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Sample records for 12-week randomized intervention

  1. Effect of a 12-Week Low vs. High Intensity Aerobic Exercise Training on Appetite-Regulating Hormones in Obese Adolescents: A Randomized Exercise Intervention Study.

    Prado, Wagner Luiz; Lofrano-Prado, Mara Cristina; Oyama, Lila Missae; Cardel, Michelle; Gomes, Priscyla Praxedes; Andrade, Maria Laura S S; Freitas, Camila R M; Balagopal, Prabhakaran; Hill, James O

    2015-11-01

    Little is known about how the intensity of aerobic training influences appetite-regulating hormones in obese adolescents. Our goal was to assess the effect of low and high intensity aerobic trainings on food intake and appetite-regulating hormones in obese adolescents. Forty three obese adolescents (age: 13-18y, BMI: 34.48 ± 3.94 kg/m2) were randomized into high intensity training (HIT; n = 20) or low intensity training (LIT; n = 23) groups for 12 weeks. All participants also received the same nutritional, psychological and clinical counseling. Pre- and postintervention energy intake (EI) and circulating levels of insulin, leptin, peptide YY3-36 (PYY3-36) and ghrelin were measured. Adolescents in the HIT showed a reduction in total EI and an increase in PYY3-36 (p exercise training performed at ventilatory threshold 1 intensity, reduced EI and augmented PYY3-36 in obese adolescents, compared with LIT. The data suggest that HIT and LIT have differential effects in the regulation of appetite signals and subsequent EI in obese adolescents. PMID:26680421

  2. Sustained improvements in fitness and exercise tolerance in obese adolescents after a 12 week exercise intervention.

    Gow, Megan L; van Doorn, Nancy; Broderick, Carolyn R; Hardy, Louise L; Ho, Mandy; Baur, Louise A; Cowell, Chris T; Garnett, Sarah P

    2016-01-01

    A 12 week exercise program was evaluated for its effect on aerobic fitness, anaerobic threshold, physical activity and sedentary behavior levels in obese insulin resistant adolescents post intervention and at follow up. 111 obese insulin resistant 10-17 year olds were recruited to a 12 month lifestyle intervention, known as RESIST. From months 4 to 6, adolescents participated in supervised exercise sessions twice per week (45-60min/session). Aerobic fitness and anaerobic threshold were measured by gas analysis at baseline, 6 months (post intervention) and 12 months (follow up). Self-reported physical activity and sedentary behavior was measured using the CLASS questionnaire. At 6 months aerobic fitness and time to reach the anaerobic threshold had improved by 5.8% [95% CI: 0.8-11.3] and 19.7% [95% CI: 10.4-29.0], respectively compared with baseline. These improvements were maintained at 12 months. Compared to baseline, 6 month physical activity levels increased by 19min/day [95% CI: 5-33] and screen time decreased by 49min/day [95% CI: 23-74] but returned to baseline levels by 12 months. Improved fitness and anaerobic threshold can be sustained up to 6 months following completion of an exercise program possibly enhancing capacity to perform daily functional tasks. PMID:25959765

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

    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...... patients declined to be enrolled in the exercise programme but completed the Cystic Fibrosis Questionnaire for Adolescents and Adults (CFQ-R 14+). Four patients did not want to participate at all. The 14 patients completing the exercise programme had a significantly increased VO(2max), but they showed no...

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

    Alessandra S. Braz; Liana Clébia S. Morais; Ana Patríca Paula; Margareth de F.F.M. Diniz; Reinaldo N. Almeida

    2013-01-01

    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. g...

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

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

    2013-01-01

    =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...... 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......-grain intervention increased the relative abundance of Bifidobacterium compared to baseline, supporting a prebiotic effect of whole-grain wheat. Faecal water increased TER independent of dietary intervention, indicating that commensal bacteria produce metabolites that generally provide a positive effect on...

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

    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.

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

    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

  8. 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

    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

  9. 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.

    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.

  10. 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.

    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.

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

    Vestman, Nelly Romani; Chen, Tsute; Lif Holgerson, Pernilla; Öhman, Carina; Johansson, Ingegerd

    2015-01-01

    BACKGROUND: Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear. METHODS AND FINDINGS: 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/loze...

  12. Evaluation of Immediate and 12-Week Effects of a Smartphone Sun-Safety Mobile Application: A Randomized Trial

    Buller, David B.; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-01-01

    Importance Mobile apps on smart phones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether Americans can be convinced to use them. Objective A smart phone mobile application delivering real-time sun protection advice was evaluated for a second time in a randomized trial. Design The trial conducted in 2013 utilized a randomized pretest-posttest controlled design. Screening procedures and a 3-week run-in period were added to increase use of the mobile app. Also, follow-ups at 3- and 8-weeks after randomization were conducted to examine immediate and longer-term effects. Setting Data was collected from participants recruited nationwide through online promotions. Participants A volunteer sample of adults aged 18 or older who owned an Android or iPhone smart phones. Intervention The mobile application gave feedback on sun protection (i.e., sun safety practices and sunburn risk) and alerted users to apply/reapply sunscreen and get out of the sun. Also, it displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Main Outcomes and Measures Percent of days using sun protection and days and minutes outdoors in the midday sun and number of sunburns in the past 3 months were assesed. Results Treatment group participants used wide-brimmed hats more at 7-weeks than controls. Women who used Solar Cell reported using all sun protection combined more than men but men and older individuals used sunscreen and hats less. Conclusions and Relevance The mobile application appeared to weakly improve sun protection initially. Use of the mobile application was higher than in a previous trial and associated with greater sun protection especially by women. Strategies to increase use are needed if the mobile app is to be effective deployed to the general adult population. PMID:25629819

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

    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

  14. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial

    Ho Suleen S

    2012-08-01

    Full Text Available Abstract Background Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Methods Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16; Group 2 (Aerobic, n = 15; Group 3 (Resistance, n = 16; Group 4 (Combination, n = 17. Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Results Significant improvements in body weight (−1.6%, p = 0.044 for the Combination group compared to Control and Resistance groups and total body fat compared to Control (−4.4%, p = 0.003 and Resistance (−3%, p = 0.041. Significant improvements in body fat percentage (−2.6%, p = 0.008, abdominal fat percentage (−2.8%, p = 0.034 and cardio-respiratory fitness (13.3%, p = 0.006 were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04. Conclusion A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese

  15. 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

    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...

  16. Whole Grain Compared with Refined Wheat Decreases the Percentage of Body Fat Following a 12-Week, Energy-Restricted Dietary Intervention in Postmenopausal Women

    Kristensen, Mette; Toubro, Søren; Jensen, Morten Georg;

    2012-01-01

    intervention diets. Body weight decreased significantly from baseline in both the RW (–2.7 ± 1.9 kg) and WW (–3.6 ± 3.2 kg) groups, but the decreases did not differ between the groups (P = 0.11). The reduction in body fat percentage was greater in the WW group (–3.0%) than in the RW group (–2.1%) (P = 0.......04). Serum total and LDL cholesterol increased by approximately 5% (P <0.01) in the RW group but did not change in the WW group; hence, the changes differed between the groups (P = 0.02). In conclusion, consumption of whole-grain products resulted in a greater reduction in the percentage fat mass, whereas...... whole-grain wheat (WW) for 12 wk on body weight and composition after a 2-wk run-in period of consumption of RW-containing food intake. In this open-label randomized trial, 79 overweight or obese postmenopausal women were randomized to an energy-restricted diet (deficit of approximately 1250 kJ/d) with...

  17. 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

    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

  18. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee

    Kneer, Werner; Rother, Matthias; Mazgareanu, Stefan; Seidel, Egbert J; ,

    2013-01-01

    Objective To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033) in comparison with a ketoprofen-free vehicle (TDT 064) for the treatment of osteoarthritis (OA) of the knee. Methods Patients with knee OA (N = 866) were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC®)...

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

    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...

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

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

    Courneya Kerry S; Plotnikoff Ronald C; Liebreich Tanis; Boulé Normand

    2009-01-01

    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...

  2. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033 compared with the ketoprofen-free vehicle (TDT 064, in patients with osteoarthritis of the knee

    Kneer W

    2013-10-01

    Full Text Available Werner Kneer,1 Matthias Rother,2 Stefan Mazgareanu,3 Egbert J Seidel4 On behalf of the European IDEA-033 study group 1Orthopaedic Outpatient Centre, Stockach, Germany; 2IMR Partner GmbH, Graefelfing, Germany; 3Cardiorentis Ltd, Zug, Switzerland; 4Sophien- und Hufeland-Clinic, Weimar, Germany Objective: To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033 in comparison with a ketoprofen-free vehicle (TDT 064 for the treatment of osteoarthritis (OA of the knee. Methods: Patients with knee OA (N = 866 were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC® Osteoarthritis Index pain subscale score. The coprimary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy. The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT-Osteoarthritis Research Society International (OARSI responder rates. Results: The WOMAC pain scores were reduced by approximately 50% or more in all four groups. The 100 and 50 mg ketoprofen groups, but not the 25 mg group, showed a superior reduction in the WOMAC pain score versus the TDT 064 group (100 mg: −57.4% [P = 0.0383]; 50 mg: −57.1% [P = 0.0204]; and 25 mg: −53.4% [P = 0.3616] versus TDT 064: −49.5%. The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score, whereas the patient global assessment of 50 mg ketoprofen group, but not the 100 or 25 mg group, was superior to that of the TDT 064 group (P = 0.0283. Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group, but were high in all groups (100 mg: 88.6%; 50 mg: 86.8%; 25 mg: 88.6%; and TDT 064

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

    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

  4. 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

    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

  5. 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

    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...

  6. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women.

    Choi, JiWon; Lee, Ji Hyeon; Vittinghoff, Eric; Fukuoka, Yoshimi

    2016-05-01

    Introduction Physical inactivity is prevalent in pregnant women, and innovative strategies to promote physical activity are strongly needed. The purpose of the study was to test a 12-week mobile health (mHealth) physical activity intervention for feasibility and potential efficacy. Methods Participants were recruited between December 2012 and February 2014 using diverse recruitment methods. Thirty pregnant women between 10 and 20 weeks of gestation were randomized to an intervention (mobile phone app plus Fitbit) or a control (Fitbit) group. Both conditions targeted gradual increases in physical activity. The mHealth intervention included daily messages and a mobile phone activity diary with automated feedback and self-monitoring systems. Results On monthly average, 4 women were screened for initial eligibility by telephone and 2.5 were randomized. Intervention participants had a 1096 ± 1898 step increase in daily steps compared to an increase of 259 ± 1604 steps in control participants at 12 weeks. The change between groups in weekly mean steps per day during the 12-week study period was not statistically significant (p = 0.38). The intervention group reported lower perceived barrier to being active, lack of energy, than the control group at 12-week visit (p = 0.02). The rates of responding to daily messages and using the daily diary through the mobile app declined during the 12 week study period. Discussion It was difficult to recruit and randomize inactive women who wanted to increase physical activity during pregnancy. Pregnant women who were motivated to increase physical activity might find using mobile technologies in assessing and promoting PA acceptable. Possible reasons for the non-significant treatment effect of the mHealth intervention on physical activity are discussed. Public awareness of safety and benefits of physical activity during pregnancy should be promoted. Clinicaltrials.Gov Identifier NCT01461707. PMID:26649879

  7. 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

    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

  8. 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

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

    intestinal integrity, which in this study was evaluated in vitro by determining transepithelial resistance (TER) across a Caco-2 cell monolayer. Fecal water collected after the run-in period and following the intervention period for 26 participants (WW; 15 participants, RW; 11 participants) were used to...... determine effects of WW, RW, and microbiota composition on TER. Preliminary results indicate that fecal water from WW and RW both before and after intervention in general had a positive effect on TER, however, there was no difference in TER between WW and RW. Correlations between microbial composition and......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 in...

  9. The Effect of Structured Exercise Intervention on Intensity and Volume of Total Physical Activity

    Niko Wasenius; Mika Venojärvi, Sirpa Manderoos, Jukka Surakka, Harri Lindholm, Olli J. Heinonen, Sirkka Aunola, Johan G. Eriksson, Esko Mälkiä

    2014-01-01

    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...

  10. 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

    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

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

    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...

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

    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…

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

    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. The......OBJECTIVES: The combination of high physical work demands and low physical capacity has been shown to increase the risk for cardiovascular disease and musculoskeletal disorders. The aim of this study was to assess the physical capacity of construction workers and evaluate the effect of individually...... participants completed health checks before and after the intervention period. Data from the first health check were used to tailor the exercise in the interventions. RESULTS: At baseline, participants had maximal oxygen consumption (VO (2max)) of 2.9 [standard deviation (SD) 0.7L/min] and body mass index (BMI...

  14. 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

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

    2010-01-01

    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 ...

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

    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

  16. Nutrition intervention for migraine: a randomized crossover trial

    Bunner, Anne E.; Agarwal, Ulka; Gonzales, Joseph F; Valente, Francesca; Barnard, Neal D.

    2014-01-01

    Background Limited evidence suggests that dietary interventions may offer a promising approach for migraine. The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency. Methods Forty-two adult migraine sufferers were recruited from the general community in Washington, DC, and divided randomly into two groups. This 36-week crossover study included two treatments: dietary instruction and placebo supplement. Each treatment...

  17. 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

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

    2004-01-01

    .0003) compared with placebo. Improvement in glycemic control was evident after 1 week. Body weight decreased by 1.2 kg in the 0.45-mg liraglutide group (P = 0.0184) compared with placebo. The proinsulin-to-insulin ratio decreased in the 0.75-mg liraglutide group (-0.18; P = 0.0244) compared with placebo.......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...

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

    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...

  19. Effect of physical activity intervention based on a pedometer on physical activity level and anthropometric measures after childbirth: a randomized controlled trial

    Maturi Masumeh S

    2011-12-01

    Full Text Available Abstract Background Pregnancy and childbirth are associated with weight gain in women, and retention of weight gained during pregnancy can lead to obesity in later life. Diet and physical activity are factors that can influence the loss of retained pregnancy weight after birth. Exercise guidelines exist for pregnancy, but recommendations for exercise after childbirth are virtually nonexistent. The aim of this study was to evaluate the effect of physical activity intervention based on pedometer on physical activity level and anthropometric measures of women after childbirth. Methods We conducted a randomized controlled trial in which 66 women who had given birth 6 weeks to 6 months prior were randomly assigned to receive either a 12 week tailored program encouraging increased walking using a pedometer (intervention group, n = 32 or routine postpartum care (control group, n = 34. During the 12-week study period, each woman in the intervention group wore a pedometer and recorded her daily step count. The women were advised to increase their steps by 500 per week until they achieved the first target of 5000 steps per day and then continued to increase it to minimum of 10,000 steps per day by the end of 12th week. Assessed outcomes included anthropometric measures, physical activity level, and energy expenditure per week. Data were analyzed using the paired t-test, independent t-test, Mann-Whitney, chi-square, Wilcoxon, covariance analysis, and the general linear model repeated measures procedure as appropriate. Results After 12 weeks, women in the intervention group had significantly increased their physical activity and energy expenditure per week (4394 vs. 1651 calorie, p P = 0.001, Body Mass Index (P = 0.001, waist circumference (P = 0.001, hip circumference (P = 0.032 and waist-hip ratio (P = 0.02 were presented after the intervention. The intervention group significantly increased their mean daily step count over the study period (from 3249

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

    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.

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

    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

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

    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

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

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

    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.

  5. Predictors of adherence to a 12-week exercise program among men treated for prostate cancer: ENGAGE study.

    Craike, Melinda; Gaskin, Cadeyrn J; Courneya, Kerry S; Fraser, Steve F; Salmon, Jo; Owen, Patrick J; Broadbent, Suzanne; Livingston, Patricia M

    2016-05-01

    Understanding the factors that influence adherence to exercise programs is necessary to develop effective interventions for people with cancer. We examined the predictors of adherence to a supervised exercise program for participants in the ENGAGE study - a cluster randomized controlled trial that assessed the efficacy of a clinician-referred 12-week exercise program among men treated for prostate cancer. Demographic, clinical, behavioral, and psychosocial data from 52 participants in the intervention group were collected at baseline through self-report and medical records. Adherence to the supervised exercise program was assessed through objective attendance records. Adherence to the supervised exercise program was 80.3%. In the univariate analyses, cancer-specific quality of life subscales (role functioning r = 0.37, P = 0.01; sexual activity r = 0.26, P = 0.06; fatigue r = -0.26, P = 0.06, and hormonal symptoms r = -0.31, P = 0.03) and education (d = -0.60, P = 0.011) were associated with adherence. In the subsequent multivariate analysis, role functioning (B = 0.309, P = 0.019) and hormonal symptoms (B = -0.483, P = 0.054) independently predicted adherence. Men who experienced more severe hormonal symptoms had lower levels of adherence to the exercise program. Those who experienced more positive perceptions of their ability to perform daily tasks and leisure activities had higher levels of adherence to the exercise program. Hormonal symptoms and role functioning need to be considered when conducting exercise programs for men who have been treated for prostate cancer. PMID:26872005

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

    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.

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

    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

  8. Community based intervention to optimize osteoporosis management: randomized controlled trial

    Ciaschini Patricia M

    2010-08-01

    Full Text Available Abstract Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. Methods This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. Results 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40. More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12 and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65. Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387

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

    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

  10. 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

    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

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

    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

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

    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.

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

    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

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

    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.

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

    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

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

    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

  17. Quality of life after self-management cancer rehabilitation: A randomized controlled trial comparing physical and cognitive-behavioral training versus physical training

    Korstjens, Irene; May, Anne; van Weert, Ellen; Mesters, Ilse; Tan, Frans; Ros, Wynand; Hoekstra-Weebers, Josette; van der Schans, Cees; Borne, Bart

    2008-01-01

    textabstractObjective: To conduct a randomized controlled trial and compare the effects on cancer survivors' quality of life in a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitivebehavioral training (once weekly) with those of a 12-week group-based physical training (twice weekly). In addition, both interventions were compared with no intervention. Methods: Participants (all cancer types, medical treatment co...

  18. Motivational effects of 12-week moderately restrictive diets with or without special attention to the Glycaemic Index of foods.

