self-management intervention in persons with spinal cord injury: design of the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

    OpenAIRE

    Kooijmans, H.; Post, M.W.M.; van der Woude, L H V; Groot, S.; Stam, H. J.; Bussmann, J.B.J

    2013-01-01

    Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty persons with a SCI for at least 10 years and aged 18 to 65 will randomly be assigned to the intervention (self-management) or the control group (information provision). During the 16-week self-manage...

  13. The response of the lactate minimum test to a 12-week swimming training

    Directory of Open Access Journals (Sweden)

    Eduardo Zapaterra Campos

    2014-09-01

    Full Text Available Despite the utilization of lactate minimum test (LMT in training, its intensity response to training remains controversial. The aim of the present study was to verify alterations of LMT intensity in swimmers during a 12-week training protocol. Eight swimmers were submitted to three LMT assessments: beginning of the season, T0; after four, T4; and twelve weeks, T12. The LMT consisted of a 200m maximal effort and, after eight minutes of passive rest, five incremental stages of 200m swimming. The intensities of the incremental stages were defined subjectively ("very light," "light," "moderate," "hard," and "all-out". The training was divided in two blocks of periodization: endurance training period (ETP, T0 - T4, and quality plus taper period (QTP, T4 - T12. The LMT intensity of T4 and T12 were significantly higher than T0. We conclude that LMT is modified due to swimming training and can be used for training prescription and detection of aerobic capacity alterations during a season.

  14. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study

    Directory of Open Access Journals (Sweden)

    Morillas-Arques Piedad

    2010-09-01

    Full Text Available Abstract Background Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. Methods A flexible dose of trazodone (50-300 mg/day, was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI. Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ, the Beck Depression Inventory (BDI, the Hospital Anxiety and Depression Scale (HADS, the Brief Pain Inventory (BPI, the Short-Form Health Survey (SF-36, and the Patients' Global Improvement Scale (PGI. Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. Results Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI, and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2% patients. Conclusions In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. Trial registration This trial has been registered with ClinicalTrials.gov number NCT-00791739.

  15. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Orla Doyle

    Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

  16. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

    Science.gov (United States)

    Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

    2016-01-01

    This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

  17. Effect of 12 Weeks of Periodized Resistance Training Upon Total Plasma Adiponectin Concentration in Healthy Young Men.

    Science.gov (United States)

    Davis, Greggory R; Stephens, Jacqueline M; Nelson, Arnold G

    2015-11-01

    The effects of resistance training on adiponectin have thus far yielded equivocal results. However, the effect of periodized resistance training on plasma adiponectin in offspring of type 2 diabetic and nondiabetic (ND) parents (first-degree family history) has yet to be determined. Untrained healthy young men with and without a first-degree family history of type 2 diabetes were assigned to an exercise intervention group (E) or an active control group (C). The E group performed a 12-week periodized resistance training program, whereas the C group did not participate in any structured exercise program. Fasting plasma samples were obtained pre- and posttraining. Total plasma adiponectin changed significantly in the E group (33.7 ± 14.7%, p = 0.025) but not in the C group (10.8 ± 19.2%). Offspring of type 2 diabetic parents subjects had significantly greater improvements in plasma adiponectin (69.3 ± 34.8%) compared with ND subjects (-3.2 ± 29.9%, p = 0.046). Regular aerobic exercise was significantly correlated with average plasma adiponectin (r = 0.32), whereas first-degree family history of type 2 diabetes (r = -0.58) and decreases in body fat percentage (r = -0.77) were inversely correlated with average plasma adiponectin. Periodized high-intensity resistance training seems to increase plasma adiponectin, particularly in individuals with a first-degree family history of type 2 diabetes or those who experience a significant loss of fat mass. The direct correlation between regular aerobic exercise and adiponectin further suggests that a combination of aerobic and resistance training yields greater improvements in plasma adiponectin compared with resistance training alone. PMID:26274372

  18. Parent Training for Young Children With Developmental Disabilities: Randomized Controlled Trial

    OpenAIRE

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group (n = 23) received usual care, including early childhood education and related services. Results suggest that this parent training intervention was su...

  19. A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    傅向华

    2003-01-01

    A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction!050000$河北医科大学第二医院河北医科大学心脏介入中心@傅向华

  20. Maintenance of behaviour change after a 12-week mHealth lifestyle programme for young adults.

    Directory of Open Access Journals (Sweden)

    Margaret Allman-Farinelli

    2015-09-01

    Conclusions: Young adulthood is a period of rapid weight gain but this group are hard to reach for health promotion. Despite the relatively low intensity of the TXT2BFiT programme, behaviours were maintained during the six months following the intervention. mHealth shows promise to deliver intervention with wide reach and low cost.

  1. Lifestyle intervention for gestational diabetes mellitus prevention: A cluster-randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    Shuang Wang; Jing-Mei Ma; Hui-Xia Yang

    2015-01-01

    Objective: The study was to examine whether gestational diabetes mellitus (GDM) can be prevented by early trimester lifestyle counseling in a high-risk population.Methods: From September 2012 to January 2013, 1664 pregnancies in the Department of Obstetrics and Gynecology of First Hospital of Peking University were enrolled in the study during their first prenatal care visit before the 8 gestational weeks visit and asked to fill out a questionnaire on GDM risk evaluation.According to the questionnaire and medical records, those with at least one risk factor of GDM were included in the intervention study and randomly allocated to two groups, intervention group and control group.Routine prenatal care was offered, while standardized two-step lifestyle intervention was provided to the intervention group during 6-8 gestational weeks, and at 12-13 gestational weeks, enforcement intervention based on maternal anthropometrics were offered.Both groups were followed until 75 g oral glucose tolerance test (OGTT) testing at 24-28 gestational weeks.The weight gain after intervention and the prevalence of GDM were used to evaluate the effect.Results: (1) According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, the positive rate of GDM for the intervention group was 17.16% (23/134), lower than the control group which was 23.91% (33/138), P =0.168.(2) The weight gain during the first and second trimester for the intervention group was (1.38 ± 2.34) kg and (5.51 ± 2.18) kg, lower than in the control group which was (1.41 ± 2.58) kg and (5.66 ± 2.25) kg, (P =0.905, P =0.567).(3) Positive rate of GDM for those fasting plasma glucose (FPG) ≥5.1 mmol/L during early pregnancy was 11/36 (30.55%) for the intervention group that was lower than 17/37 (45.95%) for the control group, but the statistical difference was not significant (P =0.076).Conclusion: The positive rate of GDM could be reduced by a certain amount lifestyle

  2. Estimating the health benefit of reducing indoor air pollution in a randomized environmental intervention

    Science.gov (United States)

    Peng, Roger D.; Butz, Arlene M.; Hackstadt, Amber J.; Williams, D'Ann L.; Diette, Gregory B.; Breysse, Patrick N.; Matsui, Elizabeth C.

    2016-01-01

    Recent intervention studies targeted at reducing indoor air pollution have demonstrated both the ability to improve respiratory health outcomes and to reduce particulate matter (PM) levels in the home. However, these studies generally do not address whether it is the reduction of PM levels specifically that improves respiratory health. In this paper we apply the method of principal stratification to data from a randomized air cleaner intervention designed to reduce indoor PM in homes of children with asthma. We estimate the health benefit of the intervention amongst study subjects who would experience a substantial reduction in PM in response to the intervention. For those subjects we find an increase in symptom-free days that is almost three times as large as the overall intention-to-treat effect. We also explore the presence of treatment effects amongst those subjects whose PM levels would not respond to the air cleaner. This analysis demonstrates the usefulness of principal stratification for environmental intervention trials and its potential for much broader application in this area.

  3. Impact of a Social Work Care Coordination Intervention on Hospital Readmission: A Randomized Controlled Trial.

    Science.gov (United States)

    Bronstein, Laura R; Gould, Paul; Berkowitz, Shawn A; James, Gary D; Marks, Kris

    2015-07-01

    This study assessed how a social work-led care coordination intervention would reduce the within-30-day hospital readmission rate among moderate- and high-risk patients age 50 years or older. Authors ran a randomized controlled trial to determine whether there was a significant difference in within-30-day readmission rates between patients receiving usual care post-discharge and those receiving intervention from an MSW intern (one home visit and one to two phone calls). Results were obtained using a sample of hospitalized patients with a LACE index score of 7 or higher (N = 89). Analysis suggests that the intervention improved the likelihood of not being readmitted by some 22 percent (RR = 1.222; 95% CI = 1.063-1.405). The risk improvement with the intervention was highly statistically significant (p = .003). This study shows that a time-efficient care coordination intervention by MSW interns may decrease hospital readmission rates. Replications of this study in other communities, with more diverse populations, and with larger numbers of patients will indicate whether results are generalizable.

  4. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Science.gov (United States)

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  5. Estimating the health benefit of reducing indoor air pollution in a randomized environmental intervention

    Science.gov (United States)

    Peng, Roger D.; Butz, Arlene M.; Hackstadt, Amber J.; Williams, D'Ann L.; Diette, Gregory B.; Breysse, Patrick N.; Matsui, Elizabeth C.

    2016-01-01

    Recent intervention studies targeted at reducing indoor air pollution have demonstrated both the ability to improve respiratory health outcomes and to reduce particulate matter (PM) levels in the home. However, these studies generally do not address whether it is the reduction of PM levels specifically that improves respiratory health. In this paper we apply the method of principal stratification to data from a randomized air cleaner intervention designed to reduce indoor PM in homes of children with asthma. We estimate the health benefit of the intervention amongst study subjects who would experience a substantial reduction in PM in response to the intervention. For those subjects we find an increase in symptom-free days that is almost three times as large as the overall intention-to-treat effect. We also explore the presence of treatment effects amongst those subjects whose PM levels would not respond to the air cleaner. This analysis demonstrates the usefulness of principal stratification for environmental intervention trials and its potential for much broader application in this area. PMID:27695203

  6. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    Science.gov (United States)

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  7. Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gustafsson Lars

    2008-03-01

    Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria

  8. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study.

    Directory of Open Access Journals (Sweden)

    Michèle Bisson

    Full Text Available To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity.In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2 were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2 at the anaerobic threshold, nutrition (caloric intake and macronutrients percentage and anthropometry were assessed at 14 and 28 weeks of gestation. Analyses were performed using repeated measures ANOVA.A total of fifty (50 women were randomised, 25 in each group. There was no time-group interaction for time spent at moderate and vigorous activity (pinteraction = 0.064, but the exercise group's levels were higher than controls' at all times (pgroup effect = 0.014. A significant time-group interaction was found for daily physical activity (p = 0.023; similar at baseline ((22.0 ± 6.7 vs 21.8 ± 7.3 x 10(4 counts/day the exercise group had higher levels than the control group following the intervention ((22.8 ± 8.3 vs 19.2 ± 4.5 x 10(4 counts/day, p = 0.020 and at 36 weeks of gestation ((19.2 ± 1.5 vs 14.9 ± 1.5 x 10(4 counts/day, p = 0.034. Exercisers also gained less weight than controls during the intervention period despite similar nutritional intakes (difference in weight change = -0.1 kg/week, 95% CI -0.2; -0.02, p = 0.016 and improved cardiorespiratory fitness (difference in fitness change = 8.1%, 95% CI 0.7; 9.5, p = 0.041.Compared with standard care, a supervised exercise program allows pregnant women with obesity to maintain fitness, limit weight gain and attenuate the decrease in physical activity levels observed in late pregnancy.ClinicalTrials.gov NCT01610323.

  9. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    Science.gov (United States)

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease. PMID:24704650

  10. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  11. A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

    Science.gov (United States)

    Roure, Romain; Nollent, Virginie; Dayan, Liliane; Camel, Etienne; Bertin, Christiane

    2016-06-01

    The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (Pskin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged skin, validating the potential use of NFκB inhibition as a

  12. Effects of a stepwise multidisciplinary intervention for challenging behavior in advanced dementia: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Pieper, M.J.C.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    Objectives: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. Design: Cluster randomized controlled trial. Setting: Twenty-one clusters (single independe

  13. Effect of a Community-Based Nursing Intervention on Mortality in Chronically Ill Older Adults: A Randomized, Controlled Trial

    OpenAIRE

    Bierman, Arlene S

    2012-01-01

    Arlene Bierman discusses new research findings from a randomized trial evaluating community-based nursing interventions in older adults, and and comments on how we need to to re-engineer health systems to provide greater quality of care.

  14. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    Science.gov (United States)

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

    2016-10-01

    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies. PMID:26848872

  15. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Maria Navascues-Cornago

    Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752.

  16. Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial

    Science.gov (United States)

    Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.

    2015-01-01

    Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235

  17. Improving well-being at work: A randomized controlled intervention based on selection, optimization, and compensation.

    Science.gov (United States)

    Müller, Andreas; Heiden, Barbara; Herbig, Britta; Poppe, Franziska; Angerer, Peter

    2016-04-01

    This study aimed to develop, implement, and evaluate an occupational health intervention that is based on the theoretical model of selection, optimization, and compensation (SOC). We conducted a stratified randomized controlled intervention with 70 nurses of a community hospital in Germany (94% women; mean age 43.7 years). Altogether, the training consisted of 6 sessions (16.5 hours) over a period of 9 months. The training took place in groups of 6-8 employees. Participants were familiarized with the SOC model and developed and implemented a personal project based on SOC to cope effectively with 1 important job demand or to activate a job resource. Consistent with our hypotheses, we observed a meaningful trend that the proposed SOC training enhanced mental well-being, particularly in employees with a strong commitment to the intervention. While highly committed training participants reported higher levels of job control at follow-up, the effects were not statistical significant. Additional analyses of moderation effects showed that the training is particularly effective to enhance mental well-being when job control is low. Contrary to our assumptions, perceived work ability was not improved by the training. Our study provides first indications that SOC training might be a promising approach to occupational health and stress prevention. Moreover, it identifies critical success factors of occupational interventions based on SOC. However, additional studies are needed to corroborate the effectiveness of SOC trainings in the occupational contexts. PMID:26322438

  18. A randomized controlled evaluation of a psychosocial intervention in adults with chronic lung disease.

    Science.gov (United States)

    Blake, R L; Vandiver, T A; Braun, S; Bertuso, D D; Straub, V

    1990-01-01

    The effect of a stress management program on morbidity and psychosocial and physical function in patients with chronic lung disease was assessed. Adults attending either a VA pulmonary clinic or university hospital pulmonary rehabilitation clinic who met criteria for obstructive or restrictive pulmonary disease were randomly assigned to receive the intervention or to a control group. The intervention was provided by a nurse and included one to three teaching sessions, reading material, audiotapes, and telephone follow-up. The program focused on stress management techniques such as cognitive restructuring, progressive relaxation, breathing exercises, and visual imagery. The 45 experimental subjects were similar to the 49 controls with respect to baseline characteristics. Experimental and control subjects had similar rates of mortality, hospital days, bed-disability days, restricted-activity days, and physician visits during the 12-month follow-up. There were no differences between the two groups in physical or psychosocial function at six months or in levels of stressful life changes, social supports, and self-esteem at six and 12 months. Intervention recipients had better function at 12 months, suggesting a possible benefit of the intervention. PMID:2227172

  19. Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

    Directory of Open Access Journals (Sweden)

    Moskowitz JT

    2014-09-01

    currently few established interventions for people who are newly diagnosed with HIV. We present the design and methods for a randomized trial in which we test the efficacy of one such skills-based intervention that targets positive affect as a novel mechanism of change. The proposed research builds on observational findings of the important unique functions of positive affect. We aim to determine whether a five-session theory- and evidence-based intervention designed to teach skills for increasing the frequency and intensity of daily positive affect does so, and whether this intervention has beneficial effects on subsequent psychological well-being, health behaviors, and physical health up to 15 months after diagnosis with HIV. This is a randomized controlled trial in a sample of adults recruited within 12 weeks of testing positive for HIV. The control group is attention-matched, and follow up assessments will be conducted immediately post intervention (approximately 5 months post diagnosis and at 10 and 15 months post diagnosis. This study is an important next step in research concerning the adaptive functions of positive affect for people coping with HIV or other health-related life stress. Keywords: positive affect, HIV diagnosis, stress, coping, RCT, intervention, physical health

  20. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Farah Jindani

    2015-01-01

    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  1. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Science.gov (United States)

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  2. Low Baseline Interleukin-17A Levels Are Associated with Better Treatment Response at 12 Weeks to Tocilizumab Therapy in Rheumatoid Arthritis Patients

    Directory of Open Access Journals (Sweden)

    Sang Jin Lee

    2015-01-01

    Full Text Available T helper 17-related cytokines have been implicated in rheumatoid arthritis (RA pathogenesis. The study aimed to identify cytokines associated with the treatment response of RA patients to tocilizumab (TCZ, a humanized monoclonal antibody against the interleukin- (IL- 6 receptor. As an independent substudy of the 24-week, randomized, double-blinded CWP-TCZ301 trial of TCZ in RA patients with an inadequate response to disease-modifying antirheumatic drugs, serum levels of cytokines including tumor necrosis factor-alpha, IL-17A, IL-21, IL-23, IL-6, and soluble IL-6 receptor were measured. Baseline IL-17A levels were significantly lower in RA patients who achieved disease activity score 28 (DAS28 remission at 12 weeks of TCZ treatment, compared to patients not in remission. Patients were stratified into IL-17A low group and IL-17A high group. Significantly more patients in the IL-17A low group achieved remission as compared to the IL-17A high group (47.6 versus 17.4%, P=0.032. DAS28 improvement was significantly better in the IL-17A low group than in the IL-17A high group at 12 weeks (P=0.045 and 24 weeks (P=0.046 after adjustment. Other baseline cytokines were not associated with treatment response to TCZ. The data demonstrate that low baseline IL-17A levels are associated with better clinical response to TCZ treatment in RA patients.

  3. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    Science.gov (United States)

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

    2014-11-01

    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  4. Randomized controlled trial of a family intervention for children bullied by peers.

    Science.gov (United States)

    Healy, Karyn L; Sanders, Matthew R

    2014-11-01

    This study examined the effects of a family intervention on victimization and emotional distress of children bullied by peers. The intervention, Resilience Triple P, combined facilitative parenting and teaching children social and emotional skills relevant to developing strong peer relationships and addressing problems with peers. Facilitative parenting is parenting that supports the development of children's peer relationship skills. A randomized controlled trial was conducted with 111 families who reported chronic bullying of children aged 6 to 12 years. Families were randomly allocated to either an immediate start to Resilience Triple P (RTP) or an assessment control (AC) condition. Assessments involving children, parents, teachers, and observational measures were conducted at 0 (pre), 3 (post) and 9 months follow-up. RTP families had significantly greater improvements than AC families on measures of victimization, child distress, child peer and family relationships, including teacher reports of overt victimization (d=0.56), child internalizing feelings (d=0.59), depressive symptoms (d=0.56), child overt aggression towards peers (d=0.51), acceptance by same sex and opposite sex peers (d=0.46/ 0.60), and child liking school (d=0.65). Families in both conditions showed significant improvements on most variables over time including child reports of bullying in the last week reducing to a near zero and indistinguishable from the normative sample. The intervention combining facilitative parenting and social and emotional skills training for children produced better results than the comparison assessment control condition. This study demonstrated that family interventions can reduce victimization and distress and strengthen school efforts to address bullying. PMID:25311286

  5. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    Directory of Open Access Journals (Sweden)

    Korshøj Mette

    2012-08-01

    Full Text Available Abstract Background Prevalence of cardiovascular risk factors is unevenly distributed among occupational groups. The working environment, as well as lifestyle and socioeconomic status contribute to the disparity and variation in prevalence of these risk factors. High physical work demands have been shown to increase the risk for cardiovascular disease and mortality, contrary to leisure time physical activity. High physical work demands in combination with a low cardiorespiratory fitness infer a high relative workload and an excessive risk for cardiovascular mortality. Therefore, the aim of this study is to examine whether a worksite aerobic exercise intervention will reduce the relative workload and cardiovascular risk factors by an increased cardiorespiratory fitness. Methods/design A cluster-randomized controlled trial is performed to evaluate the effect of the worksite aerobic exercise intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I a reference group, receiving lectures concerning healthy living, or II an intervention group, performing worksite aerobic exercise “60 min per week”. Data collection will be conducted at baseline, four months and 12 months after baseline, at the worksite during working hours. The data collection will consist of a questionnaire-based interview, physiological testing of health and capacity-related measures, and objective diurnal measures of heart rate, physical activity and blood pressure. Primary outcome is cardiorespiratory fitness. Discussion Information is lacking about whether an improved cardiorespiratory fitness will affect

  6. Effectiveness of a tailor-made intervention for pregnancy-related pelvic girdle and/or low back pain after delivery: Short-term results of a randomized clinical trial [ISRCTN08477490

    Directory of Open Access Journals (Sweden)

    Bastiaanssen Janneke M

    2006-02-01

    Full Text Available Abstract Background For the moment, scientific evaluation of programs on treatment of pregnancy-related pelvic girdle and/or low back pain after delivery is hardly available with only one study with a positive result, suggesting uncertainty about the optimal approach. Investigators draw particular attention to biomedical factors but there is growing evidence that biopsychosocial factors appear to be even more important as a basis of an intervention program. Methods We studied the effectiveness of a tailor-made program with respect to biopsychosocial factors (intervention group in women with pregnancy-related pelvic girdle and/ or low back pain versus usual care based on a pain contingent basis (control group shortly after delivery in a randomized controlled trial. Women with severe complaints shortly after delivery were selected from a longitudinal prospective cohort study (n = 7526, aimed at pregnancy-related pelvic girdle and/or low back pain in the Netherlands. A concealed block randomization was performed after collecting baseline data. Researchers were blinded to treatment assignment. Outcomes were evaluated within the domains of the biopsychosocial approach. Primary outcome concerned limitations in activities (RDQ. Follow-up measurements were performed 12 weeks after delivery. Results Since May 2001 until July 2003, 869 women out of the cohort made a request for treatment by a physiotherapist, 10 days after delivery. Because of a quick recovery in two weeks time, we included only 126 women three weeks after delivery. There was a statistically significant and clinically relevant difference in improvement on the primary outcome (RDQ between the two groups in favor of the experimental intervention. Conclusion The results favored the hypotheses. Women's worries about their condition were major targets in the experimental intervention. The prognosis after delivery, especially in de first weeks, turned out to be favorable.

  7. Effects of a 12-week intervention period with football and running for habitually active men with mild hypertension

    DEFF Research Database (Denmark)

    Knoepfli-Lenzin, C.; Sennhauser, C.; Toigo, M.;

    2010-01-01

    /L) but was not altered in R and C. We conclude that football training, consisting of high-intensity intermittent exercise, results in positive effects on blood pressure, body composition, stroke volume and supine heart rate variability, and elicits at least the same cardiovascular health benefits as...

  8. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    Science.gov (United States)

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  9. Mathematics Learned by Young Children in An Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

    Science.gov (United States)

    Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.

    2011-01-01

    This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous professional…

  10. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  11. A Chinese Chan-Based Mind-Body Intervention Improves Sleep on Patients with Depression: A Randomized Controlled Trial

    OpenAIRE

    Chan, Agnes S.; Wong, Queenie Y.; Sophia L. Sze; Kwong, Patrick P. K.; Yvonne M. Y. Han; Mei-chun Cheung

    2012-01-01

    Sleep disturbance is a common problem associated with depression, and cognitive-behavioral therapy (CBT) is a more common behavioral intervention for sleep problems. The present study compares the effect of a newly developed Chinese Chan-based intervention, namely Dejian mind-body intervention (DMBI), with the CBT on improving sleep problems of patients with depression. Seventy-five participants diagnosed with major depressive disorder were randomly assigned to receive 10 weekly sessions of C...

  12. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

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    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  13. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

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    Arija Victoria

    2012-05-01

    Full Text Available Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain. These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA, food intake, dentures, degree of dependency (Barthel test, cognitive state (Pfeiffer test, mood status (Yesavage test, and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits up to 6 months. The North American Nursing Diagnosis Association (NANDA methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of

  14. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial.

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    Anne N Thorndike

    Full Text Available BACKGROUND: Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. METHODS: We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention or to a blinded monitor (control. Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1 median steps/day and 2 proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day. Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. RESULTS: In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16 and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73. In Phase 2 (team competition, residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; INTERVENTION: 7,832 vs. 7,739, p = 0.13. Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001. Mean systolic blood pressure decreased (p = 0.004 and HDL cholesterol increased (p<0.001 among all participants at end of study compared to baseline. CONCLUSIONS: Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more

  15. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

    Science.gov (United States)

    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier

    2016-01-01

    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  16. Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

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    Nuttall Jacqueline

    2011-02-01

    Full Text Available Abstract Background Cognitive behaviour therapy (CBT is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. Methods/Design This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. Discussion This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have

  17. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement

    DEFF Research Database (Denmark)

    Skou, Søren Thorgaard; Rasmussen, Sten; Laursen, Mogens Berg;

    2015-01-01

    secondary care with knee OA, confirmed by radiography (Kellgren-Lawrence grade ≥1), but not eligible for a TKR. The 12-week non-surgical treatment program consisted of individualized progressed neuromuscular exercise, patient education, insoles, dietary advice and prescription of pain medication...

  18. Physiological changes following a 12 week gym based stair-climbing, elliptical trainer and treadmill running program in females

    OpenAIRE

    EGANA, MIKEL

    2004-01-01

    PUBLISHED Despite the growing popularity of the elliptical trainer aerobic exercise modality the physiological changes induced following a training program using elliptical trainers remains unknown. Donne investigates the metabolic and cardiorespiratory improvements following a 12-week aerobic training program using elliptical trainer, treadmill or stair-climbing modalities. Findings reveal that in moderately active females similar physiological improvements were observed using stair-climb...

  19. A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

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    Tourangeau Ann

    2008-12-01

    Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This

  20. Short-term effects of a randomized controlled worksite relaxation intervention in Greece

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    Evangelos C Alexopoulos

    2014-06-01

    Full Text Available objective. To evaluate the short-term benefits of simple relaxation techniques in white-collar employees. materials and methods. The study was a two-arm parallel group randomized controlled trial. 152 employees were randomly assigned to receive the 8-week programme (N=80 (relaxation breathing and progressive muscle relaxation, twice a day or not (wait-list group N=72. Self-reported validated measures were used to evaluate perceived stress, health locus of control, job and lifestyle related variables. Saliva cortisol were also sampled and measured. Adjusted mean changes on outcomes were estimated by linear mixed model analysis. 127 employees were finally analyzed (68 in the intervention and 59 in the control group. results. Specific stress-related symptoms, psychological job demands and cortisol levels were found to be significantly decreased after 8-weeks in the intervention group. The result was probably affected by the general socio-economic condition during the study period. Cortisol levels were also significantly related with age, family situation, gender and sampling time. conclusions. Simple relaxation training (diaphragmatic breathing and progressive muscle relaxation could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings

  1. Diffusion of an Evidence-Based Smoking Cessation Intervention Through Facebook: A Randomized Controlled Trial

    Science.gov (United States)

    Cobb, Nathan K.; Jacobs, Megan A.; Wileyto, Paul; Valente, Thomas

    2016-01-01

    Objectives. To examine the diffusion of an evidence-based smoking cessation application (“app”) through Facebook social networks and identify specific intervention components that accelerate diffusion. Methods. Between December 2012 and October 2013, we recruited adult US smokers (“seeds”) via Facebook advertising and randomized them to 1 of 12 app variants using a factorial design. App variants targeted components of diffusion: duration of use (t), “contagiousness” (β), and number of contacts (Z). The primary outcome was the reproductive ratio (R), defined as the number of individuals installing the app (“descendants”) divided by the number of a seed participant’s Facebook friends. Results. We randomized 9042 smokers. App utilization metrics demonstrated between-variant differences in expected directions. The highest level of diffusion (R = 0.087) occurred when we combined active contagion strategies with strategies to increase duration of use (incidence rate ratio = 9.99; 95% confidence interval = 5.58, 17.91; P < .001). Involving nonsmokers did not affect diffusion. Conclusions. The maximal R value (0.087) is sufficient to increase the numbers of individuals receiving treatment if applied on a large scale. Online interventions can be designed a priori to spread through social networks. PMID:27077358

  2. Family nurture intervention (FNI: methods and treatment protocol of a randomized controlled trial in the NICU

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    Welch Martha G

    2012-02-01

    Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally

  3. A 12-Week Exercise Therapy Program in Middle-Aged Patients With Degenerative Meniscus Tears

    DEFF Research Database (Denmark)

    Stensrud, Silje; Roos, Ewa M.; Risberg, May Arna

    2012-01-01

    , progression, tolerance, and potential benefit from an exercise therapy program in these patients who have not had surgery. This study describes a progressive exercise therapy program aiming at improving neuromuscular function and muscle strength in middle-aged patients with degenerative meniscus tears...... global rating of change scale, isokinetic knee muscle strength tests, and 3 lower extremity performance tests. Post intervention there were clinically meaningful changes (greater than 10 points) in 16 of 20 patients on the KOOS knee related quality of life, 19 of 20 patients rated themselves as "a lot...... better" or "better" on the global rating of change scale, all patients had increased quadriceps muscle strength, and the majority of patients improved on the lower extremity performance tests. At 1 year post-intervention, the majority of patients had sustained the improvements and none of the patients...

  4. Intervention for homeless, substance abusing mothers: findings from a non-randomized pilot.

    Science.gov (United States)

    Slesnick, Natasha; Erdem, Gizem

    2012-01-01

    Little empirically-based information is available regarding how best to intervene with substance-abusing homeless mothers. This study pilot-tested a comprehensive intervention with 15 homeless women and their 2- to 6-year-old children, recruited from a local family shelter. All participants were offered integrated intervention with three major components. The first component was housing which included 3 months of rental and utility assistance, and these services were not contingent upon women's abstinence from drugs or alcohol. The second and third components included 6 months of case management services and an evidence-based substance abuse treatment (Community Reinforcement Approach; CRA). Analysis revealed that women showed reductions in substance use (F(2,22) = 3.63; p homelessness (F(2,24) = 25.31; p intervention is a promising approach to meet the multiple needs of this vulnerable population. These positive outcomes support the need for future research to replicate the findings with a larger sample using a randomized design.

  5. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Science.gov (United States)

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  6. A randomized clinical trial of the effectiveness of premarital intervention: moderators of divorce outcomes.

    Science.gov (United States)

    Markman, Howard J; Rhoades, Galena K; Stanley, Scott M; Peterson, Kristina M

    2013-02-01

    This study examined the effects of premarital relationship intervention on divorce during the first 8 years of first marriage. Religious organizations were randomly assigned to have couples marrying through them complete the Prevention and Relationship Education Program (PREP) or their naturally occurring premarital services. Results indicated no differences in overall divorce rates between naturally occurring services (n = 44), PREP delivered by clergy at religious organizations (n = 66), or PREP delivered by professionals at a university (n = 83). Three moderators were also tested. Measured premaritally and before intervention, the level of negativity of couples' interactions moderated effects. Specifically, couples observed to have higher levels of negative communication in a video task were more likely to divorce if they received PREP than if they received naturally occurring services; couples with lower levels of premarital negative communication were more likely to remain married if they received PREP. A history of physical aggression in the current relationship before marriage and before intervention showed a similar pattern as a moderator, but the effect was only marginally significant. Family-of-origin background (parental divorce and/or aggression) was not a significant moderator of prevention effects across the two kinds of services. Implications for defining risk, considering divorce as a positive versus negative outcome, the practice of premarital relationship education, and social policy are discussed.

  7. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    Science.gov (United States)

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.

  8. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  9. Mindfulness Training Improves Attentional Task Performance in Incarcerated Youth: A Group Randomized Controlled Intervention Trial

    Directory of Open Access Journals (Sweden)

    Noelle R Leonard

    2013-11-01

    Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.

  10. Antioxidants and muscle growth in elderly : the effect of supplementation with vitamin C and E on muscle growth and maximal strength during 12 weeks of resistance exercise in eldery men

    OpenAIRE

    Bjørnsen, Thomas

    2013-01-01

    INTRODUCTION: Supplementation with antioxidants could either facilitate or hamper adaptations to resistance exercise due to redox-sensitive signaling pathways that regulate protein synthesis. Thus, the aim of the present study was to investigate the effect supplementation with vitamin C and E on muscle growth and maximal strength during 12 weeks of resistance exercise in elderly men. METHODS: Thirty-four elderly males (60 – 81 years) were randomized to either an antioxidant group (N=17; 1000 ...

