Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.
Full Text Available Abstract Background Human papillomavirus (HPV infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics. Methods Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408 and their mothers (N = 305 enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months. Results At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9% but not significantly after adjusting for patient’s age and mother’s education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm. Conclusions Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines. Trial registration Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16
Darren J Gray
Full Text Available Zoonotic schistosomiasis japonica is a major public health problem in China. Bovines, particularly water buffaloes, are thought to play a major role in the transmission of schistosomiasis to humans in China. Preliminary results (1998-2003 of a praziquantel (PZQ-based pilot intervention study we undertook provided proof of principle that water buffaloes are major reservoir hosts for S. japonicum in the Poyang Lake region, Jiangxi Province.Here we present the results of a cluster-randomised intervention trial (2004-2007 undertaken in Hunan and Jiangxi Provinces, with increased power and more general applicability to the lake and marshlands regions of southern China. The trial involved four matched pairs of villages with one village within each pair randomly selected as a control (human PZQ treatment only, leaving the other as the intervention (human and bovine PZQ treatment. A sentinel cohort of people to be monitored for new infections for the duration of the study was selected from each village. Results showed that combined human and bovine chemotherapy with PZQ had a greater effect on human incidence than human PZQ treatment alone.The results from this study, supported by previous experimental evidence, confirms that bovines are the major reservoir host of human schistosomiasis in the lake and marshland regions of southern China, and reinforce the rationale for the development and deployment of a transmission blocking anti-S. japonicum vaccine targeting bovines.Australian New Zealand Clinical Trials Registry ACTRN12609000263291.
Basso, Cáritas Relva; Helena, Ernani Tiaraju Santa; Caraciolo, Joselita Maria Magalhães; Paiva, Vera; Nemes, Maria Ines Battistela
To assess the effectiveness of a psychosocial individual intervention to improve adherence to ART in a Brazilian reference-center, consenting PLHIV with viral load >50 copies/ml were selected. After 4 weeks of MEMS cap use, participants were randomized into an intervention group (IG) (n = 64) or control group (CG) (n = 57). CG received usual care only. The IG participated in a human rights-based intervention approach entailing four dialogical meetings focused on medication intake scenes. Comparison between IG and CG revealed no statistically significant difference in adherence measured at weeks 8, 12, 16, 20 and 24. Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups. The lower number of eligible patients than expected underpowered the study. Ongoing qualitative analysis should provide deeper understanding of the trial results. NIH Clinical Trials: NCT00716040.
Fairhall, Nicola; Aggar, Christina; Kurrle, Susan E; Sherrington, Catherine; Lord, Stephen; Lockwood, Keri; Monaghan, Noeline; Cameron, Ian D
Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further
Poutanen, Kaisa S; Dussort, Pierre; Erkner, Alfrun
Background: Many intervention studies have tested the effect of dietary fibers (DFs) on appetite-related outcomes, with inconsistent results. However, DFs comprise a wide range of compounds with diverse properties, and the specific contribution of these to appetite control is not well characterized...... the effects of DF properties on appetite and preclude the development of reliable, predictive, structure-function relations. Improved standards for characterization and reporting of DF sources and DF-containing materials are strongly recommended for future studies on the effects of DF on human physiology.......Objective: The influence of specific DF characteristics [i.e., viscosity, gel-forming capacity, fermentability, or molecular weight (MW)] on appetite-related outcomes was assessed in healthy humans.Design: Controlled human intervention trials that tested the effects of well-characterized DFs on appetite ratings or energy...
Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a
increased CRP levels, but not with increased risk of atherothrombosis. A human intervention trial in healthy people with low LDL cholesterol and elevated CRP demonstrated that aggressive statin treatment caused reductions of 50% in LDL cholesterol, 37% in CRP, 50% in atherothrombotic cardiovascular events......, 20% in total mortality, and 45% in venothrombotic events. Importantly, the maximal atherothrombotic treatment benefits were obtained in those who achieved the lowest levels of both LDL cholesterol and CRP. SUMMARY: Given the data available in mid-2009, elevated CRP per se does not seem to cause...
Hekler, Eric B; Buman, Matthew P; Otten, Jennifer; Castro, Cynthia M; Grieco, Lauren; Marcus, Bess; Friedman, Robert H; Napolitano, Melissa A; King, Abby C
Little research has explored who responds better to an automated vs. human advisor for health behaviors in general, and for physical activity (PA) promotion in particular. The purpose of this study was to explore baseline factors (i.e., demographics, motivation, interpersonal style, and external resources) that moderate intervention efficacy delivered by either a human or automated advisor. Data were from the CHAT Trial, a 12-month randomized controlled trial to increase PA among underactive older adults (full trial N = 218) via a human advisor or automated interactive voice response advisor. Trial results indicated significant increases in PA in both interventions by 12 months that were maintained at 18-months. Regression was used to explore moderation of the two interventions. Results indicated amotivation (i.e., lack of intent in PA) moderated 12-month PA (d = 0.55, p 0.12). Results provide preliminary evidence for generating hypotheses about pathways for supporting later clinical decision-making with regard to the use of either human- vs. computer-delivered interventions for PA promotion.
Fekete, Ágnes A; Givens, D Ian; Lovegrove, Julie A
The prevalence of cardiometabolic diseases is a significant public health burden worldwide. Emerging evidence supports the inverse association between greater dairy consumption and reduced risk of cardiometabolic diseases. Dairy proteins may have an important role in the favourable impact of dairy on human health such as blood pressure (BP), blood lipid and glucose control. The purpose of this review is to update and critically evaluate the evidence on the impacts of casein and whey protein in relation to metabolic function. Evidence from short-term clinical studies assessing postprandial responses to milk protein ingestion suggests benefits on vascular function independent of BP, as well as improvement in glycaemic homeostasis. Long-term interventions have been less conclusive, with some showing benefits and others indicating a lack of improvement in vascular function. During chronic consumption BP appears to be lowered and both dyslipidaemia and hyperglacaemia seem to be controlled. Limited number of trials investigated the effects of dairy proteins on oxidative stress and inflammation. Although the underlying mechanisms of milk proteins on cardiometabolic homeostasis remains to be elucidated, the most likely mechanism is to improve insulin resistance. The incorporation of meals enriched with dairy protein in the habitual diet may result in the beneficial effects on cardiometabolic health. Nevertheless, future well-designed, controlled studies are needed to investigate the relative effects of both casein and whey protein on BP, vascular function, glucose homeostasis and inflammation.
Regenberg, Alan; Mathews, Debra JH; Blass, David M; Bok, Hilary; Coyle, Joseph T; Duggan, Patrick; Faden, Ruth; Finkel, Julia; Gearhart, John D; Hillis, Argye; Hoke, Ahmet; Johnson, Richard; Johnston, Michael; Kahn, Jeffrey; Kerr, Douglas; King, Patricia; Kurtzberg, Joanne; Liao, S Matthew; McDonald, John W; McKhann, Guy; Nelson, Karin B; Rao, Mahendra; Siegel, Andrew W; Smith, Kirby; Solter, Davor; Song, Hongjun; Sugarman, Jeremy; Vescovi, Angelo; Young, Wise; Greely, Henry T; Traystman, Richard J
Progress in regenerative medicine seems likely to produce new treatments for neurologic conditions that use human cells as therapeutic agents; at least one trial for such an intervention is already under way. The development of cell-based interventions for neurologic conditions (CBI-NCs) will likely include preclinical studies using animals as models for humans with conditions of interest. This paper explores predictive validity challenges and the proper role for animal models in developing CBI-NCs. In spite of limitations, animal models are and will remain an essential tool for gathering data in advance of first-in-human clinical trials. The goal of this paper is to provide a realistic lens for viewing the role of animal models in the context of CBI-NCs and to provide recommendations for moving forward through this challenging terrain. PMID:18728679
Sossauer, Gaëtan; Zbinden, Michel; Tebeu, Pierre-Marie; Fosso, Gisèle K; Untiet, Sarah; Vassilakos, Pierre; Petignat, Patrick
Human papillomavirus (HPV) self-sampling (Self-HPV) may be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women's knowledge and confidence in the Self-HPV method. Women aged between 25 and 65 years old, eligible for cervical cancer screening, were randomly chosen to receive standard information (control group) or standard information followed by educational intervention (interventional group). Standard information included explanations about what the test detects (HPV), the link between HPV and cervical cancer and how to perform HPV self-sampling. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test. All participants completed a questionnaire that assessed sociodemographic data, women's knowledge about cervical cancer and acceptability of Self-HPV. A total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside. 301 women (149 in the "control group" and 152 in the "intervention group") completed the full process and were included into the analysis. Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group (pEducational intervention promotes an increase in knowledge about HPV and cervical cancer. Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior. International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN78123709.
Wingood, Gina M; Diclemente, Ralph J; Robinson-Simpson, Lashun; Lang, Delia L; Caliendo, Angela; Hardin, James W
This trial evaluated the efficacy of an HIV-intervention condition, relative to a health-promotion condition, in reducing incidence of nonviral sexually transmitted infections (STIs; Chlamydia, gonorrhea, and trichomoniasis), oncogenic human papillomavirus (HPV) subtypes 16 and 18, sexual concurrency, and other HIV-associated behaviors over a 12-month period. Randomized-controlled trial. Data analysts blinded to treatment allocation. Kaiser Permanente, GA. A random sample of 848 African American women. The two 4-hour HIV intervention sessions were based on Social Cognitive Theory and the Theory of Gender and Power. The intervention was designed to enhance participants' self-sufficiency and attitudes and skills associated with condom use. The HIV intervention also encouraged STI testing and treatment of male sex partners and reducing vaginal douching and individual and male partner concurrency. Incident nonviral STIs. In generalized estimating equations' analyses, over the 12-month follow-up, participants in the HIV intervention, relative to the comparison, were less likely to have nonviral incident STIs (odds ratio [OR] = 0.62; 95% confidence interval [CI]: 0.40 to 0.96; P = 0.033) and incident high-risk HPV infection (OR = 0.37; 95% CI: 0.18 to 0.77; P = 0.008) or concurrent male sex partners (OR = 0.55; 95% CI: 0.37 to 0.83; P = 0.005). In addition, intervention participants were less likely to report multiple male sex partners, more likely to use condoms during oral sex, more likely to inform their main partner of their STI test results, encourage their main partner to seek STI testing, report that their main partner was treated for STIs, and report not douching. This is the first trial to demonstrate that an HIV intervention can achieve reductions in nonviral STIs, high-risk HPV, and individual concurrency.
Bennett, Alaina T; Patel, Divya A; Carlos, Ruth C; Zochowski, Melissa K; Pennewell, Sarah M; Chi, Alice M; Dalton, Vanessa K
Educational interventions may be a strategy to increase human papillomavirus (HPV) vaccination among female university students, but studies to date have shown mixed results. This study evaluated the effect of MeFirst, an individually tailored, online educational intervention, on HPV vaccine-related knowledge, vaccination intention, and uptake among previously unvaccinated female university students. All female students aged 18-26 years who reported being unvaccinated against HPV at a midwestern university were invited via email to enroll. Participants completed an online survey that assessed baseline HPV vaccine-related knowledge, attitudes and vaccination intention. Participants (n = 661) were then randomized to receive either an educational website automatically tailored to their baseline survey responses (MeFirst intervention) or a standard CDC information factsheet on HPV vaccine (control). Vaccine uptake and repeat knowledge and attitude measures were assessed with online surveys 3 months following the intervention and analyzed using logistic regression models. HPV vaccine uptake was similar in both the MeFirst and control groups at 3 months following the intervention (p = 0.98). Three months after the intervention, the proportion of participants with high knowledge regarding HPV vaccination increased from baseline (32% to 50%; p online educational tool had similar effects as a nontailored factsheet on HPV-related knowledge, intention to HPV undergo vaccination, and HPV vaccine uptake among previously unvaccinated female university students.
Jan de Vries; Anne Birkett; Toine Hulshof; Kristin Verbeke; Kernon Gibes
Cereal fibers are known to increase fecal weight and speed transit time, but far less data are available on the effects of fruits and vegetable fibers on regularity. This study provides a comprehensive review of the impact of these three fiber sources on regularity in healthy humans. We identified English-language intervention studies on dietary fibers and regularity and performed weighted linear regression analyses for fecal weight and transit time. Cereal and vegetable fiber groups had comp...
Poutanen, Kaisa S; Dussort, Pierre; Erkner, Alfrun; Fiszman, Susana; Karnik, Kavita; Kristensen, Mette Bredal; Marsaux, Cyril Fm; Miquel-Kergoat, Sophie; Pentikäinen, Saara P; Putz, Peter; Slavin, Joanne L; Steinert, Robert E; Mela, David J.
Background: Many intervention studies have tested the effect of dietary fibers (DFs) on appetite-related outcomes, with inconsistent results. However, DFs comprise a wide range of compounds with diverse properties, and the specific contribution of these to appetite control is not well characterized.Objective: The influence of specific DF characteristics [i.e., viscosity, gel-forming capacity, fermentability, or molecular weight (MW)] on appetite-related outcomes was assessed in healthy humans...
de Vries, Jan; Birkett, Anne; Hulshof, Toine; Verbeke, Kristin; Gibes, Kernon
Cereal fibers are known to increase fecal weight and speed transit time, but far less data are available on the effects of fruits and vegetable fibers on regularity. This study provides a comprehensive review of the impact of these three fiber sources on regularity in healthy humans. We identified English-language intervention studies on dietary fibers and regularity and performed weighted linear regression analyses for fecal weight and transit time. Cereal and vegetable fiber groups had comparable effects on fecal weight; both contributed to it more than fruit fibers. Less fermentable fibers increased fecal weight to a greater degree than more fermentable fibers. Dietary fiber did not change transit time in those with an initial time of vegetable fibers, regardless of fermentability. Cereal fibers have been studied more than any other kind in relation to regularity. This is the first comprehensive review comparing the effects of the three major food sources of fiber on bowel function and regularity since 1993.
Jan de Vries
Full Text Available Cereal fibers are known to increase fecal weight and speed transit time, but far less data are available on the effects of fruits and vegetable fibers on regularity. This study provides a comprehensive review of the impact of these three fiber sources on regularity in healthy humans. We identified English-language intervention studies on dietary fibers and regularity and performed weighted linear regression analyses for fecal weight and transit time. Cereal and vegetable fiber groups had comparable effects on fecal weight; both contributed to it more than fruit fibers. Less fermentable fibers increased fecal weight to a greater degree than more fermentable fibers. Dietary fiber did not change transit time in those with an initial time of <48 h. In those with an initial transit time ≥48 h, transit time was reduced by approximately 30 min per gram of cereal, fruit or vegetable fibers, regardless of fermentability. Cereal fibers have been studied more than any other kind in relation to regularity. This is the first comprehensive review comparing the effects of the three major food sources of fiber on bowel function and regularity since 1993.
Ferk, Franziska; Mišík, Miroslav; Nersesyan, Armen; Pichler, Christoph; Jäger, Walter; Szekeres, Thomas; Marculescu, Rodrig; Poulsen, Henrik E; Henriksen, Trine; Bono, Roberto; Romanazzi, Valeria; Al-Serori, Halh; Biendl, Martin; Wagner, Karl-Heinz; Kundi, Michael; Knasmüller, Siegfried
Xanthohumol (XN) is a hop flavonoid found in beers and refreshment drinks. Results of in vitro and animal studies indicate that it causes beneficial health effects due to DNA protective, anti-inflammatory, antioxidant, and phytoestrogenic properties. Aim of the present study was to find out if XN causes alterations of health-related parameters in humans. The effects of the flavonoid were investigated in a randomized crossover intervention trial (n = 22) in which the participants consumed a XN drink (12 mg XN/P/day). We monitored alterations of the DNA stability in single cell gel electrophoresis assays in lymphocytes and of several health-related biomarkers. A decrease of oxidatively damaged purines and protection toward reactive oxygen species induced DNA damage was found after the consumption of the beverage; also the excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-guanosine in urine was reduced. The assumption that the flavonoid causes DNA protection was confirmed in a randomized follow-up study with pure XN (n = 10) with a parallel design. Other biochemical parameters reflecting the redox- and hormonal status and lipid- and glucose metabolism were not altered after the intervention. Taken together, our data indicate that low doses of XN protect humans against oxidative DNA damage. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population
Poutanen, Kaisa S; Dussort, Pierre; Erkner, Alfrun
the effects of DF properties on appetite and preclude the development of reliable, predictive, structure-function relations. Improved standards for characterization and reporting of DF sources and DF-containing materials are strongly recommended for future studies on the effects of DF on human physiology...
Zhong, Jia; Trevisi, Letizia; Urch, Bruce; Lin, Xinyi; Speck, Mary; Coull, Brent A.; Liss, Gary; Thompson, Aaron; Wu, Shaowei; Wilson, Ander; Koutrakis, Petros; Silverman, Frances; Gold, Diane R.; Baccarelli, Andrea A.
Ambient fine particle (PM2.5) pollution triggers acute cardiovascular events. Individual-level preventions are proposed to complement regulation in reducing the global burden of PM2.5-induced cardiovascular diseases. We determine whether B vitamin supplementation mitigates PM2.5 effects on cardiac autonomic dysfunction and inflammation in a single-blind placebo-controlled crossover pilot trial. Ten healthy adults received two-hour controlled-exposure-experiment to sham under placebo, PM2.5 (250 μg/m3) under placebo, and PM2.5 (250 μg/m3) under B-vitamin supplementation (2.5 mg/d folic acid, 50 mg/d vitamin B6, and 1 mg/d vitamin B12), respectively. At pre-, post-, 24 h-post-exposure, we measured resting heart rate (HR) and heart rate variability (HRV) with electrocardiogram, and white blood cell (WBC) counts with hematology analyzer. Compared to sham, PM2.5 exposure increased HR (3.8 bpm, 95% CI: 0.3, 7.4; P = 0.04), total WBC count (11.5%, 95% CI: 0.3%, 24.0%; P = 0.04), lymphocyte count (12.9%, 95% CI: 4.4%, 22.1%; P = 0.005), and reduced low-frequency power (57.5%, 95% CI: 2.5%, 81.5%; P = 0.04). B-vitamin supplementation attenuated PM2.5 effect on HR by 150% (P = 0.003), low-frequency power by 90% (P = 0.01), total WBC count by 139% (P = 0.006), and lymphocyte count by 106% (P = 0.02). In healthy adults, two-hour PM2.5 exposure substantially increases HR, reduces HRV, and increases WBC. These effects are reduced by B vitamin supplementation.
Kelly, David; Nolan, John M; Howard, Alan N; Stack, Jim; Akuffo, Kwadwo O; Moran, Rachel; Thurnham, David I; Dennison, Jessica; Meagher, Katherine A; Beatty, Stephen
The macular carotenoids lutein (L), zeaxanthin (Z) and meso-zeaxanthin (MZ) accumulate at the macula, where they are collectively referred to as macular pigment (MP). Augmentation of this pigment, typically achieved through diet and supplementation, enhances visual function and protects against progression of age-related macular degeneration. However, it is known that eggs are a rich dietary source of L and Z, in a highly bioavailable matrix. In this single-blind placebo-controlled study, L- and MZ-enriched eggs and control non-enriched eggs were fed to human subjects (mean age 41 and 35 years, respectively) over an 8-week period, and outcome measures included MP, visual function and serum concentrations of carotenoids and cholesterol. Serum carotenoid concentrations increased significantly in control and enriched egg groups, but to a significantly greater extent in the enriched egg group (Peggs may represent an effective dietary source of L, Z and MZ, reflected in significantly raised serum concentrations of these carotenoids, and consequentially improved bioavailability for capture by target tissues. However, benefits in terms of MP augmentation and /or improved visual performance were not realised over the 8-week study period, and a study of greater duration will be required to address these questions.
Dalky, Heyam F
This article reviews the literature evaluating the effectiveness of various stigma reduction interventions related to mental health illnesses. An integrated search of the English language literature from 1998 to May 2008 was done using CINAHL, Medline, PubMed, Scopus, and PsychINFO databases. The results of this review emphasize that experimental clinical trials hold promise for providing evidence-based data that can be used in mental health practice. Educational and contact-based strategies used in various stigma reduction programs resulted in the most durable gains in knowledge as well as positive attitudinal and behavioral changes needed to decrease the stigma associated with mental illness. Special stigma reduction programs are to be planned for adolescent and elderly targets. Future studies have yet to be designed to identify cost-effective stigma reduction programs. Moreover, interventional studies from different cultures are encouraged. Cross-cultural interventions need to be evaluated and modified to ensure providing culturally relevant interventions.
Full Text Available Orientation: Programme evaluation is a transdiscipline, which examines whether a programme has merit or not. A programme is a coherent set of activities aimed at bringing about a change in people or their circumstances.Research purpose: The purpose of this special edition is to introduce readers to the evaluation of human resource (HR programmes.Motivation for the study: There are few comprehensive evaluations of HR programmes despite many publications on functional efficiency measures of HR (i.e. measures of cost, time, quantity, error and quality.Research design, approach and method: This article provides a value chain for HR activities and introduces the reader to programme theory-driven evaluation.Main findings: In summarising all of the contributions in this edition, one of the main findings was the lack of programme evaluation experience within HR functions and the difficulty this posed for the evaluators.Practical/managerial implications: This introductory article presents answers to two simple questions: What does HR do? and, What is programme evaluation? These answers will enable practitioners to understand what programme evaluators mean when we say that programme evaluation seeks to determine the merit of a programme.Contribution/value-add: The main contribution of this introductory article is to set the scene for the HR evaluations that follow. It alerts the reader to the rich theory contribution in HR literature and how to apply this in a theory-driven evaluation.
Full Text Available Long-term dietary fatty acid intake is believed to induce changes in the human gut microbiome which might be associated with human health or obesity status; however, considerable debate remains regarding the most favorable ratios of fatty acids to optimize these processes. The objective of this sub-study of a double-blinded randomized crossover clinical study, the canola oil multi-center intervention trial (COMIT, was to investigate effects of five different novel oil blends fed for 30 days each on the intestinal microbiota in 25 volunteers with risk of metabolic syndrome. The 60 g treatments included three MUFA-rich diets: 1 conventional canola oil (Canola; 2 DHA-enriched high oleic canola oil (CanolaDHA; 3 high oleic canola oil (CanolaOleic; and two PUFA-rich diets: 4 a blend of corn/safflower oil (25:75 (CornSaff; and 5 a blend of flax/safflower oil (60:40 (FlaxSaff. Stool samples were collected at the end of each period. DNA was extracted and amplified for pyrosequencing. A total of 17 phyla and 187 genera were identified. While five novel oil treatments failed to alter bacterial phyla composition, obese participants produced a higher proportion of Firmicutes to Bacteroidetes than overweight or normal weight groups (P = 0.01. Similarly at the genus level, overall bacterial distribution was highly associated with subjects’ body mass index (BMI. Treatment effects were observed between MUFA- and PUFA-rich diets, with the three MUFA diets elevating Parabacteroides, Prevotella, Turicibacter, and Enterobacteriaceae (F’s populations, while the two PUFA-rich diets favored the abundance of Isobaculum. High MUFA content feedings also resulted in an increase of Parabacteroides and a decrease of Isobaculum in obese, but not overweight subjects. Data suggest that BMI is a predominant factor in characterization of human gut microbiota profiles, and that MUFA-rich and PUFA-rich diets impact the composition of gut microbiota at lower taxonomical levels
Gale, E A M; Bingley, P J; Emmett, C L
Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done...... with a pseudorandom number generator and we used size balanced blocks of four and stratified by age and national group. Primary outcome was development of diabetes, as defined by WHO criteria. Analysis was done on an intention-to-treat basis. FINDINGS: There was no difference in the development of diabetes between...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used....
Martin, Gina S; Tapsell, Linda C; Batterham, Marijka J; Russell, Kenneth G
Investigation of relative bias in diet history measurement during dietary intervention trials. Retrospective analysis of human dietary data from two randomised controlled trials examining modified fat diets in the prevention and treatment of type II diabetes mellitus. Wollongong, Australia. Thirty-five overweight, otherwise healthy subjects in trial 1 and 56 subjects with diabetes in trial 2. Diet history interviews and three-day weighed food records administered at one-month intervals in trial 1 and three-month intervals in trial 2. In a cross-sectional bias analysis, graphs of the association between bias and mean dietary intake showed that bias decreased in higher carbohydrate consumers in trial 1 (r = -0.344, P bias did not change over time in either trial. There were no significant differences in bias magnitudes between the trials, with the exception of monounsaturated fat measurement where bias was significantly greater and more positive in trial 2, indicating overestimation of monounsaturated fat intake with the diet history. Subjects in control and intervention groups underestimated energy, fat, saturated fat and alcohol intakes with the diet history in both trials. Overweight and obese individuals appeared to make the greatest contribution to the overall underestimation of saturated fat intake by the diet history regardless of whether they were in the control or intervention group and whether they were healthy or had diabetes. Bias in diet history measurement appears to be macronutrient-specific, with energy, fat and saturated fat consistently underreported in the interview by subjects with and without diabetes and in both intervention and control groups in a dietary intervention trial. Relative bias analysis appears to be an informative tool in quality control for dietary intervention trials when biochemical markers are unavailable.
Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia
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…
Mohr, David C; Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.
Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C
Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates
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
Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M
Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.
The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories.
Fiellin, Lynn E; Kyriakides, Tassos C; Hieftje, Kimberly D; Pendergrass, Tyra M; Duncan, Lindsay R; Dziura, James D; Sawyer, Benjamin G; Fiellin, David A
To address the need for risk behavior reduction and human immunodeficiency virus prevention interventions that capture adolescents "where they live," we created a tablet-based videogame to teach skills and knowledge and influence psychosocial antecedents for decreasing risk and preventing human immunodeficiency virus infection in minority youth in schools, after-school programs, and summer camps. We developed PlayForward: Elm City Stories over a 2-year period, working with researchers, commercial game designers, and staff and teens from community programs. The videogame PlayForward provides an interactive world where players, using an avatar, "travel" through time, facing challenges such as peer pressure to drink alcohol or engage in risky sexual behaviors. Players experience how their choices affect their future and then are able to go back in time and change their choices, creating different outcomes. A randomized controlled trial was designed to evaluate the efficacy of PlayForward. Participants were randomly assigned to play PlayForward or a set of attention/time control games on a tablet at their community-based program. Assessment data were collected during face-to-face study visits and entered into a web-based platform and unique real-time "in-game" PlayForward data were collected as players engaged in the game. The innovative methods of this randomized controlled trial are described. We highlight the logistical issues of conducting a large-scale trial using mobile technology such as the iPad(®), and collecting, transferring, and storing large amounts of in-game data. We outline the methods used to analyze the in-game data alone and in conjunction with standardized assessment data to establish correlations between behaviors during gameplay and those reported in real life. We also describe the use of the in-game data as a measure of fidelity to the intervention. In total, 333 boys and girls, aged 11-14 years, were randomized over a 14-month period: 166 were
Montgomery, Paul; Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean
Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines ( http://tinyurl.com/consort-study ).
Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.
Fjeldsoe Brianna S
Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also
Since the early 2000s, a significant number of programs and policies have been developed and implemented to prevent and combat human trafficking. At the international, regional and national levels, government, and international, and nongovernment organizations have established plans of action, conducted training, developed policy tools, and…
Mohr, D.C.; Schueller, S.M.; Riley, W.T.; Brown, C.H.; Cuijpers, P.; Duan, N.; Kwasny, M.J.; Stiles-Shields, C.; Cheung, K.
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down
Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools
Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R
The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best
Robinson, Hayley; Norton, Sam; Jarrett, Paul; Broadbent, Elizabeth
Psychological stress has been shown to delay wound healing. Several trials have investigated whether psychological interventions can improve wound healing, but to date, this evidence base has not been systematically synthesized. The objective was to conduct a systematic review of randomized controlled trials in humans investigating whether psychological interventions can enhance wound healing. A systematic review was performed using PsychINFO, CINAHL, Web of Science, and MEDLINE. The searches included all papers published in English up until September 2016. The reference lists of relevant papers were screened manually to identify further review articles or relevant studies. Nineteen studies met inclusion criteria and were included in the review. Fifteen of nineteen studies were of high methodological quality. Six studies were conducted with acute experimentally created wounds, five studies with surgical patients, two studies with burn wounds, two studies with fracture wounds, and four studies were conducted with ulcer wounds. Post-intervention standardized mean differences (SMD) between groups across all intervention types ranged from 0.13 to 3.21, favouring improved healing, particularly for surgical patients and for relaxation interventions. However, there was some evidence for publication bias suggesting negative studies may not have been reported. Due to the heterogeneity of wound types, population types, and intervention types, it is difficult to pool effect sizes across studies. Current evidence suggests that psychological interventions may aid wound healing. Although promising, more research is needed to assess the efficacy of each intervention on different wound types. Statement of contribution What is already known on this subject? Psychological stress negatively affects wound healing. A number of studies have investigated whether psychological interventions can improve healing. However, no systematic reviews have been conducted. What does this study add
Sperduto, R D; Hu, T S; Milton, R C; Zhao, J L; Everett, D F; Cheng, Q F; Blot, W J; Bing, L; Taylor, P R; Li, J Y
To determine whether the vitamin/mineral supplements used in two cancer intervention trials affected the risk of developing age-related cataracts. Two randomized, double-masked trials with a duration of 5 to 6 years and end-of-trial eye examinations. Rural communes in Linxian, China. In trial 1, 2141 participants aged 45 to 74 years, and, in trial 2, 3249 participants aged 45 to 74 years. Multivitamin/mineral supplement or matching placebo in trial 1; factorial design to test the effect of four different vitamin/mineral combinations in trial 2 (retinol/zinc, riboflavin/niacin, ascorbic acid/molybdenum, and selenium/alpha-tocopherol/beta carotene). Prevalence of nuclear, cortical, and posterior subcapsular cataracts in treatment groups at end of trials. In the first trial, there was a statistically significant 36% reduction in the prevalence of nuclear cataract for persons aged 65 to 74 years who received the supplements. In the second trial, the prevalence of nuclear cataract was significantly lower in persons receiving riboflavin/niacin compared with persons not receiving these vitamins. Again, persons in the oldest group, 65 to 74 years, benefited the most (44% reduction in prevalence). No treatment effect was noted for cortical cataract in either trial. Although the number of posterior subcapsular cataracts was very small, there was a statistically significant deleterious effect of treatment with riboflavin/niacin. Findings from the two trials suggest that vitamin/mineral supplements may decrease the risk of nuclear cataract. Additional research is needed in less nutritionally deprived populations before these findings can be translated into general nutritional recommendations.
Wagman, Jennifer A; Paul, Amy; Namatovu, Fredinah; Ssekubugu, Robert; Nalugoda, Fred
We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial. Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.
Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno
Background In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers a...
Kostis, John B; Wilson, Alan C; Shindler, Daniel M; Cosgrove, Nora M; Lacy, Clifton R
Weight loss and sodium reduction programs are effective in treating hypertension, but there is little information about the persistence of the benefit after discontinuation of the intervention. The Trial of Nonpharmacologic Interventions in the Elderly (TONE) was a four-center controlled clinical trial of weight loss, reduced sodium intake, or both in maintaining normotension after withdrawal of antihypertensive drug therapy in older men and women whose hypertension was controlled with a single antihypertensive medication. Information on maintenance of normotension without need for drug therapy was obtained on 222 of 223 participants at the Robert Wood Johnson Medical School clinical center on average of 48.4 months (range 45 to 54 months) after the end of TONE. At the end of TONE follow-up, 43% of participants in the combined intervention group were off medication compared with 25% in the usual care group (P = .011). At 48 months after the end of TONE and discontinuation of contact of the participants with the clinical center, 23% of the combined intervention group v 7% in the usual care group were off medication (P = .012). Some benefits of structured dietary intervention appears to persist long term in a significant number of patients after discontinuation of the intervention.
Full Text Available Human papilloma virus (HPV vaccine was developed to reduce HPV-attributable cancers, external genital warts (EGW, and recurrent respiratory papillomatosis. Adolescent HPV vaccination series completion rates are less than 40% in the United States of America, but up to 80% in Australia and the United Kingdom. Population-based herd immunity requires 80% or greater vaccination series completion rates. Pro-vaccination counseling facilitates increased vaccination rates. Multimodal counseling interventions may increase HPV vaccination series non-completers’ HPV-attributable disease knowledge and HPV-attributable disease prophylaxis (vaccination acceptance over a brief 14-sentence counseling intervention. An online, 4-group, randomized controlled trial, with 260 or more participants per group, found that parents were more likely to accept HPV vaccination offers for their children than were childless young adults for themselves (68.2% and 52.9%. A combined audiovisual and patient health education handout (PHEH intervention raised knowledge of HPV vaccination purpose, p = 0.02, and HPV vaccination acceptance for seven items, p < 0.001 to p = 0.023. The audiovisual intervention increased HPV vaccination acceptance for five items, p < 0.001 to p = 0.006. That HPV causes EGW, and that HPV vaccination prevents HPV-attributable diseases were better conveyed by the combined audiovisual and PHEH than the control 14-sentence counseling intervention alone.
Kalkman, Shona; Kim, Scott Y H; van Thiel, Ghislaine J M W; Grobbee, Diederick E; van Delden, Johannes J M
Pragmatic trials evaluate the comparative benefits, risks, and burdens of health care interventions in real-world conditions. Such studies are now recognized as valuable to the perimarketing stage of drug development and evaluation, with early pragmatic trials (EPTs) being explored as a means to generate real-world evidence at the time of regulatory market approval. In this article, we present an analysis of the ethical issues involved in informed consent for EPTs, in light of the generally recognized concern that traditional ethical rules governing randomized clinical trials, such as lengthy informed consent procedures, could threaten the "real world" nature of such trials. Specifically, we examine to what extent modifications (waivers or alterations) to regulatory consent for EPTs would be ethical. We first identify broadly accepted necessary conditions for modifications of informed consent (namely, the research involves no more than minimal risk of harm, the research is impracticable with regulatory consent, and the alternative to regulatory consent does not violate legitimate patient expectations) and then apply those criteria to the premarket and early postmarket contexts. The analysis shows that neither waivers nor alterations of regulatory consent for premarket EPTs will be ethically permissible. For postmarket EPTs with newly approved interventions, waivers of consent will be ethically problematic, but some studies might be conducted in an ethical manner with alterations to regulatory consent. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Huisjes Anjoke JM
Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN
Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to
Christopher, Paul P; Appelbaum, Paul S; Truong, Debbie; Albert, Karen; Maranda, Louise; Lidz, Charles
Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. An enhanced educational intervention augmenting
Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders
intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...
Full Text Available Abstract Background The Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH trial tested a family intervention to reduce screen-based sedentary behaviour in overweight children. The trial found no significant effect of the intervention on children’s screen-based sedentary behaviour. To explore these null findings, we conducted a pre-planned process evaluation, focussing on intervention delivery and uptake. Methods SWITCH was a randomised controlled trial of a 6-month family intervention to reduce screen time in overweight children aged 9–12 years (n = 251. Community workers met with each child’s primary caregiver to deliver the intervention content. Community workers underwent standard training and were monitored once by a member of the research team to assess intervention delivery. The primary caregiver implemented the intervention with their child, and self-reported intervention use at 3 and 6 months. An exploratory analysis determined whether child outcomes at 6 months varied by primary caregiver use of the intervention. Results Monitoring indicated that community workers delivered all core intervention components to primary caregivers. However, two thirds of primary caregivers reported using any intervention component “sometimes” or less frequently at both time points, suggesting that intervention uptake was poor. Additionally, analyses indicated no effect of primary caregiver intervention use on child outcomes at 6 months, suggesting the intervention itself lacked efficacy. Conclusions Poor uptake, and the efficacy of the intervention itself, may have played a role in the null findings of the SWITCH trial on health behaviour and body composition. Trial registration The trial was registered in the Australian and New Zealand Clinical Trials Registry (no. ACTRN12611000164998 ; registration date: 10/02/2011.
Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A
To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright Â© 2016 Elsevier Ltd. All rights reserved.
Hoffmann, Tammy C.; Erueti, Chrissy; Glasziou, Paul P.
Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Design Analysis of consecutive sample of randomised trials of non-pharmacological interventions. Data sources and study selection All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial repo...
Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A
If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.
Patel, Rita; Oken, Emily; Bogdanovich, Natalia; Matush, Lidia; Sevkovskaya, Zinaida; Chalmers, Beverley; Hodnett, Ellen D; Vilchuck, Konstantin; Kramer, Michael S; Martin, Richard M
The PROmotion of Breastfeeding Intervention Trial (PROBIT) is a multicentre, cluster-randomized controlled trial conducted in the Republic of Belarus, in which the experimental intervention was the promotion of increased breastfeeding duration and exclusivity, modelled on the Baby-friendly hospital initiative. Between June 1996 and December 1997, 17,046 mother-infant pairs were recruited during their postpartum hospital stay from 31 maternity hospitals, of which 16 hospitals and their affiliated polyclinics had been randomly assigned to the arm of PROBIT investigating the promotion of breastfeeding and 15 had been assigned to the control arm, in which breastfeeding practices and policies in effect at the time of randomization was continued. Of the mother-infant pairs originally recruited for the study, 16,492 (96.7%) were followed at regular intervals until the infants were 12 months of age (PROBIT I) for the outcomes of breastfeeding duration and exclusivity; gastrointestinal and respiratory infections; and atopic eczema. Subsequently, 13,889 (81.5%) of the children from these mother-infant pairs were followed-up at age 6.5 years (PROBIT II) for anthropometry, blood pressure (BP), behaviour, dental health, cognitive function, asthma and atopy outcomes, and 13,879 (81.4%) children were followed to the age of 11.5 years (PROBIT III) for anthropometry, body composition, BP, and the measurement of fasted glucose, insulin, adiponectin, insulin-like growth factor-I, and apolipoproteins. The trial registration number for Current Controlled Trials is ISRCTN37687716 and that for ClinicalTrials.gov is NCT01561612. Proposals for collaboration are welcome, and enquires about PROBIT should be made to an executive group of the study steering committee (M.S.K., R.M.M., and E.O.). More information, including information about how to access the trial data, data collection documents, and bibliography, is available at the trial website (http
Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first
Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first national randomised
Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.
Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash
To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.
Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients
Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R
Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P < 0.001) and proportion virologically suppressed in the intervention arm compared with the control arm (comparative improvement in proportion of 0.33 suppressed, odds ratio 7.6, 95% confidence interval: 2.2-26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.
Daniel M. Riche
Full Text Available Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans. Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL. Eighty subjects were divided equally into one of four groups: (1 pterostilbene 125 mg twice daily, (2 pterostilbene 50 mg twice daily, (3 pterostilbene 50 mg + grape extract (GE 100 mg twice daily, and (4 matching placebo twice daily for 6–8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects. Results. The majority of patients completed the trial (91.3%. The average age was 54 years. The majority of patients were females (71% and Caucasians (70%. There were no adverse drug reactions (ADRs on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs. Conclusion. Pterostilbene is generally safe for use in humans up to 250 mg/day.
Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet
Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional
Garbutt Jane M
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
Pockley A Graham
Full Text Available Abstract Background The success of a human intervention trial depends upon the ability to recruit eligible volunteers. Many trials fail because of unrealistic recruitment targets and flawed recruitment strategies. In order to predict recruitment rates accurately, researchers need information on the relative success of various recruitment strategies. Few published trials include such information and the number of participants screened or approached is not always cited. Methods This paper will describe in detail the recruitment strategies employed to identify older adults for recruitment to a 6-month randomised controlled dietary intervention trial which aimed to explore the relationship between diet and immune function (The FIT study. The number of people approached and recruited, and the reasons for exclusion, will be discussed. Results Two hundred and seventeen participants were recruited to the trial. A total of 7,482 letters were sent to potential recruits using names and addresses that had been supplied by local Family (General Practices. Eight hundred and forty three potential recruits replied to all methods of recruitment (528 from GP letters and 315 from other methods. The eligibility of those who replied was determined using a screening telephone interview, 217 of whom were found to be suitable and agreed to take part in the study. Conclusion The study demonstrates the application of multiple recruitment methods to successfully recruit older people to a randomised controlled trial. The most successful recruitment method was by contacting potential recruits by letter on NHS headed note paper using contacts provided from General Practices. Ninety percent of recruitment was achieved using this method. Adequate recruitment is fundamental to the success of a research project, and appropriate strategies must therefore be adopted in order to identify eligible individuals and achieve recruitment targets. Trial registration number ISRCTN45031464.
Stiles, Carla R; Biondo, Patricia D; Cummings, Greta; Hagen, Neil A
Robust recommendations on the reporting of methods and results of clinical trials such as therapeutic intervention trials are widely used, such as the Consolidated Standards of Reporting Trials (CONSORT) recommendation. There has not been agreement on analogous publication standards for educational intervention trials, making interpretation of educational intervention studies difficult. The purpose of this report is to describe common deficiencies in reporting of educational intervention trials for cancer pain control, and to offer suggestions for authors to consider as they plan their studies, and report and publish research findings for educational interventions that use randomized controlled trials and other educational trial methodologies. A systematic review of published knowledge translation intervention trials intended to improve cancer pain was undertaken, of which most were educational interventions. Many educational intervention clinical trials designed to improve management of cancer pain appeared methodologically weak, and their results were more difficult to interpret because of reporting deficiencies. In the course of the review, patterns of deficiencies in reporting of methods and trial results were documented. Deficiencies in reporting were compared with the CONSORT recommendations for reporting clinical trials, and parallel recommendations were drafted for educational intervention trials. Patterns of deficiency in reporting cancer pain educational intervention trials were synthesized into seven domains, generically applicable to a range of study designs. Draft recommendations intended to address these deficiencies were constructed to improve communication of educational research results. Development of a standardized reporting template for clinical trials in cancer pain educational interventions could advance knowledge transfer research and thereby increase effectiveness of national and international cancer control policy designed to support cancer
The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories
Fiellin, Lynn E; Kyriakides, Tassos C; Hieftje, Kimberly D; Pendergrass, Tyra M; Duncan, Lindsay R; Dziura, James D; Sawyer, Benjamin G; Fiellin, David A
Background To address the need for risk behavior reduction and HIV prevention interventions that capture adolescents “where they live,” we created a tablet-based videogame to teach skills and knowledge and influence psychosocial antecedents for decreasing risk and preventing HIV infection in minority youth in schools, after-school programs, and summer camps. Methods We developed PlayForward: Elm City Stories over a 2-year period, working with researchers, commercial game designers, and staff and teens from community programs. The videogame PlayForward provides an interactive world where players, using an avatar, “travel” through time, facing challenges such as peer pressure to drink alcohol or engage in risky sexual behaviors. Players experience how their choices affect their future and then are able to go back in time and change their choices, creating different outcomes. A randomized controlled trial was designed to evaluate the efficacy of PlayForward. Participants were randomly assigned to play PlayForward or a set of attention/time control games on a tablet at their community-based program. Assessment data were collected during face-to-face study visits and entered into a web-based platform and unique real-time “in-game” PlayForward data were collected as players engaged in the game. The innovative methods of this randomized controlled trial are described. We highlight the logistical issues of conducting a large-scale trial using mobile technology such as the iPad®, and collecting, transferring, and storing large amounts of in-game data. We outline the methods used to analyze the in-game data alone and in conjunction with standardized assessment data to establish correlations between behaviors during gameplay and those reported in real life. We also describe the use of the in-game data as a measure of fidelity to the intervention. Results In total, 333 boys and girls, aged 11–14 years, were randomized over a 14-month period: 166 were assigned to
Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E
To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials...
Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
.... The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling...
Sarah Mummah; Thomas N Robinson; Maya Mathur; Sarah Farzinkhou; Stephen Sutton; Christopher D Gardner
Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials...
Incorporation of n-3 PUFA and γ-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis - a randomized controlled human intervention trial
Full Text Available Abstract Background and aim Marine n-3 fatty acids and γ-linolenic acid both have anti-inflammatory effects and may be useful to help treat inflammatory diseases. The effects of these alone or combined were examined in patients with arthritis in a randomized controlled trial. Design Patients with rheumatoid arthritis or psoriatic arthritis were randomized into four groups in a double-blind, placebo-controlled parallel designed study. Patients received the respective capsules (1: 3.0 g n-3 LC-PUFA/d; 2: 3.2 g γ-linolenic acid/d; 3: 1.6 g n-3 LC-PUFA + 1.8 g γ-linolenic acid/d; 4: 3.0 g olive oil for a twelve week period. Clinical status was evaluated and blood samples were taken at the beginning and at the end of the period. Differences before and after intervention were tested with paired t-test or with Wilcoxon test for non-normal data distribution. Results 60 patients (54 rheumatoid arthritis, 6 psoriatic arthritis were randomised, 47 finished per protocol. In group 1, the ratio of arachidonic acid (AA/eicosapentaenoic acid (EPA decreased from 6.5 ± 3.7 to 2.7 ± 2.1 in plasma lipids and from 25.1 ± 10.1 to 7.2 ± 4.7 in erythrocyte membranes (p ≤ 0.001. There was no significant influence on AA/EPA ratio due to interventions in group 2-4. In group 2, the intake of γ-linolenic acid resulted in a strong rise of γ-linolenic acid and dihomo-γ-linolenic acid concentrations in plasma lipids, cholesteryl esters, and erythrocyte membranes. The combination of n-3 LC-PUFA and γ-linolenic acid (group 3 led to an increase of γ-linolenic acid and dihomo-γ-linolenic acid concentrations in plasma lipids, cholesteryl esters, and erythrocyte mem-branes. This increase was only half of that in group 2. Conclusions Incorporation of eicosanoid precursor FAs was influenced by an intake of n-3 LC-PUFA and γ-linolenic acid suggesting a possible benefit for therapy of chronic inflammatory diseases. Trial Registration ClinicalTrials NCT01179971
Gladstone, Tracy G; Marko-Holguin, Monika; Rothberg, Phyllis; Nidetz, Jennifer; Diehl, Anne; DeFrino, Daniela T; Harris, Mary; Ching, Eumene; Eder, Milton; Canel, Jason; Bell, Carl; Beardslee, William R; Brown, C Hendricks; Griffiths, Kathleen; Van Voorhees, Benjamin W
The high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system. We developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed. The current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model
Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V
Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.
Callahan Christopher M
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
Cockayne, S; Adamson, J.; Clarke, A.; Corbacho, B; Fairhurst, C; Green, L; Hewitt, CE; Hicks, K.; Keenan, A-M; Lamb, SE; McInstosh, C; Menz, HB; Redmond, A; Richardson, Z.; Rodgers, S.
Background\\ud \\ud Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.\\ud \\ud Design\\ud \\ud Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls pr...
Bird, Lydia; Arthur, Antony; Cox, Karen
The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul
Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely
Grant, Sean P; Mayo-Wilson, Evan; Melendez-Torres, G J; Montgomery, Paul
Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and
Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...
Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L
Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.
Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J
Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.
Bloom, Sarah E.; Lambert, Joseph M.; Dayton, Elizabeth; Samaha, Andrew L.
Previous studies have focused on whether a trial-based functional analysis (FA) yields the same outcomes as more traditional FAs, and whether interventions based on trial-based FAs can reduce socially maintained problem behavior. We included a full range of behavior functions and taught 3 teachers to conduct a trial-based FA with 3 boys with…
Widmer, R Jay; Allison, Thomas G; Lennon, Ryan; Lopez-Jimenez, Francisco; Lerman, Lilach O; Lerman, Amir
Digital health interventions (DHI) have been shown to improve intermediates of cardiovascular health, but their impact on cardiovascular (CV) outcomes has not been fully explored. The aim of this study was to determine whether DHI administered during cardiac rehabilitation (CR) would reduce CV-related emergency department (ED) visits and rehospitalizations in patients after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). We randomized patients undergoing CR following ACS and PCI to standard CR (n=40) or CR+DHI (n=40) for 3 months with 3 patients withdrawing from CR prior to initiation in the treatment arm and 6 in the control group. The DHI incorporated an online and smartphone-based CR platform asking the patients to report of dietary and exercise habits throughout CR as well as educational information toward patients' healthy lifestyles. We obtained data regarding ED visits and rehospitalizations at 180 days, as well as other metrics of secondary CV prevention at baseline and 90 days. Baseline demographics were similar between the groups. The DHI+CR group had improved weight loss compared to the control group (-5.1±6.5 kg vs. -0.8±3.8 kg, respectively, P=.02). Those in the DHI+CR group also showed a non-significant reduction in CV-related rehospitalizations plus ED visits compared to the control group at 180 days (8.1% vs 26.6%; RR 0.30, 95% CI 0.08-1.10, P=.054). The current study demonstrated that complementary DHI significantly improves weight loss, and might offer a method to reduce CV-related ED visits plus rehospitalizations in patients after ACS undergoing CR. The study suggests a role for DHI as an adjunct to CR to improve secondary prevention of CV disease. This trial is registered at clinicaltrials.gov (NCT01883050). Copyright © 2017 Elsevier Inc. All rights reserved.
Song, Mi-Kyung; Ward, Sandra E
Baseline assessments and repeated measures are an essential part of educational and psychosocial intervention trials, but merely measuring an outcome of interest can modify that outcome, either by the measurement process alone or by interacting with the intervention to strengthen or weaken the intervention effects. Assessment effects can result in biased estimates of intervention effects and may not be controlled by the usual two-group randomized controlled trial design. In this paper, we review the concept of assessment effects and other related phenomena, briefly describe study designs that estimate assessment effects separately from intervention effects and discuss their strengths and limitations, review evidence regarding the strength of assessment effects in intervention trials targeting behavior change, and discuss implications for intervention research. © 2015 Wiley Periodicals, Inc.