    Bellisle, F; Dalix, A M; De Assis, M A; Kupek, E; Gerwig, U; Slama, G; Oppert, J M

    2007-04-01

    Low glycaemic index (GI) diets may facilitate weight loss via behavioural and/or endocrine mechanisms. This study investigated whether the outcomes of the Weight Watchers POINTS Weight-Loss System could be improved by encouraging dieters to select low GI, high-carbohydrate foods. Ninety-six women (age 20-72 years; BMI 25-40 kg/m2) were recruited as they started the Weight Watchers POINTS programme for 12 weeks. Weekly classes were randomized so that seven (forty-five women) followed the regular programme while seven others (fifty-one women) followed a revised programme encouraging the selection of low GI foods. Anthropometric and biochemical parameters were measured before and after the 12-week diets. Participants rated hunger and desire to eat using visual analogue scales on 1 d per week, several times per d. Attrition was the same in both groups (32 v. 30 %), as well as many benefits (5 % weight loss, decreases in insulinaemia and blood lipids, waist and hip circumferences, blood pressure). Hunger and desire to eat were rated consistently lower in the low GI group over the 12-week diet. Group differences in subjective sensations were especially large in the afternoon. The 12-week weight management yielded many significant anthropometric and biochemical benefits that were not improved by encouraging dieters to select low GI foods. The subjective benefits (lower hunger and desire to eat) of the low GI diet may be a worthwhile contribution to the motivation of dieters that might affect adherence to the diet over the long term. PMID:17349094

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

    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

  20. 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.

    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. PMID:21837551

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

    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

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

    Zoran Milanovic; Goran Sporiš; Nebojša Trajkovic; Nic James; Krešimir Šamija

    2013-01-01

    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; Slal...

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

    de Vries, Juriena D.; van Hooff, Madelon L. M.; Geurts, Sabine A. E.; Kompier, Michiel A. J.

    2016-01-01

    Background 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. Methods 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. Results 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. Conclusions These results underline the value of low-intensity exercise for university students with high levels of study-related fatigue. The follow-up effects

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

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

    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-…

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

    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...

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

    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...

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

    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...

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

    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

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

    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.

  11. 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

    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

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

    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…

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

    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...

  14. A preliminary, randomized trial of aerobic exercise for alcohol dependence

    Brown, Richard A.; Abrantes, Ana M.; Minami, Haruka; Read, Jennifer P.; Marcus, Bess H.; Jakicic, John M.; Strong, David R.; Dubreuil, Mary Ella; Gordon, Alan A.; Ramsey, Susan E.; Kahler, Christopher W.; Stuart, Gregory L.

    2014-01-01

    Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relative untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n = 25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Further...

  15. 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

    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.

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

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

    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

  18. Testing a workplace physical activity intervention: a cluster randomized controlled trial

    Jackson Cath; Lawton Rebecca J; McEachan Rosemary RC; Conner Mark; Meads David M; West Robert M

    2011-01-01

    Abstract Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or cont...

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

    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...

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

    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...

  1. A 12-week after-school physical activity programme improves endothelial cell function in overweight and obese children: a randomised controlled study

    Park Jong-Hwan

    2012-07-01

    Full Text Available Abstract Background Endothelial dysfunction is associated with childhood obesity and is closely linked to the amount and function of endothelial progenitor cells. However, it remains unclear whether endothelial progenitor cells increase with after-school exercise in overweight and obese children. The purpose of this study was to investigate the effects of an after-school exercise programme on endothelial cell function in overweight and obese children. Methods A total of 29 overweight/obese children (12.2 ± 0.1 years were randomly divided into control (i.e. no after-school exercise, n = 14 and after-school exercise (n = 15 groups. The 12-week after-school exercise intervention consisted of 3 days of combined aerobic and resistance exercise per week. Each 80-minute exercise programme included 10 minutes of warm-up and 10 minutes of cool-down after school. CD34+ (a cell surface marker on hematopoietic stem cells, CD133+ (a cell surface marker on hematopoietic progenitor cells and CD34+/CD133+ (considered as endothelial progenitor cells were measured at baseline and after 12 weeks using flow cytometry. Results Increased percentages of CD34+, CD133+ and CD34+/CD133+ cells were observed in the after-school exercise group (p = 0.018; p = 0.001; p = 0.002, respectively compared with the control group. Carotid intima-media thickness decreased after 12 weeks in the after-school exercise group (p = 0.020 compared with the control group. Conclusions This study provides preliminary evidence that a combined after-school exercise programme may represent an effective intervention strategy for improving vascular repair and endothelial cell function, leading to improved cardiovascular health in overweight and obese children. Trial registration Current Controlled Trials ISRCTN19037201

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

    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…

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

    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...

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

    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…

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

    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...

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

    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...

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

    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...

  8. Effects of a Telephone-Based Exercise Intervention for Dementia Caregiving Wives: A Randomized Controlled Trial

    Connell, Cathleen M; Janevic, Mary R

    2009-01-01

    Despite the importance of self-care for dementia caregivers, few interventions have included a focus on health behaviors. The current study reports outcomes of a telephone-based exercise intervention designed for women caring for a spouse with dementia. Caregivers (N = 137) were randomized to intervention or control conditions. Participants with at or below-median exercise scores at baseline had a significantly greater increase in exercise at six-month follow-up compared to their control coun...

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

    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

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

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

    2010-01-01

    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...... male football group having the highest score for physiological improvement and the lowest score for worry. A connection between experiencing flow and physiological improvement could not be found. Future research should investigate the influence that the participant's gender and also the type of sport...

  11. 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

    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.

  12. Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial.

    Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary

    2014-09-01

    Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children's self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n=56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n=61). PMID:24814751

  13. A cluster randomized controlled trial to reduce childhood diarrhea using hollow fiber water filter and/or hygiene-sanitation educational interventions.

    Lindquist, Erik D; George, C M; Perin, Jamie; Neiswender de Calani, Karen J; Norman, W Ray; Davis, Thomas P; Perry, Henry

    2014-07-01

    Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15-0.30) for the filter arm and 0.27 (95% CI = 0.22-0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59-0.86). PMID:24865680

  14. A Cluster Randomized Controlled Trial to Reduce Childhood Diarrhea Using Hollow Fiber Water Filter and/or Hygiene–Sanitation Educational Interventions

    Lindquist, Erik D.; George, C. M.; Perin, Jamie; Neiswender de Calani, Karen J.; Norman, W. Ray; Davis, Thomas P.; Perry, Henry

    2014-01-01

    Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15–0.30) for the filter arm and 0.27 (95% CI = 0.22–0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59–0.86). PMID:24865680

  15. Guidelines for Developing Yoga Interventions for Randomized Trials

    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.

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

    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 ...

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

    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

  18. Effects of 12 weeks muscle hipetrophy training program in a young male athlete: stydy case

    Giacchi Legarra, Mikel

    2014-01-01

    PURPOSE: The main goals of the present study were: 1) to review some recommendations about how to increase lean body mass; 2) to analyse whether following scientific sources of current recommendations, visible changes can be shown or not in a participant (body composition, strength and blood analyses). METHODS: One male athlete completed 12 weeks of resistance training program and following a diet protocol. Some test were determined such as, strength 6RM, blood analyses, skindfold measurem...

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

    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

  20. Effectiveness of a Physical Activity Intervention for Head Start Preschoolers: A Randomized Intervention Study

    Bellows, Laura L.; Davies, Patricia L.; ANDERSON, JENNIFER; Kennedy, Catherine

    2013-01-01

    OBJECTIVES. The level of children’s motor skill proficiency may be an important determinant of their physical activity behaviors. This study assessed the efficacy of an intervention on gross motor skill performance, physical activity, and weight status of preschoolers.

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

    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...

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

    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…

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

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

    Arija Victoria; Martín Núria; Canela Teresa; Anguera Carme; Castelao Ana I; García-Barco Montserrat; García-Campo Antoni; González-Bravo Ana I; Lucena Carme; Martínez Teresa; Fernández-Barrés Silvia; Pedret Roser; Badia Waleska; Basora Josep

    2012-01-01

    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 t...

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

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

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

    2012-01-01

    intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed [GREATER-THAN OR EQUAL TO] 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. Data collection will be...

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

    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...

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

    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...

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

    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...

  10. One Year Effects of a Workplace Integrated Care Intervention for Workers with Rheumatoid Arthritis: Results of a Randomized Controlled Trial

    Boot, C.R.L.; Twisk, J.W.R.; Steenbeek, R.; Voskuyl, A E; Schaardenburg. D. van; Anema, J.R.

    2016-01-01

    Purpose To evaluate the effectiveness of a workplace integrated care intervention on at-work productivity loss in workers with rheumatoid arthritis (RA) compared to usual care. Methods In this randomized controlled trial, 150 workers with RA were randomized into either the intervention or control group. The intervention group received an integrated care and participatory workplace intervention. Outcome measures were the Work Limitations Questionnaire, Work Instability Scale for RA, pain, fati...

  11. 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

    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…

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

    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.

  13. A randomized controlled trial of a personalized feedback intervention for problem gamblers.

    John A Cunningham

    Full Text Available BACKGROUND: Personalized feedback is a promising self-help for problem gamblers. Such interventions have shown consistently positive results with other addictive behaviours, and our own pilot test of personalized normative feedback materials for gamblers yielded positive findings. The current randomized controlled trial evaluated the effectiveness, and the sustained efficacy, of the personalized feedback intervention materials for problem gamblers. METHODOLOGY/PRINCIPAL FINDINGS: Respondents recruited by a general population telephone screener of Ontario adults included gamblers with moderate and severe gambling problems. Those who agreed to participate were randomly assigned to receive: 1 the full personalized normative feedback intervention; 2 a partial feedback that contained all the feedback information provided to those in condition 1 but without the normative feedback content (i.e., no comparisons provided to general population gambling norms; or 3 a waiting list control condition. The primary hypothesis was that problem gamblers who received the personalized normative feedback intervention would reduce their gambling more than problem gamblers who did not receive any intervention (waiting list control condition by the six-month follow-up. CONCLUSIONS/SIGNIFICANCE: The study found no evidence for the impact of normative personalized feedback. However, participants who received, the partial feedback (without norms reduced the number of days they gambled compared to participants who did not receive the intervention. We concluded that personalized feedback interventions were well received and the materials may be helpful at reducing gambling. Realistically, it can be expected that the personalized feedback intervention may have a limited, short term impact on the severity of participants' problem gambling because the intervention is just a brief screener. An Internet-based version of the personalized feedback intervention tool, however, may

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

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

    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,…

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

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

    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

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

    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 (P<0.001) for the number of CD56+ cells per fiber (L: from 0.11 ± 0.02 to 0.13 ± 0.03; H: from 0.12 ± 0.03 to 0.15 ± 0.05, mean ± SD). The finding that 12 weeks of training skeletal muscle even with very light loads can induce an increase in the number of satellite...

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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.

  5. Pentalogy of Cantrell accompanied by scoliosis and pes equinovarus deformity at 12 weeks gestation.

    Pekin, A Tazegül; Kerimoğlu, O Seçilmiş; Yilmaz, S A; Kebapcilar, A G; Bakbak, B Gencoğlu; Celik, C

    2015-01-01

    Cantrell's pentalogy (CP) is a rare syndrome characterized by defects in the lower sternum with ectopia cordis, anterior diaphragm defects, midline supraumbilical abdominal wall defects, defects in the diaphragmatic pericardium, and congenital heart disease. The authors report a 12-weeks gestation with multiple fetal anomalies suggesting the diagnosis of CP (a large thoraco-abdominal defect with herniating liver and bowel, heart deviated anteriorly with concomitant ventricular septal defect), and the 'S' shaped fetal spine due to increased lumbar lordosis and scoliosis with accompanying pes equinovarus deformity. Chorionic villus sampling was performed due to increased nuchal translucency (3.7 mm). The fetal karotype was found to be 47, XX,+21 (trisomy 21). In the literature, three scoliosis cases have been reported accompanying the CP along with multiple anomalies and one concomitant pes equinovarus deformity has been reported previously. PMID:26152022

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

    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.

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

    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...

  8. The effect of antenatal exercise on women’s experience of labor: A randomized controlled trial

    Austad, Åshild; Forså, Marianne Inngjerdingen

    2013-01-01

    Objective: To assess whether following a standardized exercise program during pregnancy affects women’s experience of labor.Methods: 855 healthy pregnant women were randomized to an intervention or a control group. The intervention group followed a 12 weeks standardized exercise program between gestational weeks 20 and 36. The program included aerobic and strengthening exercises of moderate to high-intensity. The control group followed standard antenatal care. At inclusion and three months po...

  9. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients

    Lee, Eun Hee; Park, Ji-Eun; Choi, Young-Ju; Huh, Kap-Bum; Kim, Wha-Young

    2008-01-01

    Spirulina is a microscopic and filamentous cyanobacterium that contains essential amino acids, essential fatty acids, vitamins, minerals and anti-oxidative components. The purpose of this study was to examine effects of spirulina intervention in Korean patients with type 2 diabetes. The subjects were 37 type 2 diabetic patients who visited a diabetic clinic in Seoul and randomly assigned into spirulina (8 g/day) or control group. During the intervention period of 12 weeks, subjects were asked...

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

    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...

  11. 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

    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...

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

    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

  13. Prevention of Generalized Anxiety Disorder Using a Web Intervention, iChill: Randomized Controlled Trial

    Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin A; Gosling, John; Bennett, Kylie

    2014-01-01

    Background Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. Objective The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone an...

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

    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...

  15. Effects of a physical education intervention on cognitive function in young children: randomized controlled pilot study

    Watson Christine; Tomporowski Phillip; Paton James Y; Boyle James ME; Fisher Abigail; McColl John H; Reilly John J

    2011-01-01

    Abstract Background Randomized controlled trials (RCT) are required to test relationships between physical activity and cognition in children, but these must be informed by exploratory studies. This study aimed to inform future RCT by: conducting practical utility and reliability studies to identify appropriate cognitive outcome measures; piloting an RCT of a 10 week physical education (PE) intervention which involved 2 hours per week of aerobically intense PE compared to 2 hours of standard ...

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

    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...

  17. Helicobacter pylori eradication in dyspeptic primary care patients: a randomized controlled trial of a pharmacy intervention

    STEVENS, Victor J; Shneidman, Robert J; Johnson, Richard E; Boles, Myde; Steele, Paul E.; Lee, Nancy L

    2002-01-01

    Objective To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen. Design Randomized controlled clinical trial. Setting Nonprofit group-practice health maintenance organization (HMO). Participants HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing (UBT). Interventions Those whose tests were positive for H pylori (23.3%) were provided...

  18. A randomized controlled trial of an antenatal intervention to increase exclusive breastfeeding

    Wong Cheung, Ka-lun; 黃張嘉倫

    2014-01-01

    In Hong Kong, while around 85% of mothers choose to breastfeed their infants, most discontinue within the first one to two months postpartum. This indicates that there is room for improving the current breastfeeding education. A randomized controlled trial was conducted to evaluate the effectiveness of a professional one-to-one antenatal breastfeeding support and education intervention on the exclusivity and duration of breastfeeding. A total of 469 primiparous women who attended the ante...

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

    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...

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

    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...

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

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

    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; ...

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

    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

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

    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

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

    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

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

    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.

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

    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

  8. 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

    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

  9. A cluster randomized-controlled trial of a community mobilization intervention to change gender norms and reduce HIV risk in rural South Africa: study design and intervention

    Pettifor, Audrey; Lippman, Sheri A.; Selin, Amanda M; Peacock, Dean; Gottert, Ann; Maman, Suzanne; Rebombo, Dumisani; Suchindran, Chirayath M.; Twine, Rhian; Lancaster, Kathryn; Daniel, Tamu; Gómez-Olivé, F Xavier; Kahn, Kathleen; MacPhail, Catherine

    2015-01-01

    Background Community mobilization (CM) interventions show promise in changing gender norms and preventing HIV, but few have been based on a defined mobilization model or rigorously evaluated. The purpose of this paper is to describe the intervention design and implementation and present baseline findings of a Cluster Randomized Controlled Trial (RCT) of a two-year, theory-based CM intervention that aimed to change gender norms and reduce HIV risk in rural Mpumalanga province, South Africa. Me...

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

    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

  11. Brief motivational intervention and alcohol expectancy challenge with heavy drinking college students: a randomized factorial study.

    Wood, Mark D; Capone, Christy; Laforge, Robert; Erickson, Darin J; Brand, Nancy H

    2007-11-01

    This study is the first reported test of the unique and combined effects of Brief Motivational Intervention (BMI) and Alcohol Expectancy Challenge (AEC) with heavy drinking college students. Three hundred and thirty-five participants were randomly assigned in a 2x2 factorial design to either: BMI, AEC, BMI and AEC, and assessment only conditions. Follow-ups occurred at 1, 3, and 6 months. Unconditional latent curve analyses suggested that alcohol use (Q-F), heavy episodic drinking, and alcohol problems were best modeled as quadratic effects. BMI produced significant decreases in Q-F, heavy drinking, and problems, while AEC produced significant decreases in Q-F and heavy drinking. There was no evidence of an additive effect of combining the interventions. Intervention effects decayed somewhat for BMI and completely for AEC over 6 months. Multi-group analyses suggested similar intervention effects for men and women. BMI effects on alcohol problems were mediated by perceived norms. These findings extend previous research with BMI and AEC but do not support their utility as a combined preventive intervention to reduce collegiate alcohol abuse. PMID:17658696

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

    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

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

    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

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

    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

  16. Protocol for the Cognitive Interventions and Nutritional Supplements (CINS trial: A randomized controlled multicenter trial of a brief intervention (BI versus a BI plus cognitive behavioral treatment (CBT versus nutritional supplements for patients with long-lasting muscle and back pain

    Bjørkkjær Tormod

    2011-07-01

    Full Text Available Abstract Background Brief intervention programs are clinically beneficial, and cost efficient treatments for low back pain, when offered at 8-12 weeks, compared with treatment as usual. However, about 30% of the patients do not return to work. The European Guidelines for treatment of chronic low back pain recommends Cognitive Behavioral Therapy (CBT, but conclude that further research is needed to evaluate the effectiveness of CBT for chronic low back pain. Methods/Design The aim of the multicenter CINS trial (Cognitive Interventions and Nutritional Supplements is to compare the effectiveness of 4 different interventions; Brief Intervention, Brief Intervention and CBT, Brief Intervention and nutritional supplements of seal oil, and Brief Intervention and nutritional supplements of soy oil. All participants will be randomly assigned to the interventions. The nutritional supplements will be tested in a double blind design. 400 patients will be recruited from a population of chronic low back pain patients that have been sick listed for 2-10 months. Four outpatient clinics, located in different parts of Norway, will participate in recruitment and treatment of the patients. The Brief Intervention is a one session cognitive, clinical examination program based on a non-injury model, where return to normal activity and work is the main goal, and is followed by two booster sessions. The CBT is a tailored treatment involving 7 sessions, following a detailed manual. The nutritional supplements consist of a dosage of 10 grams of either soy or seal oil (capsules per day for 3 months, administered in a double blind design. All patients will be followed up with questionnaires after 3, 6 and 12 months, while sick leave data will be collected up to at least 24 months after randomization. The primary outcome of the study is sick leave and will be based on register data from the National Insurance Administration. Secondary outcomes include self-reported data on

  17. Effects of a 12 Week SAQ Training Programme on Agility with and without the Ball among Young Soccer Players.

    Milanović, Zoran; Sporiš, Goran; Trajković, Nebojša; James, Nic; Samija, Krešimir

    2013-01-01

    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 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. Key pointsSAQ training appears to be an effective way of improving agility with and without the ball in young soccer playersSoccer coaches could use this training during pre-season and in-season trainingCompared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training. PMID:24149731

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

    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

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

    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.