  11. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Berdoz Didier

    2011-11-01

    Full Text Available Abstract Background Sexually transmitted infections (STIs are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI and the provision of condoms on the engagement in unprotected casual sex. Methods 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. Results 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66% completed the study. 184/1115 (17% had a casual sexual relationship abroad and overall 46/1115 (4.1% had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6] and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4] had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40 in the motivational BI group, 24% (95%CI10-37 in the condoms group and 24% (95%CI14-33 in the control group (p = 0.7. Conclusion This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected Trial Registration Number ClinicalTrials.gov: NCT01056536

  12. The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Buist A

    2010-03-01

    Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

  13. The working mechanisms of an environmentally tailored physical activity intervention for older adults: a randomized controlled trial

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    Mudde Aart N

    2009-12-01

    Full Text Available Abstract Background The aim of this study was to explore the working mechanisms of a computer tailored physical activity intervention for older adults with environmental information compared to a basic tailored intervention without environmental information. Method A clustered randomized controlled trial with two computer tailored interventions and a no-intervention control group was conducted among 1971 adults aged ≥ 50. The two tailored interventions were developed using Intervention Mapping and consisted of three tailored letters delivered over a four-month period. The basic tailored intervention targeted psychosocial determinants alone, while the environmentally tailored intervention additionally targeted environmental determinants, by providing tailored environmental information. Study outcomes were collected with questionnaires at baseline, three and six months and comprised total physical activity (days/week, walking (min/week, cycling (min/week, sports (min/week, environmental perceptions and use and appreciation of the interventions. Results Mediation analyses showed that changes in cycling, sports and total physical activity behaviour induced by the environmentally tailored intervention were mediated by changes in environmental perceptions. Changes in environmental perceptions did not mediate the effect of the basic tailored intervention on behaviour. Compared with the basic tailored intervention, the environmentally tailored intervention significantly improved cycling behaviour (τ = 30.2. Additionally, the tailored letters of the environmentally tailored intervention were better appreciated and used, although these differences did not mediate the intervention effect. Discussion This study gave some first indications of the relevance of environmental perceptions as a determinant of changing physical activity behaviours and the potential effectiveness of providing environmental information as an intervention strategy aimed at

  14. Effects of a three-month therapeutic lifestyle modification program to improve bone health in postmenopausal Korean women in a rural community: a randomized controlled trial.

    Science.gov (United States)

    Oh, Eui Geum; Yoo, Jae Yong; Lee, Jung Eun; Hyun, Sa Saeng; Ko, Il Sun; Chu, Sang Hui

    2014-08-01

    In this randomized controlled trial, we examined the effects of a 3-month therapeutic lifestyle modification (TLM) intervention on knowledge, self-efficacy, and health behaviors related to bone health in postmenopausal women in rural Korea. Forty-one women ages 45 or older were randomly assigned to either the intervention (n = 21) or control (n = 20) group. The intervention group completed a 12-week, 24-session TLM program of individualized health monitoring, group health education, exercise, and calcium-vitamin D supplementation. Compared with the control group, the intervention group showed significant increases in knowledge and self-efficacy and improvement in diet and exercise after 12 weeks, providing evidence that a comprehensive TLM program can be effective in improving health behaviors to maintain bone health in women at high risk of osteoporosis.

  15. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    Directory of Open Access Journals (Sweden)

    López-García-Franco Alberto

    2012-05-01

    Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity

  16. A 12-week resistance training program elicits positive changes in hemodynamic responses in the elderly

    OpenAIRE

    Cinthya Campos Salazar; Norbel Román Garita

    2009-01-01

    The aim of the study was to determine the effect of a resistance training program in hemodynamic responses and adaptations in 60 yr. old elderly. Volunteers were 60 healthy-elderly who underwent a training program 3 times/wk. for 12 wk. Participants were randomly assigned to either a control group, an exercise group who trained at 30% intensity of 5 maximal repetitions (5RM) (30% of 5RM) or an exercise group at an intensity of 70% (70% of 5RM). Hemodynamic variables measured were mean arteria...

  17. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women

    Directory of Open Access Journals (Sweden)

    Cargo Margaret

    2011-08-01

    Full Text Available Abstract Background Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. Methods/Design The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA, haemoglobin A1C (HbA1C, triglycerides and C-reactive protein (CRP. Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. Discussion The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP is designed

  18. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study

    OpenAIRE

    Bisson, Michèle; Alméras, Natalie; Sébastien S Dufresne; Robitaille, Julie; Rhéaume, Caroline; Bujold, Emmanuel; Frenette, Jérôme; Tremblay, Angelo; Marc, Isabelle

    2015-01-01

    Objective To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity. Methods In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2) were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2) at the anaerobic threshold), nutrition (caloric ...

  19. Experiences of training-adherence in a 12 weeks home-based IMT program for individuals with COPD

    DEFF Research Database (Denmark)

    Sørensen, Dorthe; Christensen, Marie Ernst

    2016-01-01

    . Data were collected by semi-structured face-to-face and telephone interviews with participants after completion of the 12 weeks IMT program. Maintaining self-esteem resulted from the participants' behavioural patterns, through which they resolved their main concern: avoiding to disappoint themselves...... of Maintaining Self-esteem provides knowledge of participant's variation in their need for professional support, and should be targeted specifically at participants in the Misgiving Mode....

  20. A randomized controlled trial of the effect of a brief cognitive-behavioral intervention on dental fear

    DEFF Research Database (Denmark)

    Spindler, Helle; Staugaard, Søren Risløv; Nicolaisen, Camilla;

    2015-01-01

    The objective of this study was to examine the effect of a brief cognitive-behavioral intervention for patients with dental fear in a private dental clinic. Patients presenting with subjectively reported dental fear were randomly assigned to either an immediate intervention (n = 53) or a waiting...... list (n = 51) group. Both groups received an identical intervention, but delayed by 4-6 weeks in the waiting list group. Participants were asked to fill out two self-report questionnaires of dental fear at pre- and post-intervention, and again at a 2-year follow-up assessment. Analysis of variance...... showed that dental fear was significantly reduced in the immediate intervention group (d = 1.5-2.2), compared with the waiting list group (d = 0.3-0.4). Additionally, all participants showed a significant reduction of dental fear following the brief intervention, and in the subgroup available for follow...

  1. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    Science.gov (United States)

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

  2. Effects of trans- and n-3 unsaturated fatty acids on cardiovascular risk markers in healthy males. An 8 weeks dietary intervention study

    DEFF Research Database (Denmark)

    Dyerberg, J; Eskesen, D C; Andersen, P W;

    2004-01-01

    of dietary enrichment with TFA or n-3 PUFA. DESIGN: Randomized, double-blind, parallel intervention trial. SETTING: Department of Human Nutrition, The Royal Veterinary and Agricultural University. SUBJECTS: In all, 87 healthy males included, 79 completed. INTERVENTION: Subjects were randomly assigned to 8...... pressure, heart rate variability (HRV), arterial dilatory capacity, compliance, and distensibility were recorded before and after intervention and at follow-up 12 weeks after the intervention. RESULTS: High-density lipoprotein cholesterol (HDL-C) decreased in the TFA group and triglycerides and mean...

  3. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    Science.gov (United States)

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.

    2014-01-01

    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  4. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    Science.gov (United States)

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  5. Randomized controlled evaluation of an early intervention to prevent post-rape psychopathology.

    Science.gov (United States)

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J; Kilpatrick, Dean

    2007-10-01

    A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms. PMID:17585872

  6. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    Directory of Open Access Journals (Sweden)

    Sang Hyuk Park

    2016-01-01

    Full Text Available Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P=0.191 than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks.

  7. Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial

    OpenAIRE

    Gaete, Jorge; Martinez, Vania; Fritsch, Rosemarie; Rojas, Graciela; Montgomery, Alan A.; Araya, Ricardo

    2016-01-01

    Background Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectiveness of an indicated school-based intervention to reduce depressive symptoms among at-risk adolescents from low-income families. Methods A two-arm, parallel, randomized controlled trial was conducted in 11 secondary schools in vulnerable socioeconomi...

  8. Efficacy of brief alcohol screening intervention for college students (BASICS): a meta-analysis of randomized controlled trials

    OpenAIRE

    Fachini Alexandre; Aliane Poliana P; Martinez Edson Z; Furtado Erikson F

    2012-01-01

    Abstract Background Many studies reported that brief interventions are effective in reducing excessive drinking. This study aimed to assess the efficacy of a protocol of brief intervention for college students (BASICS), delivered face-to-face, to reduce risky alcohol consumption and negative consequences. Methods A systematic review with meta-analysis was performed by searching for randomized controlled trials (RCTs) in Medline, PsycInfo, Web of Science and Cochrane Library databases. A quali...

  9. Randomized trials of alcohol-use interventions with college students and their parents: lessons from the Transitions Project

    OpenAIRE

    Fernandez, AC; Wood, MD; Laforge, R; Black, JT

    2011-01-01

    Background Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students. Therefore, this transition period is an ideal time for preventive interventions to target alcohol use and related problems. Purpose The purpose of this report is to describe the design and methods used in the Transitions Project, a randomized controlled trial of two interventions designed to prevent and reduce heavy episodic drinking and alcohol-related negative c...

  10. Parent-Directed Intervention for Children With Cancer-Related Neurobehavioral Late Effects: A Randomized Pilot Study

    OpenAIRE

    Patel, Sunita K.; Ross, Paula; Cuevas, Michelle; Turk, Anne; Kim, Heeyoung; Lo, Tracy T. Y.; Wong, Lennie F.; Bhatia, Smita

    2014-01-01

    Objective To evaluate feasibility and preliminary efficacy of an intervention directed at parents of childhood cancer survivors (CCSs) with neurobehavioral late effects to improve targeted parenting skills, and thus to indirectly benefit the child’s educational functioning. Methods 44 CCSs and their parents were randomized. Intervention-arm parents participated in eight individual training sessions augmented by a 3-month telephone support period. Pre- and postparent measures and child perform...

  11. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    OpenAIRE

    Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; CHO, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

    2016-01-01

    Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the ...

  12. The effect of health and nutrition education intervention on women's postpartum beliefs and practices: a randomized controlled trial

    OpenAIRE

    Yao Ping; Liu Liegang; Sun Xiufa; Mao Limei; Liu Nian; Chen Banghua

    2009-01-01

    Abstract Background 'Sitting month' is the Chinese tradition for postpartum customs. Available studies indicate that some of the traditional postpartum practices are potentially harmful for women's health. However, no intervention study aiming at postpartum practices has been performed. In this paper we evaluated the effect of a health and nutrition education intervention, which focused on improving postpartum dietary quality and optimal health behaviors. Methods The study design was a random...

  13. A systematic review of randomized controlled trials of mHealth interventions against non-communicable diseases in developing countries

    OpenAIRE

    Stephani, Victor; Opoku, Daniel; Quentin, Wilm

    2016-01-01

    Background The reasons of deaths in developing countries are shifting from communicable diseases towards non-communicable diseases (NCDs). At the same time the number of health care interventions using mobile phones (mHealth interventions) is growing rapidly. We review studies assessing the health-related impacts of mHealth on NCDs in low- and middle-income countries (LAMICs). Methods A systematic literature search of three major databases was performed in order to identify randomized control...

  14. Effects of a Psychosocial Intervention on Caregivers of Recently Placed Nursing Home Residents: A Randomized Controlled Trial

    OpenAIRE

    Schulz, Richard; Rosen, Jules; KLINGER, JULIE; Musa, Donald; Castle, Nicholas G; KANE, APRIL; Lustig, Amy

    2014-01-01

    Many caregivers continue to provide care and support to their care recipients after institutional placement. A two-group randomized controlled trial was carried out to test the efficacy of a psychosocial intervention for informal caregivers whose care recipients resided in a long-term care facility. The intervention was delivered during the 6 month period following baseline assessment. Follow-up assessments were carried out at 6, 12, and 18 months. Primary outcomes were caregiver depression, ...

  15. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial

    OpenAIRE

    Maher, Carol; Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ronald C; Bourdeaudhuij, Ilse de; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

    2015-01-01

    Background Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. Objective To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. Methods A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online s...

  16. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    van der Heijden, Marianne J.E.; Sadaf Oliai Araghi; Monique van Dijk; Johannes Jeekel; M G Myriam Hunink

    2015-01-01

    Objective Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery. Data Sources We searched 25 electronic databases from their first available date until October 2014. Study Selection Included were all randomized controlled trials with a parallel group, crossove...

  17. A 12-week resistance training program elicits positive changes in hemodynamic responses in the elderly

    Directory of Open Access Journals (Sweden)

    Cinthya Campos Salazar

    2009-03-01

    Full Text Available The aim of the study was to determine the effect of a resistance training program in hemodynamic responses and adaptations in 60 yr. old elderly. Volunteers were 60 healthy-elderly who underwent a training program 3 times/wk. for 12 wk. Participants were randomly assigned to either a control group, an exercise group who trained at 30% intensity of 5 maximal repetitions (5RM (30% of 5RM or an exercise group at an intensity of 70% (70% of 5RM. Hemodynamic variables measured were mean arterial pressure (MAP, calculated before and immediately after the training session, and rate pressure product (RPP, estimated once a month and before and after finishing the program. Results indicated that resistance exercise training at 30% and 70% of 5RM, with a total exercise work of 872.7 and 890.9 kg did not elicited cardiovascular risks for the elderly. A 12-wk resistance exercise training reduced the cardiovascular strain as shown by the RPP (~16% and the MAP (~9%, with no adverse effects throughout the program. Unfortunately, all the hemodynamic benefits were reverted 6 days following completion of the program. In conclusion, a healthy elderly population must perform resistance training exercises to significantly reduce the cardiovascular stress. We suggest to conduct further research that looks into different exercise intensities in longer program duration and to determine the mechanisms responsible for the deleterious effects of the detraining by using physiological, biochemical and biomechanical variables.

  18. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  19. The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial

    Science.gov (United States)

    Nugent, Chris D; McClean, Sally I; Cleland, Ian; Tschanz, JoAnn T; Clark, Christine J; Norton, Maria C

    2016-01-01

    Background Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly

  20. Guided self-help concreteness training as an intervention for major depression in primary care: a Phase II randomized controlled trial

    DEFF Research Database (Denmark)

    Watkins, E R; Taylor, R S; Baeyens, C;

    2012-01-01

    Background The development of widely accessible, effective psychological interventions for depression is a priority. This randomized trial provides the first controlled data on an innovative cognitive bias modification (CBM) training guided self-help intervention for depression. Method One hundred...

  1. A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics

    OpenAIRE

    Pham, Jade A; Pierce, William; Muhlbaier, Lawrence

    2013-01-01

    Purpose: To evaluate whether medication counseling with emphasis on auxiliary labels improves recall of auxiliary label information and adherence to medication schedules. Methods: A prospective, randomized study of an educational intervention in community pharmacies near Baltimore, Maryland. Fifty literate, English-speaking adults receiving one of the 18 commonly dispensed antibiotics were randomized to receive a counseling session or no counseling. Five to seven days after medication pickup,...

  2. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

    Directory of Open Access Journals (Sweden)

    Noella Angele Piquette

    2014-12-01

    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention (http://abralite.concordia.ca with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  3. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kwok T

    2013-09-01

    Full Text Available Timothy Kwok,1,2 Bel Wong,2 Isaac Ip,2 Kenny Chui,2 Daniel Young,2 Florence Ho2 1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region; 2Jockey Club Centre for Positive Ageing, Hong Kong, Special Administrative Region Purpose: Many family caregivers of persons with dementia (PWD are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. Subjects and methods: In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann–Whitney U tests were used to compare the differences between the intervention and control groups. Results: The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. Conclusion: A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed. Keywords: telephone intervention, psychoeducation, dementia caregivers

  4. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial

    Directory of Open Access Journals (Sweden)

    Byamugisha Robert

    2011-09-01

    Full Text Available Abstract Background The objective of the study was to evaluate the effect of a written invitation letter to the spouses of new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at subsequent antenatal clinic visits. Methods The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation letter delivered to the spouses of new antenatal attendees, while the control group received an information letter, a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant women were randomly assigned to the intervention or non-intervention groups using a randomization sequence, which was computer generated utilizing a random sequence generator (RANDOM ORG that employed a simple randomization procedure. Respondents, health workers and research assistants were masked to group assignments. Results The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally assigned (intention to treat. For the primary outcome, the percentage of trial participants who attended the antenatal clinic with their partners were 16.2% (86/530 and 14.2% (75/530 in the intervention and non-intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6. For the secondary outcome, most of the 161 male partners attended the antenatal clinic; 82 of 86 (95% in the intervention group and 68 of 75 (91% in the non-intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5. Conclusions The effect of the intervention and the control on couple antenatal attendance was similar. In addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple

  5. Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

    Science.gov (United States)

    2016-01-01

    Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance

  6. Treatment Sequencing for Childhood ADHD: A Multiple-Randomization Study of Adaptive Medication and Behavioral Interventions.

    Science.gov (United States)

    Pelham, William E; Fabiano, Gregory A; Waxmonsky, James G; Greiner, Andrew R; Gnagy, Elizabeth M; Pelham, William E; Coxe, Stefany; Verley, Jessica; Bhatia, Ira; Hart, Katie; Karch, Kathryn; Konijnendijk, Evelien; Tresco, Katy; Nahum-Shani, Inbal; Murphy, Susan A

    2016-01-01

    Behavioral and pharmacological treatments for children with attention deficit/hyperactivity disorder (ADHD) were evaluated to address whether endpoint outcomes are better depending on which treatment is initiated first and, in case of insufficient response to initial treatment, whether increasing dose of initial treatment or adding the other treatment modality is superior. Children with ADHD (ages 5-12, N = 146, 76% male) were treated for 1 school year. Children were randomized to initiate treatment with low doses of either (a) behavioral parent training (8 group sessions) and brief teacher consultation to establish a Daily Report Card or (b) extended-release methylphenidate (equivalent to .15 mg/kg/dose bid). After 8 weeks or at later monthly intervals as necessary, insufficient responders were rerandomized to secondary interventions that either increased the dose/intensity of the initial treatment or added the other treatment modality, with adaptive adjustments monthly as needed to these secondary treatments. The group beginning with behavioral treatment displayed significantly lower rates of observed classroom rule violations (the primary outcome) at study endpoint and tended to have fewer out-of-class disciplinary events. Further, adding medication secondary to initial behavior modification resulted in better outcomes on the primary outcomes and parent/teacher ratings of oppositional behavior than adding behavior modification to initial medication. Normalization rates on teacher and parent ratings were generally high. Parents who began treatment with behavioral parent training had substantially better attendance than those assigned to receive training following medication. Beginning treatment with behavioral intervention produced better outcomes overall than beginning treatment with medication. PMID:26882332

  7. Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use

    Science.gov (United States)

    Gelberg, Lillian; Andersen, Ronald M.; Afifi, Abdelmonem A.; Leake, Barbara D.; Arangua, Lisa; Vahidi, Mani; Singleton, Kyle; Yacenda-Murphy, Julia; Shoptaw, Steve; Fleming, Michael F.; Baumeister, Sebastian E.

    2015-01-01

    Aims To assess the effect of a multi-component primary care (PC)-delivered BI for reducing risky drug use (RDU) among patients identified by screening. Design Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated. Setting Primary care waiting rooms of 5 federally qualified health centers (FQHCs) in Los Angeles County (LAC), USA. Participants 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4–26) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet PCs; 261 (78%) completed follow-up. Mean age was 41.7 years; 63% were male; 38% were Caucasian. Intervention(s) and Measurement Intervention patients received brief (typically 3–4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet, and up to two 20–30 minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up. Findings Intervention and control patients reported equivalent baseline HSD use; at follow-up, after adjustment for covariates in a linear regression model, intervention patients reported using their HSD an average of 2.21 fewer days in the previous month than controls (p0.10). Conclusions A clinician-delivered brief intervention with follow-up counseling calls may decrease drug use among risky users compared with usual care in low-income community health centers of Los Angeles County, USA. PMID:26471159

  8. Strengths-based positive psychology interventions: A randomized placebo-controlled online trial on long-term effects for a signature strengths- vs. a lesser strengths-intervention

    Directory of Open Access Journals (Sweden)

    René T. Proyer

    2015-04-01

    Full Text Available Recent years have seen an increasing interest in research in positive psychology interventions. There is broad evidence for their effectiveness in increasing well-being and ameliorating depression. Intentional activities that focus on those character strengths, which are most typical for a person (i.e., signature strengths and encourage their usage in a new way have been identified as highly effective. The current study aims at comparing an intervention aimed at using signature strengths with one on using individual low scoring (or lesser strengths in a randomized placebo-controlled trial. A total of 375 adults were randomly assigned to one of the two intervention conditions (i.e., using five signature vs. five lesser strengths in a new way or a placebo control condition (i.e., early memories. We measured happiness and depressive symptoms at five time points (i.e., pre- and post-test, 1-, 3-, and 6-months follow-ups and character strengths at pre-test. The main findings are that (1 there were increases in happiness for up to three months and decreased depressive symptoms in the short term in both intervention conditions; (2 participants found working with strengths equally rewarding (enjoyment and benefit in both conditions; (3 those participants that reported generally higher levels of strengths benefitted more from working on lesser strengths rather than signature strengths and those with comparatively lower levels of strengths tended to benefit more from working on signature strengths; and (4 deviations from an average profile derived from a large sample of German-speakers completing the Values-in-Action Inventory of Strengths (VIA-IS were associated with greater benefit from the interventions in the signature strengths intervention. We conclude that working on character strengths is effective for increasing happiness and discuss how these interventions could be tailored to the individual for promoting their effectiveness.

  9. A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

    Science.gov (United States)

    Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-01-01

    Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (Prape myths (Prape victims (Prape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P<.001), and less comfort with other men’s inappropriate behaviors (P<.001). Conclusions Our results support the

  10. Characteristics of control group participants who increased their physical activity in a cluster-randomized lifestyle intervention trial

    Directory of Open Access Journals (Sweden)

    Fjeldsoe Brianna S

    2011-01-01

    Full Text Available Abstract Background Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants. Methods Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166 and intervention group (n = 175 participants. Results Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants. Conclusion This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity

  11. Reducing the Risk of Internalizing Symptoms among High-risk Hispanic Youth through a Family Intervention: A Randomized Controlled Trial.

    Science.gov (United States)

    Perrino, Tatiana; Pantin, Hilda; Huang, Shi; Brincks, Ahnalee; Brown, C Hendricks; Prado, Guillermo

    2016-03-01

    Familias Unidas is an intervention that has been found to be efficacious in preventing and reducing substance use, sexual risk, and problem behaviors among Hispanic youth. While it does not specifically target youth internalizing symptoms, the intervention works to strengthen parenting and family factors associated with reduced risk of internalizing symptoms (i.e., depression, anxiety symptoms). This study examines the effects of Familias Unidas on internalizing symptoms among high-risk youth, as well as the role of family level factors in the intervention's effects. A total of 242 12-17-year-old Hispanic youth with a history of delinquency and their primary caregivers were recruited from the school and juvenile justice systems, and randomly assigned to the Familias Unidas intervention or community practice control. A linear latent growth model was used to examine intervention effects on the trajectory of adolescent internalizing symptoms from baseline to 6 and 12 months post-baseline. Results show that the Familias Unidas intervention was more efficacious than control in reducing youth internalizing symptoms. Baseline youth externalizing and internalizing symptoms did not moderate the intervention's effects on the trajectory of youth internalizing symptoms. While parent-adolescent communication did not significantly moderate the intervention's effects, changes in parent-adolescent communication mediated the intervention's effects on internalizing symptoms, showing stronger intervention effects for youth starting with poorer communication. Findings indicate that the Familias Unidas intervention can reduce internalizing symptoms among high-risk Hispanic youth, and that improving parent-youth communication, a protective family factor, may be one of the mechanisms by which the intervention influences youth internalizing symptoms. PMID:25683164

  12. The Effects of a 12-Week Faculty and Staff Exercise Program on Health-Related Variables in a University Setting

    OpenAIRE

    Michael J Rebold; KOBAK, MALLORY S.; PEROUTKY, KYLENE; GLICKMAN, ELLEN L.

    2015-01-01

    The obesity epidemic has grown in the past decade due to physical inactivity (i.e., having a sedentary job) and an increase in caloric intake. This problem combined with the reluctance of many faculty and staff members exercising in the same environment as student’s presents a unique challenge in an academic setting. The purpose of this study was to examine the effectiveness of a 12-week exercise program focused toward the faculty and staff in improving several health-related variables such a...

  13. Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

    Science.gov (United States)

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

  14. Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

    Science.gov (United States)

    Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

    2012-01-01

    Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

  15. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick s

  16. Randomized controlled trial of dietary intervention: association between level of urinary phenolics and anti-mutagenicity.

    Science.gov (United States)

    Malaveille, Christian; Fiorini, Laura; Bianchini, Monica; Davico, Laura; Bertinetti, Sabrina; Allegro, Giovanni; Hautefeuille, Agnès; Sacerdote, Carlotta; Vineis, Paolo

    2004-07-11

    We have undertaken a randomized trial to confirm the ability of a class of phenolics, flavonoids, to increase urinary anti-mutagenicity in smokers. Ninety heavy smokers were recruited and randomly assigned to three groups, who were given three different diets. One diet was rich in flavonoids, but not based on supplementation ('flavonoid'), one was a normal iso-caloric diet with an adequate administration of fruit and vegetables ('normal'), and one was based on supplementation of flavonoids in the form of green tea and soy products ('supplement'). The urinary anti-mutagenicity-as inhibiting effect of the urinary extracts on the mutations induced by MeIQx-was measured in Salmonella typhimurium YG1024 in the presence of liver S9 from male Sprague-Dawley rats treated with Aroclor 1254. The amount of total phenolics in the urinary extracts was measured by use of spectrometric analysis. We found that important dietary modifications can be achieved through special recipes and instructions given by a cook during an intensive course. The intervention was focused on increasing the flavonoid intake, and it was successful in that respect. In fact, differences in flavonoid intake were appreciated mainly between the first group (normal diet) and the other two (flavonoid-rich and supplemented diet), suggesting that dietary modification can be as effective as supplementation. However, both urinary anti-mutagenicity and the amounts of urinary phenolics did not change as a consequence of the trial. These results suggest that only a small fraction of urinary phenolics is influenced by dietary changes in the intake of flavonoids, and that most urinary anti-mutagens and phenolics are metabolites of dietary flavonoids, whose formation is more affected by the activity and diversity of bacterial flora in the colon than by the quantity and type of intake. A strong correlation was found between urinary phenolics and anti-mutagenicity in all the groups involved in the trial. Such correlation

  17. Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Patricia Bourgault

    Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

  18. Impact of a brief intervention on physical activity and social cognitive determinants among working mothers: a randomized trial.

    Science.gov (United States)

    Mailey, Emily L; McAuley, Edward

    2014-04-01

    Working mothers exhibit high levels of inactivity, and theory-based interventions to bolster physical activity within this population are needed. This study examined the effectiveness of a brief social cognitive theory-based intervention designed to increase physical activity among working mothers. Participants (N = 141) were randomly assigned to an intervention only, intervention plus follow-up support, or waitlist control condition. The intervention consisted of two group-based workshop sessions designed to teach behavior modification strategies using social cognitive theory. Data were collected at baseline, immediately post-intervention, and 6-month follow-up. Results showed intervention participants exhibited short-term increases in physical activity, which were partially maintained 6 months later. Improvements in physical activity were mediated by increases in self-regulation and self-efficacy. This study provides some support for the effectiveness of a brief intervention to increase physical activity among working mothers. Future programs should explore alternative support mechanisms which may lead to more effective maintenance of initial behavior changes. PMID:23338616

  19. A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students

    Directory of Open Access Journals (Sweden)

    Coumaravelou Saravanan

    2014-01-01

    Full Text Available Background: Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Materials and Methods: Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1 st year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. Results: After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P < 0.01 and high intrinsic and extrinsic motivation (P < 0.01 in the postassessment compared with their preassessment scores. Conclusion: Overall psychological intervention is effective to reduce anxiety scores and its related variables.

  20. A randomized control study of psychological intervention to reduce anxiety, amotivation and psychological distress among medical students

    Science.gov (United States)

    Saravanan, Coumaravelou; Kingston, Rajiah

    2014-01-01

    Background: Test anxiety aggravates psychological distress and reduces the motivation among graduate students. This study aimed to identify psychological intervention for test anxiety, which reduces the level of psychological distress, amotivation and increases the intrinsic and extrinsic motivation among medical students. Materials and Methods: Westside test anxiety scale, Kessler Perceived Stress Scale and Academic Motivation Scale were used to measure test anxiety, psychological distress and motivation on 436 1st year medical students. Out of 436 students, 74 students who exhibited moderate to high test anxiety were randomly divided into either experimental or waiting list group. In this true randomized experimental study, 32 participants from the intervention group received five sessions of psychological intervention consist of psychoeducation, relaxation therapy and systematic desensitization. Thirty-three students from waiting list received one session of advice and suggestions. Results: After received psychological intervention participants from the intervention group experienced less anxiety, psychological distress, and amotivation (P motivation (P < 0.01) in the postassessment compared with their preassessment scores. Conclusion: Overall psychological intervention is effective to reduce anxiety scores and its related variables. PMID:25097619

  1. Engaging nurses in research for a randomized clinical trial of a behavioral health intervention.

    Science.gov (United States)

    Roll, Lona; Stegenga, Kristin; Hendricks-Ferguson, Verna; Barnes, Yvonne J; Cherven, Brooke; Docherty, Sharron L; Robb, Sheri L; Haase, Joan E

    2013-01-01

    Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses) include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA) undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings. PMID:24102024

  2. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial.

    Science.gov (United States)

    Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

  3. Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

    Directory of Open Access Journals (Sweden)

    Lona Roll

    2013-01-01

    Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

  4. Preventing Weight Gain One-Year Results of a Randomized Lifestyle Intervention : one-year results of a randomized lifestyle intervention

    NARCIS (Netherlands)

    ter Bogt, Nancy C. W.; Bemelmans, Wanda J. E.; Beltman, Frank W.; Broer, Jan; Smit, Andries J.; van der Meer, Klaas

    2009-01-01

    Background: Lifestyle interventions targeting prevention of weight gain may have better long-term success than when aimed at weight loss. Limited evidence exists about such an approach in the primary care setting. Design: An RCT was conducted. Setting/Participants were 457 overweight or obese patien

  5. Effect of 12 Weeks of Accelerated Rehabilitation Exercise on Muscle Function of Patients with ACL Reconstruction of the Knee Joint.

    Science.gov (United States)

    Lee, Joong-Chul; Kim, Ji Youn; Park, Gi Duck

    2013-12-01

    [Purpose] To examine changes in the knee joint's isokinetic muscle functions following systematic and gradual rehabilitation exercises lasting for 12 weeks for male and female patients who underwent anterior cruciate ligament (ACL) reconstruction. Differences in muscle functions between the uninvolved side (US) and the involved side (IS) before surgery, differences in muscle functions between US and IS after rehabilitation exercises lasting for 12 weeks, and changes in muscle functions on US and IS between before and after surgery were analyzed to examine the effects of accelerated rehabilitation exercises after ACL reconstruction. [Subjects] The study subjects were 10 patients, five females and five males, who underwent ACL reconstruction performed by the same surgeon. [Methods] As a measuring tool, a Biodex Multi-joint system 3pro (USA), which is an isokinetic measuring device, was used to examine the flexion and extension forces of the knee joint. During isokinetic muscle strength evaluation, the ROM of US was set to be the same as that of IS for consistency of measurement. [Results] At 60°/s, the isokinetic muscle functions of the females did not show any significant change between before and after surgery in any of the variables on both US and IS. At 60°/s, the isokinetic muscle functions of the males did not show any significant change between before and after surgery in the peak torque, average power, and entire work done on US. In extension, peak torque on IS did not show any significant change.