Nicolaisen, Anne; Gilså Hansen, Dorte; Mariet, Hagedoorn,
Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial.......Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial....
Nicolaisen, Anne; Gilså Hansen, Dorte; Hariet, Hagedoorn,
Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial......Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial...
Adams, Rebecca N; Mosher, Catherine E; Blair, Cindy K; Snyder, Denise C; Sloane, Richard; Demark-Wahnefried, Wendy
The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings and to improve the design of future trials, this study examined predictors of these process measures. An integrative data analysis was performed on data from 3 of the largest home-based diet and exercise intervention trials for cancer survivors (n = 23,841). Demographic and medical factors (ie, sex, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. Across trials, 11.1% of contacted survivors were willing to participate, and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention, and 91.1% completed the study. Race (Caucasian vs others), age, time since diagnosis, and cancer type predicted survivors' willingness to participate (P Cancer survivors' demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help to guide procedures used in future trials to enhance patient representation. © 2014 American Cancer Society.
Adams, Rebecca N.; Mosher, Catherine E.; Blair, Cindy K.; Snyder, Denise C.; Sloane, Richard; Demark-Wahnefried, Wendy
BACKGROUND The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors’ willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings as well as to improve the design of future trials, we examined predictors of these process measures. METHODS An integrative data analysis was performed on data from three of the largest home-based diet and exercise intervention trials for cancer survivors (N=23,841). Demographic and medical factors (i.e., gender, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. RESULTS Across trials, 11.1% of contacted survivors were willing to participate and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention and 91.1% completed the study. Race (Caucasian vs. others), age, time since diagnosis, and cancer type predicted survivors’ willingness to participate (p-valuesCancer survivors’ demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help guide procedures used in future trials to enhance patient representation. PMID:25155573
Basu, Anna Purna; Pearse, Janice Elizabeth; Rapley, Tim
Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed. Triallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.
Donaldson F. Conserve
Full Text Available IntroductionDisclosure of parental human immunodeficiency virus (HIV infection to their children remains a difficult process for parents living with HIV (PLWH. In order to identify the best strategies to facilitate parental HIV disclosure, it is necessary to examine the efficacy of existing interventions designed to help PLWH parents with the disclosure process to their children.ObjectivesTo systematically review the efficacy of interventions designed to assist PLWH disclose their HIV status to their children.MethodsWe conducted a systematic review and narrative synthesis of interventions designed to assist PLWH disclose their HIV status to their children. MEDLINE/PubMed, PsycINFO, Embase, Global Health, and Web of Science were searched.ResultsStudies were eligible for inclusion if they evaluated an intervention for parental HIV disclosure. Five studies published between 2001 and 2015 met the inclusion criteria. The interventions were conducted in South Africa, China, and the United States. Three of the studies used two-arm randomized controlled trials, in which the intervention group was given enhanced care while the control group received standard care. Four of the five studies included a theoretically informed intervention and three were limited to mothers. Results showed that four of the interventions increased parental HIV disclosure.ConclusionThe findings suggest that parental HIV disclosure interventions are successful in assisting parents with the disclosure process and can be adapted in different cultural context. Future parental HIV disclosure interventions should include fathers in order to assist men with parental HIV disclosure.
Hoffmann, Tammy C; Erueti, Chrissy; Glasziou, Paul P
To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Analysis of consecutive sample of randomised trials of non-pharmacological interventions. All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria. Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed. Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the "intervention materials" (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning. Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications.
Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E
To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.
Punthakee, Z; Bosch, J; Dagenais, G
AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...
Zinsstag, Jakob; Schelling, Esther; Roth, Felix; Bonfoh, Bassirou; de Savigny, Don; Tanner, Marcel
.... Cross-sectoral assessments of interventions such as mass vaccination for brucellosis in Mongolia or vaccination of dogs for rabies in Chad consider human and animal health sectors from a societal economic perspective...
Schmid, Arlene A.; Spangler-Morris, Carrie; Beauchamp, Rachel C.; Wellington, Miranda C.; Hayden, Whitney M.; Porterfield, Hannah S.; Ferguson, Denisha; Callahan, Christopher M.
There is no way to prevent functional declines related to Alzheimer’s Disease (AD). The use of occupational therapy (OT) has been shown to be successful in managing some aspects of AD. We added home-based OT to evidence-based best practice for AD with the aim of delaying functional decline in people with AD. OT was delivered in the home to a caregiver dyad including the person with AD and her/his caregiver. This paper describes the OT intervention for the AD Multiple Intervention Trial, a parallel randomized controlled trial. We include baseline data on the 180 caregiver dyads. PMID:26997685
Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno
In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). The trial interventions were
Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla
To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.
Tjia, Jennifer; Mazor, Kathleen M; Field, Terry; Doherty, Peter; Spenard, Ann; Gurwitz, Jerry H
To describe factors predictive of nursing home (NH) adherence to a clinical trial intervention. Post hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse-physician telephone communication in NHs. NH. All eligible licensed nursing staff in all participating NHs. Adherence was defined as active participation for at least 3 months of the 12-month trial. NH characteristics hypothesized to affect trial outcomes (profit status, bed size, nursing staff time, NH quality, and leadership turnover) were measured a priori. The association between intervention adherence, NH characteristics and preintervention questionnaire response rate was examined. Of 13 intervention NHs, seven adhered to the intervention. Three factors differentiated adherent from nonadherent NHs: director of nursing turnover (nonadherent NHs 50% vs adherent NHs 0%, P = .03); Centers for Medicare and Medicaid Services (CMS) nurse staffing rating (range: 1-5) (nonadherent NHs mean 3.7 ± 0.5 vs adherent NHs mean 4.3 ± 0.5), P = .048); and questionnaire response rate (nonadherent NHs 15.6 ± 10.0% vs adherent NHs 34.2 ± 12.1%, P = .02). Profit status, bed size, and number of NH deficiencies on state surveys were not significantly associated with intervention adherence. CMS nurse staffing rating, leadership turnover, and questionnaire response rate are associated with adherence to a CRT intervention. Pretrial evaluation of NH staffing rating by CMS and of response to a questionnaire can help investigators improve trial efficiency by screening for NHs likely to adhere to a CRT intervention. © 2011, Copyright the Authors Journal compilation © 2011, The American Geriatrics Society.
Sinha, Yashwant K; Craig, Jonathan C; Sureshkumar, Premala; Hayen, Andrew; Brien, Jo-anne E
To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n=100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P=.002) and blinding of outcome assessment (63% pediatric, 48% adult, P=.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.
Savović, J; Jones, He; Altman, Dg
The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...
Mahapatra, Tanmay; Mahapatra, Sanchita; Pal, Debottam; Saha, Jayanta; Lopez, AnnaLena; Ali, Mohammad; Bannerjee, Barnali; Manna, Byomkesh; Sur, Dipika; Bhattacharya, Sujit; Kanungo, Suman
Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting.
Full Text Available Abstract Background Sexually transmitted infections (STIs pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. Methods The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index (Jan 1999–July 2014. Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. Results A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1 promotion of uptake of sexual health services, 2 reduction of risky sexual behaviours and 3 reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial
Burns, Kara; Keating, Patrick; Free, Caroline
Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom
Korsten-Reck, U; Wolfarth, B; Bonk, M; Keul, J; Berg, A
Freiburg Intervention Trial for Obese Children (FITOC) is an interdisciplinary treatment program for obese children, which is established in Freiburg since 1987. Obese children at the age of 8-11 are treated in an eight months intensive period and a follow-up period of 4 months or more. Since 1990 data from 283 children coming out of 15 treatment groups (about 2 groups per year) were collected and analyzed. The program consists of regular physical training (3 times a week), comprehensive nutrition and behaviour training (overall 7 parents evenings each 4 to 6 weeks and 7 cookery courses for the kids in the same time scale). The parents evenings are filled with theoretical and practical information about nutrition as well as background information about the psychological and physiological problems in obese children. In the first examination and the regular control examinations anthropometric, biochemical and exercise physiology data are investigated. In addition, questionnaires for nutrition and behaviour are analysed on a regular basis. At each examination, depending on the progress in therapy, a new orientation with adapted goals will be discussed with the child and the parents. For the growing children a moderate reduction or long term stabilisation of weight will lead to success. Teaching goal for the children in the intensive period is to control themselves and, depending on their specific situation, to establish individual recommendations on a long term basis. The sports program should lead to an increase in self-esteem and a raise in daily energy expenditure. The team includes a physician, a nutritionist, a psychologist and a sports teacher. From 1997 the program was spread to institutions in the surroundings of Freiburg. Training for the external teams is provided for in continuous seminars. Teaching material includes a manual, forms and transparencies. The major goal is to secure quality by continuous training and close interaction between the institutions
Martinez, Joe; Laswell, Emily; Cailor, Stephanie; Ballentine, Jeb
The objective of this study was to describe the interventions and impact made by pharmacists during clinical trials. A specialty contract research organization that used clinical trial research pharmacists to communicate with patients to support clinical trial protocol adherence, retention, and health outcomes performed a retrospective, descriptive analysis of 12 clinical trials that involved 2 noninsulin glucose-lowering medications. Pharmacists called study participants at specific timepoints during the trials as per protocol. During each telephone call, the number and types of interventions were documented. Descriptive statistics (frequencies) were performed to determine the number and type of interventions by call and by patient across all noninsulin glucose-lowering medication drug A and drug B studies. Overall, 25,829 calls were made across all studies. Of these calls, 11,765 calls (45.5%) had at least one intervention that involved 3573 patients (92.3%). The most frequent interventions addressed adverse events (3774 [14.6%]), protocol violations for medication use (3341 [12.9%]), concurrent medications (1630 [5.9%]), and miscellaneous concerns (1269 [4.6%]). The greatest numbers of interventions were high-impact interventions (4772 [18.5%]) (eg, serious adverse events) that would seriously affect trial outcomes and patient adherence. Pharmacists were able to identify, support, and address multiple types of interventions related to medication management during clinical trials, including those related to concurrent medication use, adverse events, and other medication-related issues. These pharmacist interventions can result in better patient outcomes and, ultimately, more reliable study results for review and approval by regulatory agencies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck
Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim i...... microfinance, they argue that a trial registry would also enhance external validity and foster innovative research....
Staudacher, Heidi M; Irving, Peter M; Lomer, Miranda C E; Whelan, Kevin
High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.
MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh
Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I(2) index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.
Mummah, Sarah; Robinson, Thomas N.; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D.
Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Methods Overweight adults (n=135) aged 18?50 years with BMI=28?40 kg/m2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) an...
P R Srijithesh
Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.
Full Text Available This article explores how I teach about human rights and so-called humanitarian interventions to MA and Ph.D. students. The course has three main themes or foci. First, what are human rights and why have the social and economic human rights laid out in the Universal Declaration of Human Rights been so neglected or rejected, especially by the U.S. Second, how has American foreign policy used and abused human rights. Third, why have liberal or humanitarian interventions of a militarized sort become so prevalent since the end of the Cold War and why are they so damaging. The goal is to get students to look critically at the meaning and uses of human rights, about which many display a naive enthusiasm.
Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial
Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…
VanderWeele, Tyler J.; Hawkley, Louise C.; Thisted, Ronald A.; Cacioppo, John T.
Objective: Clinical scientists, policymakers, and individuals must make decisions concerning effective interventions that address health-related issues. We use longitudinal data on loneliness and depressive symptoms and a new class of causal models to illustrate how empirical evidence can be used to inform intervention trial design and clinical…
Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.
Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…
Schaaf, Roseann C.; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna
This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored…
Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen
This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of…
Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan
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-…
Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.
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…
Beich, A.; Gannik, D.; Saelan, H.
AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening......-14 months. Outcome measures focused on patients' acceptance of screening and intervention and their self-reported alcohol consumption. RESULTS: Patient acceptance of screening and intervention -10.3% (N = 794) of the target population (N = 7, 691) explicitly refused screening. All intervention group...
Bricker, Jonathan B.; Liu, Jingmin; Comstock, Bryan A; Peterson, Arthur V.; Kealey, Kathleen A.; Marek, Patrick M.
Only one prior study has examined why adolescent smoking cessation interventions are effective. To address this understudied and important issue, this study examined whether a large adolescent smoking cessation intervention trial’s outcomes were mediated by Social Cognitive Theory processes. In a randomized trial (N = 2,151), counselors proactively delivered a telephone intervention to senior year high school smokers. Mediators and smoking status were self-reported at 12 months post-intervent...
Dunn, Kelly E; Yepez-Laubach, Claudia; Nuzzo, Paul A; Fingerhood, Michael; Kelly, Anne; Berman, Suzan; Bigelow, George E
Opioid overdose (OD) has become a significant public health problem in need of effective interventions. The majority of existing educational interventions target provision of naloxone and are conducted in-person; these elements present logistical barriers that may limit wide-spread implementation. This study developed and evaluated an easily disseminated opioid OD educational intervention and compared computerized versus pamphlet delivery METHODS: Participants (N=76) undergoing opioid detoxification were randomly assigned to receive OD education via a Pamphlet (N=25), Computer (N=24), or Computer+Mastery (N=27) with identical content for all delivery modalities. Primary outcomes were changes from pre- to post-intervention in knowledge of opioid effects, opioid OD symptoms, and recommended opioid OD responses, as well as intervention acceptability. Also assessed at 1 and 3-month follow-ups were retention of knowledge and change in reported OD risk behaviors. Knowledge increased following all three intervention-delivery modalities with few between-group differences observed in knowledge gain or acceptability ratings. Largest gains were in the domain of opioid OD response (from 41.8% to 73.8% mean correct responses; poverdose education delivered by computer or written pamphlet produced sustained increases in knowledge and reduction in a key behavioral risk factor. Results support further evaluation of this educational intervention that can be used alone or to complement naloxone-training programs. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.
Ndebele Paul M
Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions
Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M
Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial
Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for intervention delivery and data collection. Australian
Julie A Luker
Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver
Full Text Available One hundred and five grape samples were collected during two consecutive years from 33 locations on seven oceanic islands of the Azores Archipelago. Grape samples were obtained from vineyards that were either abandoned or under regular cultivation involving common viticultural interventions, to evaluate the impact of regular human intervention on grape yeast biota diversity in vineyards. A total of 3150 yeast isolates were obtained and 23 yeast species were identified. The predominant species were Hanseniaspora uvarum, Pichia terricola, Starmerella bacillaris and Issatchenkia hanoiensis. The species Barnettozyma californica, Candida azymoides and Pichia cecembensis were reported in grapes or wine-associated environments for the first time. A higher biodiversity was found in active vineyards where regular human intervention takes place (Shannon index: 1.89 and 1.53 in the first and second years, respectively when compared to the abandoned ones (Shannon index: 0.76 and 0.31. This finding goes against the assumptions that human intervention can destroy biodiversity and lead to homogeneity in the environment. Biodiversity indices were considerably lower in the year with the heaviest rainfall. This study is the first to report on the grape yeast communities from several abandoned vineyards that have undergone no human intervention.
Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.
The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852
Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.
Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A
Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the
Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D
Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Kalarchian, Melissa A.; Marcus, Marsha D.; Courcoulas, Anita P.; Cheng, Yu; Levine, Michele D.
Background Studies of the impact of pre-surgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. Objective To evaluate whether a pre-surgery behavioral lifestyle intervention improves weight loss through 24-months post-surgery. Setting Bariatric Center of Excellence at a large, urban medical center. Methods Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual pre-surgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions followed by 16 weeks of face-to-face and telephone sessions prior to surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted at 6-, 12- and 24-months post-surgery. Results Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average BMI was 47.5 kg/m2 at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12- and 24 month assessments, respectively. Percent weight loss from study enrollment to 6- and 12-months post-surgery was comparable for both groups, but at 24-months post-surgery, the lifestyle group had significantly smaller percent weight loss than the usual care group (26.5% vs. 29.5%, respectively, p = 0.02). Conclusions Pre-surgery lifestyle intervention did not improve weight loss at 24 months post-surgery. Findings raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. PMID:26410538
Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary
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). Copyright © 2014 Elsevier Ltd. All rights reserved.
Zhang, Melvyn W B; Ho, Roger C M
Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.
Jeong, Sohyun; Sohn, Minji; Kim, Jae Hyun; Ko, Minoh; Seo, Hee-Won; Song, Yun-Kyoung; Choi, Boyoon; Han, Nayoung; Na, Han-Sung; Lee, Jong Gu; Kim, In-Wha; Oh, Jung Mi; Lee, Euni
Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%. The globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.
Bhatta, Dharma Nand; Liabsuetrakul, Tippawan
Prevention and antiretroviral therapy (ART) management for human immunodeficiency virus (HIV) infected people need to have long-term health care. An empowerment focused intervention is a procedure by which HIV infected people obtain combined possession of programs to attain mainly cost-effective HIV outcomes and deal with social and structural difficulties related to their universal health access and human rights. Empowerment is a key approach for addressing HIV related issues that focuses on addressing a broader context. However, the practices of empowerment based approaches are sparse. We assessed the effect of an intervention to empower HIV infected people receiving ART. In this open-label randomized controlled trial, HIV infected people from Nepal who were using ART from 6 to 24 months and were aged 18 years and above were randomly assigned to receive either the intervention or routine care. The intervention was led by two counselors for a period lasting six weeks. Participants were followed up at three and six months after the baseline. The primary outcome was change in empowerment scores, analyzed by using Difference-in-Difference (DiD). Between September and November 2014, 1447 HIV infected people were screened, of whom 132 were randomly assigned to the intervention (n = 66) or control (n = 66) group. All the participants completed the 3- and 6- months follow up. A significant difference in mean empowerment score was found between the groups at 3- (46.77, p-value HIV infected people during ART increased their empowerment. This intervention can be expanded to be utilized in routine services. Thai Clinical Trials Registry, number TCTR20140814002 .
Dyer, A R
Gene therapy for a particular disease like Parkinson's involves ethical principles worked out for other diseases. The major ethical issues for gene therapy (and the corresponding ethical principles) are safety (nonmalfeasance), efficacy (beneficence), informed consent (autonomy), and allocation of resources (justice). Yet genetic engineering (germ-line interventions or interventions to enhance human potentialities) raises emotions and fears that might cause resistance to gene therapies. Looking at these technologies in a postmodern perspective helps one to appreciate the issues at stake in social and cultural change with a new technology such as gene therapy. While "modern" technology and ethics have focused on the autonomy of the individual, we are beginning to see a lessening of such emphasis on individualism and autonomy and more emphasis on the health of the population. Such a social change could cause technologies about which society may currently be cautious (such as human genetic interventions) to become more acceptable or even expected.
Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277
Dragsted, L. O.; Kristensen, M.; Ravn-Haren, Gitte
Metabolomics is a promising tool for searching out new biomarkers and the development of hypotheses in nutrition research. This chapter will describe the design of human dietary intervention studies where samples are collected for metabolomics analyses as well as the analytical issues and data...
D'Augelli, Anthony R.
Describes limitations of the psychological view that has dominated obesity research. The "brand" of psychology represented is assessed on its conceptual strengths, its implications for intervention program development, and its consequences for the delivery of services to people in communities. Suggests use of a human development model.…
Lavinia Ferrante di Ruffano
Full Text Available Abstract Background The most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decision-making and treatment. The multi-staged nature of these interventions, combined with the need to relay diagnostic decision-making and treatment planning, has led researchers to hypothesise that test-treatment strategies may be very challenging to document. However, no reviews have yet examined the reporting quality of interventions used in test-treatment RCTs. In this study we evaluate the completeness of intervention descriptions in a systematically identified cohort of test-treatment RCTs. Methods We ascertained all test-treatment RCTs published 2004–2007, indexed in CENTRAL. Included trials randomized patients to diagnostic tests and measured patient outcomes after treatment. Two raters examined the completeness of test-treatment intervention descriptions in four components: 1 the test, 2 diagnostic decision-making, 3 management decision-making, 4 treatments. Results One hundred and three trials compared 105 control with 119 experimental interventions, most commonly in cardiovascular medicine (35, 34%, obstetrics and gynecology (17%, gastroenterology (14% or orthopedics (10%. A broad range of tests were evaluated, including imaging (50, 42%, biochemical assays (21% and clinical assessment (12%. Only five (5% trials detailed all four components of experimental and control interventions, none of which also provided a complete care pathway diagram. Experimental arms were missing descriptions of tests, diagnostic-decision making, management planning and treatments (36%, 51%, 55% and 79% of trials respectively; control arms were missing the same details in 61%, 66%, 67% and 84% of trials. Conclusion Reporting of test-treatment interventions is very poor, inadequate for understanding the results of these trials, and
Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640
Full Text Available Abstract Background Malaria transmission is highly heterogeneous in most settings, resulting in the formation of recognizable malaria hotspots. Targeting these hotspots might represent a highly efficacious way of controlling or eliminating malaria if the hotspots fuel malaria transmission to the wider community. Methods/design Hotspots of malaria will be determined based on spatial patterns in age-adjusted prevalence and density of antibodies against malaria antigens apical membrane antigen-1 and merozoite surface protein-1. The community effect of interventions targeted at these hotspots will be determined. The intervention will comprise larviciding, focal screening and treatment of the human population, distribution of long-lasting insecticide-treated nets and indoor residual spraying. The impact of the intervention will be determined inside and up to 500 m outside the targeted hotspots by PCR-based parasite prevalence in cross-sectional surveys, malaria morbidity by passive case detection in selected facilities and entomological monitoring of larval and adult Anopheles populations. Discussion This study aims to provide direct evidence for a community effect of hotspot-targeted interventions. The trial is powered to detect large effects on malaria transmission in the context of ongoing malaria interventions. Follow-up studies will be needed to determine the effect of individual components of the interventions and the cost-effectiveness of a hotspot-targeted approach, where savings made by reducing the number of compounds that need to receive interventions should outweigh the costs of hotspot-detection. Trial registration NCT01575613. The protocol was registered online on 20 March 2012; the first community was randomized on 26 March 2012.
Gonzales, N.A.; Dumka, L.E.; Millsap, R.E.; Gottschall, A.; McClain, D.B.; Wong, J.J.; Germán, M.; Mauricio, A.M.; Wheeler, L.; Carpentier, F.D.; Kim, S.Y.
Objective This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, one year after completion of the intervention. The study also examined hypothesized mediators and moderators of intervention effects. Method Stratified by language of program delivery (English vs. Spanish), the trial included a sample of 516 MA adolescents (50.8% female; M =12.3 years, SD=.54) and at least one caregiver that were randomized to receive a low dosage control group workshop or the 9-week group intervention that included parenting, adolescent coping, and conjoint family sessions. Results Positive program effects were found on all five outcomes at one-year posttest, but varied depending on whether adolescents, parents, or teachers reported on the outcome. Intervention effects were mediated by posttest changes in effective parenting, adolescent coping efficacy, adolescent school engagement, and family cohesion. The majority of direct and mediated effects were moderated by language, with a larger number of significant effects for families that participated in Spanish. Intervention effects also were moderated by baseline levels of mediators and outcomes, with the majority showing stronger effects for families with poorer functioning at baseline. Conclusion Findings support the efficacy of the intervention to decrease multiple problem outcomes for MA adolescents, but also demonstrate differential effects for parents and adolescents receiving the intervention in Spanish vs. English, and depending on their baseline levels of functioning. PMID:22103956
Full Text Available 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 control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg and resting heart rate (B = -2.08 beats and significantly increased body mass index (B = .18 units compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396
Drabble, Sarah J; Foster, Alexis; Horspool, Kimberley; Edwards, Louisa; Thomas, Clare; Salisbury, Chris
motivation to make lifestyle changes to address their specific risk factors. Implementation was not optimal in the early part of the CVD risk trial owing to technical difficulties and the need to adapt the intervention for use in practice. For both conditions, enthusiastic and motivated staff offering continuity of intervention delivery tailored to individual patients’ needs were identified as important for patient engagement with telehealth; this was not delivered consistently, particularly in the early stages of the trials. Finally, there was a lack of active engagement from primary care. Conclusions The conceptual model was supported and could be used to develop further telehealth interventions for chronic conditions. It may be possible to increase the effectiveness of this, and similar interventions, by attending to the human as well as the technical aspects of telehealth: offering it to patients actively wanting the intervention, ensuring continuity of delivery by enthusiastic and motivated staff, and encouraging active engagement from primary care staff. PMID:27363434
O'Cathain, Alicia; Drabble, Sarah J; Foster, Alexis; Horspool, Kimberley; Edwards, Louisa; Thomas, Clare; Salisbury, Chris
their specific risk factors. Implementation was not optimal in the early part of the CVD risk trial owing to technical difficulties and the need to adapt the intervention for use in practice. For both conditions, enthusiastic and motivated staff offering continuity of intervention delivery tailored to individual patients' needs were identified as important for patient engagement with telehealth; this was not delivered consistently, particularly in the early stages of the trials. Finally, there was a lack of active engagement from primary care. The conceptual model was supported and could be used to develop further telehealth interventions for chronic conditions. It may be possible to increase the effectiveness of this, and similar interventions, by attending to the human as well as the technical aspects of telehealth: offering it to patients actively wanting the intervention, ensuring continuity of delivery by enthusiastic and motivated staff, and encouraging active engagement from primary care staff.
Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris
Introduction School canteens represent an opportune setting in which to deliver public health nutrition strategies given their wide reach, and frequent use by children. Online school canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer behaviour strategies that impact on purchasing decisions. The aim of this study is to assess the efficacy of a consumer behaviour intervention implemented in an online school canteen ordering system in reducing the kilojoule, saturated fat, sugar and sodium content of primary student lunch orders. Methods and analysis The study will employ a cluster randomised controlled trial design. Approximately 1040 students (aged 5–12 years) from 10 primary schools in New South Wales, Australia, currently using an online canteen ordering system will be invited to participate. Schools will be randomised in a 1:1 ratio to receive either the intervention (enhanced system) or control (standard online ordering only). The intervention will include evidence-based strategies shown to influence healthy food purchasing (strategies targeting availability, menu labelling, placement and prompting). The primary outcomes of the trial will be the mean content per student online lunch order of (1) energy (kJ), (2) saturated fat (g), (3) sugar (g) and (4) sodium (mg). The impact of the intervention will be determined by between-group assessment of the nutritional content of lunch purchases over a 2-month period postintervention initiation. Ethics and dissemination The study was approved by the Hunter New England Human Research Ethics Committee, University of Newcastle Human Research Ethics Committee and New South Wales Department of Education and School Communities. Study findings will be disseminated widely through peer-reviewed publications and relevant presentations in international conferences and to stakeholders. Trial registration number
Pigeot, I; Baranowski, T; De Henauw, S
One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.
Kahn, Richard; Bonuck, Karen; Trombley, Michelle
Inappropriate baby bottle use is associated with tooth decay, anemia, and overweight, and it may adversely affect dietary patterns. Parents often do not follow guidance to wean by 18 months of life. We piloted a brief, counseling-based weaning intervention in an urban WIC agency among primarily Hispanic parent/toddler dyads. At baseline (n = 48), toddlers consumed a mean 4.7 bottles/day. At follow-up (n = 39), the intervention group consumed fewer mean bottles/day than controls (0.09 vs 2.0 bottles/day, P < .045). Half the toddlers in the experimental group and one third of the control groups weaned completely. Parents of weaned children were satisfied with the outcome.
Karen J. Sherman
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.
Symon, Andrew; Pringle, Jan; Downe, Soo; Hundley, Vanora; Lee, Elaine; Lynn, Fiona; McFadden, Alison; McNeill, Jenny; Renfrew, Mary J; Ross-Davie, Mary; van Teijlingen, Edwin; Whitford, Heather; Alderdice, Fiona
Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models. A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions. Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or
Anthon, Carl Thomas; Granholm, Anders; Perner, Anders
INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not app...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....
Osrin, D.; Azad, K.; Fernandez, A.; Manandhar, D. S.; Mwansambo, C. W.; Tripathy, P.; Costello, A. M.
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common ...
Full Text Available Human experience is a critical subject for research. By discussing Video Intervention/Prevention Assessment (VIA, a patient-centered health research method where patients teach their clinicians about living with a chronic condition through the creation of visual illness narratives, this paper examines the value of qualitative inquiry and why human experience rarely is investigated directly. An analysis of a sample VIA data is presented to demonstrate how, by utilizing grounded theory and qualitative analysis, one can derive rich and unique information from human experience.
Pratoomsoot, Chayanin; Sruamsiri, Rosarin; Dilokthornsakul, Piyameth; Chaiyakunapruk, Nathorn
Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention. To systematically review the quality of reporting of RCTs of herbal interventions conducted in the ASEAN Plus Six Countries. Searches were performed using PubMed, EMBASE, The Cochrane Library, and Allied and Complementary Medicine (AMED), from inception through October 2013. These were limited to studies specific to humans and RCTs. Herbal species search terms were based on those listed in the National List of Essential Medicines [NLEM (Thailand, 2011)]. Studies conducted in the ASEAN Plus Six Countries, published in English were included. Seventy-one articles were identified. Thirty (42.25%) RCTs were from ASEAN Countries, whereas 41 RCTs (57.75%) were from Plus Six Group. Adherence to the recommended CONSORT checklist items for reporting of RCTs of herbal interventions among ASEAN Plus Six Countries ranged from 0% to 97.18%. Less than a quarter of the RCTs (18.31%) reported information on standardisation of the herbal products. However, the scope of our interventions of interest was limited to those developed from 20 herbal species listed in the NLEM of Thailand. The present study highlights the need to improve reporting quality of RCTs of herbal interventions across ASEAN Plus Six Communities.
Hopewell, S; McDonald, S; Clarke, M; Egger, M
The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most
Doss, Brian D.; Cicila, Larisa N.; Hsueh, Annie C.; Morrison, Kristen R.; Carhart, Kathryn
The transition to parenthood has been repeatedly identified as a stressful period, with couples reporting difficulties in domains of individual, coparenting, and relationship functioning. Moreover, these difficulties have been shown to impact children’s development. To buffer against these difficulties, numerous effective parenting, couple, and combined interventions have been developed; however, these interventions are typically lengthy, which limits their potential for dissemination. Therefore, in the present study, we developed and tested separate six-hour interventions that focused exclusively on improving either coparenting or relationship functioning. In a randomized control trial, 90 heterosexual couples (180 individuals) were randomly assigned to an information control group, a coparenting intervention, or a relationship intervention and assessed on seven occasions during the two years following birth. Results revealed that women and high-risk men in both the couple and coparenting interventions showed fewer declines in relationship satisfaction (Cohen’s d = 0.53–0.99) and other areas of relationship functioning. Women also reported improved coparenting in both intervention groups (Cohen’s d = 0.47–1.06). Additionally, women in both interventions experienced less perceived stress during the first year after birth. Given similar effects of the two interventions on coparenting and relationship functioning, future dissemination may be enhanced by delivery of coparenting interventions, as coparenting (compared to relationship) interventions seem to attract more interest from couples and are likely easier to integrate into existing services. PMID:25090255
Figueiras, Maria João; Maroco, João; Monteiro,Rita; Caeiro, Raúl; Neto, David Dias
There is converging evidence that changing beliefs about an illness leads to positive recovery outcomes. However, cardiac misconceptions interventions have been investigated mainly in Angina or Coronary Heart Disease patients, and less in patients following Myocardial Infarction (MI). In these patients, cardiac misconceptions may play a role in the adjustment or lifestyle changes. This article reports a randomized controlled trial of an intervention designed to reduce the strength of misconce...
Powell, John; Newhouse, Nikki; Martin, Angela; Jawad, Sena; Yu, Ly-Mee; Davoudianfar, Mina; Locock, Louise; Ziebland, Sue
The internet is frequently used to share experiences of health and illness, but this phenomenon has not been harnessed as an intervention to achieve health behaviour change. The aim of this study was to determine the feasibility of a randomised trial assessing the effects of a novel, experience-based website as a smoking cessation intervention. The secondary aim was to measure the potential impact on smoking behaviour of both the intervention and a comparator website. A feasibility randomised controlled single-blind trial assessed a novel, experience-based website containing personal accounts of quitting smoking as a cessation intervention, and a comparator website providing factual information. Feasibility measures including recruitment, and usage of the interventions were recorded, and the following participant-reported outcomes were also measured: Smoking Abstinence Self-Efficacy Questionnaire, the single-item Motivation to Stop Scale, self-reported abstinence, quit attempts and health status outcomes. Eligible smokers from two English regions were entered into the trial and given access to their allocated website for two weeks. Eighty-seven smokers were randomised, 65 completed follow-up (75 %). Median usage was 15 min for the intervention, and 5 min for the comparator (range 0.5-213 min). Median logins for both sites was 2 (range 1-20). All participant-reported outcomes were similar between groups. It was technically feasible to deliver a novel intervention harnessing the online sharing of personal experiences as a tool for smoking cessation, but recruitment was slow and actual use was relatively low, with attrition from the trial. Future work needs to maximize engagement and to understand how best to assess the value of such interventions in everyday use, rather than as an isolated 'dose of information'. ISRCTN29549695 DOI 10.1186/ISRCTN29549695 . Registered 17/05/2013.
Briley, Annette L; Barr, Suzanne; Badger, Shirlene; Bell, Ruth; Croker, Helen; Godfrey, Keith M.; Holmes, Bridget; Kinnunen, Tarja I.; Nelson, Scott N.; Oteng-Ntim, Eugene; Patel, Nashita; Robson, Stephen C.; Sandall, Jane; Sanders, Thomas; Sattar, Naveed
Background:\\ud Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery ...
Dieng, Mbathio; Kasparian, NA; Mireskandari, Shab; Butow, Phyllis; Costa, Daniel; Morton, Rachael; Mann, Graham; Menzies, Scott; Cust, Anne
Introduction Information and psychological needs have been reported as one of the greatest areas of unmet needs for patients with melanoma. To respond to these needs, we developed the Melanoma Care Intervention, a developed psychoeducational intervention for people at high risk of developing another melanoma comprising of a newly developed melanoma educational booklet and individually tailored telephone support sessions provided by trained psychologists. The purpose of this study was to investigate the acceptability and feasibility of the Melanoma Care Intervention. Methods Twenty-four adults (14 men, 10 women, mean age: 58 years, SD: 12.2) at high risk of developing a subsequent primary melanoma were recruited and randomly assigned 1:1 to the intervention (a psychoeducational booklet, a Cancer Council booklet on melanoma and up to five telephone-based sessions with a psychologist) or usual care (Cancer Council booklet only). Acceptability, feasibility, fear of cancer recurrence and secondary psychosocial outcomes were assessed at baseline, 1 and 6 months. Results Satisfaction and perceived benefits were rated highly for all intervention components, particularly the telephone-based psychology sessions (mean satisfaction and benefits: both 9.27 out of 10, SD=2.41). The quality of information and support provided throughout the trial was rated as ‘high’ by the intervention group, with a mean score of 4.6 out of a possible 5 (SD=0.9) and 4.2 (SD=1.2) for the control group. Conclusions The intervention was feasible and acceptable for improving psychological adjustment. Timely access to effective, evidence-based, psychological care is a recognised need for people with melanoma. The intervention is designed to directly address this need in a way that is feasible in a clinical setting, acceptable to patients and health professionals. Trial registration number The trial was registered with the Australian and New Zealand Clinical Trials Registry on 19
Okesene-Gafa, Karaponi; Li, Minglan; Taylor, Rennae S; Thompson, John M D; Crowther, Caroline A; McKinlay, Christopher J D; McCowan, Lesley M E
Maternal obesity is associated with adverse pregnancy outcomes and has lifelong negative implications for offspring health. The Institute of Medicine recommends limited gestational weight gain (GWG) in obese women for optimal maternal and infant outcomes. However, there is a gap regarding an effective and sustainable intervention strategy to achieve this goal. The aim of the healthy mums and babies (HUMBA) demonstration trial is to assess whether a multifaceted nutritional intervention and/or an oral probiotic treatment in obese pregnant women can reduce excessive GWG and optimise pregnancy outcomes. The study is a two by two factorial randomised controlled demonstration trial conducted in Counties Manukau health region, New Zealand, a multi-ethnic region with a high prevalence of obesity. A total of 220 non-diabetic obese women with a singleton pregnancy will be recruited between 12 0 and 17 6 weeks. At recruitment, women are randomised to receive either a culturally tailored multifaceted dietary intervention or routine dietary advice, and either an oral probiotic or placebo capsule. Randomisation is undertaken via a web-based protocol, randomize.net, with a 1:1 ratio using stratification by body mass index (BMI) category (BMI of 30-34.9 or BMI ≥35 kg/m 2 ). The dietary intervention includes 4 customised nutrition education visits by a trained community health worker combined with motivational text messaging. Probiotic capsules consist of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 at a dose of 7 × 10 9 colony-forming units one per day until birth. Probiotic and placebo capsules are identically pre-packed and labelled by a third party, and are prescribed in a double blinded fashion. Research assessments are conducted at enrolment, 28 weeks, 36 weeks, at birth and at 5 months post-delivery. The primary outcomes for the study are proportion of women with excessive GWG and infant birthweight. The HUMBA demonstration trial will assess the
Stout, Steven C; Amundson, Jeffrey C; Miller, Ralph R
The influences of order of trial type and retention interval on human predictive judgments were assessed for a cue that was reinforced on half of its training presentations. Subjects observed 10 cue-outcome presentations (i.e., reinforced trials) and 10 cue-alone presentations (i.e., nonreinforced trials) in one of three different orders: all nonreinforced trials followed by all reinforced trials(latent inhibition), reinforced and nonreinforced trials interspersed (partial reinforcement), or al lreinforced trials followed by all nonreinforced trials (extinction). Ratings were based mainly on the most recent event type (i.e., a recency effect) when the test occurred immediately after training but were based mainly on initial event types (i.e., a primacy effect) when the test occurred after a 48-h delay. The subjects tested both immediately and with a long retention interval did not exhibit this shift to primacy (i.e., the recency effect persisted). These results demonstrate noncatastrophic forgetting and the flexible use of trial order information in predictive judgments.
Underwood, Martin; Eldridge, Sandra; Lamb, Sallie; Potter, Rachel; Sheehan, Bartley; Slowther, Anne-Marie; Taylor, Stephanie; Thorogood, Margaret; Weich, Scott
Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months. INTERVENTION GROUP: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or a depression awareness training session for care home staff.Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. [ISRCTN: ISRCTN43769277].
Background Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. Methods In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to intervention group received behavioral intervention and control group received the usual care for two years. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of month 24 to the end of month 30. Participants were followed up at month 48. Results Continuous smoking abstinence rates from month 24 to 30 were significantly higher in participants receiving behavioral intervention than in those receiving usual care (46.4% vs 3.4%, p intervention than in those control group. Family members or family physicians/nurses smoking were first identified to influence smoking cessation. Conclusions Behavioral intervention doubled the smoking cessation rate in patients with COPD and was complied well by the general practitioners. The family members and family physicians/nurses smoking were the main risk factors for smoking cessation. Trial registration Chinese Clinical Trials Registration (ChiCTR-TRC-12001958). PMID:23802809
Müssener, Ulrika; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; McCambridge, Jim; Bendtsen, Preben
Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results. The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention. The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary
Normansell, Rebecca; Holmes, Rebecca; Victor, Christina; Cook, Derek G; Kerry, Sally; Iliffe, Steve; Ussher, Michael; Fox-Rushby, Julia; Whincup, Peter; Harris, Tess
Trials in primary care to increase physical activity (PA) typically experience poor recruitment rates and may not recruit those with lower PA levels and who are most in need of the intervention. Despite the well-publicised benefits of physical activity, the majority of adults in the UK remain inactive and, therefore, at greater risk of many health problems. Our aim was to investigate the reasons for non-participation in the PACE-UP trial, which is a primary care pedometer-based walking intervention. This is important for successful recruitment and retention in future PA trials and programmes. We conducted semi-structured audio-recorded telephone interviews with 30 participants, aged 45-75 years, purposively sampled from those declining participation in the PACE-UP trial. Recruitment continued until data saturation and a demographically balanced sample was achieved. Interviews were transcribed verbatim, coded and subjected to thematic analysis. Interviewees supported walking as suitable exercise for most people in this age group, recognised the importance of this type of research and general practice as an appropriate setting. Key reasons for declining were: the perception of being already 'too active'; existing medical conditions; work; travel and other commitments. Less frequently cited reasons included reluctance to be randomised, the intervention's duration, wearing a pedometer, perceived inappropriateness of trial literature and a preference for a different kind of PA or for a group activity. Whilst most interviewees perceived themselves to be sufficiently active, an important minority did not participate due to existing medical conditions and other commitments. Recruitment to future PA trials might be improved by tailoring activity to compensate for medical problems, and adapting PA interventions to fit around work and travel commitments. Ensuring that patient-targeted literature is succinct and inclusive and that equipment is user-friendly are also important
Jones, Jannah; Wolfenden, Luke; Wyse, Rebecca; Finch, Meghan; Yoong, Sze Lin; Dodds, Pennie; Pond, Nicole; Gillham, Karen; Freund, Megan; McElduff, Patrick; Wye, Paula; Wiggers, John
Childhood overweight and obesity tracks into adulthood, increasing the risk of developing future chronic disease. Implementing initiatives promoting healthy eating and physical activity in childcare settings has been identified as a priority to prevent excessive child weight gain. Despite this, few trials have been conducted to assess the effectiveness of interventions to support population-wide implementation of such initiatives. The aim of this study is to assess the effectiveness of a multicomponent intervention in increasing the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study will employ a parallel group randomised controlled trial design. A sample of 128 childcare services in the Hunter region of New South Wales, Australia, will be recruited to participate in the trial. 64 services will be randomly allocated to a 12-month implementation intervention. The remaining 64 services will be allocated to a usual care control group. The intervention will consist of a number of strategies to facilitate childcare service implementation of healthy eating and physical activity policies and practices. Intervention strategies will include implementation support staff, securing executive support, consensus processes, staff training, academic detailing visits, performance monitoring and feedback, tools and resources, and a communications strategy. The primary outcome of the trial will be the prevalence of services implementing all healthy eating and physical activity policies and practices targeted by the intervention. To assess the effectiveness of the intervention, telephone surveys with nominated supervisors and room leaders of childcare services will be conducted at baseline and immediately postintervention. The study was approved by the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee. Study findings will be disseminated widely
Full Text Available Abstract Background Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women. Methods A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline and 36-37 (end of intervention. The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method. Results The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml (p = 0.018, 95% CI 1.1-2.3 and 1.4 ng/mg (p = 0.08, 95% CI 1.0-1.9 higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations. Conclusion The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women. Trial registration ISRCTN21512277, http://www.isrctn.org
Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette
Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).
Madurasinghe, V W; Sohanpal, Ratna; James, Wai; Steed, Liz; Eldridge, Sandra; Taylor, Sjc; Griffiths, C; Walton, Robert
UK government policy aims to strengthen the role of community pharmacies in health promotion. Thus, we conducted feasibility studies for an intervention to enhance delivery of the NHS Smoking Cessation Service. The overall aims were to assess acceptability and feasibility of conducting the intervention in community pharmacies and piloting this with a cluster randomised trial. Specific objectives were (1) to estimate likely participation rates of pharmacies and stop smoking advisors, (2) to establish the potential impact of the training intervention on throughput and retention of smokers in smoking services, (3) to establish potential impact on smoking cessation outcomes, (4) to optimise logistics for conducting a cluster randomised trial in the next phase of the research programme and (5) to consider the feasibility of collecting pharmacy and service user data. In this cluster randomised parallel group pilot trial, 12 community pharmacies in East London were allocated to intervention or usual practice using simple randomisation (allocation ratio 2:1). Data were analysed descriptively. Twelve of 54 (22.2%, 95% CI 12.0% to 35.6%) pharmacies and 20 of 23 (87.0%, 95% CI 66.4% to 97.2%) advisors invited, agreed to participate. Over 5 months, 302 smokers in intervention pharmacies (mean per pharmacy 43.1, 95% CI: -4.3 to 90.5) and 319 in usual practice pharmacies (mean per pharmacy 79.8, 95% CI: 19.0 to 140.5) joined the service. 51 of 621 smokers (6.3% in intervention vs 10.0% in usual practice) consented to provide additional data on smoking cessation. 17 of 19 smokers that consented were retained at 4 weeks in intervention arm (89.5%, 95% CI: 66.9% to 98.7%) and 24 of 32 in usual practice (75.0%, 95% CI: 56.6% to 88.5%). 10 of 19 in the intervention arm (52.6%, 95% CI: 28.9% to 75.6%) stopped smoking compared to 7 of 32 in usual practice arm (21.9%, 95% CI: 9.3% to 40.0%). The pilot was useful in providing insights on how best to conduct the definitive trial and
Zinsstag, Jakob; Schelling, Esther; Roth, Felix; Bonfoh, Bassirou; de Savigny, Don; Tanner, Marcel
Although industrialized countries have been able to contain recent outbreaks of zoonotic diseases, many resource-limited and transitioning countries have not been able to react adequately. The key for controlling zoonoses such as rabies, echinococcosis, and brucellosis is to focus on the animal reservoir. In this respect, ministries of health question whether the public health sector really benefits from interventions for livestock. Cross-sectoral assessments of interventions such as mass vaccination for brucellosis in Mongolia or vaccination of dogs for rabies in Chad consider human and animal health sectors from a societal economic perspective. Combining the total societal benefits, the intervention in the animal sector saves money and provides the economic argument, which opens new approaches for the control of zoonoses in resource-limited countries through contributions from multiple sectors.
Wangberg, Silje C; Nilsen, Olav; Antypas, Konstantinos; Gram, Inger Torhild
Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components. The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content. We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email. Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P Internet-based intervention for smoking cessation seems to increase the success rates in the short term, but not in the long term.
Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi
The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.
Bunner, Anne E; Agarwal, Ulka; Gonzales, Joseph F; Valente, Francesca; Barnard, Neal D
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. 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 period was 16 weeks, with a 4-week washout between. During the diet period, a low-fat vegan diet was prescribed for 4 weeks, after which an elimination diet was used. Participants were assessed at the beginning, midpoint, and end of each period. Significance was determined using student's t-tests. Worst headache pain in last 2 weeks, as measured by visual analog scale, was initially 6.4/10 cm (SD 2.1 cm), and declined 2.1 cm during the diet period and 0.7 cm during the supplement period (p=0.03). Average headache intensity (0-10 scale) was initially 4.2 (SD 1.4) per week, and this declined by 1.0 during the diet period and by 0.5 during the supplement period (p=0.20). Average headache frequency was initially 2.3 (SD 1.8) per week, and this declined by 0.3 during the diet period and by 0.4 during the supplement period (p=0.61). The Patient's Global Impression of Change showed greater improvement in pain during the diet period (pnutritional approach may be a useful part of migraine treatment, but that methodologic issues necessitate further research. Clinicaltrials.gov, NCT01699009 and NCT01547494.
McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney
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…
Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie
Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…
Bello, Segun; Wei, Maoling; Hilden, Jørgen
Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...
Meulenbeek, Petrus Antonius Maria
EFFECTIVENESS OF AN EARLY INTERVENTION FOR PANIC SYMPTOMS: RANDOMIZED CONTROLLED TRIAL Peter Meulenbeek¹,3,4, Godelief Willemse², Filip Smit²,3, Pim Cuijpers²,3 ¹ GGNet, the Netherlands; UTwente ² Trimbos instituut, Netherlands Institute of Mental Health and Addiction ³ Vrije Universiteit van
Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty
Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…
Savović, Jelena; Jones, Hayley E; Altman, Douglas G
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...
Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D
Abstract Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Methods Overweight adults ...
Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.
Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial
Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.
Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was
Phillips, Beth M.; Tabulda, Galiya; Ingrole, Smriti A.; Webb Burris, Pam; Sedgwick, T. Kayla; Chen, Shiyi
Purpose: The present article reports on the implementation and results of a randomized intervention trial targeting the literate language skills of prekindergarten children without identified language disorders but with low oral language skills. Method: Children (N = 82; 45 boys and 37 girls) were screened-in and randomized to a business-as-usual…
Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.
Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…
White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence
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 evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…
Ebbels, Susan H.; van der Lely, Heather K. J.; Dockrell, Julie E.
Purpose: The authors aimed to establish whether 2 theoretically motivated interventions could improve use of verb argument structure in pupils with persistent specific language impairment (SLI). Method: Twenty-seven pupils with SLI (ages 11;0-16;1) participated in this randomized controlled trial with "blind" assessment. Participants were randomly…
M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); M.G.M. Hunink (Myriam); M. Van Dijk (Monique)
textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the
Duff, Fiona J; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J; Miles, Jeremy N V; Snowling, Margaret J
Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice. © 2014 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.
Chenquan Gan; Xiaofan Yang; Wanping Liu; Qingyi Zhu; Xulong Zhang
This paper examines the propagation behavior of computer virus under human intervention. A dynamical model describing the spread of computer virus, under which a susceptible computer can become recovered directly and an infected computer can become susceptible directly, is proposed. Through a qualitative analysis of this model, it is found that the virus-free equilibrium is globally asymptotically stable when the basic reproduction number R0≤1, whereas the viral equilibrium is globally asympt...