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

    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.

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

    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

  2. Skin and needle hygiene intervention for injection drug users: Results from a randomized, controlled Stage I pilot trial

    Phillips, Kristina T.; Stein, Michael D.; Anderson, Bradley J.; Corsi, Karen F.

    2012-01-01

    A new skin and needle hygiene intervention, designed to reduce high-risk injection practices associated with bacterial and viral infections, was tested in a pilot, randomized controlled trial. Participants included 48 active heroin injectors recruited through street outreach and randomized to either the two-session intervention or an assessment-only condition (AO) and followed for six months. The primary outcome was skin and needle cleaning behavioral skills measured by videotaped demonstrati...

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

    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.

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

    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

  5. 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.

    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 (Pantiaging. J Drugs Dermatol. 2016;15(6):750-758. PMID:27272084

  6. Psychological Outcomes After a Sexual Assault Video Intervention: A Randomized Trial.

    Miller, Katherine E; Cranston, Christopher C; Davis, Joanne L; Newman, Elana; Resnick, Heidi

    2015-01-01

    Sexual assault survivors are at risk for a number of mental and physical health problems, including posttraumatic stress disorder and anxiety. Unfortunately, few seek physical or mental health services after a sexual assault (Price, Davidson, Ruggiero, Acierno, & Resnick, 2014). Mitigating the impact of sexual assault via early interventions is a growing and important area of research. This study adds to this literature by replicating and expanding previous studies (e.g., Resnick, Acierno, Amstadter, Self-Brown, & Kilpatrick, 2007) examining the efficacy of a brief video-based intervention that provides psychoeducation and modeling of coping strategies to survivors at the time of a sexual assault nurse examination. Female sexual assault survivors receiving forensic examinations were randomized to standard care or to the video intervention condition (N = 164). The participants completed mental health assessments 2 weeks (n = 69) and 2 months (n = 74) after the examination. Analyses of covariance revealed that women in the video condition had significantly fewer anxiety symptoms at the follow-up assessments. In addition, of those participants in the video condition, survivors reporting no previous sexual assault history reported significantly fewer posttraumatic stress symptoms 2 weeks after the examination than those with a prior assault history. Forensic nurses have the unique opportunity to intervene immediately after a sexual assault. This brief video intervention is a cost-effective tool to aid with that process. PMID:26291847

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

    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

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

    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.

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

    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. 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

    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

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

    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

  12. Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial

    Richards Julie

    2011-03-01

    Full Text Available Abstract Background Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52. This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05 and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004 Conclusions Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration The trial is registered with ClinicalTrials.gov (NCT00644995.

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

    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.…

  14. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

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

    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

  16. HIV Sexual Risk-Reduction Interventions for Youth: A Review and Methodological Critique of Randomized Controlled Trials

    Pedlow, C. Teal; Carey, Michael P.

    2003-01-01

    We review and provide a methodological critique of randomized controlled studies of HIV risk reduction interventions that measured sexual risk behavior outcomes with adolescents. Studies conducted in school, community, and health care settings were reviewed. Overall, 13 of 23 interventions (57%) were effective in reducing sexual risk behavior. Methodological strengths of extant studies included an emphasis on a theoretical framework, evaluation of both group- and individualized intervention f...

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

    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

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

    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.

  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

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

    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

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

    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

  2. Evaluating the impact of a school-based health intervention using a randomized field experiment.

    Greve, Jane; Heinesen, Eskil

    2015-07-01

    We conduct an econometric evaluation of a health-promoting programme in primary and lower secondary schools in Denmark. The programme includes health-related measurements of the students, communication of knowledge about health, and support of health-promoting projects for students. Half of the schools in the fourth largest municipality in Denmark were randomly selected into a treatment group implementing the programme, while the remainder served as a control group. We estimate both OLS models using only post-intervention observations and difference in differences (DID) models using also pre-intervention observations. We estimate effects of the initiative on BMI, waist/height ratio, overweight and obesity for the entire sample and by gender and grade. We find no consistent effect of the programme. When we use the entire sample, no estimates are statistically significant at conventional levels, although the point estimates for the effect on BMI, indicating an average reduction in the range of 0.10-0.15 kg/m(2), are consistent with the results in a recent Cochrane review evaluating 55 studies of diet and exercise interventions targeting children; and DID estimates which are marginally significant (at the 10% level) indicate that the intervention reduces the risk of obesity by 1% point. Running separate estimations by gender and grade we find a few statistically significant estimates: OLS estimates indicate that the intervention reduces BMI in females in grade 5 by 0.39 kg/m(2) and reduces the risk of obesity in females in grade 9 by 2.6% points; DID estimates indicate an increase in waist for females in preschool class by 1.2 cm and an increase in the risk of obesity in grade 9 males by 4% points. However, if we corrected for multiple hypotheses testing these estimates would be insignificant. There is no statistically significant correlation between participation in the programme and the number of other health-promoting projects at the schools. PMID:25898077

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

    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...

  4. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-01-01

    Background Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Objective Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inact...

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

    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

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

    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

  7. Randomized controlled trials in industrial low back pain. Part 3. Subacute/chronic pain interventions.

    Scheer, S J; Watanabe, T K; Radack, K L

    1997-04-01

    The most significant costs attributed to settlement of workplace back injury claims are related to chronic low back pain (LBP). Unfortunately, our knowledge of this fact has not led to a reduction of the considerable costs paid out annually by employers and insurers to deal with the chronic pain syndrome. This article is the third in a series of reviews on randomized controlled trials found in the English language medical literature between 1975 and 1993. Of more than 4,000 LBP citations, 35 studies met-the selection criteria of randomization, reasonable concurrent controls and work return comparisons. This review focuses on the 12 studies utilizing nonsurgical interventions for subacute and chronic LBP, including multidisciplinary pain clinics, exercise, cognitive-behavioral strategies, and others. A 26-point quality system was again used to compare the methodologic rigor of each study. The majority of prospective studies investigating return to work after chronic LBP have methodological limitations; additional research is clearly needed to more confidently answer the question of what interventions improve work capacity in patients with chronic LBP. PMID:9111463

  8. Effects of 12 weeks of treatment with fermented milk on blood pressure, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes

    Hove, K D; Brøns, C; Færch, K;

    2015-01-01

    helveticus on BP, glycaemic control and cardiovascular risk factors in T2D. DESIGN: A randomised, double-blinded, prospective, placebo-controlled study. METHODS: In one arm of a factorial study design, 41 patients with T2D were randomised to receive 300 ml milk fermented with L. helveticus (Cardi04 yogurt......) (n=23) or 300 ml artificially acidified milk (placebo yogurt) (n=18) for 12 weeks. BPs were measured over 24-h, and blood samples were collected in the fasting state and during a meal test before and after the intervention. RESULTS: Cardi04 yogurt did not reduce 24-h, daytime or nighttime systolic...... or diastolic BPs compared with placebo (P>0.05). Daytime and 24-h heart rate (HR) were significantly reduced in the group treated by Cardi04 yogurt compared with the placebo group (P

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

    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

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

    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...

  11. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

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

    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

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

    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.

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

    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

  15. 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

    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 ...

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

    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

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

    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, the...... specific program is significantly better than other interventions. LEVEL OF EVIDENCE: Therapy, level 4. J Orthop Sports Phys Ther, Epub 5 September 2012. doi:10.2519/jospt.2012.4165....

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

    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

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

    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...

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

    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

  1. 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

    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

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

    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

  3. Results of a large-scale randomized behavior change intervention on road safety in Kenya

    Habyarimana, James; Jack, William

    2015-01-01

    Road accidents kill 1.3 million people each year, most in the developing world. We test the efficacy of evocative messages, delivered on stickers placed inside Kenyan matatus, or minibuses, in reducing road accidents. We randomize the intervention, which nudges passengers to complain to their drivers directly, across 12,000 vehicles and find that on average it reduces insurance claims rates of matatus by between one-quarter and one-third and is associated with 140 fewer road accidents per year than predicted. Messages promoting collective action are especially effective, and evocative images are an important motivator. Average maximum speeds and average moving speeds are 1–2 km/h lower in vehicles assigned to treatment. We cannot reject the null hypothesis of no placebo effect. We were unable to discern any impact of a complementary radio campaign on insurance claims. Finally, the sticker intervention is inexpensive: we estimate the cost-effectiveness of the most impactful stickers to be between $10 and $45 per disability-adjusted life-year saved. PMID:26261326

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

    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...

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

    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...

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

    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...

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

    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...

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

    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, ...

  9. Dejian Mind-Body Intervention on Depressive Mood of Community-Dwelling Adults: A Randomized Controlled Trial

    Chan, Agnes S.; Mei-chun Cheung; Tsui, Wilson J.; Sophia L Sze; Dejian Shi

    2011-01-01

    The present study evaluated the effectiveness of a short-term mind-body intervention program on improving the depressive mood of an adult community sample. Forty adult volunteers with various degrees of depressive mood were randomly assigned to the experimental group (Dejian Mind-Body Intervention, DMBI) and control group (Cognitive-Behavioral Therapy, CBT). For each group, a total of four 90-min weekly sessions were conducted. Treatment-related changes were measured using the Beck Depression...

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

    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...

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

    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...

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

    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...

  13. Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study

    Smaïl-Faugeron, Violaine; Fron-Chabouis, Hélène; Courson, Frédéric; Durieux, Pierre

    2014-01-01

    Background Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. Methods We performed a meta-epidemiological study. We systematically...

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

    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 ...

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

    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...

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

    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....

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

    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 ...

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

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

    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,...

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

    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

  1. Brief Motivational Intervention in a Non-Treatment Seeking Population of Heavy Drinkers - a Randomized Controlled Trial

    Hansen, Anders Blædel Gottlieb; Becker, Ulrik; Søgaard Nielsen, Anette;

    2010-01-01

    : To determine whether a brief motivational intervention resulted in lowering of self-reported alcohol use in a non-treatment seeking population of heavy drinkers. Method: Before participating in a Danish Health Examination Survey study all participants completed a mailed questionnaire. Systematic...... screening of 12,364 adults led to inclusion of 772 heavy drinkers (defined as weekly alcohol consumption above the Danish safe drinking limits (168 grams of alcohol for women, 252 grams for men), who were randomized into a control (n=381) or an intervention (n=391) group. The intervention consisted of a...

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

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

    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.

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

    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

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

    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. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

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

    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…

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

    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…

  9. Effects of a comprehensive educational group intervention in older women with cognitive complaints: a randomized controlled trial

    Hoogenhout, Esther; De Groot, Renate; van der Elst, Wim; Jolles, Jelle

    2012-01-01

    Hoogenhout, E. M., De Groot, R. H. M., Van der Elst, W., Jolles J. (2012). Effects of a comprehensive educational group intervention in older women with cognitive complaints: a randomized controlled trial. Aging & Mental Health, 16, 135-144. doi:10.1080/13607863.2011.598846

  10. Unanticipated Effect of a Randomized Peer Network Intervention on Depressive Symptoms among Young Methamphetamine Users in Thailand

    German, D.; Sutcliffe, C. G.; Sirirojn, B.; Sherman, S. G.; Latkin, C. A.; Aramrattana, A.; Celentano, D. D.

    2012-01-01

    We examined the effect on depressive symptoms of a peer network-oriented intervention effective in reducing sexual risk behavior and methamphetamine (MA) use. Current Thai MA users aged 18-25 years and their drug and/or sex network members enrolled in a randomized controlled trial with 4 follow-ups over 12 months. A total of 415 index participants…

  11. Improvement in Personal Meaning Mediates the Effects of a Life Review Intervention on Depressive Symptoms in a Randomized Controlled Trial

    Westerhof, Gerben J.; Bohlmeijer, Ernst T.; van Beljouw, Ilse M. J.; Pot, Anne Margriet

    2010-01-01

    Purpose: The purpose of the study was to assess the impact of a life review intervention on personal meaning in life and the mediating effect of personal meaning on depressive symptoms as the primary outcome of this form of indicated prevention. Design and Methods: A multicenter randomized controlled trial was conducted with one group of older…

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

    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

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

    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

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

    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

  15. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers

    Moadel, Alyson B.; Bernstein, Steven L.; Mermelstein, Robin J.; Arnsten, Julia H.; Dolce, Eileen H.; Shuter, Jonathan

    2013-01-01

    Background More than half of persons living with HIV (PLWH) in the US smoke cigarettes, and tobacco use is responsible for considerable morbidity and mortality in this group. Little is known about the efficacy of tobacco treatment strategies in PLWH. Design Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group therapy intervention targeting HIV-infected smokers, to standard care. Methods A cohort of 145 PLWH smokers, recruited from an HIV-care center in the Bronx, New York, were randomized 1:1 into the PSF program or standard care. All were offered a 3-month supply of nicotine replacement therapy. PSF is an eight session program tailored to address the needs and concerns of HIV-infected smokers. Sessions were co-facilitated by a graduate student and an HIV-infected peer. The primary outcome was biochemically-confirmed, seven-day point-prevalence abstinence at three months. Results In the intention to treat analysis, PSF condition subjects had nearly double the quit rate of controls (19.2% vs 9.7%, P=0.11). In the complete case, as-treated analysis, assignment to PSF was associated with increased odds of quitting (ORadj 3.55, 95% CI: 1.04– 12.0). Latino ethnicity and lower loneliness score were predictive of abstinence. Subjects in the PSF condition exhibited significant decreases in daily cigarette consumption and significant increases in self-efficacy and in motivation to quit. Attendance of ≥7 sessions was associated with higher quit rates. Conclusions These findings suggest a positive effect of PSF on cessation rates in PLWH smokers. Loneliness and self-efficacy are influential factors in the smoking behaviors of PLWH. PMID:22732470

  16. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

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

    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.

    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

    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

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

    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.

  1. Video-feedback intervention increases sensitive parenting in ethnic minority mothers: a randomized control trial.

    Yagmur, Sengul; Mesman, Judi; Malda, Maike; Bakermans-Kranenburg, Marian J; Ekmekci, Hatice

    2014-01-01

    Using a randomized control trial design we tested the effectiveness of a culturally sensitive adaptation of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) in a sample of 76 Turkish minority families in the Netherlands. The VIPP-SD was adapted based on a pilot with feedback of the target mothers, resulting in the VIPP-TM (VIPP-Turkish Minorities). The sample included families with 20-47-month-old children with high levels of externalizing problems. Maternal sensitivity, nonintrusiveness, and discipline strategies were observed during pretest and posttest home visits. The VIPP-TM was effective in increasing maternal sensitivity and nonintrusiveness, but not in enhancing discipline strategies. Applying newly learned sensitivity skills in discipline situations may take more time, especially in a cultural context that favors more authoritarian strategies. We conclude that the VIPP-SD program and its video-feedback approach can be successfully applied in immigrant families with a non-Western cultural background, with demonstrated effects on parenting sensitivity and nonintrusiveness. PMID:24972105

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

    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.

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

    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

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

    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

  5. Heterotropic pregnancy: Rare occurrence of a 12- week ruptured right isthmo-cornual ectopic along with a viable intrauterine pregnancy

    Priya Selvaraj

    2012-01-01

    Full Text Available Heterotropic pregnancy, although a rare condition, is associated with a greater frequency in assisted reproduction. It occurs in approximately 1 in 100 pregnancies conceived by in vitro fertilization (IVF particularly when multiple embryos are transferred into the uterus. We report a case of heterotropic pregnancy following IVF with the rupture of an isthmo-cornual pregnancy at 12 weeks of gestation with uneventful progression of the intrauterine pregnancy. Laparotomy was performed for the excision of the isthmo-cornual pregnancy. The intrauterine pregnancy continued uneventfully. A female baby was delivered by elective cesarean section at 33 weeks.

  6. Differences in Maximum Upper and Lower Limb Strength in Older Adults After a 12 Week Intense Resistance Training Program

    Sousa, Nelson; Mendes, Romeu; Abrantes, Catarina; Sampaio, Jaime

    2011-01-01

    The purpose of this study was to identify differences in maximum strength after an intense strength training program, contrasting muscle groups from upper limbs versus lower limbs. The sample consisted of 10 healthy elderly males (age 73±6 years) with independent living. The training program lasted 12 weeks (3 × week, 50 to 80% of 1RM, 2–3 sets, 6 to 12 repetitions). Two muscle groups were analyzed: LOWER (sum of average values of three exercises for the lower limbs) and UPPER (sum of average...

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

    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...

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

    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 are...

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

    Yao Ping

    2009-02-01

    Full Text Available 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 randomized controlled trial conducted in both urban and rural area of Hubei between August 2003 and June 2004. A total of 302 women who attended the antenatal clinic during the third trimester with an uncomplicated pregnancy were recruited. Women randomized to the education intervention group in both urban and rural area received two two-hour prenatal education sessions and four postpartum counseling visits. Control group women received usual health care during pregnancy and postpartum period. Women were followed up until 42 days postpartum. Outcome measures were nutrition and health knowledge, dietary behavior, health behavior and health problems during the postpartum period. Results Women in the intervention groups exhibited significantly greater improvement in overall dietary behaviors such as consumption of fruits, vegetables, soybean and soybean products as well as nutrition and health knowledge than those in the control groups. Significantly more women in the intervention groups give up the traditional behavior taboos. The incidence of constipation, leg cramp or joint pain and prolonged lochia rubra was significantly lower in the intervention groups as compared with the control groups. Conclusion The study shows that health and nutrition education intervention enable the women take away some of the unhealthy traditional postpartum practices and decrease the prevalence of postpartum health problems. The intervention has potential for adaptation and

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

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

    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

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

    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

  13. Adolescent HIV Risk Reduction in the Bahamas: Results from Two Randomized Controlled Intervention Trials Spanning Elementary School Through High School.