  6. Strengths-based positive psychology interventions: a randomized placebo-controlled online trial on long-term effects for a signature strengths- vs. a lesser strengths-intervention.

    Science.gov (United States)

    Proyer, René T; Gander, Fabian; Wellenzohn, Sara; Ruch, Willibald

    2015-01-01

    Recent years have seen an increasing interest in research in positive psychology interventions. There is broad evidence for their effectiveness in increasing well-being and ameliorating depression. Intentional activities that focus on those character strengths, which are most typical for a person (i.e., signature strengths, SS) and encourage their usage in a new way have been identified as highly effective. The current study aims at comparing an intervention aimed at using SS with one on using individual low scoring (or lesser) strengths in a randomized placebo-controlled trial. A total of 375 adults were randomly assigned to one of the two intervention conditions [i.e., using five signature vs. five lesser strengths (LS) in a new way] or a placebo control condition (i.e., early memories). We measured happiness and depressive symptoms at five time points (i.e., pre- and post-test, 1-, 3-, and 6-months follow-ups) and character strengths at pre-test. The main findings are that (1) there were increases in happiness for up to 3 months and decreases in depressive symptoms in the short term in both intervention conditions; (2) participants found working with strengths equally rewarding (enjoyment and benefit) in both conditions; (3) those participants that reported generally higher levels of strengths benefitted more from working on LS rather than SS and those with comparatively lower levels of strengths tended to benefit more from working on SS; and (4) deviations from an average profile derived from a large sample of German-speakers completing the Values-in-Action Inventory of Strengths were associated with greater benefit from the interventions in the SS-condition. We conclude that working on character strengths is effective for increasing happiness and discuss how these interventions could be tailored to the individual for promoting their effectiveness.

  7. Changes in stress and coping from a randomized controlled trial of a three-month stress management intervention

    DEFF Research Database (Denmark)

    Willert, M.V.; Thulstrup, A.M.; Hertz, J.;

    2009-01-01

    Objectives The aim of this study was to investigate whether it group-based stress management intervention, based on principles from cognitive behavior therapy, call reduce stress and alter coping strategies in an occupationally diverse population with extensive symptoms of work-related stress....... Methods Using a randomized wait list control design, 102 participants were divided into two groups: intervention and wait list control. The intervention was a three-month group-based stress management program. Outcomes measures were the Perceived Stress Scale (PSS-10, range 0-40 points) and five......% Cl -0.89-0.07) favouring the intervention. The gains achieved during treatment were maintained when followed up three months later. Conclusions Treatment is Superior to the control condition in positively affecting perceived stress and positive reframing. When followed up, the gains achieved...

  8. A Randomized Controlled Trial of an Individualized Preoperative Education Intervention for Symptom Management After Total Knee Arthroplasty.

    Science.gov (United States)

    Wilson, Rosemary A; Watt-Watson, Judith; Hodnett, Ellen; Tranmer, Joan

    2016-01-01

    Pain and nausea limit recovery after total knee arthroplasty (TKA) patients. The aim of this study was to determine the effect of a preoperative educational intervention on postsurgical pain-related interference in activities, pain, and nausea. Participants (n = 143) were randomized to intervention or standard care. The standard care group received the usual teaching. The intervention group received the usual teaching, a booklet containing symptom management after TKA, an individual teaching session, and a follow-up support call. Outcome measures assessed pain, pain interference, and nausea. There were no differences between groups in patient outcomes. There were no group differences for pain at any time point. Respondents had severe postoperative pain and nausea and received inadequate doses of analgesia and antiemetics. Individualizing education content was insufficient to produce a change in symptoms for patients. Further research involving the modification of system factors affecting the provision of symptom management interventions is warranted. PMID:26814004

  9. Single-session interventions for problem gambling may be as effective as longer treatments: Results of a randomized control trial.

    Science.gov (United States)

    Toneatto, Tony

    2016-01-01

    Empirically supported treatments for problem gambling tend to be multimodal combining cognitive, behavior and motivational interventions. Since problem gamblers often prefer briefer treatments it is important that interventions adopt strategies that are optimally effective. In this study, 99 community-recruited problem gamblers (74% male, mean age: 47.5 years) were randomized to one of four treatments: six sessions of cognitive therapy, behavior therapy, and motivational therapy or a single-session intervention. The sample was followed up for 12 months post-treatment. In both the Intent-to-Treat and Completer statistical analyses, no significant group differences on key gambling variables (i.e., frequency, expenditures, severity) were found. All four treatments showed significant improvement as a result of treatment that endured throughout the follow-up period. These results, although preliminary, suggest that very brief, single-session interventions may be as effective as longer treatments.

  10. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  11. A randomized, controlled study of an online intervention to promote job satisfaction and well-being among physicians

    Directory of Open Access Journals (Sweden)

    Liselotte N. Dyrbye

    2016-09-01

    Full Text Available Although burnout, poor quality of life (QOL, depression, and other forms of psychological distress are common among physicians, few studies testing interventions to reduce distress have been reported. We conducted a randomized trial to determine the impact of a 10-week, individualized, online intervention on well-being among physicians (n = 290. Participants were randomized to either the intervention or control arm. Those in the intervention arm received a menu of self-directed micro-tasks once a week for 10 weeks, and were asked to select and complete one task weekly. Baseline and end-of-study questionnaires evaluating well-being (i.e., burnout, depression, QOL, fatigue and professional satisfaction (i.e., job satisfaction, work engagement, meaning in work, and satisfaction with work-life balance were administered to both arms. Overall quality of life and fatigue improved over the 10 weeks of the study for those in the intervention arm (both p < 0.01. When compared to the control arm, however, no statistically significant improvement in these dimensions of well-being was observed. At the completion of the study, those in the intervention arm were more likely to report participating in the study was worthwhile compared to those in the control arm. The findings suggest that although participants found the micro-tasks in the intervention arm worthwhile, they did not result in measurable improvements in well-being or professional satisfaction when compared to the control group. These results also highlight the critical importance of an appropriate control group in studies evaluating interventions to address physician burnout and distress.

  12. Issues Relating to Confounding and Meta-analysis When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    Science.gov (United States)

    Valentine, Jeffrey C.; Thompson, Simon G.

    2013-01-01

    Background: Confounding caused by selection bias is often a key difference between non-randomized studies (NRS) and randomized controlled trials (RCTs) of interventions. Key methodological issues: In this third paper of the series, we consider issues relating to the inclusion of NRS in systematic reviews on the effects of interventions. We discuss…

  13. A randomized multifactorial intervention study for prevention of ischaemic heart disease (Inter99): The long-term effect on physical activity

    DEFF Research Database (Denmark)

    Smith, L.V.H.; Ladelund, S.; Borch-Johnsen, K.;

    2008-01-01

    AIM: To examine the effect of a randomized multiple risk factor intervention study for prevention of ischaemic heart disease (IHD) on the development in physical activity over a 36-month period. METHODS: Two random samples (high intensity intervention, group A, n=11,708; low intensity interventio...

  14. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study.

    Directory of Open Access Journals (Sweden)

    Maria Rubio-Valera

    Full Text Available Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care.Patients were recruited by general practitioners and randomized to community pharmacist intervention (87 that received an educational intervention and usual care (92. Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs, use of healthcare services and productivity losses were measured at baseline, 3 and 6 months.There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective. From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000.A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended.ClinicalTrials.gov NCT

  15. The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Shu-Ling Huang

    Full Text Available This study aims to intensively evaluate the effectiveness of mindfulness-based intervention (MBI on mental illness risks (including psychological distress, prolonged fatigue, and perceived stress and job strain (job control and job demands for employees with poor mental health.A longitudinal research design was adopted. In total, 144 participants were randomized to the intervention group or the control group. The intervention group participated in MBI for eight weeks. Measurements were collected for both groups at five time points: at pre-intervention (T1, at mid-intervention (T2, at the completion of intervention (T3, four weeks after intervention (T4, and eight weeks after intervention (T5. Data were analyzed according to the intention-to-treat principle. A linear mixed model with two levels was employed to analyze the repeated measurement data.Compared with the control group, the intercepts (means at T3 for the intervention group were significantly lower on psychological distress, prolonged fatigue, and perceived stress when MBI was completed. Even with the demographic variables controlled, the positive effects remained. For growth rates of prolonged fatigue and perceived stress, participants in the intervention group showed a steeper decrease than did the participants in the control group. Regarding job strain, although the intercept (mean at T3 of job demands showed a significant decline when BMI was completed, the significance disappeared when the demographic variables were controlled. Moreover, the other results for job control and job demands did not show promising findings.As a workplace health promotion program, the MBI seems to have potential in improving mental illness risks for employees with poor mental health. However, there was insufficient evidence to support its effect on mitigating job strain. Further research on maintaining the positive effects on mental health for the long term and on developing innovative MBI to suit job

  16. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Prchal Alice

    2012-01-01

    Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

  17. Comparison of Explicit Forgiveness Interventions with an Alternative Treatment: A Randomized Clinical Trial

    Science.gov (United States)

    Wade, Nathaniel G.; Worthington, Everett L.; Haake, Shawn

    2009-01-01

    Forgiveness interventions can help people forgive past offenses. However, few studies have compared forgiveness interventions with genuine alternative treatments. The authors compared forgiveness interventions with a therapeutic alternative treatment. Participants reduced unforgiveness and increased forgiveness regardless of treatment condition.…

  18. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    Science.gov (United States)

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases.

  19. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    Science.gov (United States)

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases. PMID:24611630

  20. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach. PMID:26132048

  1. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies

    Directory of Open Access Journals (Sweden)

    Sheridan Stacey L

    2011-12-01

    Full Text Available Abstract Background Efficacious strategies for the primary prevention of coronary heart disease (CHD are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice. Methods We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk and self-reported adherence between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved. Results We randomized 160 eligible patients (81 intervention; 79 control and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%, with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%, with a larger effect in a pre-specified subgroup of high risk patients. Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk. Clinical trials registration number Clinical

  2. A teachable moment communication process for smoking cessation talk: description of a group randomized clinician-focused intervention

    Directory of Open Access Journals (Sweden)

    Flocke Susan A

    2012-05-01

    Full Text Available Abstract Background Effective clinician-patient communication about health behavior change is one of the most important and most overlooked strategies to promote health and prevent disease. Existing guidelines for specific health behavior counseling have been created and promulgated, but not successfully adopted in primary care practice. Building on work focused on creating effective clinician strategies for prompting health behavior change in the primary care setting, we developed an intervention intended to enhance clinician communication skills to create and act on teachable moments for smoking cessation. In this manuscript, we describe the development and implementation of the Teachable Moment Communication Process (TMCP intervention and the baseline characteristics of a group randomized trial designed to evaluate its effectiveness. Methods/Design This group randomized trial includes thirty-one community-based primary care clinicians practicing in Northeast Ohio and 840 of their adult patients. Clinicians were randomly assigned to receive either the Teachable Moments Communication Process (TMCP intervention for smoking cessation, or the delayed intervention. The TMCP intervention consisted of two, 3-hour educational training sessions including didactic presentation, skill demonstration through video examples, skills practices with standardized patients, and feedback from peers and the trainers. For each clinician enrolled, 12 patients were recruited for two time points. Pre- and post-intervention data from the clinicians, patients and audio-recorded clinician‒patient interactions were collected. At baseline, the two groups of clinicians and their patients were similar with regard to all demographic and practice characteristics examined. Both physician and patient recruitment goals were met, and retention was 96% and 94% respectively. Discussion Findings support the feasibility of training clinicians to use the Teachable Moments

  3. Improving Quality of Life in Men With Prostate Cancer: A Randomized Controlled Trial of Group Education Interventions

    OpenAIRE

    Lepore, Stephen J.; Helgeson, Vicki S.; Eton, David T; Schulz, Richard

    2003-01-01

    Men who were recently treated for prostate cancer (N = 250) were randomly assigned to a control group, a group education intervention (GE), or a group education-plus-discussion intervention (GED). Both GE and GED increased prostate cancer knowledge. In the year postintervention, men in the GED condition were less bothered by sexual problems than men in the control condition, and they were more likely to remain steadily employed (93.0%) than men in the GE (75.6%) or control (72.5%) conditions....

  4. Issues Relating to Study Design and Risk of Bias When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    Science.gov (United States)

    Higgins, Julian P. T.; Ramsay, Craig; Reeves, Barnaby C.; Deeks, Jonathan J.; Shea, Beverley; Valentine, Jeffrey C.; Tugwell, Peter; Wells, George

    2013-01-01

    Non-randomized studies may provide valuable evidence on the effects of interventions. They are the main source of evidence on the intended effects of some types of interventions and often provide the only evidence about the effects of interventions on long-term outcomes, rare events or adverse effects. Therefore, systematic reviews on the effects…

  5. The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia: a randomized controlled trial

    NARCIS (Netherlands)

    Prick, A.J.C.; Lange, J. de; Scherder, E.; Twisk, J.; Pot, A.M.

    2016-01-01

    Purpose: The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia living in the community were evaluated in a randomized controlled trial. This multicomponent dyadic intervention is a translated and adapted version of an intervention that

  6. An economic evaluation alongside a randomized controlled trial evaluating an individually tailored lifestyle intervention compared with usual care in people with Familial Hypercholesterolemia.

    NARCIS (Netherlands)

    Broekhuizen, K.; Wier, M.F. van; Koppes, L.L.J.; Brug, J.; Mechelen, W. van; Bosmans, J.E.; Poppel, M.N.M. van

    2015-01-01

    Background: Cost-effectiveness analyses provide insight in the use of lifestyle interventions. To evaluate the cost-effectiveness of a lifestyle intervention compared to usual care in people with Familial Hypercholesterolemia, 340 people with FH were randomized to the intervention or control group.

  7. An economic evaluation alongside a randomized controlled trial evaluating an individually tailored lifestyle intervention compared with usual care in people with Familial Hypercholesterolemia

    NARCIS (Netherlands)

    Broekhuizen, K.; Wier, M.F. van; Koppes, L.L.J.; Brug, J.; Mechelen, W. van; Bosmans, J.E.; Poppel, M.N.

    2015-01-01

    Background: Cost-effectiveness analyses provide insight in the use of lifestyle interventions. To evaluate the cost-effectiveness of a lifestyle intervention compared to usual care in people with Familial Hypercholesterolemia, 340 people with FH were randomized to the intervention or control group.

  8. The influence of maternal age on the outcomes of pregnancies complicated by bleeding at less than 12 weeks.

    Science.gov (United States)

    Mbugua Gitau, Godfrey; Liversedge, Helen; Goffey, Dawn; Hawton, Annemarie; Liversedge, Neil; Taylor, Myles

    2009-01-01

    The effect of maternal age on the outcome of threatened miscarriage after ultrasound has confirmed fetal heart (FH) pulsation was assessed. At a university teaching hospital, 138 women presenting with bleeding before 12 weeks' gestation were followed up until delivery or pregnancy loss. Those with multiple or ectopic pregnancy, social termination of pregnancy, assisted conception and temporary residence were excluded. Outcome measures were pregnancy loss, fetal abnormalities, preterm delivery, low birthweight and cesarean delivery. Age over 35 years was significantly associated with reduced live-birth and increased miscarriage rates. Women over 35 years of age had higher cesarean section and pregnancy loss rates than the younger women. The combination of bleeding in early pregnancy and advanced age increases risk of pregnancy loss even after ultrasound has confirmed FH pulsation. PMID:19140048

  9. Effect of birth weight and 12 weeks of exercise training on exercise-induced AMPK signaling in human skeletal muscle

    DEFF Research Database (Denmark)

    Mortensen, Brynjulf; Hingst, Janne Rasmuss; Frederiksen, Nicklas;

    2013-01-01

    Subjects with a low birth weight (LBW) display increased risk of developing type 2 diabetes (T2D). We hypothesized that this is associated with defects in muscle adaptations following acute and regular physical activity, evident by impairments in the exercise-induced activation of AMPK signaling....... We investigated 21 LBW and 21 normal birth weight (NBW) subjects during 1 hour of acute exercise performed at the same relative workload before and after 12 weeks of exercise training. Multiple skeletal muscle biopsies were obtained before and after exercise. Protein levels and phosphorylation status......, adenine nucleotides as well as Hexokinase II mRNA levels were all reduced after exercise training. Increased exercise-induced muscle AMPK activation and ACC2 Ser(221) phosphorylation in LBW subjects may indicate a more sensitive AMPK system in this population. Long term exercise training may reduce...

  10. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa

    Directory of Open Access Journals (Sweden)

    Wanga Zembe-Mkabile

    2014-08-01

    Full Text Available Background: Cash transfers (CTs are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30. Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. Methods: This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. Results: At the 12-week visit, half (52% of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327 of all children had received the CSG. Conclusions: In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery.

  11. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study

    Directory of Open Access Journals (Sweden)

    Lee Tsz

    2010-10-01

    Full Text Available Abstract Background Decreased bone mineral density and osteoporosis in postmenopausal women represents a growing source of physical limitations and financial concerns in our aging population. While appropriate medical treatments such as bisphosphonate drugs and hormone replacement therapy exist, they are associated with serious side effects such as osteonecrosis of the jaw or increased cardiovascular risk. In addition to calcium and vitamin D supplementation, previous studies have demonstrated a beneficial effect of dietary silicon on bone health. This study evaluated the absorption of silicon from bottled artesian aquifer water and its effect on markers of bone metabolism. Methods Seventeen postmenopausal women with low bone mass, but without osteopenia or osteoporosis as determined by dual x-ray absorptiometry (DEXA were randomized to drink one liter daily of either purified water of low-silicon content (PW or silicon-rich artesian aquifer water (SW (86 mg/L silica for 12 weeks. Urinary silicon and serum markers of bone metabolism were measured at baseline and after 12 weeks and analyzed with two-sided t-tests with p Results The urinary silicon level increased significantly from 0.016 ± 0.010 mg/mg creatinine at baseline to 0.037 ± 0.014 mg/mg creatinine at week 12 in the SW group (p = 0.003, but there was no change for the PW group (0.010 ± 0.004 mg/mg creatinine at baseline vs. 0.009 ± 0.006 mg/mg creatinine at week 12, p = 0.679. The urinary silicon for the SW group was significantly higher in the silicon-rich water group compared to the purified water group (p Conclusions These findings indicate that bottled water from artesian aquifers is a safe and effective way of providing easily absorbed dietary silicon to the body. Although the silicon did not affect bone turnover markers in the short-term, the mineral's potential as an alternative prevention or treatment to drug therapy for osteoporosis warrants further longer-term investigation

  12. Changed activation, oxygenation, and pain response of chronically painful muscles to repetitive work after training interventions: a randomized controlled trial

    DEFF Research Database (Denmark)

    Søgaard, Karen; Blangsted, Anne Katrine; Nielsen, Pernille Kofoed;

    2012-01-01

    assigned to: (1) general fitness training performed as leg-bicycling (GFT); (2) specific strength training of the neck/shoulder muscles (SST) or (3) reference intervention without physical exercise. Electromyographic activity (EMG), tissue oxygenation (near infrared spectroscopy), and pain intensity were......The aim of this randomized controlled trial was to assess changes in myalgic trapezius activation, muscle oxygenation, and pain intensity during repetitive and stressful work tasks in response to 10 weeks of training. In total, 39 women with a clinical diagnosis of trapezius myalgia were randomly...... measured in trapezius during pegboard and stress tasks before and after the intervention period. During the pegboard task, GFT improved trapezius oxygenation from a relative decrease of -0.83 ± 1.48 μM to an increase of 0.05 ± 1.32 μM, and decreased pain development by 43%, but did not affect resting...

  13. The effect of a structured intervention on caregivers of patients with dementia and problem behaviors: a randomized controlled pilot study.

    Science.gov (United States)

    Nobili, Alessandro; Riva, Emma; Tettamanti, Mauro; Lucca, Ugo; Liscio, Mariarosaria; Petrucci, Bianca; Porro, Gabriella Salvini

    2004-01-01

    The objective was to assess the effect of a structured intervention on caregiver stress and the institutionalization rate of patients with dementia and problem behaviors. Caregivers contacting the Federazione Alzheimer Italia (AI) to receive help, advice, or information in relation to problem behaviors of outpatients were enrolled. Eligible caregiver-patient dyads were randomized to receive either a structured intervention or the counseling AI usually provides (control group). After basal assessment, families were reassessed at 6 and 12 months. Problem behavior (particularly agitation) was the only variable significantly correlated (P = 0.006) with the baseline caregivers' stress score. Thirty-nine families completed the 12-month follow-up; the mean problem behavior score was significantly lower in the intervention than the control group (p < 0.03); the time needed for care of the patient increased by 0.5 +/- 9.7 hours/day in the control group and decreased by 0.3 +/- 4.1 in the intervention group (p = 0.4, Wilcoxon test). The main determinant of institutionalization seemed to be the level of caregiver stress (p = 0.03). In patients of the intervention group, there was a significant reduction in the frequency of delusions. This pilot study suggests that caregiver stress is relieved by a structured intervention. The number of families lost to follow-up, the relatively short duration of the study, and the ceiling effect due to the severity of the clinical characteristics of patients probably all partly dilute the observed findings.

  14. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    Science.gov (United States)

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  15. Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial.

    Science.gov (United States)

    Albert, Dustin; Belsky, Daniel W; Crowley, D Max; Latendresse, Shawn J; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M; Dodge, Kenneth A

    2015-01-01

    Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track randomized control trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era.

  16. Parent-directed intervention for children with cancer-related neurobehavioral late effects: a randomized pilot study.

    Science.gov (United States)

    Patel, Sunita K; Ross, Paula; Cuevas, Michelle; Turk, Anne; Kim, Heeyoung; Lo, Tracy T Y; Wong, Lennie F; Bhatia, Smita

    2014-10-01

    OBJECTIVE : To evaluate feasibility and preliminary efficacy of an intervention directed at parents of childhood cancer survivors (CCSs) with neurobehavioral late effects to improve targeted parenting skills, and thus to indirectly benefit the child's educational functioning.  METHODS : 44 CCSs and their parents were randomized. Intervention-arm parents participated in eight individual training sessions augmented by a 3-month telephone support period. Pre- and postparent measures and child performance on Wechsler Individual Achievement Test-II and School Motivation and Learning Strategies Inventory assessed intervention effects.  RESULTS : 90% of intervention parents completed the program with high adherence/perceived benefit. Between-group effect sizes ranged from d = 0.77 to d = 1.45 for parent knowledge, efficacy, frequency of pro-learning behaviors, and d = 0.21 to d = 0.76 for child academic scores. Parental time spent in intervention activities was associated with academic change.  CONCLUSIONS : A parent-directed intervention to indirectly promote academic functioning in CCSs appears feasible and effective in improving targeted parenting outcomes and for selected child academic outcomes. PMID:24966398

  17. A workplace exercise versus health promotion intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel

    DEFF Research Database (Denmark)

    Johnston, V; O'Leary, S; Comans, T;

    2014-01-01

    -intervention and 12 months after commencement. PROCEDURE: 640 volunteering office personnel will be randomly allocated to either an intervention or control arm in work group clusters. ANALYSIS: Analysis will be on an 'intent-to-treat' basis and per protocol. Multilevel, generalised linear models will be used...... controlled trial. PARTICIPANTS AND SETTING: Office personnel aged over 18 years, and who work>30 hours/week. INTERVENTION: Individualised best practice ergonomics intervention plus 3×20 minute weekly, progressive neck/shoulder girdle exercise group sessions for 12 weeks. CONTROL: Individualised best practice...

  18. Classroom-based Interventions and Teachers’ Perceived Job Stressors and Confidence: Evidence from a Randomized Trial in Head Start Settings

    OpenAIRE

    Zhai, Fuhua; Raver, C. Cybele; Li-Grining, Christine

    2011-01-01

    Preschool teachers’ job stressors have received increasing attention but have been understudied in the literature. We investigated the impacts of a classroom-based intervention, the Chicago School Readiness Project (CSRP), on teachers’ perceived job stressors and confidence, as indexed by their perceptions of job control, job resources, job demands, and confidence in behavior management. Using a clustered randomized controlled trial (RCT) design, the CSRP provided multifaceted services to the...

  19. Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial

    OpenAIRE

    Schmidt, Maria Inês; Bruce B. Duncan; Castilhos, Cristina; Wendland, Eliana Márcia; Hallal, Pedro C; Schaan, Beatriz D’Agord; Drehmer, Michele; Costa e Forti, Adriana; Façanha, Cristina; Nunes, Maria Angélica

    2016-01-01

    Background Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregn...

  20. Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol

    OpenAIRE

    Cunningham, John A; Hendershot, Christian S; Rehm, Jürgen

    2015-01-01

    Background Problem drinking causes great harm to the person and to society. Most problem drinkers will never seek treatment. The current trial will test the efficacy of two Internet interventions for problem drinking – one minimal and the other extended – as an alternate means of providing help to those in need. Methods/Design A double blinded, four-wave panel design with random assignment to two experimental conditions will be used in this study. Participants will be recruited through a comp...

  1. School-based mental health intervention for children in war-affected Burundi: a cluster randomized trial

    OpenAIRE

    Tol, W.A.; Komproe, I. H.; Jordans, M. J. D.; Ndayisaba, A.; Ntamatumba, P.; Sipsma, H.; Smallegange, E.S.; Macy, R.D.; Jong, de, J.

    2014-01-01

    Background: Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents. We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder, depression, and anxiety (treatment aim); and improving a sense of hope and functioning (preventive aim). Methods: We conducted a cluster randomized trial with 329 children in war-affected Burundi (aged 8 to 17 (mean 12.29 years, standard deviation 1.61...

  2. School-based mental health intervention for children in war-affected Burundi : A cluster randomized trial

    OpenAIRE

    Tol, Wietse A.; Komproe, Ivan H; Jordans, Mark J D; Ndayisaba, Aline; Ntamutumba, Prudence; Sipsma, Heather; Smallegange, Eva S.; Macy, Robert D; de Jong, Joop T. V. M.; Komproe, J

    2014-01-01

    Background: Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents. We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder, depression, and anxiety (treatment aim); and improving a sense of hope and functioning (preventive aim). Methods: We conducted a cluster randomized trial with 329 children in war-affected Burundi (aged 8 to 17 (mean 12.29 years, standard deviation 1.61...

  3. Religious and spiritual interventions in mental health care: a systematic review and meta-analysis of randomized controlled clinical trials

    OpenAIRE

    Gonçalves, J. P. B.; G. Lucchetti; Menezes, P. R.; Vallada, H.

    2015-01-01

    Background. Despite the extensive literature assessing associations between religiosity/spirituality and health, few studies have investigated the clinical applicability of this evidence. The purpose of this paper was to assess the impact of religious/spiritual interventions (RSI) through randomized clinical trials (RCTs). Method. A systematic review was performed in the following databases: PubMed, Scopus, Web of Science, PsycINFO, Cochrane Collaboration, Embase and SciELO. Through the use o...

  4. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.

    Directory of Open Access Journals (Sweden)

    2005-11-01

    Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..

  5. Using community readiness key informant assessments in a randomized group prevention trial: impact of a participatory community-media intervention.

    Science.gov (United States)

    Slater, Michael D; Edwards, Ruth W; Plested, Barbara A; Thurman, Pamela J; Kelly, Kathleen J; Comello, Maria Leonora G; Keefe, Thomas J

    2005-02-01

    This study examines the role of key informant community readiness assessments in a randomized group trial testing the impact of a participatory community-media intervention (which was also complemented by in-school efforts). These assessments were used to help match communities in random assignment, as a source of formative data about the community, as the basis for a coalition-building workshop, and as an evaluation tool, with a follow-up set of surveys approximately 2 years after the baseline survey. Results of the nested, random effects analysis indicated that the intervention influenced community knowledge of efforts and (at marginally significant levels) improved prevention leadership quality and community climate supportive of prevention efforts. There was evidence that the professional affiliation of informants in some cases had an effect on their assessments, which could be controlled in the analysis. The authors conclude that key informant community readiness assessments can usefully serve to supplement aggregated measures of individual attitudes and behavior (reported elsewhere for this study) in evaluating community-based interventions. PMID:15751598

  6. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Effects on distress

    Science.gov (United States)

    Laudenslager, Mark L.; Simoneau, Teri L.; Kilbourn, Kristin; Natvig, Crystal; Philips, Sam; Spradley, Janet; Benitez, Patrick; McSweeney, Peter; Mikulich-Gilbertson, Susan K.

    2015-01-01

    Caregivers of patients receiving allogeneic hematopoietic stem cell transplants (Allo-HSCT) serve a pivotal role in patient care but experience high stress, anxiety, and depression as a result. We theorized that a stress management adapted for Allo-HSCT caregivers would reduce distress compared to treatment as usual (TAU). From 267 consecutive caregivers of Allo-HSCT patients approached, 148 (mean=53.5 years, 75.7% female) were randomized to either psychosocial intervention (n=74) or TAU (n=74). Eight 1-on-1 stress management sessions delivered across the 100 day post-transplant period focused on understanding stress, changing role(s) as caregiver, cognitive behavioral stress management, pacing respiration, and identifying social support. Primary outcomes included perceived stress (psychological) and salivary cortisol awakening response (CAR) (physiological). Randomized groups were not statistically different at baseline. Mixed models analysis of covariance (intent-to-treat) showed that intervention was associated with significantly lower caregiver stress 3 months post-transplant (Mean=20.0, CI95=17.9-22.0) compared to TAU (Mean=23.0, CI95=21.0-25.0) with an effect size (ES) of 0.39 (p=0.039). Secondary psychological outcomes, including depression and anxiety, were significantly reduced with ESs of 0.46 and 0.66 respectively. Caregiver CAR did not differ from non-caregiving controls at baseline and was unchanged by intervention. Despite significant caregiving burden, this psychosocial intervention significantly mitigated distress in Allo-HSCT caregivers. PMID:25961767

  7. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication — A randomized controlled trial

    OpenAIRE

    Wurdak, M.; Wolstein, J; Kuntsche, E.N.

    2015-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in ...

  8. Effectiveness of specific factors in community-based intervention for child-witnesses of interparental violence: a randomized trial.

    Science.gov (United States)

    Overbeek, Mathilde M; de Schipper, J Clasien; Lamers-Winkelman, Francien; Schuengel, Carlo

    2013-12-01

    A community-based intervention with specific factors for children and parents exposed to interparental violence (IPV) was compared with a control intervention based on non-specific factors. We hypothesized that participation in an intervention with specific factors, focused on IPV, parenting and coping, would be associated with better recovery. IPV exposed children and parents were group randomized over a specific factors- and control intervention. Baseline, posttest and follow-up measurements of 155 parents and children (aged 6-12 years, 55.5% boys) were fitted in a multilevel model. Outcomes were parent and teacher reported children's internalizing and externalizing problems (CBCL, TRF), child self-reported depressive symptoms (CDI) and parent and child reported children's post-traumatic stress symptoms (TSCYC, TSCC). Based on intention-to-treat and completer analyses, children in the specific factors intervention did not show better recovery than children in the control intervention. Children in both interventions decreased significantly in parent-reported children's internalizing and externalizing problems and post-traumatic stress symptoms. Children reported a decrease in their mean level of depressive and post-traumatic stress symptoms. Teachers reported a decrease in internalizing problems, but not in externalizing problems. No association between time since exposure and level and course of symptoms was found. Treatment differentiation was assessed and both programs were significantly different on hypothesized effective factors. Higher treatment adherence in both programs did not result in a larger difference in recovery. IPV exposed children improve over the course and after participating in a community-based child- and parent program, but specific factors in intervention may not carry additional benefits when implemented in community settings. PMID:23948313

  9. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial

    Science.gov (United States)

    Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

    2015-01-01

    Background Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. Objective To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. Methods A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online social networking physical activity intervention which included self-monitoring, social elements, and pedometers (“Active Team” Facebook app; n=51 individuals, 12 teams) or a wait-listed control condition (n=59 individuals, 13 teams). Assessments were undertaken online at baseline, 8 weeks, and 20 weeks. The primary outcome measure was self-reported weekly moderate-to-vigorous physical activity (MVPA). Secondary outcomes were weekly walking, vigorous physical activity time, moderate physical activity time, overall quality of life, and mental health quality of life. Analyses were undertaken using random-effects mixed modeling, accounting for potential clustering at the team level. Usage statistics were reported descriptively to determine engagement and feasibility. Results At the 8-week follow-up, the intervention participants had significantly increased their total weekly MVPA by 135 minutes relative to the control group (P=.03), due primarily to increases in walking time (155 min/week increase relative to controls, Psocial networking physical activity intervention with pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www

  10. Effectiveness of a Multidimensional Randomized Control Intervention to Reduce Quartz Exposure Among Construction Workers

    NARCIS (Netherlands)

    Deurssen, E. van; Meijster, T; Oude Hengel, K.M.; Boessen, R.; Spaan, S.; Tielemans, E.; Heederik, D.; Pronk, A.