Wilson Graeme B
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
John A Cunningham
Full Text Available 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.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.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 offer an easy to access and non-threatening portal that can be used to
Starren, Justin B; Payne, Philip R O; Kaufman, David R
Clinical trials increasingly rely upon web-based Clinical Trials Management Systems (CTMS). As with clinical care systems, Human Computer Interaction (HCI) issues can greatly affect the usefulness of such systems. Evaluation of the user interface of one web-based CTMS revealed a number of potential human-computer interaction problems, in particular, increased workflow complexity associated with a web application delivery model and potential usability problems resulting from the use of ambiguous icons. Because these design features are shared by a large fraction of current CTMS, the implications extend beyond this individual system.
Adamsen, Lis; Quist, Morten; Andersen, Christina
OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced dis...... disease. The intervention reduced fatigue and improved vitality, aerobic capacity, muscular strength, and physical and functional activity, and emotional wellbeing, but not quality of life. TRIAL REGISTRATION: Current Controlled trials ISRCTN05322922.......OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo(2)max). Statistical methods The general linear model was used...
Appel, L J; Espeland, M; Whelton, P K; Dolecek, T; Kumanyika, S; Applegate, W B; Ettinger, W H; Kostis, J B; Wilson, A C; Lacy, C
National and international policy-making organizations advocate nonpharmacologic therapies to reduce blood pressure (BP). However, data to support such recommendations in older persons are virtually nonexistent. The Trials of Nonpharmacologic Intervention in the Elderly (TONE) is a randomized, controlled trial that will test whether weight loss or a reduced sodium (Na) intake or both can maintain satisfactory BP control, without unacceptable side effects, after withdrawal of antihypertensive drug therapy. Medication-treated hypertensives (aged 60 to 80 years) with a systolic BP less than 145 mm Hg and a diastolic BP less than 85 mm Hg who are taking one antihypertensive medication are randomly assigned to one of four groups: (1) weight loss alone, (2) reduced Na intake alone, (3) combined weight loss and reduced Na intake, or (4) usual life-style (control group). Overweight participants are randomized to one of these four groups, while nonoverweight individuals are assigned to either the reduced Na intake or the usual life-style group. The interventions, tailored to the needs of older persons, use behavioral approaches to accomplish intervention-specific goals (weight loss > or = 10 lb, daily Na intake mEqa). Three months after the start of intervention, antihypertensive drug therapy is withdrawn. The primary trial end point is a BP of 150/90 mm Hg or higher, resumption of antihypertensive drug therapy, or the occurrence of a BP-related clinical complication during 2 to 3 years of follow-up. It is anticipated that TONE findings may identify an effective and acceptable nonpharmacologic approach to control hypertension in the increasingly large number of older persons treated with antihypertensive drug therapy.
Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory
A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating theory-based interventions were systematically identified. Sample, intervention, methodology, and theory implementation characteristics were extracted, coded by three duos of independent investigators, and tested as moderators of interventions effect in a multiple-meta-regression model. Three moderators were negatively associated with the efficacy of theory-based interventions on PA behavior: intervention length (≥14 weeks; β = -.22, p = .004), number of experimental patients (β = -.10, p = .002), and global methodological quality score (β = -.08, p = .04). Our findings suggest that the efficacy of theory-based interventions to promote PA could be overestimated consequently due to methodological weaknesses of RCTs and that interventions shorter than 14 weeks could maximize the increase of PA behavior.
K.D. Allen (Kelli); S.M. Bierma-Zeinstra (Sita); N.E. Foster (Nadine); Y.M. Golightly (Yvonne); G. Hawker (Gillian)
textabstractRigorous implementation research is important for testing strategies to improve the delivery of effective osteoarthritis (OA) interventions. The objective of this manuscript is to describe principles of implementation research, including conceptual frameworks, study designs and
Full Text Available Abstract Background Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Methods Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. Results 312 participants were recruited (69% women. Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05. Mean age of all participants was 81 years (SD 5. On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics with a median of 2 falls (interquartile range 1, 3 in the previous year. Conclusion The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a
Renjith, Vishnu; Pai, Aparna; Radhakrishnan, Kurupath; Nayak, Baby S; Devi, Elsa Sanatombi; Ladd, Elissa; George, Anice
To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in, ). CTRI reference ID: CTRI/2015/10/006282. © 2017 John Wiley & Sons Ltd.
Full Text Available Abstract Background There is still debate as to which features, types or components of primary care interventions are associated with improved depression outcomes. Previous reviews have focused on components of collaborative care models in general practice settings. This paper aims to determine the effective components of depression care in primary care through a systematic examination of both general practice and community based intervention trials. Methods Fifty five randomised and controlled research trials which focused on adults and contained depression outcome measures were identified through PubMed, PsycInfo and the Cochrane Central Register of Controlled Trials databases. Trials were classified according to the components involved in the delivery of treatment, the type of treatment, the primary focus or setting of the study, detailed features of delivery, and the discipline of the professional providing the treatment. The primary outcome measure was significant improvement on the key depression measure. Results Components which were found to significantly predict improvement were the revision of professional roles, the provision of a case manager who provided direct feedback and delivered a psychological therapy, and an intervention that incorporated patient preferences into care. Nurse, psychologist and psychiatrist delivered care were effective, but pharmacist delivery was not. Training directed to general practitioners was significantly less successful than interventions that did not have training as the most important intervention. Community interventions were effective. Conclusion Case management is important in the provision of care in general practice. Certain community models of care (education programs have potential while others are not successful in their current form (pharmacist monitoring.
Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris; Wolfenden, Luke
School canteens represent an opportune setting in which to deliver public health nutrition strategies given their wide reach, and frequent use by children. Online school canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer behaviour strategies that impact on purchasing decisions. The aim of this study is to assess the efficacy of a consumer behaviour intervention implemented in an online school canteen ordering system in reducing the kilojoule, saturated fat, sugar and sodium content of primary student lunch orders. The study will employ a cluster randomised controlled trial design. Approximately 1040 students (aged 5-12 years) from 10 primary schools in New South Wales, Australia, currently using an online canteen ordering system will be invited to participate. Schools will be randomised in a 1:1 ratio to receive either the intervention (enhanced system) or control (standard online ordering only). The intervention will include evidence-based strategies shown to influence healthy food purchasing (strategies targeting availability, menu labelling, placement and prompting). The primary outcomes of the trial will be the mean content per student online lunch order of (1) energy (kJ), (2) saturated fat (g), (3) sugar (g) and (4) sodium (mg). The impact of the intervention will be determined by between-group assessment of the nutritional content of lunch purchases over a 2-month period postintervention initiation. The study was approved by the Hunter New England Human Research Ethics Committee, University of Newcastle Human Research Ethics Committee and New South Wales Department of Education and School Communities. Study findings will be disseminated widely through peer-reviewed publications and relevant presentations in international conferences and to stakeholders. ACTRN12616000499482. Published by the BMJ Publishing Group Limited. For permission to
Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups
Lou, Peian; Zhu, Yanan; Chen, Peipei; Zhang, Pan; Yu, Jiaxi; Zhang, Ning; Chen, Na; Zhang, Lei; Wu, Hongmin; Zhao, Jing
Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to intervention group received behavioral intervention and control group received the usual care for two years. The primary efficacy endpoint was the complete and continuous abstinence from smoking from the beginning of month 24 to the end of month 30. Participants were followed up at month 48. Continuous smoking abstinence rates from month 24 to 30 were significantly higher in participants receiving behavioral intervention than in those receiving usual care (46.4% vs 3.4%, p intervention than in those control group. Family members or family physicians/nurses smoking were first identified to influence smoking cessation. Behavioral intervention doubled the smoking cessation rate in patients with COPD and was complied well by the general practitioners. The family members and family physicians/nurses smoking were the main risk factors for smoking cessation. Chinese Clinical Trials Registration (ChiCTR-TRC-12001958).
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..
Lindemann, Kristina; Kok, Peey-Sei; Stockler, Martin; Jaaback, Ken; Brand, Alison
We sought to summarize the evidence for interventions aiming at enhanced recovery after surgery (ERAS) in ovarian cancer through a systematic review. We searched MEDLINE, EMBASE, and The Cochrane Library for studies testing ERAS interventions in patients undergoing surgery for ovarian cancer. Study selection and data extraction were done independently by 2 reviewers with disagreements resolved by discussion with a senior, third reviewer. We identified 25 studies including 1648 participants with ovarian cancer. Nine observational studies addressed ERAS protocols. Four of them were prospective, and 3 included historical controls. The other 16 studies reported single interventions, for example, early feeding, omission of pelvic drains, early orogastric tube removal, Doppler-guided fluid management, and patient-controlled epidural analgesia. Early feeding protocols were tested in 7 of the 12 randomized trials. Early feeding appeared to be safe and was associated with significantly faster recovery of bowel function. Few studies have specifically studied ERAS interventions in ovarian cancer. All studies on protocols including multiple interventions were susceptible to bias. Early feeding is the intervention that is best supported by randomized trials. Application of evidence for ERAS derived from nonovarian cancer is challenged by the differences not only in the scope of surgery but also in ovarian cancer patients' comorbidities. Postoperative morbidity is particularly high in these patients because of their poor nutritional status, perioperative fluids shifts, and long operating times. These patients may also show excessive response to surgical stress. Innovative, randomized trials are needed to reliably determine the feasibility, safety, and effectiveness of specific ERAS interventions in ovarian cancer.
van Balkom Anton
Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an
McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M
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. 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 control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.
Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen
In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health
Mackay, Dylan S; Jew, Stephanie; Jones, Peter J H
Dietary oils are a significant contributor to overall energy and fatty acid intakes. Changes in the amount and/or type of dietary oils consumed have the potential to impact human health. Clinical trials represent the gold standard for testing the health impacts of such changes in dietary oils. The objective of this review is to explore best practices for clinical trials examining impacts of dietary oils including 1) pre-clinical topics such as research question generation, study design, participant population, outcome measures and intervention product selection and/or preparation; 2) clinical trial implementation topics such as recruitment, trial management, record keeping and compliance monitoring; and 3) post-clinical trial topics dealing with sample analysis and storage as well as management, publication and data access. The use of digital case report forms, and the best practices in reporting and publishing results are also addressed. In summary, properly designed and implemented clinical trials studying dietary oils produce strong scientific evidence-guiding their use. Copyright © 2016 Elsevier B.V. All rights reserved.
Kothe, Emily J; Mullan, Barbara A; Amaratunga, Rajith
The present study sought to test the efficacy of a brief theory-based intervention to promote regular consumption of breakfast, and to expand previous results suggesting that the theory of planned behaviour (TPB) can be meaningfully applied to breakfast consumption. A four-armed randomised controlled trial was conducted. Participants (n=349) were allocated to receive either a (1) positively framed attitude intervention, (2) negatively framed attitude intervention, (3) Perceived Behavioural Control (PBC) intervention, or (4) control task. Attitude, subjective norm, PBC and behaviour were measured at baseline and 4-week follow-up. All three interventions employed persuasive communication and an implementation intention task. The intervention did not result in expected increases in breakfast consumption, or in changes in attitude, subjective norm or PBC. However, baseline attitude, subjective norm and PBC predicted 39.3% of baseline intention. Baseline intention in turn predicted 33% of breakfast consumption at 4 weeks. Change in breakfast consumption was predicted by change in attitude, subjective norm, and PBC between baseline and follow-up. Despite a lack of intervention effects, the TPB provided a good model of breakfast consumption over the four-week follow-up period. By expanding on previous work investigating breakfast consumption using the TPB, this study provides further support for the argument that that theory based interventions could result in meaningful increases in breakfast consumption. Copyright © 2010 Elsevier Ltd. All rights reserved.
Ondersma, Steven J; Svikis, Dace S; Schuster, Charles R
Drug use among parenting women is a significant risk factor for a range of negative child outcomes, including exposure to violence, child maltreatment, and child behavior problems. Implementation of brief interventions with this population may be greatly facilitated by computer-based interventions. Randomized clinical trial with 4-month follow-up. Participants were 107 postpartum women recruited from an urban obstetric hospital primarily serving a low-income population. Women were randomized into assessment only versus assessment plus brief intervention conditions; 76 (71%) returned for follow-up evaluation. A 20-minute, single-session, computer-based motivational intervention (based on motivational interviewing methods), combined with two nontailored mailings and voucher-based reinforcement of attendance at an initial intake/treatment session. Illicit drug use as measured by qualitative urinalysis and self-report. Frequency of illicit drug use other than marijuana increased slightly for the control group, but declined among intervention group participants (pmarijuana use frequency was similar, but did not reach statistical significance. Point-prevalence analysis at follow-up did not show significant group differences in drug use. However, trends under a range of assumptions regarding participants lost to follow-up all favored the intervention group, with most effect sizes in the moderate range (odds ratios 1.4 to 4.7). Results tentatively support the efficacy of this high-reach, replicable brief intervention. Further research should seek to replicate these findings and to further develop the computer as a platform for validated brief interventions.
Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D
The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.
Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C
Childcare settings are an opportune location for early intervention programs seeking to prevent childhood obesity. This article reports on a systematic review of controlled trials of obesity prevention interventions in childcare settings. The review was limited to English language articles published in PubMed, Web of Science, and Education Resources Information Center (ERIC) between January 2000 and April 2012. childhood obesity prevention interventions in childcare settings using controlled designs that reported adiposity and behavior outcomes. no interventions, non-childcare settings, clinical weight loss programs, non-English publications. Publications were identified by key word search. Two authors reviewed eligible studies to extract study information and study results. Qualitative synthesis was conducted, including tabulation of information and a narrative summary. Fifteen studies met the eligibility criteria. Seven studies reported improvements in adiposity. Six of the 13 interventions with dietary components reported improved intake or eating behaviors. Eight of the 12 interventions with physical activity components reported improved activity levels or physical fitness. Evidence was mixed for all outcomes. Results should be interpreted cautiously given the high variability in study designs and interventions. Further research needs long-term follow-up, multistrategy interventions that include changes in the nutrition and physical activity environment, reporting of cost data, and consideration of sustainability.
Day, Crispin; Briskman, Jackie; Crawford, Mike J; Harris, Lucy; McCrone, Paul; McMurran, Mary; Moran, Paul; Morgan, Lou; Scott, Stephen; Stahl, Daniel; Ramchandani, Paul; Weaver, Timothy
The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session). The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers' and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.
Full Text Available The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session. The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers’ and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.
Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen
This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a measure of parent-child play at follow-up. Therefore, this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad(™) apps for amelioration of difficulties in interaction. However, positive attitudes among participants, lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further, perhaps targeting other skill domains. © The Author(s) 2015.
Gallegos, Esther C; Villarruel, Antonia M; Loveland-Cherry, Carol; Ronis, David L; Yan Zhou, Ms
To test the efficacy of a behavioral intervention designed to decrease risk sexual behaviors for HIV/AIDS and unplanned pregnancies in Mexican adolescents. Randomized controlled trial with four follow ups; 832 adolescents recruited from high schools, age 14-17, were randomly assigned to the experimental or control group. The six hour intervention used active learning strategies, and was delivered in two sessions on two consecutive Saturdays. The study was carried out in Monterrey, Mexico, 2002-2005. GEE analysis indicated no differences in sexual relationships intentions between the two conditions, however, the experimental group had higher intentions to use condoms and contraceptives (mean differences 0.15 and 0.16, CI 95%) in the next three months, as compared with the control group. Theoretical variables, such as control beliefs, were significant mediators of the intervention. The behavioral intervention represents an important effort in promoting safe sexual behaviors among Mexican adolescents.
Meichsner, Franziska; Schinköthe, Denise; Wilz, Gabriele
Dementia caregivers often experience loss and grief related to general caregiver burden, physical, and mental health problems. Through qualitative content analysis, this study analyzed intervention strategies applied by therapists in a randomized-controlled trial in Germany to assist caregivers in managing losses and associated emotions. Sequences from 61 therapy sessions that included interventions targeting grief, loss, and change were transcribed and analyzed. A category system was developed deductively, and the intercoder reliability was satisfactory. The identified grief intervention strategies were recognition and acceptance of loss and change,addressing future losses,normalization of grief, and redefinition of the relationship Therapists focused on identifying experienced losses, managing associated feelings, and fostering acceptance of these losses. A variety of cognitive-behavioral therapy-based techniques was applied with each strategy. The findings contribute to understanding how dementia caregivers can be supported in their experience of grief and facilitate the development of a manualized grief intervention. © The Author(s) 2015.
Bricker, Jonathan B.; Liu, Jingmin; Comstock, Bryan A.; Peterson, Arthur V.; Kealey, Kathleen A.; Marek, Patrick M.
Only one prior study has examined why adolescent smoking cessation interventions are effective. To address this understudied and important issue, this study examined whether a large adolescent smoking cessation intervention trial’s outcomes were mediated by Social Cognitive Theory processes. In a randomized trial (N = 2,151), counselors proactively delivered a telephone intervention to senior year high school smokers. Mediators and smoking status were self-reported at 12 months post-intervention-eligibility (88.8% retention). At-least-6-months abstinence was the outcome. Among all enrolled smokers, increased self-efficacy to resist smoking in (a) social & (b) stressful situations together statistically mediated 55.6% of the intervention’s effect on smoking cessation (p smoking in stressful situations statistically mediated 56.9% of the intervention’s effect (p smoking is a possible mediator of the intervention’s effect on smoking cessation. PMID:20853929
Verdurmen, J.E.E.; Koning, I.M.; Vollebergh, W.A.M.; Eijnden, R.J.J.M. van den; Engels, R.C.M.E.
Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m = 12.68 years, SD = 0.51) and their parents randomized over four conditions: parent intervention, student intervention,
Verdurmen, Jacqueline E E; Koning, Ina M.|info:eu-repo/dai/nl/304822329; Vollebergh, Wilma A M|info:eu-repo/dai/nl/090632893; van den Eijnden, Regina J J M|info:eu-repo/dai/nl/17399394X; Engels, Rutger C M E
Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention,
Poslawsky, Irina E; Naber, Fabiënne BA; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H
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…
Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform
Briley, Annette L; Barr, Suzanne; Badger, Shirlene; Bell, Ruth; Croker, Helen; Godfrey, Keith M; Holmes, Bridget; Kinnunen, Tarja I; Nelson, Scott M; Oteng-Ntim, Eugene; Patel, Nashita; Robson, Stephen C; Sandall, Jane; Sanders, Thomas; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Poston, Lucilla
Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery of a large for gestational age (LGA) infant. A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring. Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women.Inclusion criteria; women with a BMI ≥30 kg/m2 and a singleton pregnancy between 15+0 weeks and 18+6 weeks' gestation. Exclusion criteria; pre-defined, pre-existing diseases and multiple pregnancy. Randomisation is on-line by a computer generated programme and is minimised by BMI category, maternal age, ethnicity, parity and centre. Intervention; this is delivered by a health trainer over 8 sessions. Based on control theory, with elements of social cognitive theory, the intervention is designed to improve maternal glycemic control. Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines. All women have a 75 g oral glucose tolerance test at 27+0- 28+6 weeks' gestation.Primary outcome; Maternal: diagnosis of GDM, according to the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria. Neonatal; infant LGA defined as >90th customised birth weight centile.Sample size; 1546 women to provide 80% power to detect a 25% reduction in the incidence of GDM and a 30% reduction in infants large for gestational age. All aspects of this protocol have been evaluated in a pilot randomised controlled trial
Eades, Sandra J; Sanson-Fisher, Rob W; Wenitong, Mark; Panaretto, Katie; D'Este, Catherine; Gilligan, Conor; Stewart, Jessica
To determine the effectiveness of an intensive quit-smoking intervention on smoking rates at 36 weeks' gestation among pregnant Aboriginal and Torres Strait Islander women. Randomised controlled trial. Pregnant Aboriginal and Torres Strait Islander women (n = 263) attending their first antenatal visit at one of three Aboriginal community-controlled health services between June 2005 and December 2009. A general practitioner and other health care workers delivered tailored advice and support to quit smoking to women at their first antenatal visit, using evidence-based communication skills and engaging the woman's partner and other adults in supporting the quit attempts. Nicotine replacement therapy was offered after two failed attempts to quit. The control ("usual care") group received advice to quit smoking and further support and advice by the GP at scheduled antenatal visits. Self-reported smoking status (validated with a urine cotinine measurement) between 36 weeks' gestation and delivery. Participants in the intervention group (n = 148) and usual care group (n = 115) were similar in baseline characteristics, except that there were more women who had recently quit smoking in the intervention group than the control group. At 36 weeks, there was no significant difference between smoking rates in the intervention group (89%) and the usual care group (95%) (risk ratio for smoking in the intervention group relative to usual care group, 0.93 [95% CI, 0.86-1.08]; P = 0.212). Smoking rates in the two groups remained similar when baseline recent quitters were excluded from the analysis. An intensive quit-smoking intervention was no more effective than usual care in assisting pregnant Aboriginal and Torres Strait Islander women to quit smoking during pregnancy. Contamination of the intervention across groups, or the nature of the intervention itself, may have contributed to this result. Australian New Zealand Clinical Trials Registry ACTRN12609000929202.
Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z
Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in
Wohl, David A; Golin, Carol E; Knight, Kevin; Gould, Michele; Carda-Auten, Jessica; Groves, Jennifer S; Napravnik, Sonia; Cole, Stephen R; White, Becky L; Fogel, Cathie; Rosen, David L; Mugavaro, Michael J; Pence, Brian W; Flynn, Patrick M
HIV-infected individuals transitioning from incarceration to the community are at risk for loss of viral suppression. We compared the effects of imPACT, a multidimensional intervention to promote care engagement after release, to standard care on sustaining viral suppression after community re-entry. This trial randomized 405 HIV-infected inmates being released from prisons in Texas and North Carolina with HIV-1 RNA levels HIV-1 RNA HIV-1 RNA 0.99). Higher rates of HIV suppression and medical care engagement than expected based on previous literature were observed among HIV-infected patients with suppressed viremia released from prison. Randomization to a comprehensive intervention to motivate and facilitate HIV care access after prison release did not prevent loss of viral suppression. A better understanding of the factors influencing prison releasees' linkage to community care, medication adherence, and maintenance of viral suppression is needed to inform policy and other strategic approaches to HIV prevention and treatment.
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.
Silverman, Henry J; Miller, Franklin G
Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be
Cunningham, John Alastair
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. To evaluate whether providing access to an extended Internet intervention for alcohol problems offers additional benefits in promoting reductions in alcohol consumption compared with a brief Internet intervention. The hypothesis for the current trial was that respondents who were provided with access to an extended Internet intervention (the Alcohol Help Center [AHC]) would display significantly improved drinking outcomes at 6-month follow-up, compared with respondents who were provided with access to a brief Internet intervention (the Check Your Drinking [CYD] screener). A single-blinded randomized controlled trial with a 6-month follow-up. A general population sample of problem drinkers was recruited through newspaper advertisements in a large metropolitan city. Baseline and follow-up data were collected by postal mail. A volunteer sample of problem drinkers of legal drinking age with home access to the Internet were recruited for the trial. Of 239 potential respondents recruited in 2010, 170 met inclusion criteria (average age 45 years; 101/170, 59.4% male; average Alcohol Use Disorders Identification Test [AUDIT] score of 22). Follow-up rates were 90.0% (153/170) with no adverse effects of the interventions reported. A repeated-measures multivariate analysis of variance of the outcome measures using an intent-to-treat approach found a significantly greater reduction in amount of drinking among participants provided access to the AHC than among participants provided access to the CYD (P = .046). The provision of the
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
Full Text Available Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.In the primary analysis were 484 (98.2% intervention and 507 (98.1% control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16. The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05 as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01. There was an increase (p = 0.02 in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY difference 0.0129, 95% CI -0.0050 to 0.0314 and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.There was a small reduction in falls. The intervention may be cost-effective.ISRCTN ISRCTN68240461.
Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David J
Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. There was a small reduction in falls. The intervention may be cost-effective. ISRCTN ISRCTN68240461.
Northouse, Laurel L; Katapodi, Maria C; Song, Lixin; Zhang, Lingling; Mood, Darlene W
Family caregivers of cancer patients receive little preparation, information, or support to perform their caregiving role. However, their psychosocial needs must be addressed so they can maintain their own health and provide the best possible care to the patient. The purpose of this article is to analyze the types of interventions offered to family caregivers of cancer patients, and to determine the effect of these interventions on various caregiver outcomes. Meta-analysis was used to analyze data obtained from 29 randomized clinical trials published from 1983 through March 2009. Three types of interventions were offered to caregivers: psychoeducational, skills training, and therapeutic counseling. Most interventions were delivered jointly to patients and caregivers, but they varied considerably with regard to dose and duration. The majority of caregivers were female (64%) and Caucasian (84%), and ranged in age from 18 to 92 years (mean age, 55 years). Meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced caregiver burden, improved caregivers' ability to cope, increased their self-efficacy, and improved aspects of their quality of life. Various intervention characteristics were also examined as potential moderators. Clinicians need to deliver research-tested interventions to help caregivers and patients cope effectively and maintain their quality of life. Copyright 2010 American Cancer Society, Inc.