    Stanton, Bonita; Dinaj-Koci, Veronica; Wang, Bo; Deveaux, Lynette; Lunn, Sonja; Li, Xiaoming; Rolle, Glenda; Brathwaite, Nanika; Marshall, Sharon; Gomez, Perez

    2016-06-01

    To address global questions regarding the timing of HIV-prevention efforts targeting youth and the possible additional benefits of parental participation, researchers from the USA and The Bahamas conducted two sequential longitudinal, randomized trials of an evidence-based intervention spanning the adolescent years. The first trial involved 1360 grade-6 students and their parents with three years of follow-up and the second 2564 grade-10 students and their parents with two years of follow-up. Through grade-12, involvement in the combined child and parent-child HIV-risk reduction interventions resulted in increased consistent condom-use, abstinence/protected sex, condom-use skills and parent-child communication about sex. Receipt of the grade-6 HIV-prevention intervention conferred lasting benefits regarding condom-use skills and self-efficacy. Youth who had not received the grade-six intervention experienced significantly greater improvement over baseline as a result of the grade-10 intervention. The HIV-risk reduction intervention delivered in either or both grade-6 and grade-10 conferred sustained benefits; receipt of both interventions appears to confer additional benefits. PMID:26499123

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

    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

  15. Changes in selected cardiorespiratory responses to exercise and in body composition following a 12-week aerobic dance programme.

    Williams, L D; Morton, A R

    1986-01-01

    Cardiorespiratory and body composition changes were evaluated in 25 sedentary females, aged 18 to 30 years, following 12 weeks of aerobic dance training (3 days a week, 45 min a session). Fifteen subjects, from the same population, comprised a control group: they maintained their normal activity and dietary habits over the course of the study. Analysis of variance of the values for selected cardiorespiratory responses revealed that the aerobic dance programme produced training effects in the experimental group. These training effects were indicated by significant improvements in O2 pulse, VE, heart rate and perceived exertion during submaximal exercise. Significant improvements were also noted in VO2 max, maximal O2 pulse, VE max, maximal heart rate and maximal running time on the treadmill. Additionally, increases in lean body mass and body density, together with decreases in percentage body fat and the sum of four skinfold thicknesses were found to be significant for the experimental group. No significant improvements in any of these variables were found for the control group. It was concluded that this 12-week aerobic dance programme was successful in promoting beneficial changes in cardiorespiratory fitness and body composition. PMID:3586112

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

    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

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

    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

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

    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

  19. Outcomes and moderators of a preventive school-based mental health intervention for children affected by war in Sri Lanka: a cluster randomized trial

    TOL, WIETSE A.; KOMPROE, IVAN H.; Jordans, Mark J. D.; Vallipuram, Anavarathan; Sipsma, Heather; SIVAYOKAN, SAMBASIVAMOORTHY; Macy, Robert D; de Jong, Joop T.

    2012-01-01

    We aimed to examine outcomes, moderators and mediators of a preventive school-based mental health intervention implemented by paraprofessionals in a war-affected setting in northern Sri Lanka. A cluster randomized trial was employed. Subsequent to screening 1,370 children in randomly selected schools, 399 children were assigned to an intervention (n=199) or waitlist control condition (n=200). The intervention consisted of 15 manualized sessions over 5 weeks of cognitive behavioral techniques ...

  20. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients.

    Lee, Eun Hee; Park, Ji-Eun; Choi, Young-Ju; Huh, Kap-Bum; Kim, Wha-Young

    2008-01-01

    Spirulina is a microscopic and filamentous cyanobacterium that contains essential amino acids, essential fatty acids, vitamins, minerals and anti-oxidative components. The purpose of this study was to examine effects of spirulina intervention in Korean patients with type 2 diabetes. The subjects were 37 type 2 diabetic patients who visited a diabetic clinic in Seoul and randomly assigned into spirulina (8 g/day) or control group. During the intervention period of 12 weeks, subjects were asked to keep usual diet and prohibited to take any functional foods or dietary supplements. Spirulina supplementation for 12 weeks did not affect anthropometric parameters, however, lowered plasma triglycerides level significantly (pdiabetes. The results suggest that spirulina is a promising agent as a functional food for diabetes management. PMID:20016733

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

    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....

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

    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

  3. Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial

    Verhaeghe Nick

    2012-06-01

    Full Text Available Abstract Background Growing attention is given to the effects of health promotion programs targeting physical activity and healthy eating in individuals with mental disorders. The design of evaluation studies of public health interventions poses several problems and the current literature appears to provide only limited evidence on the effectiveness of such programs. The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders living in sheltered housing. In this paper, the design of the study and baseline findings are described. Methods/design The design consists of a cluster preference randomized controlled trial. All sheltered housing organisations in the Flanders region (Belgium were asked if they were interested to participate in the study and if they were having a preference to serve as intervention or control group. Those without a preference were randomly assigned to the intervention or control group. Individuals in the intervention group receive a 10-week health promotion intervention above their treatment as usual. Outcome assessments occur at baseline, at 10 and at 36 weeks. The primary outcomes include body weight, Body Mass Index, waist circumference, and fat mass. Secondary outcomes consist of physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. Cost-effectiveness of the intervention will be examined by calculating the Cost-Effectiveness ratio and through economic modeling.Twenty-five sheltered housing organisations agreed to participate. On the individual level 324 patients were willing to participate, including 225 individuals in the intervention group and 99 individuals in the control group. At baseline, no statistical significant differences between the two groups were found for the primary outcome variables. Discussion This is the first trial

  4. Effects of yoga intervention on sleep and quality-of-life in elderly: A randomized controlled trial

    Hariprasad, V. R.; Sivakumar, P. T.; Koparde, V.; Varambally, S.; Thirthalli, J.; Varghese, M; Basavaraddi, I. V.; B N Gangadhar

    2013-01-01

    Context: Yoga as a life-style practice has demonstrated beneficial effects. The role of yoga in the elderly for such benefits merits investigation. Aims: The aim of this study is to examine the effects of yoga intervention on quality-of-life (QOL) and sleep quality in the elderly living in old age homes. Settings and Design: Single blind controlled study with block randomization of elderly homes. Materials and Methods: A total of 120 subjects from nine elderly homes were randomized in to yoga...

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

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

    2012-01-01

    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...... 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...... 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...

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

    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

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

    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

  8. Using online computer tailoring to promote physical activity: a randomized trial of text, video, and combined intervention delivery modes.

    Soetens, Katja C M; Vandelanotte, Corneel; de Vries, Hein; Mummery, Kerry W

    2014-12-01

    Website-delivered interventions are increasingly used to deliver physical activity interventions, yet problems with engagement and retention result in reduced effectiveness. Hence, alternative modes of online intervention delivery need to be explored. Therefore, this study aimed to evaluate the acceptability and effectiveness of a computer-tailored physical activity intervention delivered on the Internet in 3 delivery modes: video, text, or both. Australian adults (N = 803), recruited through e-mail, were randomized into the three delivery modes and received personal physical activity advice. Intervention content was identical across groups. Repeated measures analyses of variance were used to compare the three groups regarding acceptability, website usability, and physical activity. Participants in the video group accepted the content of the physical activity advice significantly better (F = 5.59; p website (F = 21.19; p < .001) compared with the text and combination groups. Total physical activity improved significantly over time in all groups (F = 3.95; p < .01). Although the combination group increased physical activity the most, few significant differences between groups were observed. Providing video-tailored feedback has advantages over the conventional text-tailored interventions; however, this study revealed few behavioral differences. More studies, examining alternative delivery modes, that can overcome the limitations of the present study, are needed. PMID:24749983

  9. The Effect of 12-Week Exercise with Omega-3 Supplement Consumption on Serum Level Changes of Adiponectin, Leptin, and Insulin in Girls

    F. Piroozan

    2015-07-01

    Full Text Available Introduction & Objective: Adiponectin and leptin are peptide hormones regulating the energy balance. Therefore, the present study aims to identify the possible mechanisms of the effect of omega-3 and aerobic exercise on the balance of these two hormones. Materials & Methods: 60 healthy young women with the average age of 23.4±1.8 and the average weight of 60.45±5.85 were randomly selected and divided into training, omega 3-training, omega-3 and control groups. A basketball training program was performed including specialized training 3 times a week for 90 minutes. During the 12 weeks of training, omega-3+exercise and omega -3 groups were fed a number of oral capsules of omega-3 every night. Blood samples were taken from the brachial vein. To analyze the data and determine the relationship, one way ANOVA and Tukey test and Pearson's correlation coefficient were used. Results: Significant differences in serum levels of adiponectin, leptin and insulin secretion in exercise, omega-3 and exercise+omega-3 groups were observed. However, there was a significant correlation between changes in serum levels of adiponectin, and leptin and insulin secretion was not observed in any of the groups. Conclusion: It seems that omega-3 fatty acid intake with exercise enhances fat metabolism and is helpful to regulate the secretion of adiponectin and leptin hormone.(Sci J Hamadan Univ Med Sci 2015; 22 (2: 129-136

  10. Effectiveness of a Randomized Controlled Lifestyle Intervention to Prevent Obesity among Chinese Primary School Students: CLICK-Obesity Study

    Xu, Fei; Ware, Robert S.; Leslie, Eva; Tse, Lap Ah; Wang, Zhiyong; Li, Jiequan; Wang, Youfa

    2015-01-01

    Background Childhood obesity has been increasing rapidly worldwide. There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide, especially in developing countries like China. The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program (the CLICK-Obesity study) in Mainland China. Methods A cluster randomized controlled trial was developed among grade 4 students from 8 urban primary schools (638 students in intervention, 544 as control) in Nanjing City, China. Students were randomly allocated to the control or intervention group at school-level. A one-year multi-component intervention program (classroom curriculum, school environment support, family involvement and fun programs/events) together with routine health education was provided to the intervention group, while the control group received routine health education only. The main outcome variables assessed were changes in body mass index, obesity occurrence, obesity-related lifestyle behaviors and knowledge. Results Overall, 1108 (93.7%) of the 1182 enrolled students completed the intervention study. The intervention group had a larger marginal reduction than did the control group in overall mean BMI value (-0.32±1.36 vs. -0.29±1.40, p = 0.09), although this was not significant. Compared with the control group, the intervention group was more likely to decrease their BMI (OR = 1.44, 95%CI = 1.10, 1.87) by 0.5 kg/m2 or above, increase the frequency of jogging/running (OR = 1.55, 95%CI = 1.18, 2.02), decrease the frequency of TV/computer use (OR = 1.41, 95%CI = 1.09, 1.84) and of red meat consumption (OR = 1.50, 95%CI = 1.15, 1.95), change commuting mode to/from school from sedentary to active mode (OR = 2.24, 95%CI = 1.47, 3.40), and be aware of the harm of selected obesity risk factors. Conclusions The school-based lifestyle intervention program was practical and effective in improving

  11. A Parenting Intervention for Childhood Behavioral Problems: A Randomized Controlled Trial in Disadvantaged Community-Based Settings

    McGilloway, Sinéad; Ní Mháille, Gráinne; Bywater, Tracey; Furlong, Mairéad; Leckey, Yvonne; Kelly, Paul; Comiskey, Catherine; Donnelly, Michael

    2012-01-01

    OBJECTIVE: A community-based randomized controlled trial (RCT) was conducted in urban areas characterized by high levels of disadvantage to test the effectiveness of the Incredible Years BASIC parent training program (IYBP) for children with behavioral problems. Potential moderators of intervention effects on child behavioral outcomes were also explored. METHOD: Families were included if the child (aged 32-88 months) scored above a clinical cutoff on the Eyberg Child Behavior Inven...

  12. Musculoskeletal disorders and psychosocial factors at work : Effects of a participatory ergonomics intervention in a cluster randomized controlled trial

    Haukka, Eija

    2010-01-01

    This study examined the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders (MSDs) and changing unsatisfactory psychosocial working conditions among municipal kitchen workers. The occurrence of multiple-site musculoskeletal pain (MSP) and associations between MSP and psychosocial factors at work over time were studied secondarily. A cluster randomized controlled trial was conducted during 2002-2005 in 119 municipal kitchens with 504 workers. The ki...

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

    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...

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

    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...

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

    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 searches of PubMed. METHODS: Twenty-two residents and specialists working at the Radboud University Nijmegen Medical Centre were trained in formulating PICO queries and then presented with a randomi...

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

    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...

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

    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...

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

    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...

  19. Mobile Phone Intervention and Weight Loss Among Overweight and Obese Adults: A Meta-Analysis of Randomized Controlled Trials

    Liu, Fangchao; Kong, Xiaomu; Cao, Jie; Chen, Shufeng; Li, Changwei; Huang, Jianfeng; Gu, Dongfeng; Kelly, Tanika N.

    2015-01-01

    We conducted a meta-analysis of randomized controlled trials to examine the association of mobile phone intervention with net change in weight-related measures among overweight and obese adults. We searched electronic databases and conducted a bibliography review to identify articles published between the inception date of each database and March 27, 2014. Fourteen trials (including 1,337 participants in total) that met the eligibility criteria were included. Two investigators independently a...

  20. Improvement in Social Competence Using a Randomized Trial of a Theatre Intervention for Children with Autism Spectrum Disorder

    Corbett, Blythe A.; Key, Alexandra P.; Qualls, Lydia; Fecteau, Stephanie; Newsom, Cassandra; Coke, Catherine; Yoder, Paul

    2016-01-01

    The efficacy of a peer-mediated, theatre-based intervention on social competence in participants with autism spectrum disorder (ASD) was tested. Thirty 8-to-14 year-olds with ASD were randomly assigned to the treatment (n = 17) or a wait-list control (n = 13) group. Immediately after treatment, group effects were seen on social ability,…

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

    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...

  2. An Online Randomized Controlled Trial Evaluating HIV Prevention Digital Media Interventions for Men Who Have Sex with Men

    Hirshfield, Sabina; Chiasson, Mary Ann; Joseph, Heather; Scheinmann, Roberta; Johnson, Wayne D.; Remien, Robert H.; Shaw, Francine Shuchat; Emmons, Reed; Yu, Gary; Margolis, Andrew D

    2012-01-01

    Background 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. Methods 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 ...

  3. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials

    Paulo Henrique Guerra

    2013-09-01

    Full Text Available This study reviewed the effectiveness of school-based physical activity interventions aimed at reducing overweight, obesity and hypertension in children. We searched 14 databases and analyzed studies published between April 2009 and September 2012. Only randomized controlled trials performed at the school level that included elements of physical activity but did not include nutritional co-interventions were analyzed. Studies were assessed by two recommended tools (EPHPP and GRADE, and the standardized mean differences with 95% confidence intervals were collected for a random-effect meta-analysis. A total of 12 papers were included in the meta-analysis, and these were divided according to three outcomes: body mass index (11 trials, n  =  4,273, −0.02, 95% CI: −0.13 to 0.17, p  =  0.8; body weight (5 trials, n  =  1,330, −0.07, 95% CI: −0.18 to 0.04, p  =  0.2; and blood pressure (6 trials, n  =  1,549, including systolic (0.11, 95% CI: −0.10 to 0.31, p  =  0.3 and diastolic pressure (−0.00, 95% CI: −0.10 to 0.10, p  =  0.9. This meta-analysis of data from 11 randomized, school-based physical activity interventions suggests that, regardless of the potential benefits of physical activity in the school environment, the interventions did not have a statistically significant effect. However, it is difficult to generalize from these results because the duration, intensity and type of physical activity used in the interventions varied greatly.

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

    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. The Healthy Start project: a randomized, controlled intervention to prevent overweight among normal weight, preschool children at high risk of future overweight

    Olsen Nanna; Buch-Andersen Tine; Händel Mina; Østergaard Louise; Pedersen Jeanett; Seeger Charlotte; Stougaard Maria; Trærup Maria; Livemore Kate; Mortensen Erik; Holst Claus; Heitmann Berit

    2012-01-01

    Abstract Background Research shows that obesity prevention has to start early. Targeting interventions towards subgroups of individuals who are predisposed, but yet normal weight, may prove more effective in preventing overweight than interventions towards unselected normal weight subsets. Finally, interventions focused on other factors than diet and activity are lacking. The objectives were to perform a randomized, controlled intervention aiming at preventing overweight in children aged 2–6 ...

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

    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 ...

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

    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

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

    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...... need for AMPK to control energy turnover during exercise. Thus, the remaining ¿3-associated AMPK activation by acute exercise after exercise training might be sufficient to maintain cellular energy balance....

  9. The Effect of Structured Exercise Intervention on Intensity and Volume of Total Physical Activity

    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.

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

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

    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

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

    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

  13. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE: a randomized controlled trial

    Wilson Sandra R

    2009-11-01

    Full Text Available Abstract Background Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. Design E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240 recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level and moderators (e.g., age, gender, race/ethnicity, baseline mental status of the intervention's effect on weight change also will be examined. Discussion This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care

  14. Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

    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.

  15. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial

    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

  16. Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial.

    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

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

    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

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

    Lindström, David; Sadr Azodi, Omid; Wladis, Andreas; Tønnesen, Hanne; Linder, Stefan; Nåsell, Hans; Ponzer, Sari; Adami, Johanna

    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....

  19. Family Ties to Health Program: A Randomized Intervention to Improve Vegetable Intake in Children

    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…

  20. Efficacy of a Reading and Language Intervention for Children with Down Syndrome: A Randomized Controlled Trial

    Burgoyne, Kelly; Duff, Fiona J.; Clarke, Paula J.; Buckley, Sue; Snowling, Margaret J.; Hulme, Charles

    2012-01-01

    Background: This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods: Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the…

  1. A Family-School Intervention for Children with ADHD: Results of a Randomized Clinical Trial

    Power, Thomas J.; Mautone, Jennifer A.; Soffer, Stephen L.; Clarke, Angela T.; Marshall, Stephen A.; Sharman, Jaclyn; Blum, Nathan J.; Glanzman, Marianne; Elia, Josephine; Jawad, Abbas F.

    2012-01-01

    Objective: Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with attention-deficit/hyperactivity disorder (ADHD) that target the family and school, as well as the intersection of family and school. This study evaluated the effectiveness of a family-school intervention, Family-School…

  2. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy

    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

  3. Family-based interventions for reducing sedentary time in youth: a systematic review of randomized controlled trials.

    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

  4. Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial.

    Poslawsky, Irina E; Naber, Fabiënne Ba; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

    2015-07-01

    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child interaction and reducing the child's individual Autism Spectrum Disorder-related symptomatology in five home visits. VIPP-AUTI, as compared with usual care, demonstrated efficacy in reducing parental intrusiveness. Moreover, parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing. No significant group differences were found on other aspects of parent-child interaction or on child play behavior. At 3-months follow-up, intervention effects were found on child-initiated joint attention skills, not mediated by intervention effects on parenting. Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners. PMID:24919961

  5. Effects of Multiple Cleaning and Disinfection Interventions on Infectious Diseases in Children:A Group Randomized Trial in China

    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.