    2015-01-01

    There is little evidence with respect to the effectiveness of intervention programs that focus on the reduction of occupational quartz exposure in the construction industry. This article evaluates the effectiveness of a multidimensional intervention which was aimed at reducing occupational quartz ex

  11. Effects of a perioperative smoking cessation intervention on postoperative complications: a randomized trial

    DEFF Research Database (Denmark)

    Lindström, David; Sadr Azodi, Omid; Wladis, Andreas;

    2008-01-01

    To determine whether an intervention with smoking cessation starting 4 weeks before general and orthopedic surgery would reduce the frequency of postoperative complications.......To determine whether an intervention with smoking cessation starting 4 weeks before general and orthopedic surgery would reduce the frequency of postoperative complications....

  12. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette;

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefo...... to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation....

  13. Family Ties to Health Program: A Randomized Intervention to Improve Vegetable Intake in Children

    Science.gov (United States)

    Tabak, Rachel G.; Tate, Deborah F.; Stevens, June; Siega-Riz, Anna Maria; Ward, Dianne S.

    2012-01-01

    Objective: Evaluate a home-based intervention targeted toward parents to improve vegetable intake in preschool-aged children. Methods: Four-month feasibility study of home-based intervention consisting of 4 tailored newsletters and 2 motivational phone calls compared to control; 4 children's books for the control group; and measured pre and post…

  14. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette;

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefore...... to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation....

  15. Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    R. Casañas

    2015-01-01

    Full Text Available Background. There is evidence supporting the effectiveness of psychoeducation (PE in patients with symptoms of depression in primary care (PC, but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD medication may interfere with the effects of the intervention. Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions and 56 from the control group (CG that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI and remission based on the BDI. The analysis was carried out on an intention-to-treat basis. Results. The PE program group showed remission of symptoms of 40% (P=0.001 posttreatment and 42% (P=0.012 at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P=0.008; effect size Cohen’s d′=0.55. Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered.

  16. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Hoffmann Kristina

    2010-01-01

    Full Text Available Abstract Background With rates of childhood obesity increasing, physical activity (PA promotion especially in young children has assumed greater importance. Given the limited effectiveness of most interventions to date, new approaches are needed. The General Systems theory suggests that involving parents as intervention targets may be effective in fostering healthier life styles in children. We describe the development of a parent-focused participatory intervention and the procedures used to evaluate its effectiveness in increasing daily PA in preschoolers. Methods/Design Thirty-seven South German preschools were identified for this study and agreed to participate. Using a two-armed, controlled cluster-randomized trial design we test a participatory intervention with parents as the primary target group and potential agents of behavioural change. Specifically, the intervention is designed to engage parents in the development, refinement and selection of project ideas to promote PA and in incorporating these ideas into daily routines within the preschool community, consisting of children, teachers and parents. Our study is embedded within an existing state-sponsored programme providing structured gym lessons to preschool children. Thus, child-based PA outcomes from the study arm with the parent-focused intervention and the state-sponsored programme are compared with those from the study arm with the state-sponsored programme alone. The evaluation entails baseline measurements of study outcomes as well as follow-up measurements at 6 and 12 months. Accelerometry measures PA intensity over a period of six days, with the mean over six days used as the primary outcome measure. Secondary outcomes include childrens' BMI, a sum of averaged skin fold thickness measurements across multiple sites, and PA behaviour. Longitudinal multilevel models are used to assess within-subject change and between-group differences in study outcomes, adjusted for covariates

  17. Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial.

    Directory of Open Access Journals (Sweden)

    Karlijn J Joling

    Full Text Available BACKGROUND: Family caregivers of dementia patients are at increased risk of developing depression or anxiety. A multi-component program designed to mobilize support of family networks demonstrated effectiveness in decreasing depressive symptoms in caregivers. However, the impact of an intervention consisting solely of family meetings on depression and anxiety has not yet been evaluated. This study examines the preventive effects of family meetings for primary caregivers of community-dwelling dementia patients. METHODS: A randomized multicenter trial was conducted among 192 primary caregivers of community dwelling dementia patients. Caregivers did not meet the diagnostic criteria for depressive or anxiety disorder at baseline. Participants were randomized to the family meetings intervention (n = 96 or usual care (n = 96 condition. The intervention consisted of two individual sessions and four family meetings which occurred once every 2 to 3 months for a year. Outcome measures after 12 months were the incidence of a clinical depressive or anxiety disorder and change in depressive and anxiety symptoms (primary outcomes, caregiver burden and quality of life (secondary outcomes. Intention-to-treat as well as per protocol analyses were performed. RESULTS: A substantial number of caregivers (72/192 developed a depressive or anxiety disorder within 12 months. The intervention was not superior to usual care either in reducing the risk of disorder onset (adjusted IRR 0.98; 95% CI 0.69 to 1.38 or in reducing depressive (randomization-by-time interaction coefficient = -1.40; 95% CI -3.91 to 1.10 or anxiety symptoms (randomization-by-time interaction coefficient = -0.55; 95% CI -1.59 to 0.49. The intervention did not reduce caregiver burden or their health related quality of life. CONCLUSION: This study did not demonstrate preventive effects of family meetings on the mental health of family caregivers. Further research should determine

  18. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy

    Directory of Open Access Journals (Sweden)

    Ulberg Randi

    2012-09-01

    Full Text Available Abstract Background Depression in adolescents seems to be a growing problem that causes mental suffering and prevents young people from joining the workforce. There is also a high risk of relapse during adult life. There is emerging evidence for the effect of psychodynamic psychotherapy in adolescents. In-session relational intervention (that is, transference intervention is a key component of psychodynamic psychotherapy. However, whether depressed adolescents profit most from psychodynamic psychotherapy with or without transference interventions has not been stated. Object The effect of transference interventions in depressed adolescents and the moderator moderating effect of quality of object relations, personality disorder and gender will be explored. Methods and study design The First Experimental Study of Transference Work–In Teenagers (FEST–IT will be a randomized clinical trial with a dismantling design. The study is aimed to explore the effects of transference work in psychodynamic psychotherapy for adolescents with depression. One hundred patients ages 16 to 18 years old will be randomized to one of two treatment groups, in both of which general psychodynamic techniques will be used. The patients will be treated over 28 weeks with either a moderate level of transference intervention or no transference intervention. Follow-up will be at 1 year after treatment termination. The outcome measures will be the Psychodynamic Functioning Scales (PFS, Inventory of Interpersonal Problems–Circumplex Version (IIP-C, Global Assessment of Functioning (GAF, and the total mean score of Symptom Checklist–90 (Global Severity Index; GSI, Beck Depression Inventory (BDI, and Montgomery Åsberg Rating Scale (MADRS. The quality of adolescents’ relationships will be a central focus of the study, and the Adolescent Relationship Scales (ARS and Differentiation–Relatedness Scale (DRS will also be used. Change will be assessed using linear-mixed models

  19. Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

    Science.gov (United States)

    Lanpher, Michele G; Askew, Sandy; Bennett, Gary G

    2016-01-01

    In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy. We randomized 194 participants to usual care or to the Shape Program intervention, a 12-month digital health treatment aimed at preventing weight gain among overweight and Class I obese Black women in primary care practice. We administered the Newest Vital Sign instrument to assess health literacy. More than half (55%) of participants had low health literacy, which was more common among those with fewer years of education and lower income. There was no effect of health literacy on 12-month weight change or on intervention engagement outcomes (completion of coaching calls and interactive voice response self-monitoring calls). Low health literacy did not preclude successful weight gain prevention in the Shape Program intervention. Goal-focused behavior change approaches like that used in Shape may be particularly helpful for treating and engaging populations with low health literacy. PMID:27043756

  20. Effects of Multiple Cleaning and Disinfection Interventions on Infectious Diseases in Children:A Group Randomized Trial in China

    Institute of Scientific and Technical Information of China (English)

    BAN Hai Qun; LI Tao; SHEN Jin; LI Jin; PENG Pin Zhang; YE Heng Ping; ZHANG Liu Bo

    2015-01-01

    ObjectiveTo assess the effectiveness of multiple cleaning and disinfection interventions in the homes and kindergartens, in reducing gastrointestinal and respiratory illnesses of children. MethodsFrom October 2010 to September 2011, we performed a prospective, controlled study in China. 408 children under 5 years old were recruited and group randomized into intervention and control groups. Families and kindergartens in the intervention group were provided with antibacterial products for hand hygiene and surface cleaning or disinfection for one year. Each child’s illness symptoms andsick leave were recorded every day. ResultsA total of 393 children completed the study, with similar baseline demographics in each of the 2 groups.Except for abdominal pain, the odds of symptoms(fever, cough and expectoration, runny nose and nasal congestion, diarrhea), illness (acute respiratory illness and gastrointestinal illness), and sick leave per person each month were significantly reduced by interventions. The rates of fever, diarrhea, acute respiratory illness, gastrointestinal illness and sick leave per person per year were significantly decreased as well. ConclusionNot only the acute respiratory and gastrointestinal illness but the sick leave rate in children were significantly reduced by multiple interventions.

  1. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A

    2011-05-01

    The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.

  2. A Chinese Chan-Based Mind-Body Intervention Improves Sleep on Patients with Depression: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Agnes S. Chan

    2012-01-01

    Full Text Available Sleep disturbance is a common problem associated with depression, and cognitive-behavioral therapy (CBT is a more common behavioral intervention for sleep problems. The present study compares the effect of a newly developed Chinese Chan-based intervention, namely Dejian mind-body intervention (DMBI, with the CBT on improving sleep problems of patients with depression. Seventy-five participants diagnosed with major depressive disorder were randomly assigned to receive 10 weekly sessions of CBT or DMBI, or placed on a waitlist. Measurements included ratings by psychiatrists who were blinded to the experimental design, and a standardized questionnaire on sleep quantity and quality was obtained before and after the 10-week intervention. Results indicated that both the CBT and DMBI groups demonstrated significantly reduced sleep onset latency and wake time after sleep onset (effect size range = 0.46–1.0, P≤0.05 as compared to nonsignificant changes in the waitlist group (P>0.1. Furthermore, the DMBI group, but not the CBT or waitlist groups, demonstrated significantly reduced psychiatrist ratings on overall sleep problems (effect size = 1.0, P=0.00 and improved total sleep time (effect size = 0.8, P=0.05 after treatment. The present findings suggest that a Chinese Chan-based mind-body intervention has positive effects on improving sleep in individuals with depression.

  3. Breast Health Intervention Effects on Knowledge and Beliefs Over Time Among Chinese American Immigrants--a Randomized Controlled Study.

    Science.gov (United States)

    Lee-Lin, Frances; Pedhiwala, Nisreen; Nguyen, Thuan; Menon, Usha

    2015-09-01

    Chinese American immigrant women, nonadherent with mammography in the past 12 months, (N = 300) were enrolled in a randomized controlled trial designed to change knowledge and beliefs and increase mammogram use. This report describes intervention effects on changes in knowledge and beliefs between the control and educational groups over four time points (baseline and 3, 6, and 12 months). Variables measured included knowledge, perceived susceptibility, perceived general barriers to mammography, perceived benefits to mammography, and four cultural barriers to mammography (crisis orientation, modesty, use of Eastern medicine, reliance on others). At all three post-intervention time points, women in the education group had significantly higher knowledge scores than those in the control group, regardless of whether they had completed a mammogram during the study. Women in the education group reported higher perceived susceptibility to breast cancer at 3-month post-intervention. At 3- and 6-month post-intervention, regardless of mammogram screening completion, women reported lower concerns about modesty related to mammography when compared to the control group. By the 12-month post-intervention, women in the education group reported significantly fewer perceived barriers than the control group. A targeted breast health program successfully changed breast health knowledge and beliefs that were sustained for up to 6-12 months. Education targeted to women's knowledge and beliefs has significant potential for decreasing disparity in mammogram use among Chinese American immigrant women. PMID:25200949

  4. Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

    Science.gov (United States)

    Lanpher, Michele G; Askew, Sandy; Bennett, Gary G

    2016-01-01

    In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy. We randomized 194 participants to usual care or to the Shape Program intervention, a 12-month digital health treatment aimed at preventing weight gain among overweight and Class I obese Black women in primary care practice. We administered the Newest Vital Sign instrument to assess health literacy. More than half (55%) of participants had low health literacy, which was more common among those with fewer years of education and lower income. There was no effect of health literacy on 12-month weight change or on intervention engagement outcomes (completion of coaching calls and interactive voice response self-monitoring calls). Low health literacy did not preclude successful weight gain prevention in the Shape Program intervention. Goal-focused behavior change approaches like that used in Shape may be particularly helpful for treating and engaging populations with low health literacy.

  5. A comparison of three interventions for homeless youth evidencing substance use disorders: results of a randomized clinical trial.

    Science.gov (United States)

    Slesnick, Natasha; Guo, Xiamei; Brakenhoff, Brittany; Bantchevska, Denitza

    2015-07-01

    While research on homeless adolescents and young adults evidencing substance use disorder is increasing, there is a dearth of information regarding effective interventions, and more research is needed to guide those who serve this population. The current study builds upon prior research showing promising findings of the community reinforcement approach (CRA) (Slesnick, Prestopnik, Meyers, & Glassman, 2007). Homeless adolescents and young adults between the ages of 14 to 20 years were randomized to one of three theoretically distinct interventions: (1) CRA (n = 93), (2) motivational enhancement therapy (MET, n = 86), or (3) case management (CM, n = 91). The relative effectiveness of these interventions was evaluated at 3, 6, and 12 months post-baseline. Findings indicated that substance use and associated problems were significantly reduced in all three interventions across time. Several moderating effects were found, especially for sex and history of childhood abuse. Findings show little evidence of superiority or inferiority of the three interventions and suggest that drop-in centers have choices for addressing the range of problems that these adolescents and young adults face. PMID:25736623

  6. Family-based interventions for reducing sedentary time in youth: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Marsh, S; Foley, L S; Wilks, D C; Maddison, R

    2014-02-01

    Family involvement in interventions to reduce sedentary time may help foster appropriate long-term screen-based habits in children. This review systematically synthesized evidence from randomized controlled trials of interventions with a family component that targeted reduction of sedentary time, including TV viewing, video games and computer use, in children. MEDLINE, PubMed, PsycInfo, CINAHL and Embase were searched from inception through March 2012. Seventeen articles were considered eligible and included in the review. Studies were judged to be at low-to-moderate risk of bias. Despite inconsistent study results, level of parental involvement, rather than the setting itself, appeared an important determinant of intervention success. Studies including a parental component of medium-to-high intensity were consistently associated with statistically significant changes in sedentary behaviours. Participant age was also identified as a determinant of intervention outcomes; all three studies conducted in pre-school children demonstrated significant decreases in sedentary time. Finally, TV exposure appeared to be related to changes in energy intake rather than physical activity. Future studies should assess the effects of greater parental involvement and child age on success of sedentary behaviour interventions. More research is required to better understand the relationship between screen time and health behaviours, particularly energy intake. PMID:24102891

  7. The Effect of Structured Exercise Intervention on Intensity and Volume of Total Physical Activity

    Directory of Open Access Journals (Sweden)

    Niko Wasenius

    2014-12-01

    Full Text Available This study aimed to investigate the effects of a 12-week structured exercise intervention on total physical activity and its subcategories. Twenty-three overweight or obese middle aged men with impaired glucose regulation were randomized into a 12-week Nordic walking group, a power-type resistance training group, and a non-exercise control group. Physical activity was measured with questionnaires before the intervention (1–4 weeks and during the intervention (1–12 weeks and was expressed in metabolic equivalents of task. No significant change in the volume of total physical activity between or within the groups was observed (p > 0.050. The volume of total leisure-time physical activity (structured exercises + non-structured leisure-time physical activity increased significantly in the Nordic walking group (p 0.050 compared to the control group. In both exercise groups increase in the weekly volume of total leisure-time physical activity was inversely associated with the volume of non-leisure-time physical activities. In conclusion, structured exercise intervention did not increase the volume of total physical activity. Albeit, endurance training can increase the volume of high intensity physical activities, however it is associated with compensatory decrease in lower intensity physical activities. To achieve effective personalized exercise program, individuality in compensatory behavior should be recognised.

  8. A randomized clinical trial of a brief hypnosis intervention to control venepuncture-related pain of paediatric cancer patients.

    Science.gov (United States)

    Liossi, Christina; White, Paul; Hatira, Popi

    2009-04-01

    Venepuncture for blood sampling can be a distressing experience for a considerable number of children. A prospective controlled trial was conducted to compare the efficacy of a local anaesthetic (EMLA) with a combination of EMLA with self-hypnosis in the relief of venepuncture-induced pain and anxiety in 45 paediatric cancer outpatients (age 6-16years). A secondary aim of the trial was to test whether the intervention will have a beneficial effect on parents' anxiety levels during their child's procedure. Patients were randomized to one of three groups: local anaesthetic, local anaesthetic plus hypnosis, and local anaesthetic plus attention. Results confirmed that patients in the local anaesthetic plus hypnosis group reported less anticipatory anxiety, and less procedure-related pain and anxiety, and were rated as demonstrating less behavioural distress during the procedure than patients in the other two groups. Parents whose children were randomized to the local anaesthetic plus hypnosis condition experienced less anxiety during their child's procedure than parents whose children had been randomized to the other two conditions. The therapeutic benefit of the brief hypnotic intervention was maintained in the follow-up. The present findings are particularly important in that this study was a randomized, controlled trial conducted in a naturalistic medical setting. In this context, convergence of subjective and objective outcomes was reached with large effect sizes that were consistently supportive of the beneficial effects of self-hypnosis, an intervention that can be easily taught to children, is noninvasive and poses minimal risk to young patients and their parents. PMID:19231082

  9. A benefit-finding intervention for family caregivers of persons with Alzheimer disease: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cheng Sheung-Tak

    2012-07-01

    Full Text Available Abstract Background Caregivers of relatives with Alzheimer’s disease are highly stressed and at risk for physical and psychiatric conditions. Interventions are usually focused on providing caregivers with knowledge of dementia, skills, and/or support, to help them cope with the stress. This model, though true to a certain extent, ignores how caregiver stress is construed in the first place. Besides burden, caregivers also report rewards, uplifts, and gains, such as a sense of purpose and personal growth. Finding benefits through positive reappraisal may offset the effect of caregiving on caregiver outcomes. Design Two randomized controlled trials are planned. They are essentially the same except that Trial 1 is a cluster trial (that is, randomization based on groups of participants whereas in Trial 2, randomization is based on individuals. Participants are randomized into three groups - benefit finding, psychoeducation, and simplified psychoeducation. Participants in each group receive a total of approximately 12 hours of training either in group or individually at home. Booster sessions are provided at around 14 months after the initial treatment. The primary outcomes are caregiver stress (subjective burden, role overload, and cortisol, perceived benefits, subjective health, psychological well-being, and depression. The secondary outcomes are caregiver coping, and behavioral problems and functional impairment of the care-recipient. Outcome measures are obtained at baseline, post-treatment (2 months, and 6, 12, 18 and 30 months. Discussion The emphasis on benefits, rather than losses and difficulties, provides a new dimension to the way interventions for caregivers can be conceptualized and delivered. By focusing on the positive, caregivers may be empowered to sustain caregiving efforts in the long term despite the day-to-day challenges. The two parallel trials will provide an assessment of whether the effectiveness of the intervention

  10. Randomized Nutrition Education Intervention to Improve Carbohydrate Counting in Adolescents with Type 1 Diabetes Study: Is More Intensive Education Needed?

    Science.gov (United States)

    Spiegel, Gail; Bortsov, Andrey; Bishop, Franziska K.; Owen, Darcy; Klingensmith, Georgeanna J.; Mayer-Davis, Elizabeth J.; Maahs, David M.

    2012-01-01

    Background and Objectives Youth with type 1 diabetes do not count carbohydrates (CHOs) accurately, yet it is an important strategy in blood glucose control. The study objective was to determine whether a nutrition education intervention would improve CHO counting accuracy and glycemic control. Design Randomized, controlled, nutrition intervention trial recruited February 2009 to February 2010. Participants and Methods Youth (12-18 years, n=101) with type 1 diabetes were screened to identify those with poor CHO counting accuracy, using a previously developed CHO counting accuracy test covering commonly consumed foods and beverage items presented in six mixed meals and two snacks. All participants (n=66, age=15 ± 3 yrs, 41 male, diabetes duration=6 ± 4 yrs, HbA1c=8.3 ± 1.1%) were randomized to the control or intervention group at the baseline visit. The intervention group attended a 90 minute class with a RD/CDE and twice kept three-day food records, which were used to review CHO counting progress. Main Outcome Measures CHO counting accuracy (measured as described above) and HbA1c were evaluated at baseline and three months to determine the effectiveness of the intervention. Statistical Analyses T-tests, Spearman correlations, and repeated measures models were used. Results At baseline, CHO content was over and underestimated in 16 and five of 29 food items, respectively. When foods were presented as mixed meals, participants either significantly over or underestimated 10 of the nine meals and four snacks. After three months of follow-up, HbA1c decreased in both the intervention and control groups by −0.19 ± 0.12% (p=0.12) and −0.08 ± 0.11% (p=0.51) respectively; however, the overall intervention effect was not statistically significant for change in HbA1c or CHO counting accuracy. Conclusions More intensive intervention may be required to improve adolescents’ CHO counting accuracy and nutrition management of type 1 diabetes. Further research is needed to

  11. A Randomized Evaluation of Motivational Interviewing Training for Mandated Implementation of Alcohol Screening and Brief Intervention in Trauma Centers.

    Science.gov (United States)

    Darnell, Doyanne; Dunn, Christopher; Atkins, David; Ingraham, Leah; Zatzick, Douglas

    2016-01-01

    The American College of Surgeons has mandated that level I and level II trauma centers implement universal alcohol screening and brief intervention (SBI) for injured patients. This study was a secondary analysis of a national, 20-hospital, cluster-randomized implementation trial focusing on practical issues of training and supervising alcohol SBI providers in motivational interviewing (MI). The purpose of this study was to examine whether real-world trauma center providers can be trained to provide higher quality counseling using MI as part of brief interventions for alcohol and whether MI skills can be maintained over time. Sites were randomly assigned to receive a 1day workshop training in MI for alcohol SBI or not, and all providers regardless of training completed up to seven standardized patient assessments of MI fidelity over 27months. Six domains on the Motivational Interviewing Treatment Integrity (MITI) coding system were assessed and compared to proficiency criteria. Providers in the intervention training group showed substantially improved MITI scores over the course of the 27-month time period. Domains that had particularly strong improvement were MI spirit and empathy; however, despite the overall improvement in the intervention group scores, expert-derived proficiency criteria were attained only for the global scores. Routine trauma center providers who receive MI training can deliver higher quality counseling in alcohol brief interventions, but may not, however, attain previously derived proficiency standards. Future implementation efforts in real-world acute care medical settings could further elucidate provider characteristics that predict training response and also strive to demonstrate that higher quality alcohol SBI implementation is associated with improved patient-level outcomes.

  12. Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

    Directory of Open Access Journals (Sweden)

    Susan A Stoner

    Full Text Available Naltrexone is a front-line treatment for alcohol use disorders, but its efficacy is limited by poor medication adherence. This randomized controlled trial evaluated whether a mobile health intervention could improve naltrexone adherence.Treatment-seeking participants with an alcohol use disorder (N = 76 were randomized to intervention and control conditions. All participants received naltrexone (50 mg/day with a medication event monitoring system (MEMS and a prepaid smartphone, and received a daily text message querying medication side effects, alcohol use, and craving. Those in the intervention arm received additional medication reminders and adherence assessment via text message.The primary outcome, proportion of participants with adequate adherence (defined as ≥80% of prescribed doses taken through Week 8, did not differ between groups in intent-to-treat analyses (p = .34. Mean adherence at study midpoint (Week 4 was 83% in the intervention condition and 77% in the control condition (p = .35. Survival analysis found that the intervention group sustained adequate adherence significantly longer (M = 19 days [95% CI = 0.0-44.0] than those in the control group (M = 3 days [95% CI = 0.0-8.1] during the first month of treatment (p = .04. Medication adherence did not predict drinking outcomes.These results suggest that in the context of daily monitoring and assessment via cell phone, additional text message reminders do not further improve medication adherence. Although this initial trial does not provide support for the efficacy of text messaging to improve adherence to pharmacotherapy for alcohol use disorders, additional trials with larger samples and alternate designs are warranted.ClinicalTrials.gov: NCT01349985.

  13. Lumbar disc herniation treated with qi pathway intervention and spinal adjustment:a randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    杨军雄

    2013-01-01

    Objective To compare the efficacy difference in the treatment of lumbar disc herniation(LDH)between the comprehensive therapy of Qi pathway intervention and the spinal adjustment and the conventional therapy of acupuncture and Tuina and explore the analgesic mechanism

  14. Treatment of feline lymphoma using a 12-week, maintenance-free combination chemotherapy protocol in 26 cats.

    Science.gov (United States)

    Limmer, S; Eberle, N; Nerschbach, V; Nolte, I; Betz, D

    2016-08-01

    The aim of this prospective clinical trial was to investigate the efficacy and toxicity of a short-term, maintenance-free chemotherapy protocol in feline lymphoma. Twenty-six cats with confirmed diagnosis of high-/intermediate-grade lymphoma were treated with a 12-week protocol consisting of cyclic administration of l-asparaginase, vincristine, cyclophosphamide, doxorubicin and prednisolone. Complete (CR) and partial remission (PR) rates were 46 and 27%, respectively. Median duration of first CR was 394 days compared with a median PR duration of 41 days. No factor was identified to significantly influence the likelihood to reach CR. Overall survival amounted to 78 days (range: 9-2230 days). Median survival in CR cats was 454 days and in PR cats was 82 days. Toxicosis was mainly low grade with anorexia seen most frequently. In cats achieving CR, maintenance-free chemotherapy may be sufficient to attain long-term remission and survival. Factors aiding in prognosticating the likelihood for CR, strategies enhancing response and targeting chemotherapy-induced anorexia need to be identified in future. PMID:24548273

  15. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition

    Directory of Open Access Journals (Sweden)

    Jayne A. Barbour

    2015-09-01

    Full Text Available Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI 31 ± 4 kg/m2 alternated either high oleic peanuts (15%–20% of energy or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP, lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05, following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001, predominantly monounsaturated (increase 22 g, p < 0.05. Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation.

  16. Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs: clinical outcomes at 12 weeks.

    Science.gov (United States)

    Dawn Hunt, Sharon; Haycocks, Samantha; McCardle, Joanne; Guttormsen, Karl

    2016-06-23

    A recent multi-centre observational evaluation investigated the effect of a topical haemoglobin spray (Granulox, Infirst), used as an adjunct to standard care, on wound size reduction in 17 patients (4 females/13 males) with 20 chronic diabetic foot ulcers (DFUs) over a 4-week period. In 14 of the 18 wounds that completed the evaluation (one patient dropped out due to an infection) there was a mean reduction of 53.8% (range: 11.9-100%). The product was acceptable to both patients and clinicians, who all found it easy to use. This article describes the outcomes for the remaining 13 patients (with 15 wounds) who continued using the spray after the 4-week evaluation ended. (Data are not available for two patients and the one patient who healed during the 4-week evaluation.) By 12 weeks, three wounds (20%) had healed, eight (53%) were progressing towards healing, three (20%) increased in size and one (7%) was slow healing. PMID:27345086

  17. Evaluation of a Web-Based Intervention to Promote Hand Hygiene: Exploratory Randomized Controlled Trial

    OpenAIRE

    Yardley, Lucy; Miller, Sascha; Schlotz, Wolff; Little, Paul

    2011-01-01

    Background Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. Objective The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a web...

  18. Intervention for Homeless, Substance Abusing Mothers: Findings from a Non-Randomized Pilot

    OpenAIRE

    Slesnick, Natasha; Erdem, Gizem

    2012-01-01

    Little empirically-based information is available regarding how best to intervene with substance-abusing homeless mothers. This study pilot-tested a comprehensive intervention with 15 homeless women and their 2- to 6-year-old children, recruited from a local family shelter. All participants were offered integrated intervention with three major components. The first component was housing which included 3 months of rental and utility assistance, and these services were not contingent upon women...

  19. Comparison of Two Internet-Based Interventions for Problem Drinkers: Randomized Controlled Trial

    OpenAIRE

    Cunningham, John Alastair

    2012-01-01

    Background Alcohol problems are a serious public health concern, and few problem drinkers ever seek treatment. The Internet is one means of promoting access to care, but more research is needed to test the best types of interventions to employ. Evaluation of Internet-based interventions that contain a variety of research-validated cognitive-behavioral tools, which have been shown to be helpful to those with more severe alcohol concerns, should be a priority. Objective To evaluate whether prov...

  20. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial

    OpenAIRE

    Naik, Sachin; Khanagar, Sanjeev; Kumar, Amit; Ramachandra, Sujith; Vadavadagi, Sunil V.; Dhananjaya, Kiran Murthy

    2014-01-01

    Background: Tobacco smoking is an integral part of prison life and an established part of the culture. Little attention has been paid to prevention of smoking in prison. Approximately 70–80% of prisoners have been identified as current smokers. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Materials ...

  1. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sanatinia Rahil

    2012-08-01

    Full Text Available Abstract Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention or control treatment (a leaflet on healthy living. Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic

  2. Randomized controlled trials in industrial low back pain relating to return to work. Part 1. Acute interventions.

    Science.gov (United States)

    Scheer, S J; Radack, K L; O'Brien, D R

    1995-10-01

    Employers and insurers are interested in being able to use cost-effective interventions for returning injured workers to the workplace. Unfortunately, truly objective information is lacking. The purpose of this and two subsequent review articles was to perform thorough scrutiny and methodologic comparison among all obtainable, published randomized and controlled studies on low back pain (LBP) interventions leading to return to work. The study was confined to English language articles published from 1975 through 1993. Of more than 4,000 LBP citations, more than 500 were chosen for review. Of that number, 35 articles met the selection criteria of randomization, reasonable controls, and work return comparisons. This paper focuses on the 10 articles relating to interventions for acute (less than 4 weeks) LBP, and considers bed rest, exercise, spinal manipulation, back school, and case management. A 26-point quality system was used to compare the methodologic rigor of each article. This literature survey demonstrated the meager scientific foundations on which our industrial rehabilitation programs are based. PMID:7487440

  3. Dropouts and Compliance in Exercise Interventions Targeting Bone Mineral Density in Adults: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    George A. Kelley

    2013-01-01

    Full Text Available Background. Dropouts and compliance to exercise interventions targeting bone mineral density (BMD in adults are not well established. The purpose of this study was to address that gap. Methods. Meta-analysis of randomized controlled exercise intervention trials in adults ≥18 years of age. The primary outcomes were dropouts in the exercise and control groups as well as compliance to the exercise interventions. A random-effects model was used to pool results. Moderator analyses were conducted using mixed-effects ANOVA-like models and metaregression. Statistical significance was set at . Results. Thirty-six studies representing 3,297 participants (1,855 exercise, 1,442 control were included. Dropout rates in the exercise and control groups averaged 20.9% (95% CI 16.7%–25.9% and 15.9% (11.8%–21.1% while compliance to exercise was 76.3% (71.7%–80.3%. For both exercise and control groups, greater dropout rates were associated with studies conducted in the USA versus other countries, females versus males, premenopausal versus postmenopausal women, younger versus older participants, longer studies (controls only, and high- versus moderate-intensity training (exercisers only. Greater compliance to exercise was associated with being female, home- or facility-based exercise versus both, and shorter studies. Conclusion. These findings provide important information for researchers and practitioners with respect to exercise programs targeting BMD in adults.