Williams, Andrew E; Stevens, Victor J; Albright, Cheryl L; Nigg, Claudio R; Meenan, Richard T; Vogt, Thomas M
We assessed the effectiveness of a worksite management intervention (the 3W program) for overweight and obese hotel employees. The program was tested in a 2-year cluster-randomized trial involving 30 hotels that employed nearly 12,000 individuals. All participating hotels were on Oahu, Hawaii. The intervention was implemented within hotel worksites. Participants were included in the analysis if they had an initial body mass index (BMI) ≥ 25, were assessed at least twice, were not missing other data needed for the analysis, and did not switch to employment at a hotel in a different experimental condition. Of the 6519 employees we assessed, data from 1207 individuals (intervention: 598; control: 610) met these criteria and contributed to the analysis. The intervention had two components: (1) group meetings and (2) a workplace environment intervention. Weight and waist to height ratio (WHtR) were measured at three annual assessments. The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters. The effects on change in BMI and WHtR were in the expected direction but were not statistically significant. The 3W program was not effective. The low intensity of the intervention may have contributed to its ineffectiveness.
Boyde, M; Peters, R; New, N; Hwang, R; Ha, T; Korczyk, D
A variety of educational interventions have been implemented to assist patients with heart failure to maintain their own health, develop self-care behaviours and decrease readmissions. The purpose of this study was to determine the effectiveness of a multimedia educational intervention for patients with heart failure in reducing unplanned hospital readmissions. The study, a randomised controlled trial in a large tertiary referral hospital in Australia, recruited 200 patients. Patients diagnosed with heart failure were randomly allocated 1:1 to usual education or a multimedia educational intervention. The multimedia approach began with an individual needs assessment to develop an educational plan. The educational intervention included viewing a DVD, and verbal discussion supported by a written manual with a teach-back evaluation strategy. The primary outcome was all-cause unplanned hospital readmission at 28 days, three months and 12 months post-recruitment. The secondary outcomes were changes in knowledge and self-care behaviours at three months and 12 months post-recruitment. At 12 months, data on 171 participants were analysed. There were 24 participants who had an unplanned hospital readmission in the intervention group compared to 44 participants in the control group ( p=0.005). The self-care educational intervention reduced the risk of readmission at 12 months by 30% (relative risk: 0.703; 95% confidence interval: 0.548-0.903). A targeted multimedia educational intervention can be effective in reducing all-cause unplanned readmissions for people with heart failure.
Torres, Olga Herminia; Gil, Eva; Comas, Maria Teresa; Saez, Maria Encarnación; Clotet, Sandra; Ramirez, Hector David; Mateo, Miriam; Ruiz, Domingo
The main objective of this study is to determine whether a multidimensional intervention applied to elderly patients admitted to hospital due to pneumonia reduces re-admissions and emergency department visits in the year after the intervention. This is a single-centre non-pharmacological randomised clinical trial with a parallel design. Three hundred and fourteen patients will be included (157 in each arm). Eligible patients will be ≥65 years old and with a Barthel index ≥60 that are admitted to hospital due to pneumonia. Participants will be randomised to multidimensional intervention or to control group. Two months after hospital discharge the intervention group will receive a geriatric intervention, carried out by a nurse and a physician. It will include assessment of co-morbidities, nutritional, functional and cognitive status, and immunisation. The control group will receive conventional follow-up. The number of re-admissions, visits to the emergency department, functional status, survival, and institutionalisation will be evaluated one year after intervention. If the intervention shows an improvement in the studied outcomes, it would allow us to improve individual outcomes, and indirectly reduce healthcare costs using a relatively simple, standardised tool. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.
Gould, Rebecca L; Coulson, Mark C; Patel, Natasha; Highton-Williamson, Elizabeth; Howard, Robert J
The use of benzodiazepines has been advised against in older people, but prevalence rates remain high. To review the evidence for interventions aimed at reducing benzodiazepine use in older people. We conducted a systematic review, assessment of risk of bias and meta-analyses of randomised controlled trials of benzodiazepine withdrawal and prescribing interventions. Ten withdrawal and eight prescribing studies met the inclusion criteria. At post-intervention, significantly higher odds of not using benzodiazepines were found with supervised withdrawal with psychotherapy (odds ratio (OR) = 5.06, 95% CI 2.68-9.57, Pwithdrawal with prescribing interventions (OR = 1.43, 95% CI 1.02-2.02, P = 0.04) in comparison with the control interventions treatment as usual (TAU), education placebo, withdrawal with or without drug placebo, or psychotherapy alone. Significantly higher odds of not using benzodiazepines were also found for multifaceted prescribing interventions (OR = 1.37, 95% CI 1.10-1.72, P = 0.006) in comparison with control interventions (TAU and prescribing placebo). Supervised benzodiazepine withdrawal augmented with psychotherapy should be considered in older people, although pragmatic reasons may necessitate consideration of other strategies such as medication review.
van der Heijden, Marianne J E; Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K M; Hunink, M G Myriam; van Dijk, Monique
Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being. We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants.
Marianne J E van der Heijden
Full Text Available Neonatal intensive care units (NICU around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being.We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data.After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music.Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants.
Rush, Christina L.; Darling, Margaret; Elliott, Maria Gloria; Febus-Sampayo, Ivis; Kuo, Charlene; Muñoz, Juliana; Duron, Ysabel; Torres, Migdalia; Galván, Claudia Campos; Gonzalez, Florencia; Caicedo, Larisa; Nápoles, Anna; Jensen, Roxanne E.; Anderson, Emily; Graves, Kristi D.
Introduction Few studies have evaluated interventions to improve quality of life (QOL) for Latina breast cancer survivors and caregivers. Following best practices in community-based participatory research (CBPR), we established a multi-level partnership among Latina survivors, caregivers, community-based organizations (CBOs), clinicians and researchers to evaluate a survivor-caregiver QOL intervention. Methods A CBO in the mid-Atlantic region, Nueva Vida, developed a patient-caregiver program called Cuidando a mis Cuidadores (Caring for My Caregivers), to improve outcomes important to Latina cancer survivors and their families. Together with an academic partner, Nueva Vida and 3 CBOs established a multi-level team of researchers, clinicians, Latina cancer survivors, and caregivers to conduct a national randomized trial to compare the patient-caregiver program to usual care. Results Incorporating team feedback and programmatic considerations, we adapted the prior patient-caregiver program into an 8-session patient- and caregiver-centered intervention that includes skill-building workshops such as managing stress, communication, self-care, social well-being, and impact of cancer on sexual intimacy. We will measure QOL domains with the Patient-Reported Outcomes Measurement Information System (PROMIS), dyadic communication between the survivor and caregiver, and survivors’ adherence to recommended cancer care. To integrate the intervention within each CBO, we conducted interactive training on the protection of human subjects, qualitative interviewing, and intervention delivery. Conclusion The development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers. The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers, clinicians, community partners, survivors and caregivers. PMID:25377349
Rush, Christina L; Darling, Margaret; Elliott, Maria Gloria; Febus-Sampayo, Ivis; Kuo, Charlene; Muñoz, Juliana; Duron, Ysabel; Torres, Migdalia; Galván, Claudia Campos; Gonzalez, Florencia; Caicedo, Larisa; Nápoles, Anna; Jensen, Roxanne E; Anderson, Emily; Graves, Kristi D
Few studies have evaluated interventions to improve quality of life (QOL) for Latina breast cancer survivors and caregivers. Following best practices in community-based participatory research (CBPR), we established a multi-level partnership among Latina survivors, caregivers, community-based organizations (CBOs), clinicians, and researchers to evaluate a survivor-caregiver QOL intervention. A CBO in the mid-Atlantic region, Nueva Vida, developed a patient-caregiver program called Cuidando a mis Cuidadores (Caring for My Caregivers), to improve outcomes important to Latina cancer survivors and their families. Together with an academic partner, Nueva Vida and three CBOs established a multi-level team of researchers, clinicians, Latina cancer survivors, and caregivers to conduct a national randomized trial to compare the patient-caregiver program to usual care. Incorporating team feedback and programmatic considerations, we adapted the prior patient-caregiver program into an 8-session patient- and caregiver-centered intervention that includes skill-building workshops such as managing stress, communication, self-care, social well-being, and impact of cancer on sexual intimacy. We will measure QOL domains with the patient-reported outcomes measurement information system, dyadic communication between the survivor and caregiver, and survivors' adherence to recommended cancer care. To integrate the intervention within each CBO, we conducted interactive training on the protection of human subjects, qualitative interviewing, and intervention delivery. The development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers. The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers, clinicians, community partners, survivors, and caregivers.
Gage Brian F
Full Text Available Abstract Background There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. Results We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these
Pechmann, C; K. Delucchi; Lakon, CM; Prochaska, JJ
Background We evaluated a novel Twitter-delivered intervention for smoking cessation, Tweet2Quit, which sends daily, automated communications to small, private, self-help groups to encourage high-quality, online, peer-to-peer discussions. Design A 2-group randomised controlled trial assessed the net benefit of adding a Tweet2Quit support group to a usual care control condition of nicotine patches and a cessation website. Participants Participants were 160 smokers (4 cohorts of 40/cohort), age...
Lou, Peian; Zhu, Yanan; Chen, Peipei; Zhang, Pan; YU, Jiaxi; Zhang, Ning; Chen, Na; Zhang, Lei; Wu, Hongmin; Zhao, Jing
Background Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). But a fewer smoking cessation measures were conducted in communities for smokers with COPD in China. The aim of our study was to assess the preventive effects of behavioral interventions for smoking cessation and potential impact factors in smokers with COPD in China. Methods In a randomised controlled smoking cessation trial 3562 patients with COPD who were current smoker were allocated to...
Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D
Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.
Prestwich, A; Conner, MT; Lawton, RJ; Ward, JK; Ayres, K; McEachan, RRC
OBJECTIVE: The research tested the efficacy of partner- and planning-based interventions to reduce dietary fat intake over a 6-month period. DESIGN: Randomized controlled, blinded, parallel trial. METHODS: A computer randomization feature was used to allocate council employees (N = 427, of which 393 completed baseline measures) to one of four conditions (partner + implementation intentions, partner-only, implementation intentions, and control group) before they completed measures at baseline ...
Adamsen, Lis; Quist, Morten; Andersen, Christina; M?ller, Tom; Herrstedt, J?rn; Kronborg, Dorte; Baadsgaard, Marie T; Vistisen, Kirsten; Midtgaard, Julie; Christiansen, Birgitte; Stage, Maria; Kronborg, Morten T; R?rth, Mikael
Objective To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease. Design Randomised controlled trial. Setting Two university hospitals in Copenhagen, Denmark. Participants 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing...
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.
Maddison, Ralph; Marsh, Samantha; Foley, Louise; Epstein, Leonard H; Olds, Timothy; Dewes, Ofa; Heke, Ihirangi; Carter, Karen; Jiang, Yannan; Mhurchu, Cliona Ni
Screen-based activities, such as watching television (TV), playing video games, and using computers, are common sedentary behaviors among young people and have been linked with increased energy intake and overweight. Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child, small sample sizes, and short follow-up periods. The SWITCH (Screen-Time Weight-loss Intervention Targeting Children at Home) study aimed to determine the effect of a home-based, family-delivered intervention to reduce screen-based sedentary behaviour on body composition, sedentary behaviour, physical activity, and diet over 24 weeks in overweight and obese children. A two-arm, parallel, randomized controlled trial was conducted. Children and their primary caregiver living in Auckland, New Zealand were recruited via schools, community centres, and word of mouth. The intervention, delivered over 20 weeks, consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content, which focused on training and educating them to use a wide range of strategies designed to reduce their child's screen time. Families were given Time Machine TV monitoring devices to assist with allocating screen time, activity packages to promote alternative activities, online support via a website, and monthly newsletters. Control participants were given the intervention material on completion of follow-up. The primary outcome was change in children's BMI z-score from baseline to 24 weeks. Children (n = 251) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention (n = 127) or no intervention (controls; n = 124). There was no significant difference in change of zBMI between the intervention and control groups, although a favorable trend was observed (-0.016; 95% CI: -0.084, 0.051; p = 0.64). There were also no significant differences on secondary outcomes, except for a trend towards
Hattar, Anne; Hagger, Martin S; Pal, Sebely
Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of goal-reminder text messages to augment intervention effects will also be tested. The trial will determine the effects of a brief, low cost, theory-based weight-loss intervention to improve dietary intake and physical activity behaviour and facilitate weight-loss in overweight and obese individuals. Overweight or obese participants will be randomly allocated to one of three conditions: (1) a psycho-education plus an implementation intentions and mental imagery condition; (2) a psycho-education plus an implementation intentions and mental imagery condition with text messages; or (3) a psycho-education control condition. The intervention will be delivered via video presentation to increase the intervention's applicability in multiple contexts and keep costs low. We hypothesise that the intervention conditions will lead to statistically-significant changes in the primary and secondary outcome variables measured at 6 and 12 weeks post-intervention relative to the psycho-education control condition after controlling for baseline values. The primary outcome variable will be body weight and secondary outcome variables will be biomedical (body mass, body fat percentage, muscle mass, waist-hip circumference ratio, systolic and diastolic blood pressure, low-density lipoprotein, high-density lipoprotein, total cholesterol, triglycerides, blood glucose and insulin levels), psychological (quality of life, motivation, risk perception, outcome expectancy, intention, action self-efficacy, maintenance self
Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days
Full Text Available This study aimed to evaluate the effect of a lay health worker (LHW telephone intervention on completing a series of hepatitis B virus (HBV vaccinations among foreign-born Asian Americans in the Baltimore-Washington Metropolitan area.During the period of April 2013 and March 2014, we recruited Asian Americans who were 18 years of age and older in the community-based organizations. Of the 645 eligible participants, 600 (201 Chinese, 198 Korean, 201 Vietnamese completed a pretest survey and received hepatitis B screening. Based on the screening results, we conducted a randomized controlled trial among those unprotected (HBsAg-/HBsAB- by assigning them either to an intervention group (n = 124 or control group (n = 108. The intervention group received a list of resources by mails for where to get free vaccinations as well as reminder calls for vaccinations from trained LHWs, while the control group received only list of resources by mail. Seven months after mailing the HBV screening results, trained LHWs followed up with all participants by phone to ask how many of the recommended series of 3 vaccinations they had received: none, 1 or 2, or all 3 (complete. Their self-reported vaccinations were verified with the medical records. Multinomial logistic regressions were used to examine the effect of the LHW intervention. Process evaluation was conducted by asking study participants in the intervention group to evaluate the performance of the LHWs.After seven months, those in the intervention group were more likely to have 1 or more vaccines than the control group, compared to the no vaccination group (OR = 3.04, 95% CI, 1.16, 8.00. Also, those in the intervention group were more likely to complete a series of vaccinations than the control group, compared to the no vaccination group (OR = 7.29, 95% CI 3.39, 15.67. The most important barrier preventing them from seeking hepatitis B vaccinations was lack of time to get the vaccination. The most important
Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda
targeting high-risk individuals who are more likely to benefit from the intervention. International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).
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
Lancaster, G A; Campbell, M J; Eldridge, S; Farrin, A; Marchant, M; Muller, S; Perera, R; Peters, T J; Prevost, A T; Rait, G
Trials carried out in primary care typically involve complex interventions that require considerable planning if they are to be implemented successfully. The role of the statistician in promoting both robust study design and appropriate statistical analysis is an important contribution to a multi-disciplinary primary care research group. Issues in the design of complex interventions have been addressed in the Medical Research Council's new guidance document and over the past 7 years by the Royal Statistical Society's Primary Health Care Study Group. With the aim of raising the profile of statistics and building research capability in this area, particularly with respect to methodological issues, the study group meetings have covered a wide range of topics that have been of interest to statisticians and non-statisticians alike. The aim of this article is to provide an overview of the statistical issues that have arisen over the years related to the design and evaluation of trials in primary care, to provide useful examples and references for further study and ultimately to promote good practice in the conduct of complex interventions carried out in primary care and other health care settings. Throughout we have given particular emphasis to statistical issues related to the design of cluster randomised trials.
Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
Rasyid, Abd.; Akbar AS, M.; Nurdin, Nurjannah; Jaya, Ilham; Ibrahim
Climate change components that affect mangroves include changes in sea level, high water events, storms, precipitation, temperature, and oceanic circulation. Cumulative impacts of these factors have a distinct synergy with respect to an accelerated rate of mangrove degradation. development of coastal agricultural land and shrimp farming ponds in intertidal areas are considered as the major factors behind mangrove delineation. There is no agreement for the extensive of mangrove forest in Indonesia, but invarious forums it is usually used the number of 4.25 million ha for that. At approximately 9 years ago, the extensive vast of mangrove forest in Indonesia was about 4.13 million ha but now it is only 2.49 million ha (60%). The methodology of this study consisted of two main steps: (1) image analysis, and (2) post classification. The aim of this study is to analysis the human intervention base on spatial dynamic of mangrove. The study site was selected Sagara island in Spermonde Archipelago. The results of analyze shows that decreasing of mangrove is caused human intervention.
Noonan, Curtis W; Semmens, Erin O; Smith, Paul; Harrar, Solomon W; Montrose, Luke; Weiler, Emily; McNamara, Marcy; Ward, Tony J
Household air pollution due to biomass combustion for residential heating adversely affects vulnerable populations. Randomized controlled trials to improve indoor air quality in homes of children with asthma are limited, and no such studies have been conducted in homes using wood for heating. Our aims were to test the hypothesis that household-level interventions, specifically improved-technology wood-burning appliances or air-filtration devices, would improve health measures, in particular Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores, relative to placebo, among children living with asthma in homes with wood-burning stoves. A three-arm placebo-controlled randomized trial was conducted in homes with wood-burning stoves among children with asthma. Multiple preintervention and postintervention data included PAQLQ (primary outcome), peak expiratory flow (PEF) monitoring, diurnal peak flow variability (dPFV, an indicator of airway hyperreactivity) and indoor particulate matter (PM) PM2.5. Relative to placebo, neither the air filter nor the woodstove intervention showed improvement in quality-of-life measures. Among the secondary outcomes, dPFV showed a 4.1 percentage point decrease in variability [95% confidence interval (CI)=-7.8 to -0.4] for air-filtration use in comparison with placebo. The air-filter intervention showed a 67% (95% CI: 50% to 77%) reduction in indoor PM2.5, but no change was observed with the improved-technology woodstove intervention. Among children with asthma and chronic exposure to woodsmoke, an air-filter intervention that improved indoor air quality did not affect quality-of-life measures. Intent-to-treat analysis did show an improvement in the secondary measure of dPFV. ClincialTrials.gov NCT00807183. https://doi.org/10.1289/EHP849.
Ewald, H; Kirby, J.; Rees, K; W. Robertson
Background An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. Methods A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. Inclusion criteria: randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child,...
Haddeland, Ingjerd; Heinke, Jens; Biemans, Hester; Eisner, Stephanie; Flörke, Martina; Hanasaki, Naota; Konzmann, Markus; Ludwig, Fulco; Masaki, Yoshimitsu; Schewe, Jacob; Stacke, Tobias; Tessler, Zachary D.; Wada, Yoshihide; Wisser, Dominik
Humans directly change the dynamics of the water cycle through dams constructed for water storage, and through water withdrawals for industrial, agricultural, or domestic purposes. Climate change is expected to additionally affect water supply and demand. Here, analyses of climate change and direct human impacts on the terrestrial water cycle are presented and compared using a multimodel approach. Seven global hydrological models have been forced with multiple climate projections, and with and without taking into account impacts of human interventions such as dams and water withdrawals on the hydrological cycle. Model results are analyzed for different levels of global warming, allowing for analyses in line with temperature targets for climate change mitigation. The results indicate that direct human impacts on the water cycle in some regions, e.g., parts of Asia and in the western United States, are of the same order of magnitude, or even exceed impacts to be expected for moderate levels of global warming (+2 K). Despite some spread in model projections, irrigation water consumption is generally projected to increase with higher global mean temperatures. Irrigation water scarcity is particularly large in parts of southern and eastern Asia, and is expected to become even larger in the future. PMID:24344275
Gautam, Om Prasad; Schmidt, Wolf-Peter; Cairncross, Sandy; Cavill, Sue; Curtis, Valerie
In this study, we report on the results of a trial of an intervention to improve five food hygiene behaviors among mothers of young children in rural Nepal. This novel intervention targeted five behaviors; cleanliness of serving utensils, handwashing with soap before feeding, proper storage of cooked food, and thorough reheating and water treatment. Based on formative research and a creative process using the Behavior-Centered Design approach, an innovative intervention package was designed and delivered over a period of 3 months. The intervention activities included local rallies, games, rewards, storytelling, drama, competitions linking with emotional drivers of behavior, and “kitchen makeovers” to disrupt behavior settings. The effect of the package on behavior was evaluated via a cluster-randomized before–after study in four villages with four villages serving as controls. The primary outcome was the difference in the mean cluster level proportions of mothers directly observed practicing all five food hygiene behaviors. The five targeted food hygiene behaviors were rare at baseline (composite performance of all five behaviors in intervention 1% [standard deviation (SD) = 2%] and in control groups 2% [SD = 2%]). Six weeks after the intervention, the target behaviors were more common in the intervention than in the control group (43% [SD = 14%] versus 2% [SD = 2%], P = 0.02) during follow-up. The intervention appeared to be equally effective in improving all five behaviors in all intervention clusters. This study shows that a theory-driven, systematic approach employing emotional motivators and modifying behavior settings was capable of substantially improving multiple food hygiene behaviors in Nepal. PMID:28719285
Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller
The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.
Bhatia, R Sacha; Dudzinski, David M; Malhotra, Rajeev; Milford, Creagh E; Yoerger Sanborn, Danita M; Picard, Michael H; Weiner, Rory B
This study sought to prospectively study the impact of an appropriate use criteria (AUC)-based educational intervention on outpatient transthoracic echocardiography (TTE) ordering by physicians-in-training. AUC were developed in response to concerns about inappropriate utilization. It is unknown whether an educational intervention can reduce inappropriate outpatient TTE. We conducted a randomized control trial in which physicians-in-training were randomized to an AUC-based educational intervention or a control group at an academic medical center in Boston, Massachusetts. The primary endpoints were the rates of inappropriate and appropriate TTE. For the cardiology physicians-in-training, the proportion of inappropriate TTE was significantly lower in the intervention than in the control group (13% vs. 34%, p intervention group was significantly higher than that of the control group (81% vs. 58%, p intervention group was 2.7 (95% confidence interval [CI]: 1.5 to 5.1, p = 0.002) relative to the control group. The internal medicine physicians-in-training ordered a small number of TTE overall, and there was a trend toward significant odds of ordering an appropriate TTE in the intervention group relative to the control group (odds ratio [OR]: 8.1, 95% CI: 0.95 to 69.0, p = 0.055). Six clinical scenarios accounted for 75% of all inappropriate TTE, with the 3 most common inappropriate indications being routine surveillance (educational and feedback intervention reduced the proportion of inappropriate outpatient TTE and increased the proportion of appropriate outpatient TTE. (Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms; NCT01944202). Copyright © 2014. Published by Elsevier Inc.
Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos
To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.
Andersen, Anette; Krølner, Rikker; Bast, Lotus Sofie; Thygesen, Lau Caspar; Due, Pernille
Uptake of smoking in adolescence is still of major public health concern. Evaluations of school-based programmes for smoking prevention show mixed results. The aim of this study was to examine the effect of X:IT, a multi-component school-based programme to prevent adolescent smoking. Data from a Danish cluster randomized trial included 4041 year-7 students (mean age: 12.5) from 51 intervention and 43 control schools. Outcome measure 'current smoking' was dichotomized into smoking daily, weekly, monthly or more seldom vs do not smoke. Analyses were adjusted for baseline covariates: sex, family socioeconomic position (SEP), best friend's smoking and parental smoking. We performed multilevel, logistic regression analyses of available cases and intention-to-treat (ITT) analyses, replacing missing outcome values by multiple imputation. At baseline, 4.7% and 6.8% of the students at the intervention and the control schools smoked, respectively. After 1 year of the intervention, the prevalence was 7.9% and 10.7%, respectively. At follow-up, 553 students (13.7%) did not answer the question on smoking. Available case analyses: crude odds ratios (OR) for smoking at intervention schools compared with control schools: 0.65 (0.48-0.88) and adjusted: 0.70 (0.47-1.04). ITT analyses: crude OR for smoking at intervention schools compared with control schools: 0.67 (0.50-0.89) and adjusted: 0.61 (0.45-0.82). Students at intervention schools had a lower risk of smoking after a year of intervention in year 7. This multi-component intervention involving educational, parental and context-related intervention components seems to be efficient in lowering or postponing smoking uptake in Danish adolescents. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.