  6. Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

    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

  7. Breast Health Intervention Effects on Knowledge and Beliefs Over Time Among Chinese American Immigrants--a Randomized Controlled Study.

    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

  8. A randomized clinical trial of a brief hypnosis intervention to control venepuncture-related pain of paediatric cancer patients.

    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. Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

    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.

  10. Chiropractic Treatment vs Self-Management in Patients With Acute Chest Pain: A Randomized Controlled Trial of Patients Without Acute Coronary Syndrome

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner; Høilund-Carlsen, Poul F; Haghfelt, Torben; Hartvigsen, Jan

    2012-01-01

    ) self-management as an example of minimal intervention. METHODS: In a nonblinded, randomized, controlled trial set at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were...... included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to 4 weeks of chiropractic treatment or self-management, with posttreatment questionnaire follow-up 4 and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical...... chiropractic treatment at 4 weeks regarding the primary outcome of self-perceived change in chest pain and at 12 weeks with respect to the primary outcome of numeric change in pain intensity. CONCLUSIONS: To the best of our knowledge, this is the first randomized trial assessing chiropractic treatment vs...

  11. Lumbar disc herniation treated with qi pathway intervention and spinal adjustment:a randomized controlled trial

    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

  12. Family-School Intervention for Children with ADHD: Results of Randomized Clinical Trial

    Power, Thomas J.; Mautone, Jennifer A.; Soffer, Stephen L.; Clarke, Angela T.; Marshall, Stephen A.; Sharman, Jaclyn; Blum, Nathan J.; Glanzman, Marianne; Elia, Josephine; Jawad, Abbas F.

    2012-01-01

    Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with ADHD that target the family and school, as well as the intersection of family and school.

  13. Intervention for Homeless, Substance Abusing Mothers: Findings from a Non-Randomized Pilot

    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...

  14. Comparison of Two Internet-Based Interventions for Problem Drinkers: Randomized Controlled Trial

    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...

  15. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial

    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 ...

  16. Evaluation of a Web-Based Intervention to Promote Hand Hygiene: Exploratory Randomized Controlled Trial

    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...

  17. A Theory-Based Video Messaging Mobile Phone Intervention for Smoking Cessation: Randomized Controlled Trial

    Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny

    2011-01-01

    Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called “STUB IT”) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. ...

  18. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    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

  19. Dropouts and Compliance in Exercise Interventions Targeting Bone Mineral Density in Adults: A Meta-Analysis of Randomized Controlled Trials

    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.

  20. Preventing weight gain: the baseline weight related behaviors and delivery of a randomized controlled intervention in community based women

    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

  1. The Impact of a School-Based Hygiene, Water Quality and Sanitation Intervention on Soil-Transmitted Helminth Reinfection: A Cluster-Randomized Trial

    Matthew C. Freeman; Clasen, Thomas; Brooker, Simon J.; Akoko, Daniel O.; Rheingans, Richard

    2013-01-01

    We conducted a cluster-randomized trial to assess the impact of a school-based water treatment, hygiene, and sanitation program on reducing infection with soil-transmitted helminths (STHs) after school-based deworming. We assessed infection with STHs at baseline and then at two follow-up rounds 8 and 10 months after deworming. Forty government primary schools in Nyanza Province, Kenya were randomly selected and assigned to intervention or control arms. The intervention reduced reinfection pre...

  2. Effect of a Family-Centered, Secondhand Smoke Intervention to Reduce Respiratory Illness in Indigenous Infants in Australia and New Zealand: A Randomized Controlled Trial

    Walker, Natalie; Johnston, Vanessa; Glover, Marewa; Bullen, Christopher; Trenholme, Adrian; Chang, Anne; Morris, Peter; Segan, Catherine; Brown, Ngiare; Fenton, Debra; Hawthorne, Eyvette; Borland, Ron; Parag, Varsha; Von Blaramberg, Taina; Westphal, Darren

    2014-01-01

    Introduction: Secondhand smoke (SHS) is a significant cause of acute respiratory illness (ARI) and 5 times more common in indigenous children. A single-blind randomized trial was undertaken to determine the efficacy of a family centered SHS intervention to reduce ARI in indigenous infants in Australia and New Zealand. Methods: Indigenous mothers/infants from homes with ≥1 smoker were randomized to a SHS intervention involving 3 home visits in the first 3 months of the infants’ lives (plus usu...

  3. ‘Red Ruby’: an interactive web-based intervention for lifestyle modification on metabolic syndrome: a study protocol for a randomized controlled trial

    Jahangiry, Leila; Shojaeizadeh, Davoud; Najafi, Mahdi; Mohammad, Kazem; Abbasalizad Farhangi, Mahdieh; MONTAZERI, Ali

    2014-01-01

    Background Although effectiveness of web-based interventions on lifestyle changes are recognized, the potential of such programs on metabolic syndrome has not been explored. We describe the protocol of a randomized controlled trial that aims to determine the feasibility, acceptability, usability, and effectiveness of interactive technology on lifestyle intervention in a population with metabolic syndrome. Methods/design This is a two-arm randomized controlled trial. The study includes 160 par...

  4. The Effect of Educational-Spiritual Intervention on The Burnout of The Parents of School Age Children with Cancer: A Randomized Controlled Clinical Trial

    , 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...

  5. Effectiveness of a low-threshold physical activity intervention in residential aged care – results of a randomized controlled trial

    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

  6. The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

    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 (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH 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. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    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

  8. Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs: clinical outcomes at 12 weeks.

    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

  9. Treatment of feline lymphoma using a 12-week, maintenance-free combination chemotherapy protocol in 26 cats.

    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

  10. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition

    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.

  11. 39-week toxicity and toxicokinetic study of ponezumab (PF-04360365) in cynomolgus monkeys with 12-week recovery period.

    Freeman, Gary B; Lin, John C; Pons, Jaume; Raha, Nancy M

    2012-01-01

    Ponezumab (PF-04360365) is a novel humanized IgG2Δa monoclonal antibody that binds to amyloid-β (Aβ). It is designed to have reduced immune effector function compared to other passive immunotherapies for Alzheimer's disease (AD). Toxicity was evaluated in cynomolgus monkeys treated intravenously with vehicle or 10, 30, or 100 mg/kg of ponezumab every 10th day for up to 39 weeks, and after a 12-week recovery phase. The Aβ peptide sequence of monkeys is identical to that of humans. No substantial difference in test article exposure between sexes was observed, and mean plasma Cmax and AUC0-n were approximately dose-proportional. Ponezumab was detectable approximately 9 weeks after cessation of dosing. All animals, except two males given 10 mg/kg, maintained exposure to test article. One of these males tested positive for anti-ponezumab antibodies. Ponezumab was detected in the cerebrospinal fluid (CSF) of animals given active treatment. The estimated CSF/plasma ponezumab concentration ratio was AUC basis, respectively, than human exposures at the highest dose (10 mg/kg) in a single-dose Phase I trial. These data suggest an acceptable safety profile for ponezumab as an immunotherapy for AD. PMID:22045481

  12. Effects of exercise intervention in breast cancer survivors: a meta-analysis of 33 randomized controlled trails

    Zhu, Guoqing; Zhang, Xiao; Wang, Yulan; Xiong, Huizi; Zhao, Yinghui; Sun, Fenyong

    2016-01-01

    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.

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

    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

  14. A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

    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.

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

    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.

  16. A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial.

    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

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

    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

  18. A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation.

    DeVito Dabbs, A; Song, M K; Myers, B A; Li, R; Hawkins, R P; Pilewski, J M; Bermudez, C A; Aubrecht, J; Begey, A; Connolly, M; Alrawashdeh, M; Dew, M A

    2016-07-01

    Lung transplant recipients are encouraged to perform self-management behaviors, including (i) monitoring health indicators, (ii) adhering to their regimen, and (iii) reporting abnormal health indicators to the transplant coordinator, yet performance is suboptimal. When hospital discharge was imminent, this two-group trial randomized 201 recipients to use either the mobile health (mHealth) intervention (n = 99) or usual care (n = 102), to compare efficacy for promoting self-management behaviors (primary outcomes) and self-care agency, rehospitalization, and mortality (secondary outcomes) at home during the first year after transplantation. The mHealth intervention group performed self-monitoring (odds ratio [OR] 5.11, 95% confidence interval [CI] 2.95-8.87, p testing. PMID:26729617

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

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

    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 intervention......, group B, n=1,308) were invited for a health examination, an assessment of absolute risk of developing IHD, and an individualized lifestyle intervention. The participation rate was 52.5%. High-risk persons in group A were also offered diet/physical activity and/or smoking cessation group counselling...... OUTCOME: Change in physical activity from baseline to 12-and 36-month follow-up. RESULTS: In men, the high-intensity (group A) intervention had a beneficial effect at 12-month follow-up, whereas after 36 months both the high-intensity and the low-intensity (group B) intervention had a beneficial effect on...

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

    von Huth Smith, Lisa; Ladelund, Steen; Borch-Johnsen, Knut; Jørgensen, Torben

    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 intervention......, group B, n=1,308) were invited for a health examination, an assessment of absolute risk of developing IHD, and an individualized lifestyle intervention. The participation rate was 52.5%. High-risk persons in group A were also offered diet/physical activity and/or smoking cessation group counselling...... OUTCOME: Change in physical activity from baseline to 12-and 36-month follow-up. RESULTS: In men, the high-intensity (group A)intervention had a beneficial effect at 12-month follow-up, whereas after 36 months both the high-intensity and the low-intensity (group B) intervention had a beneficial effect on...

  1. Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention

    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...

  2. Effectiveness of preventive family intervention in improving cognitive attributions among children of depressed parents: a randomized study.

    Punamäki, Raija-Leena; Paavonen, Juulia; Toikka, Sini; Solantaus, Tytti

    2013-08-01

    Our randomized trial examined the effectiveness of preventive interventions in increasing positive cognitive attributions and reducing negative cognitive attributions in children of depressed parents. In addition, it tested the role of attribution changes in mediating the intervention effects on children's depressive and emotional symptoms. The participants were 109 Finnish families with at least one parent in treatment for affective disorder, for a total of 145 children, 8-16 years of age. Families were randomized into two groups: the "family talk intervention" (FTI, a whole-family approach enhancing communication and child resilience, Beardslee et al., 1997) group, and an active control, the "let's talk about the children" (LTC, a parent-only psycho-educational approach, Solantaus, Paavonen, Toikka, & Punamäki, 2010) group. Children reported their cognitive attributions (CASQ-R, Children's Attributional Style Questionnaire-Revised (Thompson, Kaslow, Weiss, & Nolen-Hoeksema, 1998)), depressive (CDI/BDI, Child Depression Inventory (Kovacs, 1981)/Beck Depression Inventory (Beck, Steer, & Garbin, 1988)) and emotional (SDQ, Strengths and Difficulties Questionnaire (Goodman, 1997)) symptoms, and mothers reported their children's emotional symptoms (SDQ at baseline (T1) and 10-month (T2) and 18-month (T3)) follow-ups. Contrary to our hypothesis, no beneficial attribution changes were found in the FTI group across the follow-ups. Instead, positive cognitive appraisals increased in the LTC group, especially from T2 to T3. The increase of positive attribution further served as a mediator for changes in children's emotional and depressive symptoms. The findings suggest that a short preventive intervention can enhance beneficial cognitive processes in high-risk families in routine adult psychiatric care. PMID:23978323

  3. An online guided ACT intervention for enhancing the psychological wellbeing of university students: A randomized controlled clinical trial.

    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

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

    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

  5. A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

    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"…

  6. A Parent-Mediated Intervention to Increase Responsive Parental Behaviors and Child Communication in Children with ASD: A Randomized Clinical Trial

    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…

  7. A Comprehensive Peer Network Intervention to Improve Social Communication of Children with Autism Spectrum Disorders: A Randomized Trial in Kindergarten and First Grade

    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…

  8. Diet and Exercise Interventions among Overweight and Obese Lactating Women: Randomized Trial of Effects on Cardiovascular Risk Factors

    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...

  9. Nutritional counselling in primary health care: a randomized comparison of an intervention by general practitioner or dietician

    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...

  10. Cost-effectiveness of a workplace intervention for sick-listed employees with common mental disorders: design of a randomized controlled trial

    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 ...

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

    Prick, A.J.C.; Lange, J.; 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 has been shown to be effective for people with dementia in the US. Patients and methods: People with dementia living in the community and their family caregivers (N=111 caregiver-care recipient dy...

  12. Pilot Cluster Randomized Controlled Trials to Evaluate Adoption of Water, Sanitation, and Hygiene Interventions and Their Combination in Rural Western Kenya

    Christensen, Garret; Dentz, Holly N; Pickering, Amy J.; Bourdier, Tomoé; Arnold, Benjamin F.; Colford, John M; Null, Clair

    2015-01-01

    In preparation for a larger trial, the Water, Sanitation, and Hygiene (WASH) Benefits pilot study enrolled 72 villages and 499 subjects in two closely related randomized trials of WASH interventions in rural western Kenya. Intervention households received hardware and promotion for one of the following: water treatment, sanitation and latrine improvements, handwashing with soap, or the combination of all three. Interventions were clustered by village. A follow-up survey was conducted 4 months...

  13. Evidence of Improvement in Various Impairments by Exercise Interventions in Patients with Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Clinical Trials

    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...

  14. Effectiveness of an intervention to reduce sickness absence in patients with emotional distress or minor mental disorders: a randomized controlled effectiveness trial.

    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...

  15. Feasibility randomized controlled trial of cognitive and behavioral interventions for depression symptoms in patients accessing drug and alcohol treatment.

    Delgadillo, Jaime; Gore, Stuart; Ali, Shehzad; Ekers, David; Gilbody, Simon; Gilchrist, Gail; McMillan, Dean; Hughes, Elizabeth

    2015-08-01

    Depressed mood often co-exists with frequent drug and alcohol use. This trial examined the feasibility of screening, recruitment, randomization and engagement of drug and alcohol users in psychological interventions for depression symptoms. A total of 50 patients involved in community drugs and alcohol treatment (CDAT) were randomly allocated to behavioral activation delivered by psychological therapists (n = 23) or to cognitive behavioral therapy based self-help introduced by CDAT workers (n = 27). We examined recruitment and engagement rates, as well as changes in depression (PHQ-9) symptoms and changes in percent days abstinent (PDA within last month) at 24 weeks follow-up. The ratio of screened to recruited participants was 4 to 1, and the randomization schedule successfully generated 2 groups with comparable characteristics. Follow-up was possible with 78% of participants post-treatment. Overall engagement in psychological interventions was low; only 42% of randomized participants attended at least 1 therapy session. Patients offered therapy appointments co-located in CDAT clinics were more likely to engage with treatment (odds ratio = 7.14, p = .04) compared to those offered appointments in community psychological care clinics. Intention-to-treat analyses indicated no significant between-group differences at follow-up in mean PHQ-9 change scores (p = .59) or in PDA (p = .08). Overall, it was feasible to conduct a pragmatic trial within busy CDAT services, maximizing external validity of study results. Moderate and comparable improvements in depression symptoms over time were observed for participants in both treatment groups. PMID:25819701

  16. Positive Psychology Intervention to Alleviate Child Depression and Increase Life Satisfaction: A Randomized Clinical Trial

    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…

  17. Randomization to nutritional intervention at home did not improve postoperative function, fatigue or well-being

    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...

  18. Social Learning Theory Parenting Intervention Promotes Attachment-Based Caregiving in Young Children: Randomized Clinical Trial

    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. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    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...

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

    Harder-Lauridsen, Nina Majlund; Birk, Nina Marie; Ried-Larsen, Mathias; Juul, Anders; Andersen, Lars Bo; Pedersen, Bente Klarlund; Krogh-Madsen, Rikke

    2014-01-01

    allocated to an intervention group (n = 19) or a control group (n = 19). Anthropometric assessment, whole body dual-energy X-ray absorptiometry scan, two hours oral glucose tolerance test, steps measured by pedometer, and fitness tests were measured at baseline and at 20 weeks. RESULTS: Thirty......-seven children (30 girls) participated at baseline, aged 8.7 ± 0.9 years with a BMI of 21.8 ± 3.7 kg/m2 (mean ± SD), and 36 children completed the study. The intervention group decreased their BMI (the intervention effect is the difference in change between the groups adjusted for the respective baseline values......-to-height ratio (WHtR) (all three variables; P <0.001), area under curve for plasma insulin (P <0.05), and increased mean and minimum steps/day (P <0.05 and P <0.01, respectively). CONCLUSIONS: The multicomponent intervention had significant favorable effects on BMI, weight, WHtR, mean and minimum steps/day, and...

  1. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

    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

  2. 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

    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 ...

  3. Economic Intervention and Parenting: A Randomized Experiment of Statewide Child Development Accounts

    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)…

  4. Nutrition Education among Low-Income Older Adults: A Randomized Intervention Trial in Congregate Nutrition Sites

    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…

  5. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

  6. A Randomized Trial of an Elementary School Mathematics Software Intervention: Spatial-Temporal Math

    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…

  7. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent Versus Sequential Intervention.

    Spring, Bonnie; Pagoto, Sherry; Pingitore, Regina; Doran, Neal; Schneider, Kristin; Hedeker, Don

    2004-01-01

    The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

  8. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

    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

  9. A randomized controlled trial of a web-based psychological intervention for patients under treatment for chronic HIV infection

    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

  10. An outreach intervention to implement evidence based practice in residential care: a randomized controlled trial [ISRCTN67855475

    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

  11. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    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

  12. Promoting Physical Activity in Patients with Colon Adenomas: A Randomized Pilot Intervention Trial

    Wolin, Kathleen Y.; Fagin, Casey; James, Aimee S.; Early, Dayna S.

    2012-01-01

    Background Physical activity decreases risk of colon polyps and colon cancer and might reduce risk of colon cancer recurrence. Focusing on recent calls for translation of epidemiologic evidence into clinical care, our pilot study delivered an evidence-based physical activity intervention in adults with polyps, who are thus at elevated risk of developing colon cancer. The objective was to evaluate change in physical activity, measured by steps per day and minutes of moderate/vigorous physical ...

  13. Reducing occupational stress with a B-vitamin focussed intervention: a randomized clinical trial: study protocol

    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 ...

  14. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study

    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...

  15. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol

    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...

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

    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...

  17. Are There Benefits from Teaching Yoga at Schools? A Systematic Review of Randomized Control Trials of Yoga-Based Interventions

    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.

  18. Optimizing foster family placement for infants and toddlers: A randomized controlled trial on the effect of the foster family intervention.