  4. A mobile phone app intervention targeting fruit and vegetable consumption : The efficacy of textual and auditory tailored health information tested in a randomized controlled trial

    NARCIS (Netherlands)

    Elbert, Sarah Pietertje; Dijkstra, Arie; Oenema, Anke

    2016-01-01

    Background: Mobile phone apps are increasingly used to deliver health interventions, which provide the opportunity to present health information via different communication modes. However, scientific evidence regarding the effects of such health apps is scarce. Objective: In a randomized controlled

  5. Preventing weight gain: the baseline weight related behaviors and delivery of a randomized controlled intervention in community based women

    Directory of Open Access Journals (Sweden)

    Teede Helena J

    2009-01-01

    Full Text Available Abstract Background Women aged 25–45 years represent a high risk group for weight gain and those with children are at increased risk because of weight gain associated with pregnancy and subsequent lifestyle change. Average self-reported weight gain is approximately 0.60 kg per year, and weight gain is associated with increased risk of chronic disease. There are barriers to reaching, engaging and delivering lifestyle interventions to prevent weight gain in this population. Methods This study investigated the baseline weight related behaviors and feasibility of recruiting and delivering a low intensity self-management lifestyle intervention to community based women with children in order to prevent weight gain, compared to standard education. The recruitment and delivery of the cluster-randomized controlled intervention was in conjunction with 12 primary (elementary schools. Baseline data collection included demographic, anthropometric, behavioral and biological measures. Results Two hundred and fifty community based women were randomized as clusters to intervention (n = 127 or control (n = 123. Mean age was 40.4 years (SD 4.7 and mean BMI 27.8 kg/m2 (SD 5.6. All components of this intervention were successfully delivered and retention rates were excellent, 97% at 4 months. Nearly all women (90% reported being dissatisfied with their weight and 72% attempted to self-manage their weight. Women were more confident of changing their diet (mean score 3.2 than physical activity (mean score 2.7. This population perceived they were engaging in prevention behaviors, with 71% reporting actively trying to prevent weight gain, yet they consumed a mean of 68 g fat/day (SD30 g and 27 g saturated fat/day (SD12 g representing 32% and 13% of energy respectively. The women had a high rate of dyslipidemia (33% and engaged in an average of 9187 steps/day (SD 3671. Conclusion Delivery of this low intensity intervention to a broad cross-section of community based

  6. The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

    Science.gov (United States)

    Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

    2011-01-01

    Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (vitamin D levels (vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

  7. Patient-centered care interventions for the management of alcohol use disorders: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Barrio P

    2016-09-01

    Full Text Available Pablo Barrio, Antoni Gual Neurosciences Institute, Hospital Clinic, Institut d’Investigacions Biomèdiques Agustí Pi i Sunyer, Barcelona, Spain Issues: Patient-centered care (PCC is increasingly accepted as an integral component of good health care, including addiction medicine. However, its implementation has been controversial in people with alcohol use disorders. Approach: A systematic search strategy was devised to find completed randomized controlled trials enrolling adults (>18 years with alcohol use disorders. Studies had to use a PCC approach such that they should have been individualized, respectful to the patients’ own goals, and empowering. Studies until September 2015 were searched using PubMed, Scopus, the Cochrane Library, PsychINFO, and Web of Knowledge. Key findings: In total, 40 studies enrolling 16,020 patients met the inclusion criteria. Assessment revealed two main categories of study: psychosocial (n=35 based on motivational interviewing and pharmacological (n=5 based on an as needed dosing regimen. Psychosocial interventions were further classified according to the presence or absence of an active comparator. When no active comparator was present, studies were classified according to the number of sessions (≥1. Results from single sessions of motivational interviewing showed no clear benefit on alcohol consumption outcomes, with few studies indicating benefit of PCC versus control. Although the results for studies of multiple sessions of counseling were also mixed, many did show a significant benefit of the PCC intervention. By contrast, studies consistently demonstrated a benefit of pharmacologically supported PCC interventions, with most of the differences reaching statistical significance. Implications: PCC-based interventions may be beneficial for reducing alcohol consumption in people with alcohol use disorders. Keywords: psychosocial intervention, pharmacological intervention, motivational interviewing, as-needed

  8. Effectiveness of a low-threshold physical activity intervention in residential aged care – results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cichocki M

    2015-05-01

    Full Text Available Martin Cichocki,1 Viktoria Quehenberger,1 Michael Zeiler,1 Tanja Adamcik,1 Matthias Manousek,1 Tanja Stamm,2 Karl Krajic1 1Ludwig Boltzmann Institute Health Promotion Research, 2Medical University of Vienna & University of Applied Sciences FH Campus, Wien, Vienna, Austria Purpose: Research on effectiveness of low-threshold mobility interventions that are viable for users of residential aged care is scarce. Low-threshold is defined as keeping demands on organizations (staff skills, costs and participants (health status, discipline rather low. The study explored the effectiveness of a multi-faceted, low-threshold physical activity program in three residential aged-care facilities in Austria. Main goals were enhancement of mobility by conducting a multi-faceted training program to foster occupational performance and thus improve different aspects of health-related quality of life (QoL.Participants and methods: The program consisted of a weekly session of 60 minutes over a period of 20 weeks. A standardized assessment of mobility status and health-related QoL was applied before and after the intervention. A total of 222 of 276 participants completed the randomized controlled trial study (intervention group n=104, control group n=118; average age 84 years, 88% female.Results: Subjective health status (EuroQoL-5 dimensions: P=0.001, d=0.36 improved significantly in the intervention group, and there were also positive trends in occupational performance (Canadian Occupational Performance Measure. No clear effects were found concerning the functional and cognitive measures applied.Conclusion: Thus, the low-threshold approach turned out to be effective primarily on subjective health-related QoL. This outcome could be a useful asset for organizations offering low-threshold physical activity interventions. Keywords: physical activity, intervention, residential aged care, effectiveness, aged

  9. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Directory of Open Access Journals (Sweden)

    Paul Wallace

    Full Text Available BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption

  10. Reduction of hypoglycaemic events with a behavioural intervention: a randomized clinical trial for paediatric patients with Type 1 diabetes mellitus

    Science.gov (United States)

    Gee, B. T.; Nansel, T. R.; Liu, A.

    2015-01-01

    Aims To determine if a low-intensity, clinic-integrated behavioural intervention reduced the incidence of hypoglycaemic events in children with Type 1 diabetes. Methods A total of 390 families with children with Type 1 diabetes were enrolled in a 2-year, randomized clinical trial of a behavioural intervention. The intervention was designed to improve diabetes management practices by targeting the family’s diabetes problem-solving skills. Hypoglycaemic events were categorized in two groups: those treated by oral ingestion and those treated by parenteral therapy. Events were self-reported by participants at each clinic visit, which occurred approximately every 3–4 months. Analyses included two-sample t-tests, the mean cumulative function test, and the Cox proportional hazards model for recurrent events to compare the incidence between groups. Results Across the entire 2-year study period, the incidence of hypoglycaemic events treated by oral ingestion of glucose-rich foods and events requiring parenteral therapy did not significantly differ between study conditions; however, during the second year of participant enrolment, the incidence of events treated by oral ingestion in the intervention group was 13.6 per 100 person-years compared with 27.3 per 100 patient-years in the control group (P = 0.02). The hazard ratio of these events during the second year was 0.49 (95% CI 0.27–0.90; P = 0.02). Conclusions Our findings suggest the need for a long-term (> 1 year) focus on the implementation of interventions targeting diabetes management in young people. Behavioural interventions targeting problem-solving skills could be considered as practical, non-pharmacological strategies to reduce hypoglycaemia in adolescents with Type 1 diabetes. PMID:25763988

  11. A Multifaceted Prospective Memory Intervention to Improve Medication Adherence: Design of a Randomized Control Trial

    Science.gov (United States)

    Insel, Kathie C.; Einstein, Gilles O.; Morrow, Daniel G.; Hepworth, Joseph T.

    2012-01-01

    Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage. Unfortunately, nonadherence remains a significant problem. Previous interventions designed to improve adherence have demonstrated only small benefits of strategies that target single facets such as understanding medication directions. The intervention described here is informed by prospective memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive, multifaceted approach to improve adherence. It incorporates multiple strategies designed to support key components of prospective remembering involved in taking medication. The intervention is delivered by nurses in the home with an education control group for comparison. Differences between groups in overall adherence following the intervention and 6 months later will be tested. Systolic and diastolic blood pressure levels also will be examined between groups and as it relates to adherence. Intra-individual regression is planned to examine change in adherence over time and its predictors. Finally, we will examine the association between executive function/working memory and adherence, predicting that adherence will be related to executive/working memory in the control group but not in the intervention group. PMID:23010608

  12. Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention

    OpenAIRE

    Fox, Caroline S; Gurary, Ellen B.; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

    2016-01-01

    Background: A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30‐day page views. Whether insufficient social media intensity contributed to these results is uncertain. Methods and Results: Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journa...

  13. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Min-Ji Kim

    2016-06-01

    Full Text Available Aims: This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD. Methods: We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog, Mini-Mental State Examination, and the Clock Drawing Test. Physical performance was evaluated by exercise time, the number of pedal rotation, total load, grip strength, and the Berg Balance Scale (BBS. Results: In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements. Conclusion: This study indicates that it is possible to improve cognitive function in older adults with moderate to severe AD through 6-month physical exercise with a multicomponent cognitive intervention.

  14. Intervention leads to improvements in the nutrient profile of snacks served in afterschool programs: a group randomized controlled trial.

    Science.gov (United States)

    Beets, Michael W; Turner-McGrievy, Brie; Weaver, R Glenn; Huberty, Jennifer; Moore, Justin B; Ward, Dianne S; Freedman, Darcy A

    2016-09-01

    Widely adopted nutrition policies for afterschool programs (ASPs) focus on serving a fruit/vegetable daily and eliminating sugar-sweetened foods/beverages. The impact of these policies on the nutrient profile of snacks served is unclear. Evaluate changes in macro/micronutrient content of snacks served in ASPs. A 1-year group randomized controlled trial was conducted in 20 ASPs serving over 1700 elementary-age children. Intervention ASPs received a multistep adaptive framework intervention. Direct observation of snack served was collected and nutrient information determined using the USDA Nutrient Database, standardized to nutrients/100 kcal. By post-assessment, intervention ASPs reduced total kcal/snack served by 66 kcal (95CI -114 to -19 kcal) compared to control ASPs. Total fiber (+1.7 g/100 kcal), protein (+1.4 g/100 kcal), polyunsaturated fat (+1.2 g/100 kcal), phosphorous (+49.0 mg/100 kcal), potassium (+201.8 mg/100 kcal), and vitamin K (+21.5 μg/100 kcal) increased in intervention ASPs, while added sugars decreased (-5.0 g/100 kcal). Nutrition policies can lead to modest daily caloric reductions and improve select macro/micronutrients in snacks served. Long-term, these nutritional changes may contribute to healthy dietary habits. PMID:27528522

  15. Patient-centered care interventions for the management of alcohol use disorders: a systematic review of randomized controlled trials

    Science.gov (United States)

    Barrio, Pablo; Gual, Antoni

    2016-01-01

    Issues Patient-centered care (PCC) is increasingly accepted as an integral component of good health care, including addiction medicine. However, its implementation has been controversial in people with alcohol use disorders. Approach A systematic search strategy was devised to find completed randomized controlled trials enrolling adults (>18 years) with alcohol use disorders. Studies had to use a PCC approach such that they should have been individualized, respectful to the patients’ own goals, and empowering. Studies until September 2015 were searched using PubMed, Scopus, the Cochrane Library, PsychINFO, and Web of Knowledge. Key findings In total, 40 studies enrolling 16,020 patients met the inclusion criteria. Assessment revealed two main categories of study: psychosocial (n=35 based on motivational interviewing) and pharmacological (n=5 based on an as needed dosing regimen). Psychosocial interventions were further classified according to the presence or absence of an active comparator. When no active comparator was present, studies were classified according to the number of sessions (≥1). Results from single sessions of motivational interviewing showed no clear benefit on alcohol consumption outcomes, with few studies indicating benefit of PCC versus control. Although the results for studies of multiple sessions of counseling were also mixed, many did show a significant benefit of the PCC intervention. By contrast, studies consistently demonstrated a benefit of pharmacologically supported PCC interventions, with most of the differences reaching statistical significance. Implications PCC-based interventions may be beneficial for reducing alcohol consumption in people with alcohol use disorders. PMID:27695301

  16. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial.

    Science.gov (United States)

    Sullivan, D K; Goetz, J R; Gibson, C A; Mayo, M S; Washburn, R A; Lee, Y; Ptomey, L T; Donnelly, J E

    2016-01-01

    Despite the plethora of weight loss programs available in the US, the prevalence of overweight and obesity (BMI≥25kg/m(2)) among US adults continues to rise at least, in part, due to the high probability of weight regain following weight loss. Thus, the development and evaluation of novel interventions designed to improve weight maintenance are clearly needed. Virtual reality environments offer a promising platform for delivering weight maintenance interventions as they provide rapid feedback, learner experimentation, real-time personalized task selection and exploration. Utilizing virtual reality during weight maintenance allows individuals to engage in repeated experiential learning, practice skills, and participate in real-life scenarios without real-life repercussions, which may diminish weight regain. We will conduct an 18-month effectiveness trial (6 months weight loss, 12 months weight maintenance) in 202 overweight/obese adults (BMI 25-44.9kg/m(2)). Participants who achieve ≥5% weight loss following a 6month weight loss intervention delivered by phone conference call will be randomized to weight maintenance interventions delivered by conference call or conducted in a virtual environment (Second Life®). The primary aim of the study is to compare weight change during maintenance between the phone conference call and virtual groups. Secondarily, potential mediators of weight change including energy and macronutrient intake, physical activity, consumption of fruits and vegetables, self-efficacy for both physical activity and diet, and attendance and completion of experiential learning assignments will also be assessed.

  17. A randomized longitudinal factorial design to assess malaria vector control and disease management interventions in rural Tanzania.

    Science.gov (United States)

    Kramer, Randall A; Mboera, Leonard E G; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H; Paul, Christopher J; Miranda, Marie Lynn

    2014-05-16

    The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

  18. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial.

    Science.gov (United States)

    Sullivan, D K; Goetz, J R; Gibson, C A; Mayo, M S; Washburn, R A; Lee, Y; Ptomey, L T; Donnelly, J E

    2016-01-01

    Despite the plethora of weight loss programs available in the US, the prevalence of overweight and obesity (BMI≥25kg/m(2)) among US adults continues to rise at least, in part, due to the high probability of weight regain following weight loss. Thus, the development and evaluation of novel interventions designed to improve weight maintenance are clearly needed. Virtual reality environments offer a promising platform for delivering weight maintenance interventions as they provide rapid feedback, learner experimentation, real-time personalized task selection and exploration. Utilizing virtual reality during weight maintenance allows individuals to engage in repeated experiential learning, practice skills, and participate in real-life scenarios without real-life repercussions, which may diminish weight regain. We will conduct an 18-month effectiveness trial (6 months weight loss, 12 months weight maintenance) in 202 overweight/obese adults (BMI 25-44.9kg/m(2)). Participants who achieve ≥5% weight loss following a 6month weight loss intervention delivered by phone conference call will be randomized to weight maintenance interventions delivered by conference call or conducted in a virtual environment (Second Life®). The primary aim of the study is to compare weight change during maintenance between the phone conference call and virtual groups. Secondarily, potential mediators of weight change including energy and macronutrient intake, physical activity, consumption of fruits and vegetables, self-efficacy for both physical activity and diet, and attendance and completion of experiential learning assignments will also be assessed. PMID:26616535

  19. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    Science.gov (United States)

    Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; Cho, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

    2016-01-01

    Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Mini-Mental State Examination, and the Clock Drawing Test. Physical performance was evaluated by exercise time, the number of pedal rotation, total load, grip strength, and the Berg Balance Scale (BBS). Results In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements. Conclusion This study indicates that it is possible to improve cognitive function in older adults with moderate to severe AD through 6-month physical exercise with a multicomponent cognitive intervention. PMID:27403134

  20. A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

    Directory of Open Access Journals (Sweden)

    Randall A. Kramer

    2014-05-01

    Full Text Available The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1 a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2 vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding. The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

  1. The Effect of Educational-Spiritual Intervention on The Burnout of The Parents of School Age Children with Cancer: A Randomized Controlled Clinical Trial

    OpenAIRE

    , Nooshin Beheshtipour; Parisa Nasirpour; Shahrzad Yektatalab; Mehran Karimi; Najaf Zare

    2016-01-01

    Background: Parents of children with cancer experience high levels of stress and discomfort. Religious beliefs are important sources of comfort and support for many cancer patients and their families. The present study aimed to assess the effect of educational-spiritual intervention on burnout of the parents of the children with cancer. Methods: In this randomized clinical trial, 135 parents of children with cancer were randomly assigned into intervention and control groups. Data were collect...

  2. Effects of a Psychosocial Intervention on Caregivers of Recently Placed Nursing Home Residents: A Randomized Controlled Trial

    Science.gov (United States)

    SCHULZ, RICHARD; ROSEN, JULES; KLINGER, JULIE; MUSA, DONALD; CASTLE, NICHOLAS G.; KANE, APRIL; LUSTIG, AMY

    2014-01-01

    Many caregivers continue to provide care and support to their care recipients after institutional placement. A two-group randomized controlled trial was carried out to test the efficacy of a psychosocial intervention for informal caregivers whose care recipients resided in a long-term care facility. The intervention was delivered during the 6 month period following baseline assessment. Follow-up assessments were carried out at 6, 12, and 18 months. Primary outcomes were caregiver depression, anxiety, burden, and complicated grief. Significant time effects were found for all three primary outcomes showing that caregiver depression, anxiety, and burden improved over time. No treatment effects were found for these outcomes. However, complicated grief was significantly lower for caregivers in the treatment condition. PMID:25071302

  3. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    Science.gov (United States)

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  4. An online guided ACT intervention for enhancing the psychological wellbeing of university students: A randomized controlled clinical trial.

    Science.gov (United States)

    Räsänen, Panajiota; Lappalainen, Päivi; Muotka, Joona; Tolvanen, Asko; Lappalainen, Raimo

    2016-03-01

    Stress, anxiety and depression are relatively common problems among university students. This study examined whether an online psychological intervention aiming at enhancing the wellbeing of university students could be an effective and practical alternative for meeting the needs of a university population. University students (N = 68; 85% female; 19-32 years old) were randomly assigned to either a guided seven-week online Acceptance and Commitment Therapy (iACT) intervention or a waiting list control condition (WLC). A between-groups pre-post (iACT vs WLC) design with 12-month follow-up for the iACT participants was conducted. The intervention participants were offered two face-to-face meetings, completed online exercises during a five-week period, and received personal weekly written feedback via the website from their randomly assigned, trained student coaches. Waitlist participants were offered the intervention program soon after the post measurements. Results in this small efficacy trial showed that the iACT participants had significantly higher gains in wellbeing (between group, d = 0.46), life satisfaction (d = 0.65), and mindfulness skills (d = 0.49). In addition, iACT participants' self-reported stress (d = 0.54) and symptoms of depression (d = 0.69) were significantly reduced compared to the participants in the control group. These benefits were maintained over a 12-month follow-up period (within iACT group, d = 0.65-0.69, for primary measures). The results suggest that an online-based, coach-guided ACT program with blended face-to-face and online sessions could be an effective and well-accepted alternative for enhancing the wellbeing of university students. PMID:26848517

  5. Diet and Exercise Interventions among Overweight and Obese Lactating Women: Randomized Trial of Effects on Cardiovascular Risk Factors

    OpenAIRE

    Brekke, Hilde K; Bertz, Fredrik; Rasmussen, Kathleen M.; Bosaeus, Ingvar; Ellegård, Lars; Winkvist, Anna

    2014-01-01

    Objective To examine the effects of Diet (D) and Exercise (E) interventions on cardiovascular fitness, waist circumference, blood lipids, glucose metabolism, inflammation markers, insulin-like growth factor 1 (IGF-1) and blood pressure in overweight and obese lactating women. Methods At 10–14 wk postpartum, 68 Swedish women with a self-reported pre-pregnancy BMI of 25–35 kg/m2 were randomized to a 12-wk behavior modification treatment with D, E, both or control using a 2×2 factorial design. T...

  6. Nutritional counselling in primary health care: a randomized comparison of an intervention by general practitioner or dietician

    DEFF Research Database (Denmark)

    Willaing, Ingrid; Ladelund, Steen; Jørgensen, Torben;

    2004-01-01

    AIMS: To compare health effects and risk reduction in two different strategies of nutritional counselling in primary health care for patients at high risk of ischaemic heart disease. METHODS: In a cluster-randomized trial 60 general practitioners (GPs) in the Copenhagen County were randomized...... to give nutritional counselling or to refer patients to a dietician. Patients were included after opportunistically screening (n=503 patients), and received nutritional counselling by GP or dietician over 12 months. Health effects were measured by changes in weight, waist circumference and blood lipids...... of cardiovascular disease and addressed these when counselling. The guidance from a GP was of significant importance for risk reduction in relation to IHD. However, a long-term lifestyle intervention by GP was difficult to implement. In the case of obesity it was effective to refer to long-term nutritional...

  7. Nutritional counselling in primary health care: a randomized comparison of an intervention by general practitioner or dietician

    DEFF Research Database (Denmark)

    Willaing, Ingrid; Ladelund, Steen; Jørgensen, Torben;

    2004-01-01

    AIMS: To compare health effects and risk reduction in two different strategies of nutritional counselling in primary health care for patients at high risk of ischaemic heart disease. METHODS: In a cluster-randomized trial 60 general practitioners (GPs) in the Copenhagen County were randomized to...... give nutritional counselling or to refer patients to a dietician. Patients were included after opportunistically screening (n=503 patients), and received nutritional counselling by GP or dietician over 12 months. Health effects were measured by changes in weight, waist circumference and blood lipids...... cardiovascular disease and addressed these when counselling. The guidance from a GP was of significant importance for risk reduction in relation to IHD. However, a long-term lifestyle intervention by GP was difficult to implement. In the case of obesity it was effective to refer to long-term nutritional...

  8. A Comprehensive Peer Network Intervention to Improve Social Communication of Children with Autism Spectrum Disorders: A Randomized Trial in Kindergarten and First Grade

    Science.gov (United States)

    Kamps, Debra; Thiemann-Bourque, Kathy; Heitzman-Powell, Linda; Schwartz, Ilene; Rosenberg, Nancy; Mason, Rose; Cox, Suzanne

    2015-01-01

    The purpose of this randomized control group study was to examine the effects of a peer network intervention that included peer mediation and direct instruction for Kindergarten and First-grade children with autism spectrum disorders. Trained school staff members provided direct instruction for 56 children in the intervention group, and 39…

  9. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication: A randomized controlled trial

    NARCIS (Netherlands)

    Wurdak, M.; Wolstein, J.; Kuntsche, E.N.

    2016-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized contro

  10. A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

    Science.gov (United States)

    Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

    2014-01-01

    The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…

  11. A Parent-Mediated Intervention to Increase Responsive Parental Behaviors and Child Communication in Children with ASD: A Randomized Clinical Trial

    Science.gov (United States)

    Siller, Michael; Hutman, Ted; Sigman, Marian

    2013-01-01

    Longitudinal research has demonstrated that responsive parental behaviors reliably predict subsequent language gains in children with autism spectrum disorder. To investigate the underlying causal mechanisms, we conducted a randomized clinical trial of an experimental intervention (Focused Playtime Intervention, FPI) that aims to enhance…

  12. Effectiveness of regulatory interventions on firm behavior : a randomized field experiment with e-commerce firms

    NARCIS (Netherlands)

    Huizingh, Eelko; Mulder, Machiel

    2015-01-01

    Economic regulators use various instruments to stimulate SMEs to change their behavior, but limited evidence exists on the effectiveness of such interventions. We analyze the effectiveness of three ways of providing e-commerce firms guidance about the legal rules on information disclosure. The initi

  13. Effectiveness of a psychosocial counselling intervention for first-time IVF couples : a randomized controlled trial

    NARCIS (Netherlands)

    de Klerk, C; Hunfeld, JAM; Duivenvoorden, HJ; den Outer, MA; Fauser, BCJM; Passchier, J; Macklon, NS

    2005-01-01

    BACKGROUND: The objective of this study was to evaluate a psychosocial counselling intervention for first-time IVF couples. In this article the results on women's distress are presented. METHODS: Two hundred sixty-five couples admitted to an IVF treatment programme at the Erasmus MC were asked to pa

  14. Positive Psychology Intervention to Alleviate Child Depression and Increase Life Satisfaction: A Randomized Clinical Trial

    Science.gov (United States)

    Kwok, Sylvia Y. C. L.; Gu, Minmin; Kit, Katrina Tong Kai

    2016-01-01

    Purpose: The study aims to examine the effectiveness of a positive psychology group-based intervention program, incorporating elements of hope and gratitude, in decreasing depression and increasing life satisfaction among primary school students in Hong Kong. Method: A total of 68 children, with the Depression score of Chinese Hospital Anxiety and…

  15. An internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial

    NARCIS (Netherlands)

    Bolier, Linda; Haverman, Merel; Kramer, Jeannet; Westerhof, Gerben J.; Riper, Heleen; Walburg, Jan A.; Boon, Brigitte; Bohlmeijer, Ernst

    2013-01-01

    Background: Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. Objective: Psyfit (“ment

  16. Randomization to nutritional intervention at home did not improve postoperative function, fatigue or well-being

    DEFF Research Database (Denmark)

    Jensen, Martin Bach; Hessov, Ib

    1997-01-01

    , gain in body-weight and lean body mass, especially in the legs as shown by dual-energy X-ray absorptiometry. Changes in work capacity, hand grip and pinching strength, fatigue and quality of life were similar in patients in control and intervention groups and had returned to preoperative values 1...

  17. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G;

    2012-01-01

    Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses conta......Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta......-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated......-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 [CrI, 0.79 to 0.96]), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 [CrI, 0.02 to 0.30]). For each characteristic, average...

  18. Social Learning Theory Parenting Intervention Promotes Attachment-Based Caregiving in Young Children: Randomized Clinical Trial

    Science.gov (United States)

    O'Connor, Thomas G.; Matias, Carla; Futh, Annabel; Tantam, Grace; Scott, Stephen

    2013-01-01

    Parenting programs for school-aged children are typically based on behavioral principles as applied in social learning theory. It is not yet clear if the benefits of these interventions extend beyond aspects of the parent-child relationship quality conceptualized by social learning theory. The current study examined the extent to which a social…

  19. Effectiveness of an intervention to reduce sickness absence in patients with emotional distress or minor mental disorders: a randomized controlled effectiveness trial.

    OpenAIRE

    Brouwers, E.P.M.; Tiemens, B.G.; Terluin, B.; Verhaak, P.F.M.

    2006-01-01

    OBJECTIVE: The purpose of this study was to evaluate the effectiveness of an activating intervention designed to reduce sick leave duration in patients with emotional distress or minor mental disorders. METHOD: In a 1.5-year randomized controlled trial, 194 patients with minor mental disorders received either an experimental intervention by social workers or general practitioners' usual care. The intervention focused on understanding causes, developing and implementing problem-solving strateg...

  20. Randomized, community-based pharmacy intervention to expand services beyond sale of sterile syringes to injection drug users in pharmacies in New York City.

    Science.gov (United States)

    Crawford, Natalie D; Amesty, Silvia; Rivera, Alexis V; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M

    2013-09-01

    Structural interventions may help reduce racial/ethnic disparities in HIV. In 2009 to 2011, we randomized pharmacies participating in a nonprescription syringe access program in minority communities to intervention (pharmacy enrolled and delivered HIV risk reduction information to injection drug users [IDUs]), primary control (pharmacy only enrolled IDUs), and secondary control (pharmacy did not engage IDUs). Intervention pharmacy staff reported more support for syringe sales than did control staff. An expanded pharmacy role in HIV risk reduction may be helpful.

  1. Cost-effectiveness of a workplace intervention for sick-listed employees with common mental disorders: design of a randomized controlled trial

    OpenAIRE

    Anema Johannes R; van Oostrom Sandra H; Terluin Berend; de Vet Henrica CW; Knol Dirk L; van Mechelen Willem

    2008-01-01

    Abstract Background Considering the high costs of sick leave and the consequences of sick leave for employees, an early return-to-work of employees with mental disorders is very important. Therefore, a workplace intervention is developed based on a successful return-to-work intervention for employees with low back pain. The objective of this paper is to present the design of a randomized controlled trial evaluating the cost-effectiveness of the workplace intervention compared with usual care ...

  2. Evidence of Improvement in Various Impairments by Exercise Interventions in Patients with Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Clinical Trials

    OpenAIRE

    Tanaka, Ryo; Ozawa, Junya; Kito, Nobuhiro; Yamasaki, Takahiro; Moriyama, Hideki

    2013-01-01

    Purpose: To investigate improvement in various impairments by exercise interventions in patients with knee osteoarthritis (OA). Methods: We collected data on randomized controlled trials (RCTs) comparing the effects of exercise intervention with those of either nonintervention or psychoeducational intervention in patients with knee OA. Data on pain, stiffness, muscle strength, range of motion, flexibility, maximal oxygen uptake, and position sense were synthesized. The Grading of Recommendati...

  3. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

    Directory of Open Access Journals (Sweden)

    Matos Margarida G

    2008-07-01

    Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self

  4. A Randomized Evaluation of Smoking Cessation Interventions for Pregnant Women at a WIC Clinic.

    Science.gov (United States)

    Mayer, Jeffrey P.; And Others

    1990-01-01

    Investigates a randomized trial of a self-help smoking cessation program for pregnant smokers at the Kent County Health Department in Grand Rapids, (Michigan). Results indicate larger quit rates amongst program participants than those in the usual care group. Suggests that smoking cessation programs for low-income pregnant WIC clients are…

  5. Economic Intervention and Parenting: A Randomized Experiment of Statewide Child Development Accounts

    Science.gov (United States)

    Nam, Yunju; Wikoff, Nora; Sherraden, Michael

    2016-01-01

    Objective: We examine the effects of Child Development Accounts (CDAs) on parenting stress and practices. Methods: We use data from the SEED for Oklahoma Kids (SEED OK) experiment. SEED OK selected caregivers of infants from Oklahoma birth certificates using a probability sampling method, randomly assigned caregivers to the treatment (n = 1,132)…

  6. A Randomized Controlled Study of Brief Interventions To Teach Residents about Domestic Violence.

    Science.gov (United States)

    Coonrod, Dean V.; Bay, R. Curtis; Rowley, Beverley D.; Del Mar, Nancy B.; Gabriele, Laura; Tessman, Terrie D.; Chambliss, Linda R.

    2000-01-01

    Medical residents were randomly assigned to either a 20-minute session on the importance of screening for domestic violence or to an unrelated topic. Subsequently, 71 percent of the trained residents diagnosed at least one case of domestic violence compared to 52 percent of residents in the control group. Rates of diagnosis also differed by…

  7. Nutrition Education among Low-Income Older Adults: A Randomized Intervention Trial in Congregate Nutrition Sites

    Science.gov (United States)

    Mitchell, Roger E.; Ash, Sarah L.; McClelland, Jacquelyn W.

    2006-01-01

    Nutritional well-being among older adults is critical for maintaining health, increasing longevity, and decreasing the impact of chronic illness. However, few well-controlled studies have examined nutritional behavior change among low-income older adults. A prospective, controlled, randomized design examined a five session nutrition education…

  8. A Randomized Trial of an Elementary School Mathematics Software Intervention: Spatial-Temporal Math

    Science.gov (United States)

    Rutherford, Teomara; Farkas, George; Duncan, Greg; Burchinal, Margaret; Kibrick, Melissa; Graham, Jeneen; Richland, Lindsey; Tran, Natalie; Schneider, Stephanie; Duran, Lauren; Martinez, Michael E.