Boote, Jonathan; Julious, Steven; Horspool, Michelle; Elphick, Heather; Smithson, W Henry; Norman, Paul
Aims We describe how patient and public involvement (PPI) was integrated into the design of an intervention for a randomised controlled trial (RCT) based within primary care. The RCT, known as the PLEASANT trial, aimed to reduce unscheduled medical contacts in children with asthma associated with start of the new school year in September with a simple postal intervention, highlighting the importance of maintaining asthma medication for helping to prevent increased asthma exacerbations. PPI is a key feature of UK health research policy, and is often a requirement of funding from the National Institute for Health Research. There are few detailed accounts of PPI in the design and conduct of clinical trials in the PPI literature for researchers to learn from. We held PPI consultation events to determine whether the proposed intervention for the trial was acceptable to children with asthma and their parents, and to ascertain whether enhancements should be made. Two PPI consultation events were held with children with asthma and their parents, prior to the research commencing. Detailed field notes were taken by the research team at each consultation event. Findings At the first consultation event, parents and children endorsed the trial's rationale, made suggestions to the wording of the trial intervention letter, and made recommendations about to whom the letter should be sent out. At the second consultation event, parents discussed the timing of the intervention, commented on the lay summary of the Research Ethics Application, and were invited to join the trial's steering committee, while the children selected a logo for the study. PPI has resulted in enhancements to the PLEASANT study's intervention. A further PPI consultation event is scheduled for the end of the trial, in order for children with asthma and their parents to contribute to the trial's dissemination strategy.
Stark, Lori J; Opipari-Arrigan, Lisa; Filigno, Stephanie S; Simon, Stacey L; Leonard, Amanda; Mogayzel, Peter J; Rausch, Joseph; Zion, Cynthia; Powers, Scott W
Usability and pilot testing of a web intervention (BeInCharge.org [BIC]) of behavior plus nutrition intervention for children with cystic fibrosis (CF) ages 4-9 years. Think Aloud methodology was used with five mothers to assess usability and refine the intervention. A pilot trial was then conducted with 10 mothers of children with CF ages 4-9 years randomized to the web-based BIC or a Standard Care Control (STC). Change in weight gain for each group was compared in a pre-to-post design. Mothers rated the usability and clarity of BIC highly. The pilot trial showed children of mothers who received BIC had a significant change in weight pre-to-post-treatment (0.67 kg, p = .04). Change for the STC was not significant (0.41 kg, p = .10). A web-based behavior plus nutrition intervention appears promising in increasing weight gain in children with CF. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Franklin, James M; Gebski, Val; Poston, Graeme J; Sharma, Ricky A
Interventional oncology is a rapidly growing sub-speciality that aims to develop new disease-modifying treatment options beyond conventional surgical and oncological therapies in several disease settings. The evidence for interventional oncology success is dominated by single-arm studies reporting technical success or clinical efficacy. These studies have successfully resulted in the development of new techniques, but are not sufficient to change clinical practice uniformly across health-care systems. This Review discusses why clinical investigators must incorporate measures of cost-effectiveness and patient-reported outcomes into large-scale studies currently being designed to provide robust evidence for changing clinical practice. In particular, interventional oncology trials could be designed to show that certain treatments may be as effective as the current standard of care, but with significantly less morbidity and with better outcomes for patients with cancer. Innovative trial design and awareness of the challenges from interventional studies in other fields of medicine and surgery are also discussed to demonstrate how this new speciality can make progress. Registry-based models are emerging as an alternative means of deriving cohort data and can be used in parallel with local or national commissioning of new services.
Carla FJ Nooijen
Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural
Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas
Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted
Skår, Silje; Sniehotta, Falko F; Molloy, Gerard J; Prestwich, Andrew; Araújo-Soares, Vera
Brief planning interventions, usually delivered within paper and pencil questionnaires, have been found to be effective in changing health behaviours. Using a double-blind randomised controlled trial, this study examined the efficacy of two types of planning interventions (action plans and coping plans) in increasing physical activity levels when they are delivered via the internet. Following the completion of self-reported physical activity (primary outcome) and theory of planned behaviour (TPB) measures at baseline, students (N = 1273) were randomised into one of four conditions on the basis of a 2 (received instructions to form action plans or not) × 2 (received instructions to form coping plans or not) factorial design. Physical activity (primary outcome) and TPB measures were completed again at two-month follow-up. An objective measure (attendance at the university's sports facilities) was employed 6 weeks after a follow-up for a duration of 13 weeks (secondary outcome). The interventions did not change self-reported physical activity, attendance at campus sports facilities or TPB measures. This might be due to low adherence to the intervention protocol (ranging from 58.8 to 76.7%). The results of this study suggest that the planning interventions under investigation are ineffective in changing behaviour when delivered online to a sample of participants unaware of the allocation to different conditions. Possible moderators of the effectiveness of planning interventions in changing health behaviours are discussed.
Menezes, Mariana Carvalho de; Mingoti, Sueli Aparecida; Cardoso, Clareci Silva; Mendonça, Raquel de Deus; Lopes, Aline Cristine Souza
To analyze the effects of an intervention based on the Transtheoretical Model on anthropometric and dietetic profile among women in the Primary Health Care in Brazil. Randomized controlled trial. The control group participated in physical activity and open group-education regarding nutrition of usual care. The intervention group participated in 10 workshops based on the Transtheoretical Model. Seventy-one women completed the study, with a mean age of 57.9±11.7years. Participants in the intervention group showed an improved body perception, reduced weight and body mass index post-intervention, and lower consumption of calories and foods high in fat. Significant weight reduction in the intervention group was associated with higher per capita income, reduced consumption of protein, reduced consumption of lipids, and the removal of visible fat from red meat and skin from chicken. An intervention based on the Transtheoretical Model promoted reduction in consumption of foods high in calories and fat, with positive effects on weight and body perception. These results provide evidence of the applicability and benefit of the Transtheoretical Model within primary care. Copyright © 2014 Elsevier Ltd. All rights reserved.
van Genugten, Lenneke; van Empelen, Pepijn; Boon, Brigitte; Borsboom, Gerard; Visscher, Tommy; Oenema, Anke
Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the study, but there were no differences
Aveyard, Paul; Lewis, Amanda; Tearne, Sarah; Hood, Kathryn; Christian-Brown, Anna; Adab, Peymane; Begh, Rachna; Jolly, Kate; Daley, Amanda; Farley, Amanda; Lycett, Deborah; Nickless, Alecia; Yu, Ly-Mee; Retat, Lise; Webber, Laura; Pimpin, Laura; Jebb, Susan A
Obesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity. In this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m(2) (or at least 25 kg/m(2) if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients' about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137. Between June 4, 2013, and Dec 23, 2014
Andersen, Lars; Jørgensen, Marie Birk; Blangsted, Anne
resistance training (SRT, n = 180), all-round physical exercise (APE, n = 187), and reference intervention (REF, n = 182) with general health counseling. Physical tests were performed and questionnaires answered at pre-, mid-, and postintervention. The main outcome measures were compliance, changes......PURPOSE:: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS:: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS:: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively...
Background Research in suicide prevention using psychosocial interventions is rapidly advancing. However, randomised controlled trials are published across a range of medical, psychological and sociology journals, and it can be difficult to locate a full set of research studies. In this paper, we present a database of randomised controlled outcome studies on psychosocial interventions targeting suicidal behaviour. The database is updated annually and can be accessed by contacting the corresponding author. Description A comprehensive literature search of the major bibliographical databases (PsycINFO; PubMed; Cochrane Central Register of Controlled Trials) was conducted for articles published between 1800 to July 30 2013, and examined reference lists of previous relevant reviews and included papers to locate additional references. Studies were included if they featured a randomised controlled design in which the effects of a psychosocial intervention were compared to a control condition (no intervention, attention placebo, wait-list, treatment-as-usual [TAU]), another psychosocial intervention or a pharmacological intervention. In total, 12,250 abstracts were identified. Of these, 131 studies met eligibility criteria and were included. Each paper was then coded into categories of participant characteristics (age, gender, formal diagnosis, primary reason for recruitment); details of the intervention (recruitment setting, content, intervention setting, administering individual, delivery type, delivery format, delivery frequency, delivery length); and study characteristics (control and experimental conditions, primary outcome/s, secondary outcome/s, follow-up period). One paper has been published from the database using studies collected and coded prior to 2012. Conclusion The database and listing of 131 studies is available for use by suicide prevention researchers. It provides a strong starting point for systematic reviews and meta-analyses of treatments and
Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J
A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically
Knowlden, Adam; Sharma, Manoj
The home and family environment is a highly influential psychosocial antecedent of pediatric obesity. Implementation of conventional family- and home-based childhood obesity interventions is challenging for parents, often requiring them to attend multiple educational sessions. Attrition rates for traditional interventions are frequently high due to competing demands for parents' time. Under such constraints, an Internet-based intervention has the potential to modify determinants of childhood obesity while making judicious use of parents' time. Theory-based interventions offer many advantages over atheoretical interventions, including reduced intervention dosage, increased likelihood of behavioral change, and efficient resource allocation. Social cognitive theory (SCT) is a robust theoretical framework for addressing childhood obesity. SCT is a behavior change model rooted in reciprocal determinism, a causal paradigm that states that human functioning is the product of a dynamic interplay of behavioral, personal, and environmental factors. To evaluate the efficacy of the Enabling Mothers to Prevent Childhood Obesity Through Web-Based Education and Reciprocal Determinism (EMPOWER) program, an Internet-based, theory-driven intervention for preventing childhood overweight and obesity. The project goal is supported by two specific aims: (1) modification of four obesogenic protective factors related to childhood obesity (minutes engaged in physical activity, servings of fruits and vegetables consumed, servings of sugar-sweetened and sugar-free beverages consumed, and minutes engaged in screen time), and (2) reification of five maternal-mediated constructs of SCT (environment, expectations, emotional coping, self-control, and self-efficacy). We will recruit mothers with children ages 4 to 6 years from childcare centers and randomly assign them to either the theory-based (experimental) or knowledge-based (control) arm of the trial. Data for the intervention will be
Wyers, C E; Reijven, P L M; Evers, S M A A; Willems, P C; Heyligers, I C; Verburg, A D; van Helden, S; Dagnelie, P C
Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective. Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective. Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively. Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years. Intensive nutritional intervention in elderly hip fracture patients is likely to be cost
Von Hoff, D D; Clark, G M; Stogdill, B J; Sarosdy, M F; O'Brien, M T; Casper, J T; Mattox, D E; Page, C P; Cruz, A B; Sandbach, J F
A prospective clinical trial was performed to evaluate the usefulness of a human tumor cloning system for selecting single-agent chemotherapy for patients with advanced cancers. Six hundred four single-agent trials were performed in the 470 patients whose tumors were submitted for drug sensitivity testing. Only 246 of these 604 trials (41%) could be directed by the cloning system results because of inadequate tumor growth and other difficulties. In these 246 prospective trials, there was a 60% true positive and an 85% true negative rate for predicting for response or lack of response of an individual patient's tumor to the single agent. There was also a relationship between the percentage of decrease in survival of tumor colony-forming units and the probability of a clinical response of the patient's tumor to the same drug used in vivo. Despite these encouraging findings, work to improve tumor growth and additional prospective clinical trials of the system are needed before the system can be recommended for routine clinical use.
McKenzie, Lara B; Roberts, Kristin J; Kaercher, Roxanne M; Collins, Christy L; Comstock, R Dawn; Fernandez, Soledad; Abdel-Rasoul, Mahmoud; Casavant, Marcel J; Mihalov, Leslie
Background Although non-fire-related carbon monoxide (CO) poisoning is almost entirely preventable, over 400 people die and 20 000 people are injured each year in the USA from unintentional CO poisoning. Thus, there is a critical need for evidence-based interventions for preventing CO poisoning and increasing the proper use and installation of CO detectors. Methods A randomised, controlled trial (Project CODE, a Carbon Monoxide Detector Education intervention) with 2-week and 6-month follow-up home observations was conducted in 299 parents of children aged ≤18 years recruited in the emergency department of a level 1 paediatric trauma centre. The intervention group received an educational tool, a spiral-bound, laminated booklet that resembled a CO detector containing theory-based safety messages based on the precaution adoption process model, a plug-in CO detector and 9 V battery. The control group received a one page flyer on CO poisoning prevention. Results Although the difference was not statistically significant, mean CO knowledge score increased at a greater rate for the intervention group than the control group. Intervention group parents were more likely to exhibit ‘safe’ CO detector use than control group parents at the 2-week follow-up (RR: 2.75; 95% CI 2.06 to 3.69) and 6-month follow-up (RR: 2.78; 95% CI 2.06 to 3.76), after adjusting for self-reported CO detector use behaviour at enrolment and annual per capita income. Conclusions An emergency department-delivered intervention containing a theory-based educational tool paired with a CO detector can be an effective method for increasing knowledge about CO poisoning, for prevention and for appropriate use of a CO detector. Trial registration number NCT00959478. PMID:28007971
Chisholm, Katharine Elizabeth; Patterson, Paul; Torgerson, Carole; Turner, Erin; Birchwood, Max
With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a
Hawkins, Marquis; Braun, Barry; Marcus, Bess H; Stanek, Edward; Markenson, Glenn; Chasan-Taber, Lisa
C-reactive protein (CRP) during pregnancy has been associated with adverse maternal outcomes such as preeclampsia and gestational diabetes mellitus. Randomized trials suggest that exercise programs may be associated with reductions in CRP in non-pregnant populations; however, such studies have not been conducted among pregnant women. The purpose of this study was to evaluate the impact of an individually-tailored motivationally-matched exercise intervention on CRP in pregnant women. The Behaviors Affecting Baby and You study was a randomized controlled trial of prenatal physical activity to prevent the development of gestational diabetes mellitus in women at increased risk. Women were randomized to either a 12-week exercise intervention (n = 84) or a comparison health and wellness intervention (n = 87). High sensitivity CRP (mg/dL) was measured using a commercial immunoassay kit. Physical activity was measured using the Pregnancy Physical Activity Questionnaire. Mixed model analyses were used to evaluate the impact of the intervention on change in CRP using an intent-to-treat approach. CRP decreased (-0.09 mg/dL, 95 % CI: -0.25, 0.07) from pre- to post-intervention in the exercise arm (p = 0.14) and increased (0.08 mg/dL, 95 % CI: -0.07, 0.24) (p = 0.64) in the health and wellness arm; however the between group difference was not statistically significant (p = 0.14). Findings did not differ according to ethnic group or pre-pregnancy body mass index. In a secondary analysis based on self-reported physical activity, women who decreased their time spent in sports/exercise experienced a mean increase in CRP (0.09 mg/dL, 95 % CI: -0.14, 0.33), whereas women who maintained or increased their sports/ exercise experienced a mean decrease in CRP (-0.08 mg/dL, 95 % CI: -0.23, 0.08) (p = 0.046). Findings from this randomized trial in an ethnically and socio-economically diverse population of pregnant women were consistent with a positive impact
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
Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean
Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).
Adams, Marc A; Sallis, James F; Norman, Gregory J; Hovell, Melbourne F; Hekler, Eric B; Perata, Elyse
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. 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. 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. 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 (pgoal and feedback algorithm is a "behavior change technology" that could be incorporated into mHealth technologies and scaled to reach large populations. ClinicalTrials.gov NCT01793064.
Ciaschini, P M; Straus, S E; Dolovich, L R; Goeree, R A; Leung, K M; Woods, C R; Zimmerman, G M; Majumdar, S R; Spadafora, S; Fera, L A; Lee, H N
falls are the leading causes of accidental death and fragility fractures in older adults. Interventions that assess and reduce falls risk are underutilised. to evaluate the impact of a multifaceted community-based programme aimed at optimising evidence-based management of patients at risk for fall-related fractures. this was a randomised trial performed from 2003 to 2006. community-based intervention in Ontario, Canada. eligible patients were community-dwelling, aged > or =55 years and identified to be at risk for fall-related fractures. A total of 201 patients were allocated to the intervention group or to usual care. components of the intervention included assessment of falls risk, functional status and home environment, and patient education. primary outcome was the implementation of appropriate falls risk assessment at 6 months. Secondary outcomes included falls and fractures at 6 and 12 months. the mean age of participants was 72 years, and 41% had fallen with injury in the previous year. Compared to usual care, the intervention increased the number of referrals made to physiotherapy [21% (21/101) vs 6.0% (6/100); relative risk (RR) 3.47, 95% confidence interval (CI) 1.46-8.22] and occupational therapy [15% (15/101) vs 0%; RR 30.7, 95% CI 1.86 to >500]. At 12 months, the number of falls in the intervention group was greater than in the usual care group [23% (23/101) vs 11% (11/100); RR 2.07, 95% CI 1.07-4.02]. compared to usual care, a multi-faceted intervention increased referrals to physiotherapy and occupational therapy but did not reduce risk of falls. Similar falls reduction interventions cannot be recommended based on the results of this study.
Northouse, Laurel L; Mood, Darlene W; Schafenacker, Ann; Montie, James E; Sandler, Howard M; Forman, Jeffrey D; Hussain, Maha; Pienta, Kenneth J; Smith, David C; Kershaw, Trace
Few intervention studies have been conducted to help couples manage the effects of prostate cancer and maintain their quality of life. The objective of this study was to determine whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress, and quality of life in men with prostate cancer and their spouses. For this clinical trial, 263 patient-spouse dyads were stratified by research site, phase of illness, and treatment; then, they were randomized to the control group (standard care) or the experimental group (standard care plus a 5-session family intervention). The intervention targeted couples' communication, hope, coping, uncertainty, and symptom management. The final sample consisted of 235 couples: 123 couples in the control group and 112 couples in the experimental group. Data collection occurred at baseline before randomization and at 4 months, 8 months, and 12 months. At 4-month follow-up, intervention patients reported less uncertainty and better communication with spouses than control patients, but they reported no other effects. Intervention spouses reported higher quality of life, more self-efficacy, better communication, and less negative appraisal of caregiving, uncertainty, hopelessness, and symptom distress at 4 months compared with controls, and some effects were sustained to 8 months and 12 months. Men with prostate cancer and their spouses reported positive outcomes from a family intervention that offered them information and support. Programs of care need to be extended to spouses who likely will experience multiple benefits from intervention. 2007 American Cancer Society
Sally L. Kitch
Full Text Available Environmental humanists make compelling arguments about the importance of the environmental humanities (EH for discovering new ways to conceptualize and address the urgent challenges of the environmental crisis now confronting the planet. Many environmental scientists in a variety of fields are also committed to incorporating socio-cultural analyses in their work. Despite such intentions and rhetoric, however, and some humanists’ eagerness to incorporate science into their own work, “radical interdisciplinarity [across the humanities and sciences] is ... rare ... and does not have the impact one would hope for” (Holm et al. 2013, p. 32. This article discusses reasons for the gap between transdisciplinary intentions and the work being done in the environmental sciences. The article also describes a project designed to address that gap. Entitled “From Innovation to Progress: Addressing Hazards of the Sustainability Sciences”, the project encourages humanities interventions in problem definition, before any solution or action is chosen. Progress offers strategies for promoting expanded stakeholder engagement, enhancing understanding of power struggles and inequities that underlie problems and over-determine solutions, and designing multiple future scenarios based on alternative values, cultural practices and beliefs, and perspectives on power distribution and entitlement.
Full Text Available Abstract Background Very brief interventions (VBIs for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT. Methods Three hundred and ninety four adults aged 40–74 years were randomised to a Motivational (n = 83, Pedometer (n = 74, or Combined (n = 80 intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157. Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks. Results For the primary outcome the estimated effect sizes (95 % CI relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (−45.0, +85.7, +23.5 (−51.3, +98.3, and −3.1 (−69.3, +63.1 counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46 % for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost. Conclusions Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial. Trial registration Current Controlled Trials ISRCTN02863077 . Retrospectively registered 05/10/2012.
Firth, Joseph; Torous, John; Nicholas, Jennifer; Carney, Rebekah; Pratap, Abhishek; Rosenbaum, Simon; Sarris, Jerome
The rapid advances and adoption of smartphone technology presents a novel opportunity for delivering mental health interventions on a population scale. Despite multi‐sector investment along with wide‐scale advertising and availability to the general population, the evidence supporting the use of smartphone apps in the treatment of depression has not been empirically evaluated. Thus, we conducted the first meta‐analysis of smartphone apps for depressive symptoms. An electronic database search in May 2017 identified 18 eligible randomized controlled trials of 22 smartphone apps, with outcome data from 3,414 participants. Depressive symptoms were reduced significantly more from smartphone apps than control conditions (g=0.38, 95% CI: 0.24‐0.52, pSmartphone interventions had a moderate positive effect in comparison to inactive controls (g=0.56, 95% CI: 0.38‐0.74), but only a small effect in comparison to active control conditions (g=0.22, 95% CI: 0.10‐0.33). Effects from smartphone‐only interventions were greater than from interventions which incorporated other human/computerized aspects along the smartphone component, although the difference was not statistically significant. The studies of cognitive training apps had a significantly smaller effect size on depression outcomes (p=0.004) than those of apps focusing on mental health. The use of mood monitoring softwares, or interventions based on cognitive behavioral therapy, or apps incorporating aspects of mindfulness training, did not affect significantly study effect sizes. Overall, these results indicate that smartphone devices are a promising self‐management tool for depression. Future research should aim to distil which aspects of these technologies produce beneficial effects, and for which populations. PMID:28941113
Welch Martha G
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
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-mediated sensory experiences of
de Boer, Sanneke P M; van Leeuwen, Maarten A H; Cheng, Jin M; Oemrawsingh, Rohit M; van Geuns, Robert-Jan; Serruys, Patrick W J C; Boersma, Eric; Lenzen, Mattie J
This study examines differences in clinical outcome between trial-participants and non-participants after percutaneous coronary intervention (PCI). This study compromised of 11,931 consecutive patients who underwent PCI in a high volume center, during the period 2000 - 2009. Of these patients, 1787 (15%) participated in an interventional clinical trial with a follow-up period of at least six months. The maximum follow-up duration was 11.8 years, with a median of 3.8 years (IQR: 2.6 - 6.5). Baseline and procedural characteristics differed between trial-participants and non-participants. Trial-participants were more often male, were younger, had more cardiovascular risk factors and were treated more often for stable angina pectoris and single vessel disease. Overall mortality at maximum follow-up was lower for trial-participants compared to non-participants (8.1% versus 17.6%, pclinical trials in the field of interventional cardiology with a follow-up of at least six months differed considerably from non-participants in baseline and procedural characteristics. Trial-participants had better survival than non-participants. In contrast, a two-fold higher incidence of repeat PCI was observed in trial-participants. © 2013.
Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity
Collins, Katharine A; Wang, Claire Yt; Adams, Matthew; Mitchell, Hayley; Rampton, Melanie; Elliott, Suzanne; Reuling, Isaie J; Bousema, Teun; Sauerwein, Robert; Chalon, Stephan; Möhrle, Jörg J; McCarthy, James S
Drugs and vaccines that can interrupt the transmission of Plasmodium falciparum will be important for malaria control and elimination. However, models for early clinical evaluation of candidate transmission-blocking interventions are currently unavailable. Here we describe a new model for evaluating malaria transmission from humans to Anopheles mosquitoes using controlled human malaria infection (CHMI). Seventeen healthy malaria-naïve volunteers underwent CHMI by intravenous inoculation of P. falciparum-infected erythrocytes to initiate blood-stage infection. Seven to eight days after inoculation participants received piperaquine (480 mg) to attenuate asexual parasite replication while allowing gametocytes to develop and mature. Primary endpoints were development of gametocytemia, the transmissibility of gametocytes from humans to mosquitoes, and the safety and tolerability of the CHMI transmission model. To investigate in-vivo gametocytocidal drug activity in this model, participants were either given an experimental antimalarial, artefenomel (500 mg), a known gametocytocidal drug, primaquine (15 mg), or remained untreated during the period of gametocyte carriage. Male and female gametocytes were detected in all participants, and transmission to mosquitoes was achieved from 8/11 (73%) participants evaluated. Compared to untreated controls (n = 7), primaquine (15 mg, n = 5) significantly reduced gametocyte burden (P = 0.01), while artefenomel (500 mg, n = 4) had no effect. Adverse events (AEs) were mostly mild or moderate. Three AEs were assessed as severe - fatigue, elevated alanine aminotransferase, and elevated aspartate aminotransferase - and were attributed to malaria infection. Transaminase elevations were transient, asymptomatic, and resolved without intervention. We report the safe and reproducible induction of P. falciparum gametocytes in healthy malaria-naïve volunteers at densities infectious to mosquitoes, thereby demonstrating the potential for
Maguire, Jonathon L; Birken, Catherine S; Loeb, Mark B; Mamdani, Muhammad; Thorpe, Kevin; Hoch, Jeffrey S; Mazzulli, Tony; Borkhoff, Cornelia M; Macarthur, Colin; Parkin, Patricia C
Vitamin D levels are alarmingly low (respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI. This study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups. Identifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and
Duncan, Scott; Goodyear-Smith, Felicity; McPhee, Julia; Zinn, Caryn; Grøntved, Anders; Schofield, Grant
To assess the effects of a family-centered, physical activity and nutrition "brief" intervention (time-limited contact) on body weight and related health outcomes in primary health care patients with an elevated 5-year cardiovascular disease (CVD) risk. This study implemented a cluster randomized controlled trial design with two treatment conditions: a CVD risk assessment and one-time consultation ("usual care" control) and a CVD risk assessment and up to five home sessions that aimed to reduce obesity by encouraging physical activity and healthy eating (intervention). Three hundred and twenty patients aged 35 to 65 years from 16 primary health care clinics in Auckland, New Zealand, participated in the study. Intervention effects on BMI, waist circumference, blood pressure, blood cholesterol, triglycerides, 5-year CVD risk, physical activity, and dietary patterns were assessed using generalized linear mixed models. When compared with the control group, the intervention resulted in a significant but relatively modest decrease in BMI between baseline and the 12-month follow-up (-0.633 kg m(-2) , Padj = 0.048). Significant decreases were also observed for total cholesterol at 4 and 12 months, the total cholesterol to high-density lipoprotein cholesterol ratio at 4 months, 5-year CVD risk at 4 months, and fast food consumption at 12 months. Our findings show that a family-centered brief intervention targeting physical activity and nutrition can generate slightly better obesity-related health outcomes than usual care alone. © 2016 The Obesity Society.