    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

  19. Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial.

    Begeer, Sander; Howlin, Patricia; Hoddenbach, Elske; Clauser, Cassandra; Lindauer, Ramon; Clifford, Pamela; Gevers, Carolien; Boer, Frits; Koot, Hans M

    2015-12-01

    Limited perspective taking or "Theory of Mind" (ToM) abilities are a core deficit of autism, and many interventions are aimed to improve ToM abilities. In this study, we investigated the effectiveness of a ToM treatment for children with autism spectrum disorders (ASD) and, for the first time, the moderating roles of social interaction style (SIS) and disruptive behavior (DB), to determine which children are most likely to respond to this intervention. The trial protocol is registered at www.trialregister.nl, trial number 2327 and published before the data collection was finished (www.trialsjournal.com). Children with autism aged 7-12 years (n = 97) were randomized over a waitlist control or a treatment condition. Outcome measures included ToM and emotion understanding, parent and teacher questionnaires on children's social skills, ToM-related social behavior, and autistic traits. Six-month follow-up parent reported data were collected for the treatment group. The treatment had a positive effect on ToM understanding, parent-reported ToM behavior, and autistic traits, but not on parent or teacher-reported social behavior. Passive SIS was associated with diminished treatment effects on autistic traits, but DB was unrelated to outcomes. The ToM intervention improved conceptual social understanding and ToM-related behavior of children with ASD. However, broader application of learned skills to other domains of functioning was limited. Individual differences with regard to treatment response are discussed. PMID:25847054

  20. Randomized controlled trial to test the RHANI Wives HIV intervention for women in India at risk for HIV from husbands.

    Raj, Anita; Saggurti, Niranjan; Battala, Madhusudana; Nair, Saritha; Dasgupta, Anindita; Naik, D D; Abramovitz, Daniela; Silverman, Jay G; Balaiah, Donta

    2013-11-01

    This study involved evaluation of the short-term impact of the RHANI Wives HIV intervention among wives at risk for HIV from husbands in Mumbai, India. A two-armed cluster RCT was conducted with 220 women surveyed on marital sex at baseline and 4-5 month follow-up. RHANI Wives was a multisession intervention focused on safer sex, marital communication, gender inequities and violence; control participants received basic HIV prevention education. Generalized linear mixed models were conducted to assess program impact, with cluster as a random effect and with time, treatment group, and the time by treatment interaction as fixed effects. A significant time by treatment effect on proportion of unprotected sex with husband (p = 0.01) was observed, and the rate of unprotected sex for intervention participants was lower than that of control participants at follow-up (RR = 0.83, 95 % CI = 0.75, 0.93). RHANI Wives is a promising model for women at risk for HIV from husbands. PMID:23921584

  1. The effectiveness of a web-based self-help intervention to reduce suicidal thoughts: A randomized controlled trial

    Kerkhof Ad JFM

    2010-03-01

    Full Text Available Abstract Background Suicide, attempted suicide and suicidal thoughts are major public health problems worldwide. Effective face-to-face treatments are Cognitive Behavioural Therapy (CBT, Dialectical Behavioural Therapy (DBT and Problem Solving Treatment (PST. However, about two-thirds of persons who die by suicide have not been in contact with mental health care services in the preceding year, and many have never been treated. Furthermore, many patients do not disclose their suicidal thoughts to their care provider. This may be out of shame, due to fear of stigma or due to lack of trust in (mental health care. Since many suicidal individuals seek information online, the internet provides an opportunity to reach suicidal individuals who would not be contacted otherwise. By providing a self-help intervention online, persons can anonymously learn to gain control over their suicidal thoughts. There is convincing evidence that self-help is effective for a number of mental disorders. In this study the effectiveness for suicidal thoughts is examined. Methods/Design In this study, a recently developed self-help intervention will be evaluated in a Randomized Controlled Trial. The intervention is based on Cognitive Behavioural Therapy and is aimed at subjects who experience mild to moderate suicidal thoughts. This is defined as a score between 1 and 26 on the Beck Scale for Suicidal Ideation (BSS. Higher and lower scores are excluded. In addition, severely depressed subjects are excluded. In total, 260 subjects will be randomly allocated to the intervention-condition (N = 130 or to the information-control condition (N = 130. Self-report questionnaires will be filled out at baseline, 6 weeks after baseline and 18 weeks after baseline. Primary outcome measure is the reduction in frequency and intensity of suicidal thoughts. Secondary outcome measures are the reduction of hopelessness, anxiety and depression, sleeplessness, worry and quality of life measures

  2. Multisystemic engagement & nephrology based educational intervention: a randomized controlled trial protocol on the kidney team at home-study

    Ismail Sohal Y

    2012-07-01

    Full Text Available Abstract Background Living donor kidney transplantation (LDKT is the most successful form of renal replacement therapy in terms of wait time and survival rates. However, we observed a significant inequality in the number of LDKT performed between the Dutch and the non-Dutch patients. The objective of this study is to adapt, implement and test an educational home-based intervention to contribute to the reduction of this inequality. Our aim is to establish this through guided communication together with the social network of the patients in an attempt that well-informed decisions regarding renal replacement therapy can be made: Multisystemic Engagement & Nephrology. This manuscript is a detailed description of the Kidney Team At Home-study protocol. Methods and design All patients (>18 yrs that are referred to the pre-transplantation outpatient clinic are eligible to participate in the study. Patients will be randomly assigned to either an experimental or a control group. The control group will continue to receive standard care. The experimental group will receive standard care plus a home-based educational intervention. The intervention consists of two sessions at the patient’s home, an initial session with the patient and a second session for which individuals from their social network are invited to take part. Based on the literature and behavioural change theories we hypothesize that reducing hurdles in knowledge, risk perception, subjective norm, self-efficacy, and communication contribute to well-informed decision making and reducing inequality in accessing LDKT programs. A change in these factors is consequently our primary outcome-measure. Based on power calculations, we aim to include 160 patients over a period of two years. Discussion If we are able to show that this home-based group educational intervention contributes to 1 achieving well-informed decision regarding treatment and 2 reducing the inequality in LDKT, the quality of life

  3. Impact of prenatal education on maternal utilization of analgesic interventions at future infant vaccinations: a cluster randomized trial.

    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

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

    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.

  5. Reducing School Mobility: A Randomized Trial of a Relationship-Building Intervention

    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...

  6. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    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...

  7. A Randomized Trial of Brief Interventions for Problem and Pathological Gamblers

    Petry, Nancy M.; Weinstock, Jeremiah; Ledgerwood, David; Morasco, Benjamin

    2008-01-01

    Limited research exists regarding methods for reducing problem gambling. Problem gamblers (N=180) were randomly assigned to: assessment only control, 10 minutes of Brief Advice, 1 session of motivational enhancement therapy (MET), or 1 session of MET plus 3 sessions of cognitive-behavioral therapy (CBT). Gambling was assessed at baseline, 6 weeks later, and a 9-month follow-up. Relative to assessment only, Brief Advice was the only condition that significantly decreased gambling between basel...

  8. Nutritional Online Information for Cancer Patients: a Randomized Trial of an Internet Communication Plus Social Media Intervention.

    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

  9. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

    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.

  10. Effects of exercise intervention in breast cancer survivors: a meta-analysis of 33 randomized controlled trails

    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

  11. Trichloroethylene and trichloroethanol-induced formic aciduria and renal injury in male F-344 rats following 12 weeks exposure

    Trichloroethylene (TCE) is widely used as a cleaning and decreasing agent and has been shown to cause liver tumours in rodents and a small incidence of renal tubule tumours in male rats. The basis for the renal tubule injury is believed to be related to metabolism of TCE via glutathione conjugation to yield the cysteine conjugate that can be activated by the enzyme cysteine conjugate β-lyase in the kidney. More recently TCE and its major metabolite trichloroethanol (TCE-OH) have been shown to cause formic aciduria which can cause renal injury after chronic exposure in rats. In this study we have compared the renal toxicity of TCE and TCE-OH in rats to try and ascertain whether the glutathione pathway or formic aciduria can account for the toxicity. Male rats were given TCE (500 mg/kg/day) or TCE-OH at (100 mg/kg/day) for 12 weeks and the extent of renal injury measured at several time points using biomarkers of nephrotoxicity and prior to termination assessing renal tubule cell proliferation. The extent of formic aciduria was also determined at several time points, while renal pathology and plasma urea and creatinine were determined at the end of the study. TCE produced a very mild increase in biomarkers of renal injury, total protein, and glucose over the first two weeks of exposure and increased Kim-1 and NAG in urine after 1 and 5 weeks exposure, while TCE-OH did not produce a consistent increase in these biomarkers in urine. However, both chemicals produced a marked and sustained increase in the excretion of formic acid in urine to a very similar extent. The activity of methionine synthase in the liver of TCE and TCE-OH treated rats was inhibited by about 50% indicative of a block in folate synthesis. Both renal pathology and renal tubule cell proliferation were reduced after TCE and TCE-OH treatment compared to controls. Our findings do not clearly identify the pathway which is responsible for the renal toxicity of TCE but do provide some support for

  12. A randomized, home-based, childhood obesity intervention delivered by patient navigators

    Yun, Lourdes; Boles, Richard E.; Haemer, Matthew A.; Knierim, Shanna; Dickinson, L. Miriam; Mancinas, Heather; Hambidge, Simon J.; Davidson, Arthur J.

    2015-01-01

    Background Although Colorado is perceived as a healthy state, in 2010, 14.1 % of children aged 2–5 were overweight and 9.1 % were obese. Despite the high prevalence of obesity in this population, evidence to support particular strategies to treat obese preschoolers is lacking. The efficacy of home-based, childhood obesity interventions to reduce a child’s body mass index is inconclusive. However, this model uniquely provides an opportunity to observe and intervene with the home food and activ...

  13. Protocol of a randomized controlled trial of sun protection interventions for operating engineers

    Duffy, Sonia A.; Ronis, David L.; Waltje, Andrea H.; Choi, Seung Hee

    2013-01-01

    Background Skin cancer are increasing and some types of skin cancer are among the most lethal cancers yet are easily preventable. However, sun protection interventions are rarely implemented among outdoor workers. Our prior work shows that Michigan Operating Engineers (heavy equipment operators) spend an average of 4–5 hours in the sun, about one-third reported getting sun burned at least once a summer, and over half burned more than once a summer. About three-quarters of the sample never or ...

  14. Community-based intervention to improve dietary habits and promote physical activity among older adults: a cluster randomized trial

    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

  15. 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

    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

  16. Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

    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

  17. Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial

    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

  18. Statins in prevention of repeat revascularization after percutaneous coronary intervention--a meta-analysis of randomized clinical trials.

    Zhang, Zhi-Jiang; Cheng, Qi; Jiang, Guo-Xin; Marroquin, Oscar C

    2010-04-01

    Recent prospective cohort studies have shown that patients discharged on statins after percutaneous coronary intervention (PCI) are at lower risks of repeat revascularization and mortality when compared to those not on statins after discharge. However, few randomized clinical trials among post-PCI patients confirmed these beneficial effects. It is needed to evaluate the effects of post-procedural statin therapy on individual clinical outcomes to facilitate the further investigation on identifying the underlying mechanism(s). A meta-analysis of randomized clinical trials was conducted to examine the effects of statin therapy initiated after coronary angioplasty on repeat revascularization, all-cause mortality and myocardial infarction (MI). From relevant reports on Medline (from inception to October 2009), six randomized clinical trials comprising 2979 patients were included. Relative risks were evaluated for pooled data via random effect models. Compared with controls, post-PCI statin therapy was associated with a significantly decreased risk of repeat revascularization (risk ratio (RR)=0.73, 95% confidence interval (CI), 0.55-0.98, p=0.04), nonsignificantly decreased risks of all-cause mortality (RR=0.88, 95% CI, 0.35-2.21, p=0.79), MI (RR=0.76, 95% CI, 0.49-1.18, p=0.23), and target lesion or target vessel revascularization (RR=0.58, 95% CI, 0.24-1.39, p=0.22). In conclusion, statin therapy after PCI can reduce the risk of repeat revascularization. Further investigation is needed to identify the underlying mechanism(s). PMID:19922797

  19. The Efficacy and Safety of Add-on Ginko TD (Ginkgo Biloba Treatment for PTSD: Results of a 12-Week Double-Blind Placebo-Controlled Study

    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

  20. A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy

    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.

  1. Sequential Multiple Assignment Randomized Trial (SMART) to Construct Weight Loss Interventions for African American Adolescents.

    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

  2. A multifaceted workplace intervention for low back pain in nurses' aides

    Nørregaard Rasmussen, Charlotte Diana; Holtermann, Andreas; Bay, Hans;

    2015-01-01

    The present study established the effectiveness of a workplace multi-faceted intervention consisting of participatory ergonomics, physical training and cognitive behavioural training for low back pain. Between November 2012 and May 2014, we conducted a pragmatic stepped-wedge cluster......-randomized controlled trial with 594 workers from eldercare workplaces (nursing homes and home care) randomized to four successive time periods, three months apart. The intervention lasted 12 weeks and consisted of 19 sessions in total (physical training (12 sessions), cognitive behavioural training (2 sessions) and...... participatory ergonomics (5 sessions)). Low back pain was the outcome and was measured as days, intensity (worst pain on a 0-10 numeric rank scale) and bothersomeness (days) by monthly text messages. Linear mixed models were used to estimate the intervention effect. Analyses were performed according to...

  3. Measuring social integration in a pilot randomized controlled trial of critical time: intervention-task shifting in Latin America

    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

  4. Using Behavioral Intervention Technologies to Help Low-Income and Latino Smokers Quit: Protocol of a Randomized Controlled Trial

    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

  5. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial

    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

  6. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    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

  7. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions

    Coronado-Montoya, Stephanie; Levis, Alexander W.; Kwakkenbos, Linda; Steele, Russell J.; Turner, Erick H.; Thombs, Brett D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of “positive” results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. Methods CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. Results 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. Conclusions The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice. PMID:27058355

  8. Effects of Exercise Intervention on Vascular Risk Factors in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial

    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.

  9. A randomized trial examining the effects of parent engagement on early language and literacy: the Getting Ready intervention.

    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

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

    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.

  11. Effects of a brief school-based media literacy intervention on digital media use in adolescents: cluster randomized controlled trial.

    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. PMID:25126888

  12. The Meal Frequency Project : The effect of meal frequency on body composition during 12-weeks of strength training

    2008-01-01

    Abstract Background: Human trials on the effect of meal frequency on body composition are scarce. Short-term studies show increased rate of protein synthesis immediately after intake of amino acids (Rennie 2002), and frequent meals are shown to aid in the preservation of lean body mass when dieting (Iwao 1996). Consequently it could be hypothesised that in response to strength training interventions, more frequent meals will give larger muscle mass accumulation and lower fat mass than fewe...

  13. Mindfulness Intervention for Stress Eating to Reduce Cortisol and Abdominal Fat among Overweight and Obese Women: An Exploratory Randomized Controlled Study

    Elissa Epel; Lori Karan; Margaret Kemeny; Lustig, Robert H.; Margaret Kuwata; Jennifer Daubenmier; Nicole Maninger; Hecht, Frederick M.; Kinnari Jhaveri; Jean Kristeller

    2011-01-01

    Psychological distress and elevated cortisol secretion promote abdominal fat, a feature of the Metabolic Syndrome. Effects of stress reduction interventions on abdominal fat are unknown. Forty-seven overweight/obese women (mean BMI = 31.2) were randomly assigned to a 4-month intervention or waitlist group to explore effects of a mindfulness program for stress eating. We assessed mindfulness, psychological distress, eating behavior, weight, cortisol awakening response (CAR), and abdominal fat ...

  14. Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial

    Rogers, Laura Q.; Courneya, Kerry S.; Anton, Philip M.; Hopkins-Price, Patricia; Verhulst, Steven; Vicari, Sandra K.; Robbs, Randall S.; Mocharnuk, Robert; McAuley, Edward

    2014-01-01

    Most breast cancer survivors (BCS) are not meeting recommended physical activity guidelines. Here, we report the effects of the Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention on physical activity, aerobic fitness, and quality of life (QoL). We randomized 222 post-primary treatment BCS to the 3-month intervention (BEAT Cancer) or usual care (UC). BEAT Cancer combined supervised exercise, face-to-face counseling, and group discussions with taperi...

  15. Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial

    Storm, Vera; Dörenkämper, Julia; Reinwand, Dominique A; Wienert, Julian; Vries, Hein de; Lippke, Sonia

    2016-01-01

    Background Web-based computer-tailored interventions for multiple health behaviors can improve the strength of behavior habits in people who want to reduce their cardiovascular risk. Nonetheless, few randomized controlled trials have tested this assumption to date. Objective The study aim was to test an 8-week Web-based computer-tailored intervention designed to improve habit strength for physical activity and fruit and vegetable consumption among people who want to reduce their cardiovascula...

  16. 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

    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 ...

  17. 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

    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...

  18. 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

    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...

  19. Impact of community-based interventions on maternal and neonatal health indicators: Results from a community randomized trial in rural Balochistan, Pakistan

    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...

  20. Effects of a Phone Call Intervention to Promote Adherence to Antiretroviral Therapy and Quality of Life of HIV/AIDS Patients in Baoshan, China: A Randomized Controlled Trial

    Weibin Zheng; Virasakdi Chongsuvivatwong; Edward McNeil; Rassamee Sangthong; Dongsheng Huang; Xuemei Yang

    2013-01-01

    Background. Suboptimal adherence to antiretroviral therapy (ART) is still pervasive. The effect of using a mobile phone call intervention to improve patient adherence is currently not known. Objective. This study aims to investigate the effects of a phone call intervention on adherence to ART and quality of life (QOL) of treatment-naive and treatment-experienced patients. Methods. A randomized controlled trial was conducted in the three largest public hospitals. Adherence was measured by self...

  1. Randomized Controlled Trial of Nuevo Amanecer: A Peer-delivered Stress Management Intervention for Spanish-speaking Latinas with Breast Cancer

    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...

  2. A participatory physical and psychosocial intervention for balancing the demands and resources among industrial workers (PIPPI): study protocol of a cluster-randomized controlled trial

    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...

  3. Randomized, Blinded Trial Comparing Enoxaparin with Unfractionated Heparin in Patients Undergoing Contemporary Percutaneous Coronary Intervention

    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.

  4. Influence of general self-efficacy as a mediator in Taiji-induced stress reduction : results from a randomized controlled trial

    Nedeljkovic, Marko; Wepfer, Viviane; Ausfeld-Hafter, Brigitte; Wirtz, Petra H.; Streitberger, Konrad M.