    2014-01-01

    Fifty-two low performing schools were randomly assigned to receive Spatial-Temporal (ST) Math, a supplemental mathematics software and instructional program, in second/third or fourth/fifth grades or to a business-as-usual control. Analyses reveal a negligible effect of ST Math on mathematics scores, which did not differ significantly across…

  9. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

    2015-01-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the statistica

  10. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study

    OpenAIRE

    Gajecki, Mikael; Berman, Anne H.; Sinadinovic, Kristina; Rosendahl, Ingvar; Andersson, Claes

    2014-01-01

    Background Brief interventions via the internet have been shown to reduce university students’ alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students. Methods Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to th...

  11. Short-term effects of an educational intervention on physical restraint use: a cluster randomized trial

    OpenAIRE

    Gulpers Math JM; Hamers Jan PH; Huizing Anna R; Berger Martijn PF

    2006-01-01

    Abstract Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster rand...

  12. Reducing occupational stress with a B-vitamin focussed intervention: a randomized clinical trial: study protocol

    OpenAIRE

    Stough, Con; Simpson, Tamara; Lomas, Justine; McPhee, Grace; Billings, Clare; Myers, Stephen; Oliver, Chris; Luke A. Downey

    2014-01-01

    Background Workplace stress in Australia and other western countries has been steadily increasing over the past decade. It can be observed not only in terms of increased compensation claims but also costs due to absenteeism, loss of productivity at work and reduced psychological and physiological health and well-being. Given the cost and pervasive effects of stress in the modern workforce, time efficient and cost-effective interventions capable of reducing occupational stress (or strain) and ...

  13. Effectiveness of START psychological intervention in reducing abuse by dementia family carers: randomized controlled trial

    OpenAIRE

    Cooper, C.; Barber, J; Griffin, M.; Rapaport, P.; Livingston, G.

    2016-01-01

    BACKGROUND: Family carers of people with dementia frequently report acting abusively toward them and carer psychological morbidity predicts this. We investigated whether START (STrAtegies for RelaTives), a psychological intervention which reduces depression and anxiety in family carers also reduces abusive behavior in carers of people living in their own homes. We also explored the longitudinal course of carer abusive behavior over two year. METHODS: We included self-identified family carers ...

  14. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol

    OpenAIRE

    Tomkins-Lane, Christy C; Lafave, Lynne MZ; Parnell, Jill A.; Krishnamurthy, Ashok; Rempel, Jocelyn; Macedo, Luciana G.; Moriartey, Stephanie; Stuber, Kent J; Wilson, Philip M; Hu, Richard; Andreas, Yvette M

    2013-01-01

    Background Because of symptoms, people with lumbar spinal stenosis (LSS) are often inactive, and this sedentary behaviour implies risk for diseases including obesity. Research has identified body mass index as the most powerful predictor of function in LSS. This suggests that function may be improved by targeting weight as a modifiable factor. An e-health lifestyle intervention was developed aimed at reducing fat mass and increasing physical activity in people with LSS. The main components of...

  15. Cancer-Related Fatigue and Rehabilitation: A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    OpenAIRE

    van Weert, E; May, A M; Korstjens, I.; Post, W.J.; van der Schans, C P; van den Borne, B; Mesters, I.; Ros, W J G; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined with cognitive behavioral therapy with physical training alone and with no intervention. Design. In this multicenter randomized controlled trial, 147 survivors of cancer were randomly assigned to a ...

  16. A randomized controlled trial of a web-based psychological intervention for patients under treatment for chronic HIV infection

    Directory of Open Access Journals (Sweden)

    L Skeie

    2012-11-01

    Full Text Available Purpose of the study: One of the most prevalent mental conditions in people with HIV is depression as uniquely characterized by low positive affect. This study examined the effect of a web-based intervention (Avanti on overall mood and depressive symptoms among patients with HIV infection. Methods: Patients treated with effective antiretroviral treatment were included in a two-armed trial with substance abuse as an exclusion criterion and randomized to Avanti (n=36 or control (n=31. Patients were surveyed at baseline, as well as 1 and 3 months after the initiation of a 5-week intervention period. Outcomes were Center for Epidemiological Studies-Depression scale and the Positive and Negative Affect Schedule which was combined into an overall mood index. Changes within groups were tested by Wilcoxon matched pairs test and baseline differences between groups by chi-square and Mann-Whitney independent samples test. Summary of results: Baseline scores for both groups were similar. However, patients in the intervention group had an improvement in median (M overall mood from baseline (M=67.6 to 1 month (M=71, p=0.02 which was also maintained from 1 to 3 months (M=71.9. Moreover, these patients had a favorable reduction in negative affect from 1 (M=24 to 3 months (M=22, p=0.01 and a transient improvement in positive affect from baseline (M=31.7 to 1 month after intervention onset (M=35, p<0.01 which almost returned to baseline levels at month 3 (M=32, p=0.01. In contrast, no significant changes were observed within the control group, except for a reduction in negative affect from 1 (M=23 to 3 months (M=21.6, p=0.05. Notably, symptoms of depression at baseline were low in both the Avanti (M=13 and control (M=12 groups, possibly explaining why no further reduction in depression was observed from baseline to 3 months in either of the two groups. Conclusions: The results of this study lend support to the promise of a web-based psychological intervention

  17. An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475

    Directory of Open Access Journals (Sweden)

    Weller David

    2004-04-01

    Full Text Available Abstract Background The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting. Methods Twenty facilities took part in a randomized controlled trial with a seven month follow-up period. Two outreach visits were delivered by a pharmacist. At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates, psychotropic drug prescribing and stroke risk reduction practices (BP monitoring, aspirin and warfarin use for the facility relevant to the physician. The effect of the interventions was determined via pre- and post-intervention case note audit. Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications. Chi-square tests, independent samples t-test, and logistic regression were used in the analysis. Results Data were available from case notes at baseline (n = 897 and seven months follow-up (n = 902, 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits. Pre-and post-intervention data were available for 715 participants. There were no differences between the intervention and control groups for the three month fall rate. We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention. The exception was significantly greater use of "as required" antipsychotics in the intervention group compared with the control group after the pharmacy intervention (RR = 4.95; 95%CI 1.69–14.50. There was no statistically significant difference between groups for the numbers of patients "at risk of stroke" on aspirin at follow-up. Conclusions While the strategy was well received by the

  18. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  19. Optimizing foster family placement for infants and toddlers: A randomized controlled trial on the effect of the foster family intervention.

    Science.gov (United States)

    Van Andel, Hans; Post, Wendy; Jansen, Lucres; Van der Gaag, Rutger Jan; Knorth, Erik; Grietens, Hans

    2016-01-01

    The relationship between foster children and their foster carers comes with many risks and may be very stressful both for parents and children. We developed an intervention (foster family intervention [FFI]) to tackle these risks. The intervention focuses on foster children below the age of 5 years. The objective was to investigate the effects of FFI on the interactions between foster parents and foster children. A randomized control trial was carried out with a sample of 123 preschool aged children (mean age 18.8 months; 51% boys) and their foster carers. A pretest was carried out 6 to 8 weeks after placement and a posttest one half year later. Interactions were videotaped and coded using the Emotional Availability Scales (EAS). Foster carers were asked to fill in the Dutch version of the Parenting Stress Index. Morning and evening samples of children's salivary cortisol were taken. In the posttest, significantly positive effects were found on the following EAS subscales: Sensitivity, Structuring, Nonintrusiveness, and Responsiveness. We found no significant differences on stress levels of foster carers and children (Nijmeegse Ouderlijke Stress Index domains and salivary cortisol). This study shows that the FFI has a significant positive effect on parenting skills as measured with EAS and on Responsiveness of the foster child. Findings are discussed in terms of impact and significance relating to methodology and design of the study and to clinical relevance. (PsycINFO Database Record PMID:27196390

  20. Are There Benefits from Teaching Yoga at Schools? A Systematic Review of Randomized Control Trials of Yoga-Based Interventions.

    Science.gov (United States)

    Ferreira-Vorkapic, C; Feitoza, J M; Marchioro, M; Simões, J; Kozasa, E; Telles, S

    2015-01-01

    Introduction. Yoga is a holistic system of varied mind-body practices that can be used to improve mental and physical health and it has been utilized in a variety of contexts and situations. Educators and schools are looking to include yoga as a cost-effective, evidence-based component of urgently needed wellness programs for their students. Objectives. The primary goal of this study was to systematically examine the available literature for yoga interventions exclusively in school settings, exploring the evidence of yoga-based interventions on academic, cognitive, and psychosocial benefits. Methods. An extensive search was conducted for studies published between 1980 and October 31, 2014 (PubMed, PsycInfo, Embase, ISI, and the Cochrane Library). Effect size analysis, through standardized mean difference and Hedges'g, allowed for the comparison between experimental conditions. Results and Conclusions. Nine randomized control trials met criteria for inclusion in this review. Effect size was found for mood indicators, tension and anxiety in the POMS scale, self-esteem, and memory when the yoga groups were compared to control. Future research requires greater standardization and suitability of yoga interventions for children. PMID:26491461

  1. A pilot study of a randomized controlled trial of yoga as an intervention for PTSD symptoms in women.

    Science.gov (United States)

    Mitchell, Karen S; Dick, Alexandra M; DiMartino, Dawn M; Smith, Brian N; Niles, Barbara; Koenen, Karestan C; Street, Amy

    2014-04-01

    Posttraumatic stress disorder (PTSD) is a debilitating condition that affects approximately 10% of women in the United States. Although effective psychotherapeutic treatments for PTSD exist, clients with PTSD report additional benefits of complementary and alternative approaches such as yoga. In particular, yoga may downregulate the stress response and positively impact PTSD and comorbid depression and anxiety symptoms. We conducted a pilot study of a randomized controlled trial comparing a 12-session Kripalu-based yoga intervention with an assessment control group. Participants included 38 women with current full or subthreshold PTSD symptoms. During the intervention, yoga participants showed decreases in reexperiencing and hyperarousal symptoms. The assessment control group, however, showed decreases in reexperiencing and anxiety symptoms as well, which may be a result of the positive effect of self-monitoring on PTSD and associated symptoms. Between-groups effect sizes were small to moderate (0.08-0.31). Although more research is needed, yoga may be an effective adjunctive treatment for PTSD. Participants responded positively to the intervention, suggesting that it was tolerable for this sample. Findings underscore the need for future research investigating mechanisms by which yoga may impact mental health symptoms, gender comparisons, and the long-term effects of yoga practice. PMID:24668767

  2. Physical therapy intervention in patients with non-cardiac chest pain following a recent cardiac event: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Astrid T Berg

    2015-04-01

    Full Text Available Objectives: To assess the effect of two different physical therapy interventions in patients with stable coronary heart disease and non-cardiac chest pain. Methods: A randomized controlled trial was carried out at a university hospital in Norway. A total of 30 patients with known and stable coronary heart disease and self-reported persistent chest pain reproduced by palpation of intercostal trigger points were participating in the study. The intervention was deep friction massage and heat pack versus heat pack only. The primary outcome was pain intensity after the intervention period and 3 months after the last treatment session, measured by Visual Analogue Scale, 0 to 100. Secondary outcome was health-related quality of life. Results: Treatment with deep friction massage and heat pack gave significant pain reduction compared to heat pack only (–17.6, 95% confidence interval: –30.5, –4.7; p < 0.01, and the reduction was persistent at 3 months’ follow-up (–15.2, 95% confidence interval: –28.5, –1.8; p = 0.03. Health-related quality of life improved in all three domains in patients with no significant difference between groups. Conclusion: Deep friction massage combined with heat pack is an efficient treatment of musculoskeletal chest pain in patients with stable coronary heart disease.

  3. Are There Benefits from Teaching Yoga at Schools? A Systematic Review of Randomized Control Trials of Yoga-Based Interventions

    Directory of Open Access Journals (Sweden)

    C. Ferreira-Vorkapic

    2015-01-01

    Full Text Available Introduction. Yoga is a holistic system of varied mind-body practices that can be used to improve mental and physical health and it has been utilized in a variety of contexts and situations. Educators and schools are looking to include yoga as a cost-effective, evidence-based component of urgently needed wellness programs for their students. Objectives. The primary goal of this study was to systematically examine the available literature for yoga interventions exclusively in school settings, exploring the evidence of yoga-based interventions on academic, cognitive, and psychosocial benefits. Methods. An extensive search was conducted for studies published between 1980 and October 31, 2014 (PubMed, PsycInfo, Embase, ISI, and the Cochrane Library. Effect size analysis, through standardized mean difference and Hedges’g, allowed for the comparison between experimental conditions. Results and Conclusions. Nine randomized control trials met criteria for inclusion in this review. Effect size was found for mood indicators, tension and anxiety in the POMS scale, self-esteem, and memory when the yoga groups were compared to control. Future research requires greater standardization and suitability of yoga interventions for children.

  4. Impact of prenatal education on maternal utilization of analgesic interventions at future infant vaccinations: a cluster randomized trial.

    Science.gov (United States)

    Taddio, Anna; Smart, Sarah; Sheedy, Matthuschka; Yoon, Eugene W; Vyas, Charmy; Parikh, Chaitya; Pillai Riddell, Rebecca; Shah, Vibhuti

    2014-07-01

    Analgesic interventions are not routinely used during vaccine injections in infants. Parents report a desire to mitigate injection pain, but lack the knowledge about how to do so. The objective of this cluster-randomized trial was to evaluate the effect of a parent-directed prenatal education teaching module about vaccination pain management on analgesic utilization at future infant vaccinations. Expectant mothers enrolled in prenatal classes at Mount Sinai Hospital in Toronto were randomized to a 20-30minute interactive presentation about vaccination pain management (experimental group) or general vaccination information (control group). Both presentations included a PowerPoint (Microsoft Corporation, Redmond, WA, USA) and video presentation, take-home pamphlet, and "Question and Answer" period. The primary outcome was self-reported utilization of breastfeeding, sugar water, or topical anaesthetics at routine 2-month infant vaccinations. Between October 2012 and July 2013, 197 expectant mothers from 28 prenatal classes participated; follow-up was obtained in 174 (88%). Maternal characteristics did not differ (P>0.05) between groups. Utilization of one or more prespecified pain interventions occurred in 34% of participants in the experimental group, compared to 17% in the control group (P=0.01). Inclusion of a pain management module in prenatal classes led to increased utilization of evidence-based pain management interventions by parents at the 2-month infant vaccination appointment. Educating parents offers a novel and effective way of improving the quality of pain care delivered to infants during vaccination. Additional research is needed to determine if utilization can be bolstered further using techniques such as postnatal hospital reinforcement, reminder cards, and clinician education. PMID:24704427

  5. Efficacy of brief alcohol screening intervention for college students (BASICS: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Fachini Alexandre

    2012-09-01

    Full Text Available Abstract Background Many studies reported that brief interventions are effective in reducing excessive drinking. This study aimed to assess the efficacy of a protocol of brief intervention for college students (BASICS, delivered face-to-face, to reduce risky alcohol consumption and negative consequences. Methods A systematic review with meta-analysis was performed by searching for randomized controlled trials (RCTs in Medline, PsycInfo, Web of Science and Cochrane Library databases. A quality assessment of RCTs was made by using a validated scale. Combined mean effect sizes, using meta-analysis random-effects models, were calculated. Results 18 studies were included in the review. The sample sizes ranged from 54 to 1275 (median = 212. All studies presented a good evaluation of methodological quality and four were found to have excellent quality. After approximately 12 months of follow-up, students receiving BASICS showed a significant reduction in alcohol consumption (difference between means = −1.50 drinks per week, 95% CI: -3.24 to −0.29 and alcohol-related problems (difference between means = −0.87, 95% CI: -1.58 to −0.20 compared to controls. Conclusions Overall, BASICS lowered both alcohol consumption and negative consequences in college students. Gender and peer factors seem to play an important role as moderators of behavior change in college drinking. Characteristics of BASICS procedure have been evaluated as more favorable and acceptable by students in comparison with others interventions or control conditions. Considerations for future researches were discussed.

  6. School-based humanistic counseling for psychological distress in young people: pilot randomized controlled trial.

    Science.gov (United States)

    McArthur, Katherine; Cooper, Mick; Berdondini, Lucia

    2013-01-01

    School-based humanistic counseling (SBHC) is a widely delivered intervention for psychological distress in young people, particularly in the UK. This study piloted a set of procedures for evaluating SBHC and obtaining indications of effect. Psychologically distressed young people (aged 13-16) were randomized to either 12 weeks of SBHC or a waiting list control. The primary outcome was psychological distress at the 12-week endpoint, as measured by the Young Person's CORE. Those allocated to counseling (n=16) showed significantly greater reductions in psychological distress than participants in the control group (n=17), with an effect size (ES) (g) of 1.14 on the primary outcome and a mean ES across all four outcome measures of 0.73 at endpoint. The findings indicate that SBHC may be an effective means of reducing psychological distress in young people.

  7. Reducing School Mobility: A Randomized Trial of a Relationship-Building Intervention

    OpenAIRE

    Fiel, Jeremy E.; Haskins, Anna R.; López Turley, Ruth N.

    2013-01-01

    Student turnover has many negative consequences for students and schools, and the high mobility rates of disadvantaged students may exacerbate inequality. Scholars have advised schools to reduce mobility by building and improving relationships with and among families, but such efforts are rarely tested rigorously. A cluster-randomized field experiment in 52 predominantly Hispanic elementary schools in San Antonio, TX, and Phoenix, AZ, tested whether student mobility in early elementary school...

  8. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    OpenAIRE

    Dawson Church; De Asis, Midanelle A.; Brooks, Audrey J.

    2012-01-01

    Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI). Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques), a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were cond...

  9. Residual F-18-FDG-PET Uptake 12 Weeks After Stereotactic Ablative Radiotherapy for Stage I Non-Small-Cell Lung Cancer Predicts Local Control

    NARCIS (Netherlands)

    Bollineni, Vikram Rao; Widder, Joachim; Pruim, Jan; Langendijk, Johannes A.; Wiegman, Erwin M.

    2012-01-01

    Purpose: To investigate the prognostic value of [F-18]fluorodeoxyglucose positron emission tomography (FDG-PET) uptake at 12 weeks after stereotactic ablative radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC). Methods and Materials: From November 2006 to February 2010, 132 medically

  10. A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy

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    Basir Tareen, Jack L. Summers, James M. Jamison, Deborah R. Neal, Karen McGuire, Lowell Gerson, Ananias Diokno

    2008-01-01

    Full Text Available Purpose: To evaluate the safety and efficacy of oral Apatone® (Vitamin C and Vitamin K3 administration in the treatment of prostate cancer in patients who failed standard therapy. Materials and Methods: Seventeen patients with 2 successive rises in PSA after failure of standard local therapy were treated with (5,000 mg of VC and 50 mg of VK3 each day for a period of 12 weeks. Prostate Specific Antigen (PSA levels, PSA velocity (PSAV and PSA doubling times (PSADT were calculated before and during treatment at 6 week intervals. Following the initial 12 week trial, 15 of 17 patients opted to continue treatment for an additional period ranging from 6 to 24 months. PSA values were followed for these patients. Results: At the conclusion of the 12 week treatment period, PSAV decreased and PSADT increased in 13 of 17 patients (p ≤ 0.05. There were no dose-limiting adverse effects. Of the 15 patients who continued on Apatone after 12 weeks, only 1 death occurred after 14 months of treatment. Conclusion: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients.

  11. Effects of exercise intervention in breast cancer survivors: a meta-analysis of 33 randomized controlled trails

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    Zhu G

    2016-04-01

    Full Text Available Guoqing Zhu,1 Xiao Zhang,1 Yulan Wang,1 Huizi Xiong,2 Yinghui Zhao,1 Fenyong Sun1 1Department of Clinical Laboratory Medicine, 2Department of Dermatology, Shanghai Tenth People’s Hospital of Tongji University, Shanghai, People’s Republic of China Background: Exercise is associated with favorable outcomes in cancer survivors. The purpose of this meta-analysis is to comprehensively summarize the effects of exercise intervention in breast cancer survivors.Methods: A systematic search of PubMed, Elsevier, and Google scholar was conducted up to March 2015. References from relevant meta-analyses and reviews were also checked.Results: Thirty-three randomized controlled trials were included in this meta-analysis, including 2,659 breast cancer survivors. Compared with the control group, quality of life was significantly improved in exercise intervention group, especially in mental health and general health subscales of short form 36 questionnaire, as well as emotion well-being and social well-being subscales of the Functional Assessment of Cancer Therapy. Besides, exercise alleviated the symptoms of depression and anxiety in the exercise group. Furthermore, exercise was also associated with positive outcomes in body mass index, lean mass, and muscle strength. In addition, the serum concentration of insulin, insulin-like growth factor-II, and insulin-like growth factor binding protein-1 was significantly reduced in exercise intervention group. However, based on the current data of this meta-analysis, there were no significant differences in sleep dysfunction or fatigue between groups.Conclusion: Our study suggested that exercise intervention was beneficial to breast cancer survivors. Therefore, exercise should be recommended to this patient group. Keywords: exercise, quality of life, depression, BMI, insulin

  12. Nutritional Online Information for Cancer Patients: a Randomized Trial of an Internet Communication Plus Social Media Intervention.

    Science.gov (United States)

    Gnagnarella, Patrizia; Misotti, Alessandro Maria; Santoro, Luigi; Akoumianakis, Demosthenes; Del Campo, Laura; De Lorenzo, Francesco; Lombardo, Claudio; Milolidakis, Giannis; Sullivan, Richard; McVie, John Gordon

    2016-09-01

    We hypothesized that cancer patients using an Internet website would show an improvement in the knowledge about healthy eating habits, and this might be enhanced by social media interaction. A 6-month randomized intervention was set up. Eligible subjects were allocated in intervention (IG) and control groups (CG). IG had access to the website, and CG was provided with printed versions. All enrolled participants filled in Nutrition Questionnaire (NQ), Quality of Life Questionnaire (QoL) and Psychological Distress Inventory (PDI), at baseline and after 6 months. The difference between post- vs pre-questionnaires was calculated. Seventy-four subjects (CG 39; IG 35) completed the study. There was an increase in the score after the intervention in both groups for the NQ, even if not statistically significant. Dividing the IG into three categories, no (NI), low (LI) and high interactions (HI), we found a decreased score (improvement) in the CG (-0.2) and in the HI (-1.7), and an increased score (worsening) in the NI (+3.3) (p = NS) analysing the PDI. We found an increased score in the QoL both in CG and IG (adjusted LSMeans +3.5 and +2.8 points, respectively; p = NS). This study represents an example for support cancer patients. Despite the lack of significant effects, critical points and problems encountered may be of interest to researchers and organization working in the cancer setting. Intervention strategies to support patients during the care process are needed in order to attain the full potential of patient-centred care on cancer outcomes. PMID:25820605

  13. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

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    Obinna Onwujekwe

    Full Text Available The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT. Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs with basic instruction (control; RDTs with provider training (provider arm; and RDTs with provider training plus a school-based community intervention (provider-school arm. The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93% of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36: stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26 in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19 in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47. Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines.ClinicalTrials.gov NCT01350752.

  14. The Efficacy and Safety of Add-on Ginko TD (Ginkgo Biloba Treatment for PTSD: Results of a 12-Week Double-Blind Placebo-Controlled Study

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    Laleh Koohi Habibi

    2007-06-01

    Full Text Available "nObjective: Exposure to traumatic stressors lead to activation of arousal responses mediated by serotonergic and noradrenergic systems and it may cause a change in numerous neurotransmitters and neuroendocrine systems. There is ample experimental and clinical evidence to suggest that Ginkgo biloba extract is neuroprotective and has antioxidant properties and can restore stress-induced elevation in brain levels of catecholamines, 5-HT and plasma corticosterone to normal level. "nMethod: In a 12-week, double-blind, placebo-controlled study, the efficacy and safety of adding-on a fixed-dose (200mg of Ginkgo TD to the previous treatment regime of adults with PTSD were examined. Subjects were forty male and female outpatients from a public-owned psychiatric clinic who met criteria for PTSD seven month after a 6.3 Richter earthquake in Bam city on December 26, 2003. The changes in five symptom domains including posttraumatic stress, anxiety and affective symptoms, general health and subjective stress after trauma were ssessed at weeks 0, 12 and 16 to examine effectiveness of the added-on Ginkgo TD and stability of its effects. "nResults: Ginkgo TD was associated with a significantly greater improvement than placebo in PTSD patients as measured by five symptom domain scales including: GHQ-28; Watson PTSD Scale; HAM-D; HAM-A and IES (p= 0.02, 0.01, 0.001, 0.01, 0.02 respectively Four weeks after the discontinuation of intervention, no significant difference was determined between the two groups in the five outcome measures (p= 0.005, 0.01, 0.004, 0.005, 0.01 respectively. No significant difference was observed between the two groups in terms of side effects. "nConclusions: We found Ginkgo TD to be superior to placebo as an adding-on in the treatment of PTSD. Although we did not examine the comparative efficacy of Ginkgo TD on the three main elements of PTSD, beneficial effects both on specific PTSD symptomatology and general conditions including

  15. Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: the Weight-Wise II Program.

    Science.gov (United States)

    Samuel-Hodge, Carmen D; Garcia, Beverly A; Johnston, Larry F; Kraschnewski, Jennifer L; Gustafson, Alison A; Norwood, Arnita F; Glasgow, Russell E; Gold, Alison D; Graham, John W; Evenson, Kelly R; Stearns, Sally C; Gizlice, Ziya; Keyserling, Thomas C

    2012-01-01

    Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes of translation using the RE-AIM framework, use of an evidence-based weight loss intervention, a detailed description of participant recruitment and representativeness, and a practical randomized trial designed to assess the effectiveness of the intervention. Of 81 health departments invited to participate, 30 (37%) were eligible and willing, and 6 were selected at random to deliver the intervention. Of 432 potential participants screened by phone, 213 (49%) were eligible and of these, 189 (89%) completed baseline measures and were randomized to receive a 5-month weight loss intervention or a delayed intervention. The mean age was 51, mean BMI 37 kg/m(2), 53% were African American, and 43% had no health insurance. The results of this study should be informative to key stakeholders interested in real world weight loss interventions for low-income mid-life women.

  16. Community-based intervention to improve dietary habits and promote physical activity among older adults: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Kimura Mika

    2013-01-01

    Full Text Available Abstract Background The fastest growing age group globally is older adults, and preventing the need for long-term nursing care in this group is important for social and financial reasons. A population approach to diet and physical activity through the use of social services can play an important role in prevention. This study examined the effectiveness of a social health program for community-dwelling older adults aimed at introducing and promoting physical activity in the home at each individual’s pace, helping participants maintain good dietary habits by keeping self-check sheets, and determining whether long-standing unhealthy or less-than-ideal physical and dietary habits can be changed. Method This cluster randomized trial conducted at 6 community centers in an urban community involved 92 community-dwelling older adults aged 65–90 years. The intervention group (3 community centers; n = 57 participated in the social health program “Sumida TAKE10!” which is an educational program incorporating the “TAKE10!® for Older Adults” program, once every 2 weeks for 3 months. The control group (3 community centers; n=35 was subsequently provided with the same program as a crossover intervention group. The main outcome measures were changes in food intake frequency, food frequency score (FFS, dietary variety score (DVS, and frequency of walking and exercise. The secondary outcome measures were changes in self-rated health, appetite, and the Tokyo Metropolitan Institute of Gerontology (TMIG Index of Competence score. Results Compared to baseline, post-intervention food intake frequency for 6 of 10 food groups (meat, fish/shellfish, eggs, potatoes, fruits, and seaweed, FFS, and DVS were significantly increased in the intervention group, and interaction effects of FFS and DVS were seen between the two groups. No significant differences were observed between baseline and post-intervention in the control group. Frequency of walking and

  17. A Research Synthesis of Therapeutic Interventions for Whiplash-Associated Disorder (WAD: Part 3 – Interventions for Subacute WAD

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    Robert W Teasell

    2010-01-01

    Full Text Available Whiplash-associated disorder (WAD represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. While many treatments have been advocated for patients with WAD, scientific evidence supporting their effectiveness is often lacking. A systematic review was conducted to evaluate the strength of evidence associated with various WAD therapies. Multiple databases (including Web of Science, EMBASE and PubMed were searched to identify all studies published from January 1980 through March 2009 that evaluated the effectiveness of any clearly defined treatment for acute (less than two weeks, subacute (two to 12 weeks or chronic (longer than 12 weeks WAD. The present article, the third in a five-part series, evaluates the evidence for interventions initiated during the subacute phase of WAD. Thirteen studies that met the inclusion criteria were identified, six of which were randomized controlled trials with ‘good’ overall methodology (median Physiotherapy Evidence Database score of 6. Although some evidence was identified to support the use of interdisciplinary interventions and chiropractic manipulation, the evidence was not strong for any of the evaluated treatments. There is a clear need for further research to evaluate interventions aimed at treating patients with subacute WAD because there are currently no interventions satisfactorily supported by the research literature.

  18. Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial

    Science.gov (United States)

    Chalin, Patrice; Thompson, Nicholas

    2016-01-01

    Background Emerging technologies (ie, mobile phones, Internet) may be effective tools for promoting physical activity (PA). However, few interventions have provided effective means to enhance social support through these platforms. Face-to-face programs that use group dynamics-based principles of behavior change have been shown to be highly effective in enhancing social support through promoting group cohesion and PA, but to date, no studies have examined their effects in Web-based programs. Objective The aim was to explore proof of concept and test the efficacy of a brief, online group dynamics-based intervention on PA in a controlled experiment. We expected that the impact of the intervention on PA would be moderated by perceptions of cohesion and the partner’s degree of presence in the online media. Methods Participants (n=135) were randomized into same-sex dyads and randomly assigned to one of four experimental conditions: standard social support (standard), group dynamics-based–high presence, group dynamics-based–low presence, or individual control. Participants performed two sets of planking exercises (pre-post). Between sets, participants in partnered conditions interacted with a virtual partner using either a standard social support app or a group dynamics-based app (group dynamics-based–low presence and group dynamics-based–high presence), the latter of which they participated in a series of online team-building exercises. Individual participants were given an equivalent rest period between sets. To increase presence during the second set, participants in the group dynamics-based–high presence group saw a live video stream of their partner exercising. Perceptions of cohesion were measured using a modified PA Group Environment Questionnaire. Physical activity was calculated as the time persisted during set 2 after controlling for persistence in set 1. Results Perceptions of cohesion were higher in the group dynamics-based–low presence (overall

  19. Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Harrington Kathleen F

    2012-08-01

    Full Text Available Abstract Background E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit. Design A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Methods A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality

  20. Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Leiva A

    2014-12-01

    Full Text Available Alfonso Leiva,1 Antonio Aguiló,2 Marta Fajó-Pascual,3 Lucia Moreno,4 Ma Carmen Martín,5 Elena Marina  Garcia,6 Rosa Elena Duro,7 Francisca Serra,8 Pilar Dagosto,9 Ana Aurelia Iglesias-Iglesias,10 Rosa Maria Company,11 Aina Yañez,12 Joan Llobera13 On behalf of The Adherence Group 1Primary Care Research Unit of Mallorca, Baleares Health Services-IbSalut, Mallorca, 2Research Group on Evidence, Lifestyles and Health, Universitat Illes Balears, Palma, 3Faculty of Health and Sport Sciences, University of Zaragoza, Huesca, 4Son Cladera Health Centre, Baleares Health Services-IbSalut, Mallorca, 5Actur Sur Health Centre, Aragon Health Services-Salud, Aragón, Zaragoza, 6Coll D’en Rabassa Health Centre, Baleares Health Services-IbSalut, Mallorca, 7San Agustín Health Centre, Baleares Health Services-IbSalut, Mallorca, 8Santa María Health Centre, Baleares Health Services-IbSalut, Mallorca, 9Sineu Health Centre, Baleares Health Services-IbSalut, Mallorca, 10Santa Ponça Health Centre, Baleares Health Services-IbSalut, Mallorca, 11Department of Pharmacy, Manacor Hospital-Llevant Sector, Baleares Health Services-IbSalut, Mallorca 12Montuiri Health Centre, Baleares Health Services-IbSalut, Mallorca, 13Fundació d’Investigació Sanitaria Illes Balears (FISIB, Son Espases Hospital, Baleares Health Services-IbSalut, Mallorca, SpainBackground: Lowering blood pressure (BP by antihypertensive (AHT drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events.Objective: To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP.Methods/design: Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18–80 years, taking AHT drugs with uncontrolled BP (n=221 were randomized to a control group

  1. LEARN 2 MOVE 2-3: a randomized controlled trial on the efficacy of child-focused intervention and context-focused intervention in preschool children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Verschuren Olaf

    2010-11-01

    Full Text Available Abstract Background Little is known about the efficacy and the working mechanisms of physical and occupational therapy interventions for children with cerebral palsy (CP. In recent years a shift from a child-focused intervention approach to a more context-focused intervention approach can be recognized. Until now the evidence on the efficacy and the working mechanisms of these interventions for children with CP is inconclusive. This study aims to evaluate the efficacy and working mechanisms of two intervention approaches compared to regular care intervention in improving mobility and self-care skills of children (2-3 years with CP and their families: a child-focused intervention approach and a context-focused intervention approach. Methods/Design A multi-centre, randomized controlled trial research design will be used. Ninety-four children with CP (Gross Motor Function Classification System (GMFCS level I-IV; age 2 to 3 years, their parents, and service providers (physical and occupational therapists will be included. During a period of six months children will receive child-focused, context-focused or regular care intervention. Therapists will be randomly assigned to deliver either a child-focused intervention approach, a context-focused intervention approach or regular care intervention. Children follow their therapist into the allocated intervention arm. After the six months study-intervention period, all participants return to regular care intervention. Outcomes will be evaluated at baseline, after six months and at a three months follow-up period. Primary outcome is the capability of functional skills in self-care and mobility, using the Functional Skills Scale of the Pediatric Evaluation of Disability Inventory (PEDI. Other outcomes will be quality of life and the domains of the International Classification of Functioning, Disability and Health - for Children and Youth (ICF-CY, including body function and structure, activities (gross motor

  2. Sequential Multiple Assignment Randomized Trial (SMART) to Construct Weight Loss Interventions for African American Adolescents.

    Science.gov (United States)

    Naar-King, Sylvie; Ellis, Deborah A; Idalski Carcone, April; Templin, Thomas; Jacques-Tiura, Angela J; Brogan Hartlieb, Kathryn; Cunningham, Phillippe; Jen, Kai-Lin Catherine

    2016-01-01

    The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population.

  3. Sequential Multiple Assignment Randomized Trial (SMART) to Construct Weight Loss Interventions for African American Adolescents.

    Science.gov (United States)

    Naar-King, Sylvie; Ellis, Deborah A; Idalski Carcone, April; Templin, Thomas; Jacques-Tiura, Angela J; Brogan Hartlieb, Kathryn; Cunningham, Phillippe; Jen, Kai-Lin Catherine

    2016-01-01

    The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population. PMID:25668386

  4. Measuring social integration in a pilot randomized controlled trial of critical time: intervention-task shifting in Latin America

    Science.gov (United States)

    Baumgartner, Joy Noel; da Silva, Tatiana Fernandes Carpinteiro; Valencia, Eliecer; Susser, Ezra

    2013-01-01

    Global mental health movements increasingly highlight the importance of social integration for individuals living with severe mental illnesses. However, this important individual-level outcome is rarely measured in programs. As part of RedeAmericas, a pilot regional randomized controlled trial of critical time intervention — task shifting — will be conducted, which includes social integration as an outcome measure. It is a time-limited care coordination model to enhance continuity of support for people with severe mental illness during critical periods of transition. Given the challenges of measuring social integration, particularly for a multi-country study with unique cultural contexts, this paper has described the measurement approach used to create a composite measure that uses items from disability and quality of life instruments in addition to other key items. PMID:24288454

  5. Effectiveness of an Internet intervention for family caregivers of people with dementia: results of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Marco M Blom

    Full Text Available The World Health Organization stresses the importance of accessible and (costeffective caregiver support, given the expected increase in the number of people with dementia and the detrimental impact on the mental health of family caregivers.This study assessed the effectiveness of the Internet intervention 'Mastery over Dementia'. In a RCT, 251 caregivers, of whom six were lost at baseline, were randomly assigned to two groups. Caregivers in the experimental group (N = 149 were compared to caregivers who received a minimal intervention consisting of e-bulletins (N = 96. Outcomes were symptoms of depression (Center for Epidemiologic Studies Depression Scale: CES-D and anxiety (Hospital Anxiety and Depression Scale: HADS-A. All data were collected via the Internet, and an intention-to-treat analysis was carried out.Almost all caregivers were spouses or children (in-law. They were predominantly female and lived with the care recipient in the same household. Age of the caregivers varied from 26 to 87 years. Level of education varied from primary school to university, with almost half of them holding a bachelor's degree or higher. Regression analyses showed that caregivers in the experimental group showed significantly lower symptoms of depression (p = .034 and anxiety (p = .007 post intervention after adjustment for baseline differences in the primary outcome scores and the functional status of the patients with dementia. Effect sizes were moderate for symptoms of anxiety (.48 and small for depressive symptoms (.26.The Internet course 'Mastery over Dementia' offers an effective treatment for family caregivers of people with dementia reducing symptoms of depression and anxiety. The results of this study justify further development of Internet interventions for family caregivers of people with dementia and suggest that such interventions are promising for keeping support for family caregivers accessible and affordable. The findings are even more

  6. Using Behavioral Intervention Technologies to Help Low-Income and Latino Smokers Quit: Protocol of a Randomized Controlled Trial

    Science.gov (United States)

    Bunge, Eduardo L; Barrera, Alinne Z; Wickham, Robert E; Lee, Jessica

    2016-01-01

    Background The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically to help low-income English- and Spanish-speaking smokers to quit. Individuals from lower-income countries and those with lower social status quit at lower rates than those from high-income countries and those with higher social status. Objective We plan to launch a project designed to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public-sector health care system can significantly improve its acceptability, utilization, and effectiveness. Methods Using human-centered development methods, we will involve low-income patients in the design of a Web app/text messaging tool. We will also use their input to improve our recruitment and dissemination strategies. We will iteratively develop versions of the digital interventions informed by our human-centered approach. The project involves three specific aims: (1) human-centered development of an English/Spanish smoking cessation web app, (2) improvement of dissemination strategies, and (3) evaluation of resulting smoking cessation web app. We will develop iterative versions of a digital smoking cessation tool that is highly responsive to the needs and preferences of the users. Input from participants will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period. We will evaluate the effectiveness of the successive versions of the resulting stop smoking Web app by an online randomized controlled trial. Increased effectiveness will be defined as increased utilization of the Web app and higher abstinence rates than those obtained by a baseline usual care Web app. Results

  7. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meriwether Rebecca A

    2011-05-01

    Full Text Available Abstract Background The SenseWear™ Armband (SWA (BodyMedia, Inc. Pittsburgh, PA is a physical activity and lifestyle monitor that objectively and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake. The real-time feedback of the SWA can improve individual self-monitoring and, therefore, enhance weight loss outcomes. Methods We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 y; body mass index (BMI, 33.3 ± 5.2 kg/m2; 81% women, 32% African-American from the greater Columbia, South Carolina area. Participants were randomized into 1 of 4 groups, a self-directed weight loss program via an evidence-based weight loss manual (Standard Care, n = 50, a group-based behavioral weight loss program (GWL, n = 49, the armband alone (SWA-alone, n = 49, or the GWL plus the armband (GWL+SWA, n = 49, during the 9-month intervention. The primary outcome was change in body weight and waist circumference. A mixed-model repeated-measures analysis compared change in the intervention groups to the standard care group on weight and waist circumference status after adjusting for age, sex, race, education, energy expenditure, and recruitment wave. Results Body weight was available for 62% of participants at 9 months (52% standard care, 70% intervention. There was significant weight loss in all 3 intervention groups (GWL, 1.86 kg, P = 0.05; SWA-alone, 3.55 kg, P = 0.0002; GWL+SWA, 6.59 kg, P Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults. This strategy, combined with a group-based behavioral intervention, may yield optimal weight loss. Trial Registration ClinicalTrials.gov: NCT00957008

  8. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2011-03-01

    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  9. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  10. A randomized trial examining the effects of parent engagement on early language and literacy: the Getting Ready intervention.

    Science.gov (United States)

    Sheridan, Susan M; Knoche, Lisa L; Kupzyk, Kevin A; Edwards, Carolyn Pope; Marvin, Christine A

    2011-06-01

    Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children's language use (d=1.11), reading (d=1.25), and writing skills (d=0.93). Significant intervention effects on children's direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child's development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment's effects. PMID:21640249

  11. Randomized Trial of a Pre-Surgical Scheduled Reduced Smoking Intervention for Patients Newly Diagnosed with Cancer

    Science.gov (United States)

    Ostroff, Jamie S.; Burkhalter, Jack E.; Cinciripini, Paul M.; Li, Yuelin; Shiyko, Mariya P.; Lam, Cho Y.; Hay, Jennifer L.; Dhingra, Lara K.; Lord-Bessen, Jennifer; Holland, Susan M.; Manna, Ruth

    2014-01-01

    Objective Cancer patients are advised to quit smoking to reduce treatment complications and future cancer risk. This study's main objective was to evaluate the efficacy of a novel, pre-surgical cessation intervention in newly diagnosed cancer patients scheduled for surgical hospitalization. Methods We conducted a parallel-arm, randomized controlled trial comparing the efficacy of our hospital-based, tobacco cessation “best practices” treatment model (BP; cessation counseling and nicotine replacement therapy) with BP enhanced by a behavioral tapering regimen (scheduled reduced smoking; BP+SRS) administered by a handheld computer before hospitalization for surgery. Cessation outcomes were short (hospital admission and three months) and longer-term (6 months) biochemically-verified smoking abstinence. We hypothesized that BP+SRS would be superior to BP alone. One hundred eighty-five smokers were enrolled. Results Overall, 7-day-point prevalence, confirmed abstinence rates at six months for BP alone (32%) and BP+SRS (32%) were high; however, no main effect of treatment was observed. Patients who were older and diagnosed with lung cancer were more likely to quit smoking. Conclusions Compared to best practices for treating tobacco dependence, a pre-surgical, scheduled reduced smoking intervention did not improve abstinence rates among newly diagnosed cancer patients. PMID:23895203

  12. Effects of Exercise Intervention on Vascular Risk Factors in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kazuki Uemura

    2012-10-01

    Full Text Available Aims: The purpose of this study is to clarify the effects of exercise intervention on vascular risk factors in older adults with mild cognitive impairment (MCI. Methods: Community-dwelling older adults who met the definition of MCI using the Petersen criteria (n = 100; mean age = 75.3 years were randomly allocated to the exercise (n = 50 or education control group (n = 50. Participants in the exercise group exercised under the supervision of physiotherapists for 90 min/day, 2 days/week, 80 times for 12 months. Anthropometric profiles, blood markers, blood pressure, and physical fitness (the 6-min walking test were measured. Total cholesterol (TC, high-density lipoprotein cholesterol (HDL-C, and TC/HDL-C risk ratio measurements were taken from blood samples. Results: The exercise group showed significantly reduced TC and TC/HDL-C risk ratio after training compared with baseline levels (p Conclusion: Exercise intervention was associated with positive changes in important vascular risk factors related to cognitive decline and vascular disease in older adults with MCI.

  13. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial.

    Science.gov (United States)

    Black, David S; O'Reilly, Gillian A; Olmstead, Richard; Breen, Elizabeth C; Irwin, Michael R

    2014-09-01

    Sleep problems are prevalent among older adults, often persist untreated, and are predictive of health detriments. Given the limitations of conventional treatments, non-pharmacological treatments such as mindfulness-based interventions (MBIs) are gaining popularity for sleep ailments. However, nothing is yet known about the impact of MBIs on sleep in older adults with prodromal sleep disturbances. This article details the design and methodology of a 6-week parallel-group RCT calibrated to test the treatment effect of the Mindful Awareness Practices (MAPs) program versus sleep hygiene education for improving sleep quality, as the main outcome, in older adults with prodromal sleep disturbances. Older adults with current sleep disturbances will be recruited from the urban Los Angeles community. Participants will be randomized into two standardized treatment conditions, MAPs and sleep hygiene education. Each condition will consist of weekly 2-hour group-based classes over the course of the 6-week intervention. The primary objective of this study is to determine if mindfulness meditation practice as engaged through the MAPs program leads to improved sleep quality relative to sleep hygiene education in older adults with prodromal sleep disturbances.

  14. Randomized, Blinded Trial Comparing Enoxaparin with Unfractionated Heparin in Patients Undergoing Contemporary Percutaneous Coronary Intervention

    Directory of Open Access Journals (Sweden)

    Hosein Vakili

    2007-07-01

    Full Text Available Background: This study was designed to examine a unique and low dose use of intravenous enoxaparin in elective percutaneous coronary intervention (PCI that would be applicable to an unselected population regardless of age, weight, and renal function. There is limited experience in anticoagulation using intravenous low-molecular-weight heparin in PCI. Methods: A total of 100 consecutive patients undergoing elective PCI were treated with a single IV bolus of enoxaparin (0.5mg/kg in group A of patients (n=50 or with unfractionated heparin in group B of patients (n=50. Sheaths were removed immediately after the procedure in patients treated with enoxaparin and some hours later in those treated with unfractionated heparin. Results: In group A, ACT was 124.6±9.3 before PCI and 149.2±17.1 after that (P<0.05. In group B, one patient (2.9% developed groin hematoma. No deaths, MI, or urgent target vessel revascularization were reported. Conclusion: Low- dose (0.5 mg/kg IV enoxaparin allows a target level of anticoagulation in patients undergoing PCI, appears to be safe and effective, allows immediate sheath removal, and does not require dose adjustment.

  15. Effects of a brief school-based media literacy intervention on digital media use in adolescents: cluster randomized controlled trial.

    Science.gov (United States)

    Walther, Birte; Hanewinkel, Reiner; Morgenstern, Matthis

    2014-09-01

    The aim of this study was to evaluate the effects of a four-session school-based media literacy curriculum on adolescent computer gaming and Internet use behavior. The study comprised a cluster randomized controlled trial with three assessments (baseline, posttest, and 12-month follow-up). At baseline, a total of 2,303 sixth and seventh grade adolescents from 27 secondary schools were assessed. Of these, 1,843 (80%) could be reached at all three assessments (Mage=12.0 years; SD=0.83). Students of the intervention group received the media literacy program Vernetzte www.Welten ("Connected www.Worlds ") implemented by trained teachers during class time. The control group attended regular class. Main outcome measures were adolescents' computer gaming and Internet use: days per month, hours per day, and addictive use patterns. Parental media monitoring and rules at home were assessed as secondary outcomes. Results of multilevel growth-curve models revealed a significant intervention effect in terms of a lower increase in self-reported gaming frequency (β = -1.10 [95% CI -2.06, -0.13]), gaming time (β = -0.27 [95% CI -0.40, -0.14]), and proportion of excessive gamers (AOR=0.21 [95% CI 0.08, 0.57]) in the intervention group. There were also significant group-time interactions for the addictive gaming scale (β=-0.08 [95% CI -0.12, -0.04]), and the Internet Addiction Scale (β = -0.06 [95% CI -0.10, -0.01]). No effect was found for days and hours of Internet use or parental media behavior. The study shows that the program Vernetzte www.Welten can influence adolescents' media use behavior. Future research should address mediating and moderating variables of program effects.

  16. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Marianne J E van der Heijden

    Full Text Available Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery.We searched 25 electronic databases from their first available date until October 2014.Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music.4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators.Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated, the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale.Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07 and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16.This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  17. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Costello Anthony

    2011-06-01

    Full Text Available Abstract Background Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen. Methods/Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers. MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design. MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs are supported in convening monthly women's groups. Nine groups per cluster (270 in total work through two action research cycles in which they (i identify local issues around maternity, newborn health and nutrition, (ii prioritise key problems, (iii develop strategies to address them, (iv implement the strategies, and (v evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i identify local births, (ii identify low birth weight infants, (iii identify possible newborn infection, (iv manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v follow up infants and support families. Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal

  18. Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    T Dinesh

    2015-01-01

    Conclusion: Twelve weeks of pranayama training in young subjects showed improvement in the commonly measured PFT. This indicates that pranayama training improved pulmonary function and that this was more pronounced in the FPG.

  19. Colesevelam Added to Combination Therapy With a Statin and Ezetimibe in Patients With Familial Hypercholesterolemia : A 12-Week, Multicenter, Randomized, Double-Blind, Controlled Trial

    NARCIS (Netherlands)

    Huijgen, Roeland; Abbink, Evertine J.; Bruckert, Eric; Stalenhoef, Anton F. H.; Imholz, Ben P. M.; Durrington, Paul N.; Trip, M. D.; Eriksson, Mats; Visseren, Frank L. J.; Schaefer, Juergen R.; Kastelein, John J. P.

    2010-01-01

    Background: Familial hypercholesterolemia (FH) has been associated with increased cardiovascular risk when untreated or when normal LDL-C concentrations are not reached. Some patients with FH do not reach LDL-C goals despite intensive combination therapy. Objective: This study assessed the efficacy

  20. Neurofeedback intervention in fibromyalgia syndrome; a randomized, controlled, rater blind clinical trial.

    Science.gov (United States)

    Kayiran, Sadi; Dursun, Erbil; Dursun, Nigar; Ermutlu, Numan; Karamürsel, Sacit

    2010-12-01

    We designed a randomized, rater blind study to assess the efficacy of EEG Biofeedback (Neurofeedback-NFB) in patients with fibromyalgia syndrome (FMS). Eighteen patients received twenty sessions of NFB-sensory motor rhythm (SMR) treatment (NFB group) during 4 weeks, and eighteen patients were given 10 mg per day escitalopram treatment (control group) for 8 weeks. Visual Analog Scales for pain and fatigue, Hamilton and Beck Depression and Anxiety Inventory Scales, Fibromyalgia Impact Questionnaire and Short Form 36 were used as outcome measures which were applied at baseline and 2nd, 4th, 8th, 16th, 24th weeks. Mean amplitudes of EEG rhythms (delta, theta, alpha, SMR, beta1 and beta2) and theta/SMR ratio were also measured in NFB group. All post-treatment measurements showed significant improvements in both of the groups (for all parameters p 0.05 for all). However, theta/SMR ratio showed a significant decrease at 4th week compared to baseline in the NFB group (p < 0.05). These data support the efficacy of NFB as a treatment for pain, psychological symptoms and impaired quality of life associated with fibromyalgia. PMID:20614235

  1. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Dawson Church

    2012-01-01

    Full Text Available Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI. Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques, a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N=18. The EFT group (n=9 had significantly more depression at baseline than the control group (n=9 (EFT BDI mean=23.44, SD=2.1 versus control BDI mean=20.33, SD=2.1. After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P=.001; EFT BDI mean=6.08, SE=1.8 versus control BDI mean=18.04, SE=1.8. Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment.

  2. Plasticity of brain networks in a randomized intervention trial of exercise training in older adults

    Directory of Open Access Journals (Sweden)

    Michelle W Voss

    2010-08-01

    Full Text Available Research has shown the human brain is organized into separable functional networks during rest and varied states of cognition, and that aging is associated with specific network dysfunctions. The present study used functional magnetic resonance imaging (fMRI to examine low-frequency (.008<.08 Hz coherence of cognitively relevant and sensory brain networks in older adults who participated in a one-year intervention trial, comparing the effects of aerobic and non-aerobic fitness training on brain function and cognition. Results showed that aerobic training improved the aging brain’s resting functional efficiency in higher-level cognitive networks. One year of walking increased functional connectivity between aspects of the frontal, posterior, and temporal cortices within the Default Mode Network and a Frontal Executive Network, two brain networks central to brain dysfunction in aging. Length of training was also an important factor. Effects in favor of the walking group were observed only after 12 months of training, compared to non-significant trends after six months. A non-aerobic stretching and toning group also showed increased functional connectivity in the DMN after six months and in a Frontal Parietal Network after 12 months, possibly reflecting experience-dependent plasticity. Finally, we found that changes in functional connectivity were behaviorally relevant. Increased functional connectivity was associated with greater improvement in executive function. Therefore the study provides the first evidence for exercise-induced functional plasticity in large-scale brain systems in the aging brain, using functional connectivity techniques, and offers new insight into the role of aerobic fitness in attenuating age-related brain dysfunction.

  3. Randomized Controlled Trial of Nuevo Amanecer: A Peer-delivered Stress Management Intervention for Spanish-speaking Latinas with Breast Cancer

    OpenAIRE

    Nápoles, Anna María; Santoyo-Olsson, Jasmine; Ortiz, Carmen; Gregorich, Steven; Lee, Howard E.; Duron, Ysabel; Graves, Kristi; Luce, Judith A.; McGuire, Peggy; Díaz-Méndez, Marynieves; Stewart, Anita L.

    2014-01-01

    BackgroundLatinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population.PurposeWe describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomize...

  4. A national school-based health lifestyles interventions among Chinese children and adolescents against obesity: rationale, design and methodology of a randomized controlled trial in China

    OpenAIRE

    Chen, Yajun; Ma, Lu; Ma, Yinghua; Wang, Haijun; Luo, Jiayou; Xin ZHANG; Luo, Chunyan; Wang, Hong; Zhao, Haiping; Pan, Dehong; Zhu, Yanna; Cai, Li; Zou, Zhiyong; Yang, Wenhan; Ma, Jun

    2015-01-01

    Background The prevalence of obesity among children and adolescents has been rapidly rising in Mainland China in recent decades, both in urban and rural areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited rigid data regarding children and adolescent overweight prevention in China are available. A national random controlled school-based obesity intervention program was developed in the mainland of China. Methods/Design The study was designed ...

  5. Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research

    OpenAIRE

    Keegan Natalie; Windham Amy; Ford Carla; Brown C Hendricks; Kellam Sheppard; Poduska Jeanne; Wang Wei

    2009-01-01

    Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and o...

  6. A participatory physical and psychosocial intervention for balancing the demands and resources among industrial workers (PIPPI): study protocol of a cluster-randomized controlled trial

    OpenAIRE

    Gupta, Nidhi; Dyrlund Wåhlin-Jacobsen, Christian; Nøhr Henriksen, Louise; Abildgaard, Johan Simonsen; NIELSEN, Karina; Holtermann, Andreas

    2015-01-01

    Background: Need for recovery and work ability are strongly associated with high employee turnover, well-being and sickness absence. However, scientific knowledge on effective interventions to improve work ability and decrease need for recovery is scarce. Thus, the present study aims to describe the background, design and protocol of a cluster randomized controlled trial evaluating the effectiveness of an intervention to reduce need for recovery and improve work ability among industrial worke...

  7. Results of the Northern Manhattan Diabetes Community Outreach Project: A Randomized Trial Studying a Community Health Worker Intervention to Improve Diabetes Care in Hispanic Adults

    OpenAIRE

    Palmas, Walter; Sally E Findley; Mejia, Miriam; Batista, Milagros; Teresi, Jeanne; Kong, Jian; Silver, Stephanie; Fleck, Elaine M.; Luchsinger, Jose A.; Carrasquillo, Olveen

    2014-01-01

    OBJECTIVE The Northern Manhattan Diabetes Community Outreach Project evaluated whether a community health worker (CHW) intervention improved clinically relevant markers of diabetes care in adult Hispanics. RESEARCH DESIGN AND METHODS Participants were adult Hispanics, ages 35–70 years, with recent hemoglobin A1c (A1C) ≥8% (≥64 mmol/mol), from a university-affiliated network of primary care practices in northern Manhattan (New York City, NY). They were randomized to a 12-month CHW intervention...

  8. Impact of community-based interventions on maternal and neonatal health indicators: Results from a community randomized trial in rural Balochistan, Pakistan

    OpenAIRE

    Becker Stan; Midhet Farid

    2010-01-01

    Abstract Background Pakistan has high maternal mortality, particularly in the rural areas. The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality. Methods We present results from an experimental study in rural Pakistan. Village clusters were randomly assigned to intervention and control arms (16 clusters each). In the intervention clusters, women were provided information on safe motherhood through pictorial booklets a...

  9. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men.

    Directory of Open Access Journals (Sweden)

    Sabina Hirshfield

    Full Text Available As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM. Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.A randomized controlled trial (RCT conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631. No participant incentives were provided.Follow-up was completed by 1,631 (53% of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told' with their last sexual partner (OR 1.32, 95% CI 1.01-1.74. Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91 and webpage condition (OR 0.43, 95% CI 0.25-0.72 significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67 and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96 at follow-up.Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.ClinicalTrials.gov NCT

  10. Whole Grain Compared with Refined Wheat Decreases the Percentage of Body Fat Following a 12-Week, Energy-Restricted Dietary Intervention in Postmenopausal Women

    DEFF Research Database (Denmark)

    Kristensen, Mette; Toubro, Søren; Jensen, Morten Georg;

    2012-01-01

    .04). Serum total and LDL cholesterol increased by approximately 5% (P ... body weight changes did not differ between the RW and WW groups. Serum total and LDL cholesterol, two important risk factors of cardiovascular disease, increased with RW but not WW consumption, which may suggest a cardioprotective role for whole grain....

  11. Dairy food consumption and meal-induced cortisol response interact to influence weight loss in overweight women undergoing a 12-week meal-controlled weight loss intervention

    Science.gov (United States)

    Dairy foods enhance weight loss in animal models possibly by modifying the metabolic effects of cortisol. This study aimed to determine in overweight women (ages 20-45; n=51) whether inclusion of dairy foods in an energy-restricted diet affects basal and stimulated cortisol concentrations, and whet...

  12. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    OpenAIRE

    Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan OP; ONeill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

    2013-01-01

    Background The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. Methods/design This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. Setting: The University Health Netw...

  13. A Comparison of 12 Weeks of Pilates and Aquatic Training on the Dynamic Balance of Women with Mulitple Sclerosis

    Directory of Open Access Journals (Sweden)

    Sayyed Mohammad Marandi

    2013-01-01

    Results: The adjusted mean differences of Timed Up and Go Test (TUGT scores of the experimental groups are significantly different (P<0.05. Therefore, it can be said that Pilates exercise interventions and aquatic training can significantly increase the dynamic balance of the examinees in the post-experiment stage. Conclusions: Performing the Pilate exercises and aquatic training increases dynamic balance of the MS patients. Considering the role of dynamic balance on physical fitness and enabling the person in doing is daily chores and routines, and its direct effect on the quality of life, it leads the specialists in applying these exercises as a supplementary treatment along with the medicinal treatments for MS patients.

  14. Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial.

    Science.gov (United States)

    George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Mahamud-ur Rashid; Mahmud, Md Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Sack, R Bradley; Alam, Munirul

    2016-02-01

    Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention. PMID:26728766

  15. Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial.

    Science.gov (United States)

    George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Mahamud-ur Rashid; Mahmud, Md Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Sack, R Bradley; Alam, Munirul

    2016-02-01

    Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention.

  16. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers

    OpenAIRE

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran; Kye, Seung Hee; Park, Yoo Kyoung

    2016-01-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants we...

  17. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study

    OpenAIRE

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR) and Superoxide dismutase (SOD) is significant only for cigarette smok...

  18. The effect of worksite physical activity intervention on physical capacity, health, and productivity: A 1-year randomized controlled trial

    DEFF Research Database (Denmark)

    Pedersen, Mogens T; Blangsted, Anne K.; Andersen, Lars L.;

    2009-01-01

    OBJECTIVE: To investigate the effect of two contrasting physical activity worksite interventions versus a reference intervention (REF) on various health outcomes. METHODS: A 1-year randomized controlled trial was conducted with specific resistance training (SRT), all-round physical exercise (APE...... uptake (APE) increased approximately 10%. CONCLUSIONS: Worksite intervention with both SRT as well as APE is recommended, since these activities compared with REF resulted in clinically relevant reductions of cardiovascular and metabolic syndrome-related risk factors as well as musculoskeletal pain...... symptoms, in combination with minor increases in physical capacity....

  19. Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP)

    DEFF Research Database (Denmark)

    Vinter, C A; Jørgensen, J S; Ovesen, Per Glud;

    2014-01-01

    AIMS: The Lifestyle in Pregnancy intervention in obese pregnant women resulted in significantly lower gestational weight gain compared with the control group, but without improvement in rates of clinical pregnancy complications. The impact of the lifestyle intervention on metabolic measurements...... in the study participants is now reported. METHODS: The Lifestyle in Pregnancy study was a randomized controlled trial among 360 obese women (BMI 30-45 kg/m(2) ) who were allocated in early pregnancy to lifestyle interventions with diet counselling and physical activities or to the control group. Fasting blood...... weight gain in the intervention group, there was no difference between the groups with respect to total cholesterol, HDL, LDL or triglycerides. CONCLUSIONS: Lifestyle intervention in obese pregnant women resulted in attenuation of the physiologic pregnancy-induced insulin resistance. Despite restricted...

  20. A community-integrated home based depression intervention for older African Americans: descripton of the Beat the Blues randomized trial and intervention costs

    Directory of Open Access Journals (Sweden)

    Gitlin Laura N

    2012-02-01

    Full Text Available Abstract Background Primary care is the principle setting for depression treatment; yet many older African Americans in the United States fail to report depressive symptoms or receive the recommended standard of care. Older African Americans are at high risk for depression due to elevated rates of chronic illness, disability and socioeconomic distress. There is an urgent need to develop and test new depression treatments that resonate with minority populations that are hard-to-reach and underserved and to evaluate their cost and cost-effectiveness. Methods/Design Beat the Blues (BTB is a single-blind parallel randomized trial to assess efficacy of a non-pharmacological intervention to reduce depressive symptoms and improve quality of life in 208 African Americans 55+ years old. It involves a collaboration with a senior center whose care management staff screen for depressive symptoms (telephone or in-person using the Patient Health Questionnaire (PHQ-9. Individuals screened positive (PHQ-9 ≥ 5 on two separate occasions over 2 weeks are referred to local mental health resources and BTB. Interested and eligible participants who consent receive a baseline home interview and then are randomly assigned to receive BTB immediately or 4 months later (wait-list control. All participants are interviewed at 4 (main study endpoint and 8 months at home by assessors masked to study assignment. Licensed senior center social workers trained in BTB meet with participants at home for up to 10 sessions over 4 months to assess care needs, make referrals/linkages, provide depression education, instruct in stress reduction techniques, and use behavioral activation to identify goals and steps to achieve them. Key outcomes include reduced depressive symptoms (primary, reduced anxiety and functional disability, improved quality of life, and enhanced depression knowledge and behavioral activation (secondary. Fidelity is enhanced through procedure manuals and staff

  1. Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial

    Directory of Open Access Journals (Sweden)

    Leiva-Fernández Francisca

    2012-05-01

    Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246

  2. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Arthur V Peterson

    Full Text Available The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention.High school smokers (n = 2,151 were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention or control (no intervention condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided.No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI = -3.4 to 5.8, p = .61, nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year.There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained

  3. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury.