    2013-01-01

    Aim of the studyIn this study we examined the effects of Taiji on perceived stress and general self-efficacy (GSE), and investigated the mediating role of a Taiji-induced GSE increase on Taiji-related reduction of perceived stress.Materials and methods70 healthy participants were randomly allocated either to the Taiji intervention group or the waiting list control group. The intervention lasted for 12 weeks comprising two Taiji classes per week. Before, shortly after, and two months after the...

  5. 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.

    George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Rashid, Mahamud-Ur; Mahmud, 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

  6. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    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.

  7. Neurofeedback intervention in fibromyalgia syndrome; a randomized, controlled, rater blind clinical trial.

    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

  8. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    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...

  9. Examining the minimal required elements of a computer-tailored intervention aimed at dietary fat reduction: Results of a randomized controlled dismantling study

    Kroeze, Willemieke; Oenema, Anke; Dagnelie, Pieter; Brug, Hans

    2008-01-01

    textabstractThis study investigated the minimally required feedback elements of a computer-tailored dietary fat reduction intervention to be effective in improving fat intake. In all 588 Healthy Dutch adults were randomly allocated to one of four conditions in an randomized controlled trial: (i) feedback on dietary fat intake [personal feedback (P feedback)], (ii) P feedback and feedback on one's own behavior relative to that of peers [personal-normative feedback (PN feedback)], (iii) PN feed...

  10. Effects of an 8-Month Ashtanga-Based Yoga Intervention on Bone Metabolism in Middle-Aged Premenopausal Women: A Randomized Controlled Study

    SoJung Kim, Michael G. Bemben, Allen W. Knehans, Debra A. Bemben

    2015-01-01

    Although Yoga has the potential to be an alternative physical activity to enhance bone health, there is a lack of high quality evidence for this type of intervention. The purpose of this randomized controlled trial was to examine the effects of a progressive 8-month Ashtanga-based Yoga program on bone turnover markers (BTM), areal bone mineral density (aBMD) and volumetric bone characteristics in premenopausal women. Thirty-four premenopausal women (35-50 years) were randomly assigned either ...

  11. Plasticity of brain networks in a randomized intervention trial of exercise training in older adults

    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.

  12. Non-randomized studies as a source of complementary, sequential or replacement evidence for randomized controlled trials in systematic reviews on the effects of interventions.

    Schünemann, Holger J; Tugwell, Peter; Reeves, Barnaby C; Akl, Elie A; Santesso, Nancy; Spencer, Frederick A; Shea, Beverley; Wells, George; Helfand, Mark

    2013-03-01

    The terms applicability, generalizability, external validity and transferability are related, sometimes used interchangeably and have in common that they lack a clear and consistent definition in the classic epidemiological literature. However, all of these terms generally describe one overarching theme: whether or not available research evidence can be directly utilized to answer the healthcare questions at hand, ideally supported by a judgment about the degree of confidence for this utilization. This concept has been called directness. The objectives of this paper were to delineate how non-randomized studies (NRS) inform judgments in relation to directness and the concepts that it encompasses in the context of systematic reviews. We will briefly review what is known and describe the theoretical and practical issues as well as offer guidance to those tackling the challenges of judging directness and using research evidence to answer healthcare questions with evidence from NRS. In particular, we suggest a framework in which authors can use NRS as a complement, sequence or replacement for randomized controlled trials (RCTs) by focusing on judgments about the population, intervention, comparison and outcomes. Authors of systematic reviews will use NRS to complement judgments about the inconsistencies, the rationale and credibility of subgroup analysis, the baseline risk estimates for the determination of absolute benefits and downsides, and the directness of surrogate outcomes. This evidence includes contextual or supplementary evidence. Authors of systematic review and other summaries of the evidence use NRS as sequential evidence to provide evidence when insufficient evidence is available for an outcome from RCTs, but NRS evidence is available (e.g., long-term harms). Use of evidence from NRS may also serve to replace RCT evidence when NRS provide equivalent (or potentially higher) confidence in the evidence (i.e. quality) compared to indirect evidence from RCTs

  13. Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP)

    Vinter, C A; Jørgensen, J S; Ovesen, P;

    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...... gestational 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...

  14. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points - a randomized intervention study

    Myburgh, Corrie; Hartvigsen, Jan; Aagaard, Per;

    2012-01-01

    ABSTRACT: BACKGROUND: In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study explored muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes......-intervention and 48 hours post-intervention. Symptomatic and asymptomatic participant groups were each randomized into two treatment sub-groups (superficial (SDN) and deep dry needling (DDN)) after baseline testing. At 48 hours post-intervention participants were asked whether delayed onset muscle soreness (DOMS) and...... or intervention (p=0.001). CONCLUSIONS: In selected female neck/shoulder pain sufferers, maximum voluntary contraction and rapid force generation of the upper Trapezius was not influenced by clinically relevant self-reported pain or the presence of diagnostically relevant MFTrPs. Dry needling, deep or superficial...

  15. Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial.

    Carey, Michael P; Senn, Theresa E; Coury-Doniger, Patricia; Urban, Marguerite A; Vanable, Peter A; Carey, Kate B

    2013-09-01

    Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. PMID:23816489

  16. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  17. Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial

    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.

  18. A community-integrated home based depression intervention for older African Americans: descripton of the Beat the Blues randomized trial and intervention costs

    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

  19. 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

    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

  20. 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

    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

  1. 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

    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

  2. Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol

    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

  3. Irisin and FNDC5: effects of 12-week strength training, and relations to muscle phenotype and body mass composition in untrained women

    Ellefsen, Stian; Vikmoen, Olav; Slettaløkken, Gunnar; Whist, Jon Elling; Nygård, Håvard; Hollan, Ivana; Rauk, Irene; Vegge, Geir; Strand, Tor A.; Raastad, Truls; Rønnestad, Bent

    2014-01-01

    Purpose: To investigate the effects of strength training on abundances of irisin-related biomarkers in skeletal muscle and blood of untrained young women, and their associations with body mass composition, muscle phenotype and levels of thyroid hormones. Methods: Eighteen untrained women performed 12 weeks of progressive whole-body heavy strength training, with measurement of strength, body composition, expression of irisin-related genes (FNDC5 and PGC1α) in two different skeletal muscles,...

  4. 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

    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...

  5. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers

    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...

  6. A cross-cultural comparison of the development of the social smile: a longitudinal study of maternal and infant imitation in 6- and 12-week-old infants.

    Wörmann, Viktoriya; Holodynski, Manfred; Kärtner, Joscha; Keller, Heidi

    2012-06-01

    Social smiling is universally regarded as being an infant's first facial expression of pleasure. Underlying co-constructivist emotion theories are the assumptions that the emergence of social smiling is bound to experiences of face-to-face interactions with caregivers and the impact of two developmental mechanisms--maternal and infant imitation. We analyzed mother-infant interactions from two different socio-cultural contexts and hypothesized that cross-cultural differences in face-to-face interactions determine the occurrence of both of these mechanisms and of the frequency of social smiling by 12-week-old infants. Twenty mother-infant dyads from a socio-cultural community with many face-to-face interactions (German families, Münster) were compared with 24 mother-infant dyads from a socio-cultural community with few such interactions (rural Nso families, Cameroon) when the infants were aged 6 and 12 weeks. When infants were 6 weeks old, mothers and their infants from both cultural communities smiled at each other for similar (albeit very short) amounts of time and used imitated each other's smiling similarly rarely. In contrast, when infants were 12 weeks old, mothers and their infants from Münster smiled at and imitated each other more often than did Nso mothers and their infants. PMID:22721734

  7. A Comparison of 12 Weeks of Pilates and Aquatic Training on the Dynamic Balance of Women with Mulitple Sclerosis

    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.

  8. 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

    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

  9. The effectiveness of family interventions in preventing adolescent illicit drug use: A systematic review and meta-analysis of randomized controlled trials

    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

  10. A School-Randomized Clinical Trial of an Integrated Social-Emotional Learning and Literacy Intervention: Impacts after 1 School Year

    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…

  11. The Efficacy of Web-Based and Print-Delivered Computer-Tailored Interventions to Reduce Fat Intake: Results of a Randomized, Controlled Trial

    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.…

  12. The PEDALS Stationary Cycling Intervention and Health-Related Quality of Life in Children with Cerebral Palsy: A Randomized Controlled Trial

    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…

  13. A Randomized Study of a Literacy-Integrated Science Intervention for Low-Socio-Economic Status Middle School Students: Findings from First-Year Implementation

    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…

  14. Experimental Evidence for Differential Susceptibility: Dopamine D4 Receptor Polymorphism (DRD4 VNTR) Moderates Intervention Effects on Toddlers' Externalizing Behavior in a Randomized Controlled Trial

    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…

  15. Differential Susceptibility to Early Literacy Intervention in Children with Mild Perinatal Adversities: Short- and Long-Term Effects of a Randomized Control Trial

    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…

  16. Effectiveness of an intervention to reduce sickness absence in patients with emotional distress or minor mental disorders: a randomized controlled effectiveness trial.

    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

  17. The Impact of Two Workplace-Based Health Risk Appraisal Interventions on Employee Lifestyle Parameters, Mental Health and Work Ability: Results of a Randomized Controlled Trial

    Addley, K.; Boyd, S.; Kerr, R.; McQuillan, P.; Houdmont, J.; McCrory, M.

    2014-01-01

    Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental…

  18. Effects of Different Dietary Interventions on Blood Pressure: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Gay, Hawkins C; Rao, Shreya G; Vaccarino, Viola; Ali, Mohammed K

    2016-04-01

    Previous studies have shown beneficial effects of individual dietary approaches for blood pressure (BP) control, but their relative effectiveness is not well established. We performed a systematic review of published dietary pattern interventions and estimated the aggregate BP effects through meta-analysis. PubMed, EMBASE, and Web of Science databases were searched to identify studies published between January 1, 1990 and March 1, 2015. Studies meeting specific inclusion and exclusion criteria were selected. Data were pooled using random effects meta-analysis models. Twenty-four trials with 23 858 total participants were included. The overall pooled net effect of dietary intervention on systolic BP and diastolic BP was -3.07 mm Hg (95% confidence interval, -3.85 to -2.30) and -1.81 mm Hg (95% confidence interval, -2.24 to -1.38), respectively. The Dietary Approaches to Stop Hypertension diet had the largest net effect (systolic BP, -7.62 mm Hg [95% confidence interval, -9.95 to -5.29] and diastolic BP, -4.22 mm Hg [95% confidence interval, -5.87 to -2.57]). Low-sodium; low-sodium, high-potassium; low-sodium, low-calorie; and low-calorie diets also led to significant systolic and diastolic BP reductions, whereas Mediterranean diet participants experienced a significant incremental reduction in diastolic but not systolic BP. Subgroup analysis also showed important variations in effectiveness based on duration, size, and participant demographics. In conclusion, dietary modifications are associated with clinically meaningful, though variable, reductions in BP. Some diets are more effective than others and under different circumstances, which has important implications from both clinical and public health perspectives. PMID:26902492

  19. Metabolomics reveals the metabolic shifts following an intervention with rye bread in postmenopausal women- a randomized control trial

    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.

  20. Alcohol-related brief intervention in patients treated for opiate or cocaine dependence: a randomized controlled study

    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.

  1. E-learning interventions are comparable to user's manual in a randomized trial of training strategies for the AGREE II

    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.

  2. Diet and exercise interventions among overweight and obese lactating women: randomized trial of effects on cardiovascular risk factors.

    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.

  3. Comparison of Intervention Fidelity between COPE TEEN and an Attention-Control Program in a Randomized Controlled Trial

    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…

  4. A daily physical activity and diet intervention for individuals with type 2 diabetes mellitus: a randomized controlled trial

    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.

  5. Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

    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

  6. The Effect of Educational-Spiritual Intervention on The Burnout of The Parents of School Age Children with Cancer: A Randomized Controlled Clinical Trial

    Nooshin Beheshtipour

    2016-01-01

    Full Text Available 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 collected through SMBQ (Shirom and Melamed Burnout Questionnaire from both groups, before, immediately after and one month after the intervention. Educational-spiritual programs were held for six weeks, one session every week. The data were analyzed by SPSS using independent t-test, and repeated measure ANOVA. Results: The results showed that the mean burnout score before the intervention in the intervention group was 4.28±0.61 and in the control group it was 4.23±0.50; most of the parents reported moderate to high burnout. But, there was a significant difference between the intervention and control groups immediately after and one month after the intervention (t=10.16, P<0.0001. The mean burnout score in the intervention group was less than the control group. Results also showed that there was a significant difference between the two groups in terms of parental burnout in three times of measurements (F=58.62, P<0.0001. Conclusion: This study indicated that educational-spiritual intervention was effective on reduction of the burnout of the parents of the children with cancer. Due to high burnout of most of the parents, offering such a program could be beneficial for them. More studies in this regard are recommended.

  7. Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

    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

  8. Evaluation of the UP4FUN intervention: a cluster randomized trial to reduce and break up sitting time in European 10-12-year-old children.

    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.

  9. Psychological and behavioral interventions to reduce HIV risk: evidence from a randomized control trial among orphaned and vulnerable adolescents in South Africa.

    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

  10. Effects of Price, Information, and Transactions Cost Interventions to Raise Voluntary Enrollment in a Social Health Insurance Scheme: A Randomized Experiment in the Philippines.

    Capuno, Joseph J; Kraft, Aleli D; Quimbo, Stella; Tan, Carlos R; Wagstaff, Adam

    2016-06-01

    A cluster randomized experiment was undertaken testing two sets of interventions encouraging enrollment in the Individually Paying Program (IPP), the voluntary component of the Philippines' social health insurance program. In early 2011, 1037 unenrolled IPP-eligible families in 179 randomly selected intervention municipalities were given an information kit and offered a 50% premium subsidy valid until the end of 2011; 383 IPP-eligible families in 64 control municipalities were not. In February 2012, the 787 families in the intervention sites who were still IPP-eligible but had not enrolled had their vouchers extended, were resent the enrollment kits and received SMS reminders. Half the group also received a 'handholding' intervention: in the endline interview, the enumerator offered to help complete the enrollment form, deliver it to the insurer's office in the provincial capital, and mail the membership cards. The main intervention raised the enrollment rate by 3 percentage points (ppts) (p = 0.11), with an 8 ppt larger effect (p travel time to the insurance office affecting enrollment. The handholding intervention raised enrollment by 29 ppts (p effect (p travel times, and higher education levels facilitating unaided completion of the enrollment form. Copyright © The World Bank Health Economics © 2015 John Wiley & Sons, Ltd. PMID:26620394

  11. Effectiveness of a randomized school-based intervention involving families and teachers to prevent excessive weight gain among adolescents in Brazil.

    Diana B Cunha

    Full Text Available OBJECTIVE: To evaluate the effectiveness of a school-based intervention involving the families and teachers that aimed to promote healthy eating habits in adolescents; the ultimate aim of the intervention was to reduce the increase in body mass index (BMI of the students. DESIGN: Paired cluster randomized school-based trial conducted with a sample of fifth graders. SETTING: Twenty classes were randomly assigned into either an intervention group or a control group. PARTICIPANTS: From a total of 574 eligible students, 559 students participated in the study (intervention: 10 classes with 277 participants; control: 10 classes with 282 participants. The mean age of students was 11 years. INTERVENTION: Students attended 9 nutritional education sessions during the 2010 academic year. Parents/guardians and teachers received information on the same subjects. MAIN OUTCOME MEASUREMENT: Changes in BMI and percentage of body fat. RESULTS: Intention-to-treat analysis showed that changes in BMI were not significantly different between the 2 groups (β = 0.003; p = 0.75. There was a major reduction in the consumption of sugar-sweetened beverages and cookies in the intervention group; students in this group also consumed more fruits. CONCLUSION: Encouraging the adoption of healthy eating habits promoted important changes in the adolescent diet, but this did not lead to a reduction in BMI gain. Strategies based exclusively on the quality of diet may not reduce weight gain among adolescents. TRIAL REGISTRATION: Clinicaltrials.gov NCT01046474.

  12. Long Term Follow-Up after a Randomized Integrated Educational and Psychosocial Intervention in Patient-Partner Dyads Affected by Heart Failure.

    Maria Liljeroos

    Full Text Available To date, contemporary heart failure care remains patient-focused, but awareness of the partners' and families' situation is increasing. Randomized studies have mainly evaluated the short-term effects of dyadic interventions. Therefore, the aim of this study was to determine the 24-month effects of an intervention with psych-educational support in dyads of heart failure patients and their partners.This study used a randomized study design and 155 patient-partner dyads were enrolled. The intervention included a nurse-led program of three sessions addressing psychoeducational support.The intervention did not have any effect on health, depressive symptoms or perceived control among the patient-partner dyads after 24 months. Furthermore, time to first event did not differ significantly between the intervention group and the control patients.This study may be regarded as a first step in trying to understand dyads' need for supportive care. Individualized and more targeted interventions seem necessary to achieve a higher impact on dyad outcomes.ClinicalTrials.gov NCT02398799.

  13. Telaprevir-based triple-therapy in patients with chronic hepatitis C in Germany: a 12-week interim analysis of real-life data

    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

  14. Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania.

    Bachanas, Pamela; Kidder, Daniel; Medley, Amy; Pals, Sherri L; Carpenter, Deborah; Howard, Andrea; Antelman, Gretchen; DeLuca, Nicolas; Muhenje, Odylia; Sheriff, Muhsin; Somi, Geoffrey; Katuta, Frieda; Cherutich, Peter; Moore, Janet

    2016-09-01

    We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes. PMID:26995678

  15. Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania

    Kidder, Daniel; Medley, Amy; Pals, Sherri L.; Carpenter, Deborah; Howard, Andrea; Antelman, Gretchen; DeLuca, Nicolas; Muhenje, Odylia; Sheriff, Muhsin; Somi, Geoffrey; Katuta, Frieda; Cherutich, Peter; Moore, Janet

    2016-01-01

    We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes. PMID:26995678

  16. Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.

    Groessl, Erik J; Schmalzl, Laura; Maiya, Meghan; Liu, Lin; Goodman, Debora; Chang, Douglas G; Wetherell, Julie L; Bormann, Jill E; Atkinson, J Hamp; Baxi, Sunita

    2016-05-01

    Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans. PMID:27103548

  17. Multisensory Stimulation as an Intervention Strategy for Elderly Patients With Severe Dementia: A Pilot Randomized Controlled Trial.