    Science.gov (United States)

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-01-01

    (1) BACKGROUND: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) METHODS: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) RESULTS: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) CONCLUSION: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  4. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury

    Directory of Open Access Journals (Sweden)

    Joelle Leonie Flueck

    2016-09-01

    Full Text Available (1 Background: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2 Methods: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3 Results: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4 Conclusion: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are

  5. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

    Directory of Open Access Journals (Sweden)

    Øberg Gunn

    2012-02-01

    Full Text Available Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age. Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences

  6. A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity: rationale, design and methodology of a randomized controlled trial in Nanjing city, China

    Directory of Open Access Journals (Sweden)

    Xu Fei

    2012-06-01

    Full Text Available Abstract Background The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. Methods/design We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group. Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a classroom curriculum, (including physical education and healthy diet education, b school environment support, c family involvement, and d fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. Discussion The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools’ regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. Trial registration Registration number: ChiCTR-ERC-11001819

  7. Telaprevir-based triple-therapy in patients with chronic hepatitis C in Germany: a 12-week interim analysis of real-life data

    Directory of Open Access Journals (Sweden)

    T Berg

    2012-11-01

    Full Text Available Telaprevir (TVR-based triple therapy in patients (pts with chronic hepatitis C (HCV in daily practice in Germany is investigated in this non-interventional study. Aims are the evaluation of the implementation of futility rules, as well as safety and efficacy of TVR-based therapy. This prospective, multi-center study investigates TVR-based therapy in therapy-naïve and pretreated pts with genotype 1 chronic HCV in Germany, including pts with HIV co-infection. Patients are treated with a combination of TVR, ribavirin and peg-interferon. This interim analysis includes data from the first 100 pts (12.5% of the planned total at 32 sites completing 12 weeks (W of treatment. 66% of pts were pretreated for HCV. 36.4% of pts with pre-treatment were prior relapsers and 30.3% null or partial responders. Cirrhosis was present in 11% of all pts at baseline. HCV RNA levels below 800.000 IU/ml at baseline were present in 50% of pts. 67% of pts showed rapid virological response (RVR, undetectable HCV RNA at W4. Adherence to the futility rule (treatment stop if HCV-RNA>1000 IU/ml at W4 was 100% (N=9. At W12, 91.4% of pts had undetectable HCV RNA. 57.7% of therapy-naïve pts and 86.4% of previous relapsers were HCV-RNA negative at both W4 and 12 (70.8% in total. Only one patient achieving RVR at W4 suffered a virologic breakthrough. Nearly all pts (99% had adverse events (AE during the first 12W, 6% reported serious adverse events (SAE. AEs were mostly mild (63.9% or moderate (34.6% and frequently mentioned dry skin/pruritus (54%, gastrointestinal disorders (48%, anorectal discomfort (30%, rash (29% and anemia (23%. Rash was mostly rated as mild or moderate (97.1%. An Hb decrease<12 g/dl (female or<13 g/dl (male was reported in 87% of pts. Mean Hb levels decreased from 14.8 g/dl at baseline to 10.6 g/dl at W12; Hb levels<8.5 g/dl at any time within the first 12W of treatment were present in 11% of anemia cases and 6.6% required transfusion. Only one patient

  8. Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol

    Directory of Open Access Journals (Sweden)

    Plow Matthew

    2012-10-01

    Full Text Available Abstract Background Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels. Methods/Design A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1 a contact-control social support intervention, (2 a physical activity-only intervention, and (3 a physical activity plus fatigue management intervention. All interventions will last 12 weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ, and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e

  9. E-learning interventions are comparable to user's manual in a randomized trial of training strategies for the AGREE II

    Directory of Open Access Journals (Sweden)

    Durocher Lisa D

    2011-07-01

    Full Text Available Abstract Background Practice guidelines (PGs are systematically developed statements intended to assist in patient and practitioner decisions. The AGREE II is the revised tool for PG development, reporting, and evaluation, comprised of 23 items, two global rating scores, and a new User's Manual. In this study, we sought to develop, execute, and evaluate the impact of two internet interventions designed to accelerate the capacity of stakeholders to use the AGREE II. Methods Participants were randomized to one of three training conditions. 'Tutorial'--participants proceeded through the online tutorial with a virtual coach and reviewed a PDF copy of the AGREE II. 'Tutorial + Practice Exercise'--in addition to the Tutorial, participants also appraised a 'practice' PG. For the practice PG appraisal, participants received feedback on how their scores compared to expert norms and formative feedback if scores fell outside the predefined range. 'AGREE II User's Manual PDF (control condition'--participants reviewed a PDF copy of the AGREE II only. All participants evaluated a test PG using the AGREE II. Outcomes of interest were learners' performance, satisfaction, self-efficacy, mental effort, time-on-task, and perceptions of AGREE II. Results No differences emerged between training conditions on any of the outcome measures. Conclusions We believe these results can be explained by better than anticipated performance of the AGREE II PDF materials (control condition or the participants' level of health methodology and PG experience rather than the failure of the online training interventions. Some data suggest the online tools may be useful for trainees new to this field; however, this requires further study.

  10. Metabolomics reveals the metabolic shifts following an intervention with rye bread in postmenopausal women- a randomized control trial

    Directory of Open Access Journals (Sweden)

    Moazzami Ali A

    2012-10-01

    Full Text Available Abstract Background Epidemiological studies have consistently shown that whole grain (WG cereals can protect against the development of chronic diseases, but the underlying mechanism is not fully understood. Among WG products, WG rye is considered even more potent because of its unique discrepancy in postprandial insulin and glucose responses known as the rye factor. In this study, an NMR-based metabolomics approach was applied to study the metabolic effects of WG rye as a tool to determine the beneficial effects of WG rye on human health. Methods Thirty-three postmenopausal Finnish women with elevated serum total cholesterol (5.0-8.5 mmol/L and BMI of 20–33 kg/m2 consumed a minimum of 20% of their daily energy intake as high fiber WG rye bread (RB or refined wheat bread (WB in a randomized, controlled, crossover design with two 8-wk intervention periods separated by an 8-wk washout period. At the end of each intervention period, fasting serum was collected for NMR-based metabolomics and the analysis of cholesterol fractions. Multilevel partial least squares discriminant analysis was used for paired comparisons of multivariate data. Results The metabolomics analysis of serum showed lower leucine and isoleucine and higher betaine and N,N-dimethylglycine levels after RB than WB intake. To further investigate the metabolic effects of RB, the serum cholesterol fractions were measured. Total- and LDL-cholesterol levels were higher after RB intake than after WB (p Conclusions This study revealed favorable shifts in branched amino acid and single carbon metabolism and an unfavorable shift in serum cholesterol levels after RB intake in postmenopausal women, which should be considered for evaluating health beneficial effects of rye products.

  11. Alcohol-related brief intervention in patients treated for opiate or cocaine dependence: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Khan Riaz

    2011-08-01

    Full Text Available Abstract Background Despite the importance of heavy drinking and alcohol dependence among patients with opiate and cocaine dependence, few studies have evaluated specific interventions within this group. The aim of the present study was to evaluate the impact of screening with the Alcohol Use Disorders Identification Test (AUDIT and of brief intervention (BI on alcohol use in a sample of patients treated for opioid or cocaine dependence in a specialized outpatient clinic. Methods Adult outpatients treated for opioid or cocaine dependence in Switzerland were screened for excessive alcohol drinking and dependence with the AUDIT. Patients with AUDIT scores that indicated excessive drinking or dependence were randomized into two groups--treatment as usual or treatment as usual together with BI--and assessed at 3 months and 9 months. Results Findings revealed a high rate (44% of problematic alcohol use (excessive drinking and dependence among patients with opiate and cocaine dependence. The number of drinks per week decreased significantly between T0 (inclusion and T3 (month 3. A decrease in average AUDIT scores was observed between T0 and T3 and between T0 and T9 (month 9. No statistically significant difference between treatment groups was observed. Conclusions In a substance abuse specialized setting, screening for alcohol use with the AUDIT, followed by feedback on the score, and use of alcohol BI are both possibly useful strategies to induce changes in problematic alcohol use. Definitive conclusions cannot, however, be drawn from the study because of limitations such as lack of a naturalistic group. An important result of the study is the excellent internal consistency of AUDIT in a population treated for opiate or cocaine dependence.

  12. Diet and exercise interventions among overweight and obese lactating women: randomized trial of effects on cardiovascular risk factors.

    Directory of Open Access Journals (Sweden)

    Hilde K Brekke

    Full Text Available OBJECTIVE: To examine the effects of Diet (D and Exercise (E interventions on cardiovascular fitness, waist circumference, blood lipids, glucose metabolism, inflammation markers, insulin-like growth factor 1 (IGF-1 and blood pressure in overweight and obese lactating women. METHODS: At 10-14 wk postpartum, 68 Swedish women with a self-reported pre-pregnancy BMI of 25-35 kg/m(2 were randomized to a 12-wk behavior modification treatment with D, E, both or control using a 2×2 factorial design. The goal of D treatment was to reduce body weight by 0.5 kg/wk, accomplished by decreasing energy intake by 500 kcal/d and monitoring weight loss through self-weighing. The goal of E treatment was to perform 4 45-min walks per wk at 60-70% of max heart-rate using a heart-rate monitor. Effects were measured 12 wk and 1 y after randomization. General Linear Modeling was used to study main and interaction effects adjusted for baseline values of dependent variable. RESULTS: There was a significant main effect of the D treatment, decreasing waist circumference (P = 0.001, total cholesterol (P = 0.007, LDL-cholesterol (P = 0.003 and fasting insulin (P = 0.042, at the end of the 12-wk treatment. The decreased waist circumference (P<0.001 and insulin (P = 0.024 was sustained and HDL-cholesterol increased (P = 0.005 at the 1-y follow-up. No effects from the E treatment or any interaction effects were observed. CONCLUSIONS: Dietary behavior modification that produced sustained weight loss among overweight and obese lactating women also improved risk factors for cardiovascular disease and type 2 diabetes. This intervention may not only reduce weight-related risks with future pregnancies but also long-term risk for metabolic disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT01343238.

  13. Comparison of Intervention Fidelity between COPE TEEN and an Attention-Control Program in a Randomized Controlled Trial

    Science.gov (United States)

    Kelly, Stephanie A.; Oswalt, Krista; Melnyk, Bernadette Mazurek; Jacobson, Diana

    2015-01-01

    Fidelity in implementing an intervention is critical to accurately determine and interpret the effects of an intervention. It is important to monitor the manner in which the behavioral intervention is implemented (e.g. adaptations, delivery as intended and dose). Few interventions are implemented with 100% fidelity. In this study, high school…

  14. Thorombolytic therapy with rescue percutaneous coronary intervention versus primary percutaneous coronary intervention in patients with acute myocardial infarction: a multicenter randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    GAO Run-lin; L(U) Shu-zheng; WEI Meng; ZENG Ding-yin; CHEN Ji-lin; QIN Xue-wen; XU Bo; DU Chang-hui; HAN Ya-ling; YANG Xin-chun; MAO Jie-ming; FANG Wei-yi; WANG Lei; SHEN Wei-feng; LI Zhan-quan; JIA Guo-liang

    2010-01-01

    Background Although thrombolytic therapy with rescue percutaneous coronary intervention (PCI) is a common treatment strategy for ST-segment elevation acute myocardial infarction (STEMI), scant data are available on its efficacy relative to primary PCI, and comparison was therefore the aim of this study.Methods This multicenter, open-label, randomized, parallel trial was conducted in 12 hospitals on patients (age ≤70 years) with STEMI who presented within 12 hours of symptom onset (mean interval >3 hours). Patients were randomized to three groups: primary PCI group (n=101); recombinant staphylokinase (r-Sak) group (n=104); and recombinant tissue-type plasminogen activator (rt-PA) group (n=106). For all patients allocated to the thrombolytic therapy arm, coronary angiography was performed at 90 minutes after drug therapy to confirm infarct-related artery (IRA) patency; rescue PCI was performed in cases with TIMI flow grade ≤2. Bare-metal stent implantation was planned for all patients. Results After randomization it required an average of 113.4 minutes to start thrombolytic therapy (door-to-needle time)and 141.2 minutes to perform first balloon inflation in the IRA (door to balloon time).Rates of IRA patency (TIMI flow grade 2 or 3) and TIMI flow grade 3 were significantly lower in the thrombolysis group at 90 minutes after drug therapy than in the primary PCI group at the end of the procedure (70.5% vs. 98.0%, P <0.0001, and 53.0% vs. 85.9%, P <0.0001, respectively). Rescue PCI with stenting was performed in 117 patients (55.7%) in the thrombolytic therapy arm. Rates of patency and TIMI flow grade 3 were still significantly lower in the rescue PCI than in the primary PCI group (88.9% vs. 97.9%, P=0.0222, and 68.4% vs. 85.0%, P=0.0190, respectively). At 30 days post-therapy, mortality rate was significantly higher in the thrombolysis combined with rescue PCI group than in primary PCI group (7.1% vs. 0, P=0.0034). Rates of death/Ml and bleeding complications were

  15. Does an Exercise Intervention Improving Aerobic Capacity Among Construction Workers Also Improve Musculoskeletal Pain, Work Ability, Productivity, Perceived Physical Exertion, and Sick Leave? A Randomized Controlled Trial

    NARCIS (Netherlands)

    Gram, Bibi; Holtermann, Andreas; Bultmann, Ute; Sjogaard, Gisela; Sogaard, Karen

    2012-01-01

    Objective: To investigate whether an exercise intervention shown to increase aerobic capacity, would also lead to less musculoskeletal pain; improved work ability, productivity, and perceived physical exertion; and less sick leave. Methods: Sixty-seven construction workers were randomized into an ex

  16. Brief Alcohol Intervention by Newly Trained Workers Versus Leaflets: Comparison of Effect in Older Heavy Drinkers Identified in a Population Health Examination Survey: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Hansen, Anders Blædel Gottlieb; Becker, Ulrik; Nielsen, Anette Søgaard;

    2011-01-01

    Aims: To test if a brief motivational intervention (BMI) in a non-treatment seeking population of heavy drinkers results in a reduced alcohol intake. Methods: Screening of 12,364 participants in a Danish health examination survey led to 1026 heavy drinkers of whom 772 were included and randomized...

  17. The PEDALS Stationary Cycling Intervention and Health-Related Quality of Life in Children with Cerebral Palsy: A Randomized Controlled Trial

    Science.gov (United States)

    DeMuth, Sharon K.; Knutson, Loretta M.; Fowler, Eileen G.

    2012-01-01

    Aim: The aim of this study was to assess health-related quality of life (HRQOL) following a stationary cycling intervention in children with cerebral palsy (CP). Method: This was a phase I multisite randomized controlled trial with single blinding. HRQOL was evaluated using the Pediatric Quality of Life Inventory SF15 (PedsQL; children) and…

  18. The role of psychological flexibility in a self-help acceptance and commitment therapy intervention for psychological distress in a randomized controlled trial.

    NARCIS (Netherlands)

    Fledderus, M.; Bohlmeijer, E.T.; Fox, Jean-Paul; Schreurs, K.M.G.; Spinhoven, Philip

    2013-01-01

    This study examined the role of psychological flexibility, as a risk factor and as a process of change, in a self-help Acceptance and Commitment Therapy (ACT) intervention for adults with mild to moderate depression and anxiety. Participants were randomized to the self-help programme with e-mail sup

  19. Cost-effectiveness of a nurse-led case management intervention in general medical outpatients compared with usual care : An economic evaluation alongside a randomized controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; Bosmans, Judith E.; van Tulder, Maurits W.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2007-01-01

    Objective: The objective of this study was to evaluate the cost-effectiveness of a nurse-led, home-based, case-management intervention (NHI) after hospital discharge in addition to usual care. Methods: Economic evaluation alongside a randomized controlled trial after being discharged home with 24 we

  20. Differential Susceptibility to Early Literacy Intervention in Children with Mild Perinatal Adversities: Short- and Long-Term Effects of a Randomized Control Trial

    Science.gov (United States)

    Van der Kooy-Hofland, Verna A. C.; Van der Kooy, Jacoba; Bus, Adriana G.; van IJzendoorn, Marinus H.; Bonsel, Gouke J.

    2012-01-01

    In a randomized control trial, the authors tested whether short- and long-term effects of an early literacy intervention are moderated by mild perinatal adversities in accordance with differential susceptibility theory. One-hundred 5-year-old children (58% male) who scored at or below the 30th percentile on early literacy measures were randomized…

  1. Effectiveness of an intervention to reduce sickness absence in patients with emotional distress or minor mental disorders: a randomized controlled effectiveness trial.

    NARCIS (Netherlands)

    Brouwers, E.P.M.; Tiemens, B.G.; Terluin, B.; Verhaak, P.F.M.

    2006-01-01

    OBJECTIVE: The purpose of this study was to evaluate the effectiveness of an activating intervention designed to reduce sick leave duration in patients with emotional distress or minor mental disorders. METHOD: In a 1.5-year randomized controlled trial, 194 patients with minor mental disorders recei

  2. Experimental Evidence for Differential Susceptibility: Dopamine D4 Receptor Polymorphism (DRD4 VNTR) Moderates Intervention Effects on Toddlers' Externalizing Behavior in a Randomized Controlled Trial

    Science.gov (United States)

    Bakermans-Kranenburg, Marian J.; Van Ijzendoorn, Marinus H.; Pijlman, Femke T. A.; Mesman, Judi; Juffer, Femmie

    2008-01-01

    In a randomized controlled trial we tested the role of genetic differences in explaining variability in intervention effects on child externalizing behavior. One hundred fifty-seven families with 1- to 3-year-old children screened for their relatively high levels of externalizing behavior participated in a study implementing Video-feedback…

  3. A School-Randomized Clinical Trial of an Integrated Social-Emotional Learning and Literacy Intervention: Impacts after 1 School Year

    Science.gov (United States)

    Jones, Stephanie M.; Brown, Joshua L.; Hoglund, Wendy L. G.; Aber, J. Lawrence

    2010-01-01

    Objective: To report experimental impacts of a universal, integrated school-based intervention in social-emotional learning and literacy development on change over 1 school year in 3rd-grade children's social-emotional, behavioral, and academic outcomes. Method: This study employed a school-randomized, experimental design and included 942…

  4. A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: pronounced short-term impact but long-term adherence problems

    DEFF Research Database (Denmark)

    Lindahl, Bernt; Nilssön, Torbjörn K; Borch-Johnsen, Knut;

    2009-01-01

    AIMS: To compare data on cardiovascular risk factor changes in lipids, insulin, proinsulin, fibrinolysis, leptin and C-reactive protein, and on diabetes incidence, in relation to changes in lifestyle. METHODS: The study was a randomized lifestyle intervention trial conducted in northern Sweden be...

  5. The Efficacy of Web-Based and Print-Delivered Computer-Tailored Interventions to Reduce Fat Intake: Results of a Randomized, Controlled Trial

    Science.gov (United States)

    Kroeze, Willemieke; Oenema, Anke; Campbell, Marci; Brug, Johannes

    2008-01-01

    Objective: To test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction. Design: A 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam.…

  6. The effectiveness of family interventions in preventing adolescent illicit drug use: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Smit, E.; Verdurmen, J.E.E.; Engels, R.C.M.E.

    2015-01-01

    In order to quantify the effectiveness of family interventions in preventing and reducing adolescent illicit drug use, we conducted a systematic review and meta-analysis of randomized controlled trials. We searched the Cochrane Database of Systematic Reviews, Educational Research Information Centre

  7. A Randomized Study of a Literacy-Integrated Science Intervention for Low-Socio-Economic Status Middle School Students: Findings from First-Year Implementation

    Science.gov (United States)

    Tong, Fuhui; Irby, Beverly J.; Lara-Alecio, Rafael; Guerrero, Cindy; Fan, Yinan; Huerta, Margarita

    2014-01-01

    This paper presents the findings from a randomized control trial study of reading/literacy-integrated science inquiry intervention after 1 year of implementation and the treatment effect on 5th-grade low-socio-economic African-American and Hispanic students' achievement in science and English reading. A total of 94 treatment students and 194…

  8. A lifestyle intervention to reduce Type 2 diabetes risk in Dutch primary care: 2.5-year results of a randomized controlled trial.

    NARCIS (Netherlands)

    Vermunt, P.W.; Milder, I.E.; Wielaard, F.; Vries, J.H. de; Baan, C.A.; Oers, J.A. van; Westert, G.P.

    2012-01-01

    Diabet. Med. 29, e223-e231 (2012) ABSTRACT: Aims To determine the effectiveness of a 2.5-year lifestyle intervention for Type 2 diabetes prevention in Dutch general practice compared with usual care. Methods A randomized controlled trial of 925 individuals at high risk for Type 2 diabetes (FINDRISC-

  9. A randomized controlled trial of cognitive training using a visual speed of processing intervention in middle aged and older adults.

    Directory of Open Access Journals (Sweden)

    Fredric D Wolinsky

    Full Text Available Age-related cognitive decline is common and may lead to substantial difficulties and disabilities in everyday life. We hypothesized that 10 hours of visual speed of processing training would prevent age-related declines and potentially improve cognitive processing speed.Within two age bands (50-64 and ≥ 65 681 patients were randomized to (a three computerized visual speed of processing training arms (10 hours on-site, 14 hours on-site, or 10 hours at-home or (b an on-site attention control group using computerized crossword puzzles for 10 hours. The primary outcome was the Useful Field of View (UFOV test, and the secondary outcomes were the Trail Making (Trails A and B Tests, Symbol Digit Modalities Test (SDMT, Stroop Color and Word Tests, Controlled Oral Word Association Test (COWAT, and the Digit Vigilance Test (DVT, which were assessed at baseline and at one year. 620 participants (91% completed the study and were included in the analyses. Linear mixed models were used with Blom rank transformations within age bands.All intervention groups had (p<0.05 small to medium standardized effect size improvements on UFOV (Cohen's d = -0.322 to -0.579, depending on intervention arm, Trails A (d = -0.204 to -0.265, Trails B (d = -0.225 to -0.320, SDMT (d = 0.263 to 0.351, and Stroop Word (d = 0.240 to 0.271. Converted to years of protection against age-related cognitive declines, these effects reflect 3.0 to 4.1 years on UFOV, 2.2 to 3.5 years on Trails A, 1.5 to 2.0 years on Trails B, 5.4 to 6.6 years on SDMT, and 2.3 to 2.7 years on Stroop Word.Visual speed of processing training delivered on-site or at-home to middle-aged or older adults using standard home computers resulted in stabilization or improvement in several cognitive function tests. Widespread implementation of this intervention is feasible.ClinicalTrials.gov NCT-01165463.

  10. Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

    Science.gov (United States)

    Livingstone, Katherine M; Fallaize, Rosalind; Kolossa, Silvia; Hallmann, Jacqueline; San-Cristobal, Rodrigo; Navas-Carretero, Santiago; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Moschonis, George; Lambrinou, Christina-Paulina; Surwillo, Agnieszka; Godlewska, Magdalena; Hoonhout, Jettie; Goris, Annelies; Macready, Anna L; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Lovegrove, Julie A; Martinez, J Alfredo; Daniel, Hannelore; Gibney, Michael J; Mathers, John C; Saris, Wim HM

    2016-01-01

    Background There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention. Methods The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no). Results At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts. Conclusions No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies

  11. A daily physical activity and diet intervention for individuals with type 2 diabetes mellitus: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Agatha J. Van Rooijen

    2010-02-01

    Full Text Available Urbanisation,  a  sedentary  lifestyle  and  increasing  obesity  due  to westernization and changed eating habits have been identified as independent risk factors for diabetes in the South African population. To establish the effectiveness of a daily walk and diet education intervention program. A randomized controlled trial was performed. The study population consisted of men and women of all races, ages 40 to 65 with Type 2 Diabetes Mellitus (DM of duration at least one year attending the Steve Biko Diabetes Outpatient clinic. Patients of all weights were considered. Patients who had an HbA1c > 8 – 9.5% were included in the sample group.Four  weekly  group  classes  consisted  of  education  considered  essential  for  ongoing  nutrition  self-management  and physical activity. Yamax pedometers and walk prescriptions based on the average number of steps walked in three days were used. The participants had a follow-up assessment at 16 weeks and one year. The intervention and control groups were compared with respect to changes from baseline, using analysis of covariance (ANCOVA with baseline values as covariates.The  difference  between  the  intervention  and  control  groups  in  the  change  in  HbA1c  from  the  baseline  was significant at the 16-week follow-up assessment (p=0.041 and in the total cholesterol and LDL-cholesterol at the  one-year follow-up assessment (p =0.047; p =0.014. These results suggest that HbA1c can be improved over a period of four months. More frequent contact with the patients is necessary.

  12. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial

    Science.gov (United States)

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m2 and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  13. The Effect of Psychosocial Support Intervention on Depression in Patients with Dementia and Their Family Caregivers: An Assessor-Blinded Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Froydis Kristine Bruvik

    2013-10-01

    Full Text Available Background/Aim: A three-component tailored psychosocial 12-month assessor-blinded randomized controlled trial to reduce depression in people with dementia (PWD and carers was conducted. Methods: A total of 230 home-dwelling dyads of PWD and their carers were randomized to usual care or intervention consisting of three components over 12 months. Primary outcomes were the difference between the baseline and 12-month score on the Cornell Scale of Depression in Dementia (CSDD in the PWD and on the Geriatric Depression Scale (GDS in the carers. Results: The intent-to-treat difference between the baseline and 12- month change score was not significant between the intervention and control groups for the CSDD (p = 0.95 or GDS (p = 0.82. Conclusions: The trial did not show a significant difference between usual care and the intervention on depressive symptoms in PWD or their family caregivers.

  14. Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD

    DEFF Research Database (Denmark)

    Sørensen, Sabrina Storgaard; Pedersen, Kjeld Møller; Weinreich, Ulla Møller;

    2015-01-01

    controlled trial, conducted to evaluate the effectiveness and cost-effectiveness of a community-based case management model for patients suffering from chronic obstructive pulmonary disease (COPD). With a focus on support for self-care and care coordination, the intervention was hypothesized to result...... in a reduced number of COPD-related hospital admissions. Patients and methods: The design was a randomized controlled trial conducted from 2012 to 2014 with randomization and intervention at patient level. The study took place in Aalborg Municipality, a larger municipality in Denmark. A total of 150 COPD...... that the intervention was well accepted. Conclusion: Presented in a forthcoming paper, the results of the study will provide new evidence to the future organization of case management....

  15. Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

    Science.gov (United States)

    Vik, Frøydis N.; Lien, Nanna; Berntsen, Sveinung; De Bourdeaudhuij, Ilse; Grillenberger, Monika; Manios, Yannis; Kovacs, Eva; Chinapaw, Mai J. M.; Brug, Johannes; Bere, Elling

    2015-01-01

    Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38)) and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32)) breaking up sitting time than the control group. Conclusions/Significance No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention. Trial Registration International Standard Randomized Controlled Trial Number Registry ISRCTN34562078 PMID:25826704

  16. Evaluation of the UP4FUN intervention: a cluster randomized trial to reduce and break up sitting time in European 10-12-year-old children.

    Directory of Open Access Journals (Sweden)

    Frøydis N Vik

    Full Text Available The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time, and breaking up sitting time in school among 10-12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects.A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1-2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38 and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32 breaking up sitting time than the control group.No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention.International Standard Randomized Controlled Trial Number Registry ISRCTN34562078.

  17. Analysis of Individual Social-ecological Mediators and Moderators and Their Ability to Explain Effect of a Randomized Neighborhood Walking Intervention

    Directory of Open Access Journals (Sweden)

    Michael Yvonne L

    2009-07-01

    Full Text Available Abstract Background Using data from the SHAPE trial, a randomized 6-month neighborhood-based intervention designed to increase walking activity among older adults, this study identified and analyzed social-ecological factors mediating and moderating changes in walking activity. Methods Three potential mediators (social cohesion, walking efficacy, and perception of neighborhood problems and minutes of brisk walking were assessed at baseline, 3-months, and 6-months. One moderator, neighborhood walkability, was assessed using an administrative GIS database. The mediating effect of change in process variables on change in brisk walking was tested using a product-of-coefficients test, and we evaluated the moderating effect of neighborhood walkability on change in brisk walking by testing the significance of the interaction between walkability and intervention status. Results Only one of the hypothesized mediators, walking efficacy, explained the intervention effect (product of the coefficients (95% CI = 8.72 (2.53, 15.56. Contrary to hypotheses, perceived neighborhood problems appeared to suppress the intervention effects (product of the coefficients (95% CI = -2.48, -5.6, -0.22. Neighborhood walkability did not moderate the intervention effect. Conclusion Walking efficacy may be an important mediator of lay-lead walking interventions for sedentary older adults. Social-ecologic theory-based analyses can support clinical interventions to elucidate the mediators and moderators responsible for producing intervention effects.

  18. Psychological and behavioral interventions to reduce HIV risk: evidence from a randomized control trial among orphaned and vulnerable adolescents in South Africa.

    Science.gov (United States)

    Thurman, T R; Kidman, R; Carton, T W; Chiroro, P

    2016-01-01

    Evidence-based approaches are needed to address the high levels of sexual risk behavior and associated HIV infection among orphaned and vulnerable adolescents. This study recruited adolescents from a support program for HIV-affected families and randomly assigned them by cluster to receive one of the following: (1) a structured group-based behavioral health intervention; (2) interpersonal psychotherapy group sessions; (3) both interventions; or (4) no new interventions. With 95% retention, 1014 adolescents were interviewed three times over a 22-month period. Intent-to-treat analyses, applying multivariate difference-in-difference probit regressions, were performed separately for boys and girls to assess intervention impacts on sexual risk behaviors. Exposure to a single intervention did not impact behaviors. Exposure to both interventions was associated with risk-reduction behaviors, but the outcomes varied by gender: boys reported fewer risky sexual partnerships (β = -.48, p = .05) and girls reported more consistent condom (β = 1.37, p = .02). There was no difference in the likelihood of sexual debut for either gender. Providing both psychological and behavioral interventions resulted in long-term changes in sexual behavior that were not present when either intervention was provided in isolation. Multifaceted approaches for reducing sexual risk behaviors among vulnerable adolescents hold significant promise for mitigating the HIV epidemic among this priority population. PMID:26886261

  19. Psychological adjustment and levels of self esteem in children with visual-motor integration difficulties influences the results of a randomized intervention trial.

    Science.gov (United States)

    Lahav, Orit; Apter, Alan; Ratzon, Navah Z

    2013-01-01

    This study evaluates how much the effects of intervention programs are influenced by pre-existing psychological adjustment and self-esteem levels in kindergarten and first grade children with poor visual-motor integration skills, from low socioeconomic backgrounds. One hundred and sixteen mainstream kindergarten and first-grade children, from low socioeconomic backgrounds, scoring below the 25th percentile on a measure of visual-motor integration (VMI) were recruited and randomly divided into two parallel intervention groups. One intervention group received directive visual-motor intervention (DVMI), while the second intervention group received a non-directive supportive intervention (NDSI). Tests were administered to evaluate visual-motor integration skills outcome. Children with higher baseline measures of psychological adjustment and self-esteem responded better in NDSI while children with lower baseline performance on psychological adjustment and self-esteem responded better in DVMI. This study suggests that children from low socioeconomic backgrounds with low VMI performance scores will benefit more from intervention programs if clinicians choose the type of intervention according to baseline psychological adjustment and self-esteem measures.

  20. Multifactorial lifestyle interventions in the primary and secondary prevention of cardiovascular disease and type 2 diabetes mellitus--a systematic review of randomized controlled trials.

    Science.gov (United States)

    Angermayr, Lucia; Melchart, Dieter; Linde, Klaus

    2010-08-01

    This systematic review aims to summarize the available randomized trials of multifactorial lifestyle interventions in the primary and secondary prevention of coronary heart disease and type 2 diabetes mellitus. Randomized trials investigating the effects of lifestyle interventions including the elements of diet, physical activity, and stress management in people at increased risk for or with manifest coronary heart disease or type 2 diabetes mellitus were searched for in five electronic database and by citation tracking. Quality was assessed using the Cochrane Collaboration's risk of bias tool. Exploratory effect size calculations were performed for a variety of laboratory and clinical outcome measures. Twenty-five trials including a total of 7,703 participants met the inclusion criteria. Fifteen trials were in patients with coronary heart disease, seven in patients with type 2 diabetes mellitus, and three on primary prevention. The interventions varied greatly regarding concept, intensity, and providers. Compared to participants in "usual care" control groups, there were no consistent effects on lipid levels and blood pressure and small effects on body mass index and glycated hemoglobin (HbA1c). Composite cardiac event rates were significantly less in the intervention groups of the few trials reporting these outcomes. Mortality was also lower in the intervention groups, but the difference was not statistically significant, and confidence intervals were wide. The evidence base for multifactorial lifestyle interventions is weak. Effects on surrogate measures seem minor, but there may be clinically relevant effects on major clinical endpoints. PMID:20652464