    Sánchez, Alba; Marante-Moar, M Pilar; Sarabia, Carmen; de Labra, Carmen; Lorenzo, Trinidad; Maseda, Ana; Millán-Calenti, José Carlos

    2016-06-01

    The objective of this study was to compare the effect of multisensory stimulation environment (MSSE) and one-to-one activity sessions in the symptomatology of elderly individuals with severe dementia. Thirty-two participants were randomly assigned to the following 3 groups: MSSE, activity, and control group. The MSSE and activity groups participated in two 30-minute weekly sessions over 16 weeks. Pre-, mid-, and posttrial; 8-week follow-up behavior; mood; cognitive status; and dementia severity were registered. Patients in the MSSE group demonstrated a significant improvement in the Neuropsychiatric Inventory and Bedford Alzheimer Nursing Severity Scale scores compared with the activity group. Both MSSE and activity groups showed an improvement during the intervention in the Cohen-Mansfield Agitation Inventory aggressive behavior factor and total score, with no significant differences between groups. The MSSE may have better effects on neuropsychiatric symptoms and dementia severity in comparison with one-to-one activity sessions in patients with severe dementia. PMID:26631687

  18. Brief Client-Centered Motivational and Behavioral Intervention to Promote HPV Vaccination in a Hard-to-Reach Population: A Pilot Randomized Controlled Trial.

    Joseph, Natalie Pierre; Bernstein, Judith; Pelton, Steve; Belizaire, Myrdell; Goff, Ginette; Horanieh, Nour; Freund, Karen M

    2016-08-01

    Objective To evaluate the impact of a client-centered behavioral intervention (Brief Negotiated Interviewing) on mothers' human papillomavirus (HPV) vaccine knowledge and vaccination initiation for their adolescent daughters. Methods We randomized mothers to intervention (n = 100) and control (n = 100) groups, and followed them over 12 months. Electronic medical records were reviewed to determine vaccination status. The primary outcome was receipt of the first vaccine. The secondary outcome was HPV vaccine knowledge among mothers. Results Brief Negotiated Interviewing intervention mothers demonstrated increased knowledge about HPV (pre/post mean score of 5 to 10 out of a possible 11; P vaccine were not significantly different between groups. Conclusions Increasing HPV vaccine knowledge did not translate into increased vaccine uptake or completion of vaccination series. Future intervention must explore vaccine reminders to increase HPV vaccination rates. PMID:26968631

  19. A comprehensive peer network intervention to improve social communication of children with autism spectrum disorders: a randomized trial in kindergarten and first grade.

    Kamps, Debra; Thiemann-Bourque, Kathy; Heitzman-Powell, Linda; Schwartz, Ilene; Rosenberg, Nancy; Mason, Rose; Cox, Suzanne

    2015-06-01

    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 children participated in a comparison group. Results showed children in the intervention group displayed significantly more initiations to peers than did the comparison group during non-treatment social probes and generalization probes. Treatment session data showed significant growth for total communications over baseline levels. Children in treatment also showed more growth in language and adaptive communication. Finally, teachers' ratings of prosocial skills revealed significantly greater improvements for the intervention group. PMID:25510450

  20. Two-year Results From a Randomized Comparison of Everolimus-eluting and Sirolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV Trial). Featured clinical study

    Jensen, Lisette Okkels; Hansen, Henrik Steen; Christiansen, E H; Maeng, M; Hansen, Hans-Henrik Tilsted; Junker, Anders; Ravkilde, Jan; Kaltoft, A; Madsen, M; Sørensen, H T; Thuesen, L; Lassen, J F

    Two-year Results From a Randomized Comparison of Everolimus-eluting and Sirolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV Trial). Featured clinical study.......Two-year Results From a Randomized Comparison of Everolimus-eluting and Sirolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV Trial). Featured clinical study....

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

    Prick, Anna-Eva; de Lange, Jacomine; Scherder, Erik; Twisk, Jos; Pot, Anne Margriet

    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 has been shown to be effective for people with dementia in the US. Patients and methods People with dementia living in the community and their family caregivers (N=111 caregiver-care recipient dyads) were randomly assigned to the intervention and comparison group. The intervention group received home-based physical exercise training, psycho-education, communication skills training, and pleasant activities training during 3 months directed at both the person with dementia and the caregiver. Mood, behavior, and physical health were measured at baseline, 3 months, and 6 months. The effects of the study were determined by using generalized estimating equations based on an intention-to-treat analysis. Results Analyses showed no beneficial effects over time on any of the outcome measures. Conclusion This study showed no effects. The negative results in this study compared to the study that has been carried out in the US might be explained by the translation, adaptation, and shortening of the intervention used in the US, and a different social context. In addition, the results might be explained by the lack of room for improvement and by experiencing the intervention as too much of a burden. Furthermore, improving physical health might only be effective if the physical exercises are of moderate-to-high-intensity and are tailored in accordance with participants’ preferences and needs. For future studies, because dyads often commented positively about the pleasure and support they received, it might also be valuable to measure quality of life outcomes such as relationship quality, pleasure, and self-esteem in dyadic focused interventions. PMID:27099480

  2. Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh.

    Gary L Darmstadt

    Full Text Available BACKGROUND: To evaluate a delivery strategy for newborn interventions in rural Bangladesh. METHODS: A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. FINDINGS: A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice and postnatal (69% visited on days 0 or 1 home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30 at baseline and 0.87 (95% CI: 0.68-1.12 at endline. Primary causes of death were birth asphyxia (49% and prematurity (26%. No adverse events associated with interventions were reported. CONCLUSION: Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal

  3. Effect of a brief outreach educational intervention on the translation of acute poisoning treatment guidelines to practice in rural Sri Lankan hospitals: a cluster randomized controlled trial.

    Lalith Senarathna

    Full Text Available BACKGROUND: In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810 which aimed to assess the effect of a brief educational outreach ('academic detailing' intervention to promote the utilization of treatment guidelines for acute poisoning. METHODS AND FINDINGS: This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28-6.80]. There was no difference between hospitals in use of other decontamination methods. CONCLUSION: This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with

  4. The Effect of Educational-Spiritual Intervention on The Burnout of The Parents of School Age Children with Cancer: A Randomized Controlled Clinical Trial

    Beheshtipour, Nooshin; Nasirpour, Parisa; Yektatalab, Shahrzad; Karimi, Mehran; Zare, Najaf

    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 collected through SMBQ (Shirom and Melamed Burnout Questionnaire) from both groups, before, immediately after and one month after the intervention. Educational-spiritual programs were held for six weeks, one session every week. The data were analyzed by SPSS using independent t-test, and repeated measure ANOVA. Results: The results showed that the mean burnout score before the intervention in the intervention group was 4.28±0.61 and in the control group it was 4.23±0.50; most of the parents reported moderate to high burnout. But, there was a significant difference between the intervention and control groups immediately after and one month after the intervention (t=10.16, Pburnout score in the intervention group was less than the control group. Results also showed that there was a significant difference between the two groups in terms of parental burnout in three times of measurements (F=58.62, Pburnout of the parents of the children with cancer. Due to high burnout of most of the parents, offering such a program could be beneficial for them. More studies in this regard are recommended. Trial Registration Number: IRCT2014061818144N1 PMID:26793734

  5. Can We Increase Psychological Well-Being? The Effects of Interventions on Psychological Well-Being: A Meta-Analysis of Randomized Controlled Trials

    Westerhof, Gerben J.; Bohlmeijer, Ernst T.

    2016-01-01

    Background There is a rapidly growing interest in psychological well-being (PWB) as outcome of interventions. Ryff developed theory-based indicators of PWB that are consistent with a eudaimonic perspective of happiness. Numerous interventions have been developed with the aim to increase PWB. However, the effects on PWB measured as coherent outcome have not been examined across studies yet. This meta-analysis of randomized controlled trials of behavioral interventions aims to answer the question whether it is possible to enhance PWB. Methods A systematic literature search was performed in PsycINFO, Cochrane and Web of Science. To be included, studies had to be randomized controlled trials of behavioral interventions with psychological well-being as primary or secondary outcome measure, measured with either Ryff’s Psychological Well-Being Scales or the Mental Health Continuum—Short Form. The meta-analysis was performed using a random effects model. From the 2,298 articles found, 27 met the inclusion criteria. The included studies involved 3,579 participants. Results We found a moderate effect (Cohen’s d = 0.44; z = 5.62; p research of psychological well-being. Heterogeneity is a limitation of the study and there is need for more high-quality studies. PMID:27328124

  6. Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial

    Shojaeizadeh, Davoud; Tol, Azar; Garmaroudi, Gholamreza; Yekaninejad, Mir Saeed; Kebede, Abebaw; Ejeta, Luche Tadesse; Kassa, Desta; Klinkenberg, Eveline

    2016-01-01

    Background Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM). Methodology A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence. Results At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18–0.53), p < 0.001)). Conclusion Psychological counseling and educational interventions

  7. Mediating factors of a school-based multi-component smoking prevention intervention: the LdP cluster randomized controlled trial.

    Carreras, G; Bosi, S; Angelini, P; Gorini, G

    2016-08-01

    The aim of this study was to investigate factors mediating the effects of Luoghi di Prevenzione (LdP) smoking prevention intervention based on social competence and social influence approaches, and characterized by peer-led school-based interventions, out-of-school workshops, school lessons, and by enforcing the school anti-smoking policy. Students aged 14-15 years in 13 secondary schools in Reggio Emilia, Italy (989 students) were randomly assigned to the LdP intervention or a control condition. The baseline and follow-up surveys were carried out before and 18 months after the intervention, respectively.The outcomes were cigarette daily and frequent smoking and smoking at school. Multilevel multiple mediation analyses were carried out in order to study effect mediation. The mediators were normative perception, positive and negative beliefs, refusal skills for smoking, social acceptability perception, risk perception, smoking knowledge and awareness about dangers of second-hand smoking.The intervention effects were explained by the social influence component through the mediator refusal skills for smoking. The programme also showed to significantly increase risk perception and smoking knowledge, even though these mediators had no effect on smoking. Moreover, LdP intervention directly reduced smoking in school areas. Future interventions should maintain and strengthen the LdP social influence component and the part regarding the school anti-smoking policy. PMID:27288347

  8. CHILE: Outcomes of a group randomized controlled trial of an intervention to prevent obesity in preschool Hispanic and American Indian children

    Davis, Sally M.; Myers, Orrin B.; Cruz, Theresa H.; Morshed, Alexandra B.; Canaca, Glenda F.; Keane, Patricia C.; O'Donald, Elena R.

    2016-01-01

    Objective We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. Methods CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. Results At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Conclusions Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2 years to achieve. PMID:27222162

  9. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women

    Vinter, Christina Anne; Jensen, Dorte M; Ovesen, Per Glud; Beck-Nielsen, Henning; Jørgensen, Jan S

    2011-01-01

    To study the effects of lifestyle intervention on gestational weight gain (GWG) and obstetric outcomes.......To study the effects of lifestyle intervention on gestational weight gain (GWG) and obstetric outcomes....

  10. Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

    DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

    2014-01-01

    Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p < 0.001), HIV/STI knowledge (p < 0.001), and condom use skills (p < 0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains. PMID:25190056

  11. Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER—A Randomized Controlled Lifestyle Trial

    Tiia Ngandu

    2014-09-01

    Full Text Available Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER study population. Potential study participants (age 60–77 years, the dementia risk score ≥6 were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496, 48% (n = 2654 attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1. The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD age of the randomized participants was 69.4 (4.7 years, Mini-Mental State Examination 26.7 (2.0 points, systolic blood pressure 140.1 (16.2 mmHg, total serum cholesterol 5.2 (1.0 mmol/L for, and fasting glucose 6.1 (0.9 mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.

  12. Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)—A Randomized Controlled Lifestyle Trial †

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-01-01

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60–77 years, the dementia risk score ≥6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

  13. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-09-01

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

  14. Effectiveness of an intervention at construction worksites on work engagement, social support, physical workload, and need for recovery: results from a cluster randomized controlled trial

    Oude Hengel Karen M

    2012-11-01

    Full Text Available Abstract Background To prolong sustainable healthy working lives of construction workers, a worksite prevention program was developed which aimed to improve the health and work ability of construction workers. The aim of the current study was to investigate the effectiveness of this program on social support at work, work engagement, physical workload and need for recovery. Methods Fifteen departments from six construction companies participated in this cluster randomized controlled trial; 8 departments (n=171 workers were randomized to an intervention group and 7 departments (n=122 workers to a control group. The intervention consisted of two individual training sessions of a physical therapist to lower the physical workload, a Rest-Break tool to improve the balance between work and recovery, and two empowerment training sessions to increase the influence of the construction workers at the worksite. Data on work engagement, social support at work, physical workload, and need for recovery were collected at baseline, and at three, six and 12 months after the start of the intervention using questionnaires. Results No differences between the intervention and control group were found for work engagement, social support at work, and need for recovery. At 6 months follow-up, the control group reported a small but statistically significant reduction of physical workload. Conclusion The intervention neither improved social support nor work engagement, nor was it effective in reducing the physical workload and need for recovery among construction workers. Trial registration NTR1278

  15. Making Healthy Eating and Physical Activity Policy Practice: Process Evaluation of a Group Randomized Controlled Intervention in Afterschool Programs

    Weaver, R. Glenn; Beets, Michael W.; Hutto, Brent; Saunders, Ruth P.; Moore, Justin B.; Turner-McGrievy, Gabrielle; Huberty, Jennifer L.; Ward, Dianne S.; Pate, Russell R.; Beighle, Aaron; Freedman, Darcy

    2015-01-01

    This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs' (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying…

  16. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors

    Patterson Thomas L

    2012-10-01

    Full Text Available Abstract Background Studies of implementation of efficacious human immunodeficiency virus (HIV prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs among female sex workers (FSWs in 12 cities across Mexico. Our protocol will test a ‘train-the-trainer’ implementation model for transporting the Mujer Segura (Healthy Woman intervention into community-based organizations (CBOs. Methods We have partnered with Mexican Foundation for Family Planning (Mexfam, a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs. Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia; they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors’ fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura

  17. The Effect of 12 Weeks Aerobic Exercise Training on Visfatin, Chemerin Serum Changes in 45-60 year old Obese Women with Type2 Diabetes

    L Seifi

    2016-04-01

    Full Text Available Introduction: Adipocytokine including chemerin and visfatin have a key role in metabolic regulations, as well as obesity-related disorders such as type 2 diabetes. The aim of this study was to investigate the effect of the 12-week exercise training on changes in levels of visfatin and chemerin in obese women with type 2 diabetes. Methods: In this study, 30 overweight women with the age range of 45-60 years old were selected and ther were divided into the control group (n = 15, and the experimental group (n = 15 which had no significant differences based on the body fat percentage and the body mass index. Exercise program consisted of increasing aerobic exercise three times were for 12 weeks. To measure Chemerin and Visfatin, blood samples before and 24 hours after the last training session were collected. Data evaluation was performed using ANCOVA to compare the pre-test and post-test in each group. Results: According to the obtained results, there was no significant difference between weight, body mass index, lean body weight, fat mass and fat percentage, but the chemerin levels have been increased significantly (p=0.0001 and also visfatin and glucose levels have been decreased (respectively p=0.0001 and p=0.001. Conclusion: Aerobic activities are a stimulating factor for increasing in the chemerin hormone and also a stimulating factor for decreasing in the Visfatin hormone. It could be said that regular aerobic activities in 12 weeks are a good stimulating factor for creating changes in these hormones in women with diabetes and it is probably one of the contributing factors of physiologic changes resulted from these exercise activities is changes in these hormones.

  18. Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Controlled Trial

    Guille, Constance; Zhao, Zhuo; Krystal, John; Nichols, Breck; Brady, Kathleen; Sen, Srijan

    2016-01-01

    Importance In the United States, approximately one physician dies by suicide every day. Training physicians are at particularly high risk, with suicidal ideation increasing over four-fold during the first three months of internship year. Despite this dramatic increase, very few efforts have been made to prevent the escalation of suicidal thoughts among training physicians. Objective To assess the effectiveness of a Web-based Cognitive Behavioral Therapy (wCBT) program delivered prior to the start of internship year in the prevention of suicidal ideation in medical interns. Design, Setting and Participants A randomized controlled trial conducted at two university hospitals with 199 interns from multiple specialties during academic years 2009-10 or 2011-12. Interventions Interns were randomly assigned to study groups (wCBT, n=100; attention-control group (ACG), n=99), and completed study activities lasting 30-minutes each week for four weeks prior to starting internship year. Subjects assigned to wCBT completed online-CBT modules and subjects assigned to ACG received emails with general information about depression, suicidal thinking and local mental health providers. Main Outcome Measure The Patient Health Questionnaire (PHQ-9) was employed to assess suicidal ideation (i.e., “thoughts that you would be better off dead, or hurting yourself in some way”) prior to the start of intern year and at 3-month intervals throughout the year. Results 62.2% (199/320) of individuals agreed to take part in the study. During at least one time point over the course of internship year 12% (12/100) of interns assigned to wCBT endorsed suicidal ideation, compared to 21%(21/99) of interns assigned to ACG. After adjusting for covariates identified a priori that have previously shown to increase the risk for suicidal ideation, interns assigned to wCBT were 60% less likely to endorse suicidal ideation during internship year (RR: 0.40, 95% CI 0.17-0.91; p=0.03), compared to those

  19. The Effect on Selenium Concentrations of a Randomized Intervention with Fish and Mussels in a Population with Relatively Low Habitual Dietary Selenium Intake

    Outzen, Malene; Tjønneland, Anne; Larsen, Erik Huusfeldt;

    2015-01-01

    Selenium status of the Danish population is below that assumed optimal for the suggested protective effects against chronic diseases, including certain cancers. Fish and shellfish are important dietary sources of selenium in Denmark. We investigated the effect of increased fish and mussel intake on...... selenium blood concentrations in a population with relatively low habitual dietary selenium intake. We randomly assigned 102 healthy men and women (all non-smokers) aged 48-76 years to an intervention group (n = 51) or a control group (n = 51). Intervention participants received 1000 g fish and mussels...

  20. Do Intervention Programs in Child Care Promote the Quality of Caregiver-Child Interactions? A Meta-Analysis of Randomized Controlled Trials

    Werner, Claudia D.; Linting, Mariëlle; Harriet J. Vermeer; van IJzendoorn, Marinus H.

    2015-01-01

    This meta-analysis reports on the effectiveness of targeted interventions focusing on child care professionals to improve child care quality, caregiver interaction skills, and child social-emotional development. Within randomized controlled trials, interventions are moderately effective in improving overall caregiver-child interactions (k = 19, Hedges’ g = 0.35) and in improving child care quality on the classroom level (k = 11; Hedges’ g = 0.39), the caregiver level (k = 10; Hedges’ g = 0.44...