Spittle, Alicia J; Barton, Sarah; Treyvaud, Karli; Molloy, Carly S; Doyle, Lex W; Anderson, Peter J
To examine the child and parental outcomes at school age of a randomized controlled trial of a home-based early preventative care program for infants born very preterm and their caregivers. At term-equivalent age, 120 infants born at a gestational age of intervention (n = 61) or standard care (n = 59) groups. The intervention included 9 home visits over the first year of life focusing on infant development, parental mental health, and the parent-infant relationship. At 8 years' corrected age, children's cognitive, behavioral, and motor functioning and parental mental health were assessed. Analysis was by intention to treat. One hundred children, including 13 sets of twins, attended follow-up (85% follow-up of survivors). Children in the intervention group were less likely to have mathematics difficulties (odds ratio, 0.42; 95% confidence interval [CI], 0.18 to 0.98; P = .045) than children in the standard care group, but there was no evidence of an effect on other developmental outcomes. Parents in the intervention group reported fewer symptoms of depression (mean difference, -2.7; 95% CI, -4.0 to -1.4; P parents in the standard care group. An early preventive care program for very preterm infants and their parents had minimal long-term effects on child neurodevelopmental outcomes at the 8-year follow-up, whereas primary caregivers in the intervention group reported less depression. Copyright © 2016 by the American Academy of Pediatrics.
Zingmark, Magnus; Fisher, Anne G; Rocklöv, Joacim; Nilsson, Ingeborg
The aim of this exploratory randomised controlled trial (RCT) was to evaluate three different occupation-focused interventions for well older people by estimating effect sizes for leisure engagement and ability in activities of daily living (ADL) and thereby identifying the most effective interventions. One hundred and seventy seven persons, 77-82 years old, living alone and without home help, were randomized to a control group (CG), an individual intervention (IG), an activity group (AG), and a one-meeting discussion group (DG). All interventions focused on occupational engagement and how persons can cope with age-related activity restrictions in order to enhance occupational engagement. Data were collected by blinded research assistants at baseline, three, and 12 months. Ordinal outcome data were converted, using Rasch measurement methods, to linear measures of leisure engagement and ADL ability. Standardized between-group effect sizes, Cohen's d, were calculated. While all groups showed a decline in leisure engagement and ADL over time, the IG and the DG were somewhat effective in minimizing the decline at both three and 12 months. However, the effect sizes were small. The findings indicate that occupation-focused interventions intended to minimize a decline in leisure engagement and ADL were sufficiently promising to warrant their further research.
McCusker, Jane; Yaffe, Mark; Faria, Rosana; Lambert, Sylvie; Li, Madeline; Poirier-Bisson, Joannie; Magalhaes, Mona; de Raad, Manon
Supported self-care interventions are a low-intensity treatment for depression that has received little research attention in the cancer population. This is a phase II intervention only study to test the feasibility, acceptability and preliminary effectiveness of a depression self-care intervention for cancer patients who have completed their primary treatment and have moderate depressive symptoms. The self-care intervention was adapted from a successful model for people with chronic physical conditions, following focus groups with cancer care professionals and patients. The support was delivered by telephone by a trained lay coach who provided up to 8 weekly coaching contacts. A variety of recruitment methods were tested; those with the highest yield of eligible subjects per research staff time were electronic mailings to community support group members and social media posting. Sixty-eight people were contacted about the study over an 11-month period, of whom 34 (49%) were eligible; 32 were enrolled (94% recruitment rate); and 25 completed 2-month follow-up (78% retention). The mean severity of PHQ-9 depression decreased significantly from screening to 2 months (12.8 to 7.0, p < .0001). The intervention is a promising treatment option for cancer survivors, demonstrating sufficient effectiveness and feasibility to proceed with a phase III clinical trial. © 2017 John Wiley & Sons Ltd.
Harmsen, Hans; Bernsen, Roos; Meeuwesen, Ludwien; Thomas, Siep; Dorrenboom, Govert; Pinto, David; Bruijnzeels, Marc
Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. General practice in Rotterdam. Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the 'Western' and 'non-Western' patients, and for patients with different cultural backgrounds separately. An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with 'non-Western' patients. A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between 'Western' and 'non-Western' patients.
Chi, Ying-Chen; Wu, Chen-Long; Chen, Cheng-Yu; Lyu, Shu-Yu; Lo, Feng-En; Morisky, Donald E
This study sought to assess the effectiveness of a secondhand tobacco smoke (SHS) prevention program based on an expanded Health Belief Model (HBM) incorporating self-efficacy among pregnant women in a hospital setting in Taiwan. This study utilized a two-group longitudinal randomized controlled trial design. Participants in the intervention group (n=50) enrolled in a SHS prevention program based on the HBM, while participants in the comparison group (n=50) received standard government-mandated counseling care. Both groups were given questionnaires as a pre-test, two weeks into the intervention, and one month following the conclusion of the intervention. The questionnaire and intervention were developed based on the understanding gained through a series of in-depth interviews and a focus-group conducted among pregnant women. Exhaled carbon monoxide was also measured and used as a proxy for SHS exposure. Intervention group scores were all significantly higher than comparison group scores (pwomen regarding the harms of SHS while both empowering and equipping them with the tools to confront their family members and effectively reduce their SHS exposure while promoting smoke-free social norms. Copyright © 2014 Elsevier Ltd. All rights reserved.
Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja
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. (c) 2015 APA, all rights reserved).
Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula
Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.
Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.
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 ratings of caregiver sensitivity improved more in the PFR condition than in the comparison condition, with an effect size for the difference in adjusted means post-intervention of d = .41. Caregiver understanding of toddlers’ social emotional needs and caregiver reports of child competence also differed by intervention condition post-intervention (d = .36 and d = .42) with caregivers in the PFR condition reporting more understanding of toddlers and child competence. Models of PFR effects on within-individual change were significant for caregiver sensitivity and understanding of toddlers. At the 6-month follow-up 61% of original sample dyads were still intact and there were no significant differences on caregiver or child outcomes, although caregivers in the PFR group did report marginally (pchild sleep problems (d = −.34). PMID:22949743
Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.
Dunn, Carolyn; Olabode-Dada, Olusola; Whetstone, Lauren; Thomas, Cathy; Aggarwal, Surabhi; Nordby, Kelly; Thompson, Samuel; Johnson, Madison; Allison, Christine
To implement a randomized trial to evaluate the effectiveness of a weight loss program delivered using synchronous distance education compared with a wait-list control group with 6-month follow-up. Adults with a body mass index (BMI) ≥25 were randomized to the intervention (n = 42) or wait-list control group (n = 38). The intervention group participated in a synchronous, online, 15-week weight loss program; weight loss was the primary outcome. Secondary measures included height, BMI, and confidence in ability to be physically active and eat healthy. Assessments occurred at three and four time points in the intervention and control group, respectively. Participants who completed the program lost significantly more weight (1.8 kg) than those in the wait-list control group (0.25 kg) at week 15 [F(1,61) = 6.19, P = 0.02] and had a greater reduction in BMI (0.71 vs. 0.14 kg/m(2) ), [F(1,61) = 7.45, P = 0.01]. There were no significant differences between the intervention and the wait-list control groups for change in confidence in ability to be physically active or eat healthy. Weight loss was maintained at 6 months. Use of synchronous distance education is a promising approach for weight loss. The results of this study will help to inform future research that employs Web-based interventions. © 2015 The Obesity Society.
Yilmaz, G; Demirli Caylan, N; Karacan, C D
Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.
Pots, Wendy T M; Fledderus, Martine; Meulenbeek, Peter A M; ten Klooster, Peter M; Schreurs, Karlein M G; Bohlmeijer, Ernst T
Depression is a highly prevalent disorder, causing a large burden of disease and substantial economic costs. Web-based self-help interventions seem promising in promoting mental health. To compare the efficacy of a guided web-based intervention based on acceptance and commitment therapy (ACT) with an active control (expressive writing) and a waiting-list control condition (Netherlands Trial Register NTR1296). Adults with depressive symptoms from the general population were randomised to ACT (n = 82), expressive writing (n = 67) or waiting-list control (n = 87). The main outcome was reduction in depressive symptoms assessed with the Center for Epidemiological Studies - Depression scale. Significant reductions in depressive symptoms were found following the ACT intervention, compared with the control group (Cohen's d = 0.56) and the expressive writing intervention (d = 0.36). The effects were sustained at 6-month and 12-month follow-up. Acceptance and commitment therapy as a web-based public mental health intervention for adults with depressive symptoms can be effective and applicable. © The Royal College of Psychiatrists 2016.
Beiwinkel, Till; Eißing, Tabea; Telle, Nils-Torge; Siegmund-Schultze, Elisabeth; Rössler, Wulf
Depression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited. This study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence. In an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed. Of the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, Psignificant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI -0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: -67.23%, P<.001, CG: -82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07). The Web
Bendtsen, Preben; McCambridge, Jim; Bendtsen, Marcus; Karlsson, Nadine; Nilsen, Per
University students in Sweden routinely receive proactive mail-based alcohol Internet interventions sent from student health services. This intervention provides personalized normative feedback on alcohol consumption with suggestions on how to decrease drinking. Earlier feasibility trials by our group and others have examined effectiveness in simple parallel-groups designs. To evaluate the effectiveness of electronic screening and brief intervention, using a randomized controlled trial design that takes account of baseline assessment reactivity (and other possible effects of the research process) due to the similarity between the intervention and assessment content. The design of the study allowed for exploration of the magnitude of the assessment effects per se. This trial used a dismantling design and randomly assigned 5227 students to 3 groups: (1) routine practice assessment and feedback, (2) assessment-only without feedback, and (3) neither assessment nor feedback. At baseline all participants were blinded to study participation, with no contact being made with group 3. We approached students 2 months later to participate in a cross-sectional alcohol survey. All interventions were fully automated and did not have any human involvement. All data used in the analysis were based on self-assessment using questionnaires. The participants were unaware that they were participating in a trial and thus were also blinded to which group they were randomly assigned. Overall, 44.69% (n = 2336) of those targeted for study completed follow-up. Attrition was similar in groups 1 (697/1742, 40.01%) and 2 (737/1742, 42.31% retained) and lower in group 3 (902/1743, 51.75% retained). Intention-to-treat analyses among all participants regardless of their baseline drinking status revealed no differences between groups in all alcohol parameters at the 2-month follow-up. Per-protocol analyses of groups 1 and 2 among those who accepted the email intervention (36.2% of the students who
Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P
There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.
Goldfeld, Sharon; Napiza, Natasha; Quach, Jon; Reilly, Sheena; Ukoumunne, Obioha C; Wake, Melissa
Early shared reading and literacy promotion benefits have stimulated international interest in the development of early-years literacy-promotion programs despite limited evidence of effectiveness at a broader population level. To determine whether a population-based primary care literacy promotion intervention during the first 2 years of life improves early markers of subsequent literacy by 2 years of age. This cluster randomized controlled trial took place in 5 relatively disadvantaged areas in Melbourne, Australia. Infants attending their maternal and child health centers were recruited at age 1-2 months. The intervention (4-8, 12, and 18 months) comprised maternal and child health nurses modelling shared reading activities to parents, supported by parent information and free books. Outcomes (at 2 years) included expressive vocabulary (MacArthur Bates Communicative Development Inventory), communication (Communication and Symbolic Behavior Scales), and home literacy environment (StimQ-Toddler). We analyzed the outcomes using random-effects (linear regression) models allowing for clustering. A total of 552 families (87.6%; 324 intervention and 228 control families) of 630 recruited families (66.5% response) were retained to outcome. A total of 97.3% of intervention parents received some (93.7% to all) of the intervention. At 2 years, the trial arms had similar vocabulary (adjusted mean difference: -2.0 [95% confidence interval: -6.2 to 2.2]; P = .36), communication (adjusted mean difference: 0.2 [95% confidence interval: -2.3 to 2.7]; P = .87), and home literacy (adjusted mean difference: -0.4 [95% confidence interval: -1.0 to 0.2]; P = .21). This universal literacy-promotion program was not beneficial in relatively disadvantaged communities by the age of 2 years and may be ineffective. Alternative interpretations may relate to program intensity, reach and/or sleeper effects. Definitive outcomes at 4 years are awaited.
Quach, Jon; Hiscock, Harriet; Ukoumunne, Obioha Chukwunyere; Wake, Melissa
To determine the feasibility of screening for child sleep problems and the efficacy of a behavioral sleep intervention in improving child and parent outcomes in the first year of schooling. A randomized controlled trial was nested in a population survey performed at 22 elementary schools in Melbourne, Australia. Intervention involved 2 to 3 consultations that covered behavioral sleep strategies for children whose screening results were positive for a moderate/severe sleep problem. Outcomes were parent-reported child sleep problem (primary outcome), sleep habits, psychosocial health-related quality of life, behavior, and parent mental health (all at 3, 6, and 12 months) and blinded, face-to-face learning assessment (at 6 months). The screening survey was completed by 1512 parents; 161 (10.8%) reported a moderate/severe child sleep problem, and 108 of 136 (79.2% of those eligible) entered the trial. Sleep problems tended to resolve more rapidly in intervention children. Sleep problems affected 33% of 54 intervention children versus 43% of 54 control children at 3 months (P = .3), 25.5% vs 46.8% at 6 months (P = .03), and 32% vs 33% at 12 months (P = .8). Sustained sleep-habit improvements were evident at 3, 6, and 12 months (effect sizes: 0.33 [P = .03]; 0.51 [P = .003]; and 0.40 [P = .02]; respectively), and there were initial marked improvements in psychosocial scores that diminished over time (effect sizes: 0.47 [P = .02]; 0.41 [P = .09]; and 0.26 [P = .3]; respectively). Better prosocial behavior was evident at 12 months (effect size: 0.35; P = .03), and learning and parent outcomes were similar between groups. School-based screening for sleep problems followed by a targeted, brief behavioral sleep intervention is feasible and has benefits relevant to school transition.
Hooten, W Michael; Townsend, Cynthia O; Hays, J Taylor; Ebnet, Kaye L; Gauvin, Thomas R; Gehin, Jessica M; Laures, Heidi J; Patten, Christi A; Warner, David O
Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n=30) or the control condition (n=30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. Copyright © 2013 Elsevier Ltd. All rights reserved.
Carroll, Kathleen M.; Stefanovics, Elina; Rosenheck, Robert A.
Objective Money management has been implemented, often in bundled interventions, as a strategy to counteract spending of public support checks and other funds on drugs and alcohol. The authors conducted a randomized controlled trial of a voluntary money management program as an adjunctive treatment for patients in treatment for mental illness, substance use disorders, or both. In the advisor-teller money manager (ATM) intervention, a money manager stores patients’ checkbooks and automated bank cards, trains patients to manage their own funds, and links spending to activities related to their treatment goals. Methods Eighty-five veterans with recent use of alcohol or cocaine were randomly assigned to 36 weeks of the ATM intervention or a control intervention (completion of a simple financial workbook). Results With ATM, 75% of veterans gave their checkbook to their money manager to hold, and participants attended significantly more therapy sessions than those assigned to the control therapy (mean of 20.6 versus 8.1 sessions). Although participants assigned to ATM did not show significantly greater improvement over time on the primary outcomes (self-reported abstinence from alcohol and cocaine and negative urine tests for cocaine metabolite), they reduced their Addiction Severity Index drug and alcohol use composite scale scores more rapidly than the control group. High rates of abstinence in both groups created a ceiling effect, limiting the power to detect improved abstinence rates. Conclusions In this relatively small trial, ATM, a money management intervention, showed promise in engaging patients, improving their money management, and improving some substance abuse outcomes. PMID:19339325
Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis
Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…
White, Bethany; Madden, Annie; Hellard, Margaret; Kerr, Thomas; Prins, Maria; Page, Kimberly; Dore, Gregory J.; Maher, Lisa
While people who inject drugs are at high risk of hepatitis C virus (HCV) infection and will be the target population for future HCV vaccine trials, little is known about clinical trial literacy (CTL) in this group. We assessed the impact of a brief intervention (BI) designed to improve HCV vaccine
Danaher, Brian G.; Severson, Herbert H.; Zhu, Shu-Hong; Andrews, Judy A.; Cummins, Sharon E.; Lichtenstein, Edward; Tedeschi, Gary J.; Hudkins, Coleen; Widdop, Chris; Crowley, Ryann; Seeley, John R.
Quitline interventions did not result in additive or synergistic effects, as have been found for smoking. Both interventions were more effective than a self-help control condition in helping motivated smokeless tobacco users quit tobacco. Intervention usage and satisfaction were related to the amount intervention content offered. Usage of the Quitline intervention decreased when offered in combination, though rates of helpfulness and recommendations were higher when offered in combination. Trial Registration Clinicaltrials.gov NCT00820495; http://clinicaltrials.gov/ct2/show/NCT00820495 PMID:25914872
Bailey, Donald E; Hendrix, Cristina C; Steinhauser, Karen E; Stechuchak, Karen M; Porter, Laura S; Hudson, Julie; Olsen, Maren K; Muir, Andrew; Lowman, Sarah; DiMartini, Andrea; Salonen, Laurel Williams; Tulsky, James A
We tested an uncertainty self-management telephone intervention (SMI) with patients awaiting liver transplant and their caregivers. Participants were recruited from four transplant centers and completed questionnaires at baseline, 10, and 12 weeks from baseline (generally two and four weeks after intervention delivery, respectively). Dyads were randomized to either SMI (n=56) or liver disease education (LDE; n=59), both of which involved six weekly telephone sessions. SMI participants were taught coping skills and uncertainty management strategies while LDE participants learned about liver function and how to stay healthy. Outcomes included illness uncertainty, uncertainty management, depression, anxiety, self-efficacy, and quality of life. General linear models were used to test for group differences. No differences were found between the SMI and LDE groups for study outcomes. This trial offers insight regarding design for future interventions that may allow greater flexibility in length of delivery beyond our study's 12-week timeframe. Our study was designed for the time constraints of today's clinical practice setting. This trial is a beginning point to address the unmet needs of these patients and their caregivers as they wait for transplants that could save their lives. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel
This study tested the effect of beginning treatment with a speech-generating device (SGD) in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. A total of 61 minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a SGD for 6 months with a 3-month follow-up. The intervention consisted of 2 stages. In stage 1, all children received 2 sessions per week for 3 months. Stage 2 intervention was adapted (by increased sessions or adding the SGD) based on the child's early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were the total number of novel words and total comments from a natural language sample. Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes. Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children's response to treatment. Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Díez, Elia; López, Maria J; Marí-Dell'Olmo, Marc; Nebot, Laia; Pérez, Gloria; Villalbi, Joan R; Carreras, Ramon
This study aims to evaluate the effects of a community-based counselling intervention to improve contraception use among immigrant and native residents in deprived neighbourhoods. : Randomized controlled trial. Women aged 14-49 years and men aged 14-39 years from two low-income neighbourhoods with high proportion of immigration in Barcelona (Catalonia, Spain) who had not undergone irreversible contraception and were not planning a pregnancy were recruited (2011-13). A culturally developed and theoretically based brief counselling intervention was delivered in community settings. The primary outcome was the consistent use of effective contraceptive methods (optimal use). Secondary outcomes were the incorrect use of effective methods and the use of less effective methods stratified by sex and migrant status. Differences within subgroups from baseline to the 3-month follow-up were analysed by intention to treat and per protocol. The effects were assessed with adjusted robust Poisson regressions. : The study enrolled and randomized 746 eligible participants. There were no differences between the intervention and control groups in demographic characteristics. Optimal use significantly increased in men, women, immigrants and natives in the intervention group, with no changes in the control group. In the intervention group, inconsistent use of effective methods decreased by 54.9% and that of less effective methods by 47.2%. The overall adjusted prevalence ratio of optimal use in the intervention group versus the control group was 1.138 (95% CI: 1.010-1.284). : This brief counselling intervention increased the consistent use of effective contraception in low-income neighbourhoods with a high proportion of immigration.
Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel
Objective This study tested the effect of beginning treatment with a speech-generating device in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. Method Sixty-one minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a speech-generating device (SGD) for 6 months with a 3-month follow-up. The intervention consisted of two stages. In Stage 1 all children received two sessions per week for 3 months. Stage 2 intervention was adapted (increased sessions or adding the SGD) based on the child’s early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were total number of novel words and total comments from a natural language sample. Results Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better post-treatment outcomes. Conclusion Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children’s response to treatment. Clinical trial registration information—Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. PMID:24839882
Pardavila-Belio, Miren I; García-Vivar, Cristina; Pimenta, Adriano Marçal; Canga-Armayor, Ana; Pueyo-Garrigues, Sara; Canga-Armayor, Navidad
To evaluate the effectiveness of a nurse intervention aimed at helping college student smokers quit smoking. Single-blind, pragmatic randomized controlled trial which compares a multi-component intervention, tailored specifically to college students, with a brief advice session with a 6-month follow-up. This study was conducted at the University of Navarra, Spain. A total of 255 college student smokers (age range = 18-24 years) were randomized to an intervention group (n = 133) or to a control group (n = 122). A multi-component intervention based on the Theory of Triadic Influence of Flay was developed. The intervention consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The primary outcome was self-reported abstinence, with biochemical verification at 6 months. The secondary outcomes consisted of the mean number of cigarettes smoked per day, self-reported attempts to quit smoking and stage of change at 6 months. At the 6-month follow-up, the smoking cessation incidence was 21.1% in the intervention group compared with 6.6% in the control group (difference = 14.5 confidence interval = 6.1-22.8; relative risk = 3.41, 95% confidence interval = 1.62-7.20). The difference in the mean number of cigarettes at 6 months was significantly different (difference = -2.2, confidence interval = -3.6 to -0.9). A multi-component intervention tailored to college students and managed by a nurse is effective in increasing smoking cessation among college students. © 2015 Society for the Study of Addiction.
Wennehorst, Katharina; Mildenstein, Klas; Saliger, Brunhild; Tigges, Corinna; Diehl, Hans; Keil, Thomas; Englert, Heike
The prevalence of type 2 diabetes is continuously increasing. This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system. In view of the fact that type 2 diabetes is primarily caused by behavioral factors, effective preventive strategies are urgently needed. We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes. We conducted a randomized controlled trial in a primary care setting in Hannover, Germany, with 83 patients diagnosed as (pre)diabetic or at risk for diabetes. CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases. The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach. The primary outcome parameter was the body mass index (BMI). Secondary outcome parameters included body weight, blood pressure, fasting glucose, HbA1c, blood lipids, and the FINDRISK score, which assesses long-term diabetes risk. At the final measurement after 12 months, in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m(2) in controls (p = .119). The mean sustained weight loss after 12 months was -4.1 kg in the intervention group versus -0.8 kg in controls. Furthermore, we found a trend toward a stronger reduction in blood pressure, fasting glucose, and HbA1c as well as an improved FINDRISK score in the intervention group, compared to controls. Although failing to reach statistical significance at the final assessment, this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes.
Figueiras, Maria João; Maroco, João; Monteiro, Rita; Caeiro, Raúl; Dias Neto, David
There is converging evidence that changing beliefs about an illness leads to positive recovery outcomes. However, cardiac misconceptions interventions have been investigated mainly in Angina or Coronary Heart Disease patients, and less in patients following Myocardial Infarction (MI). In these patients, cardiac misconceptions may play a role in the adjustment or lifestyle changes. This article reports a randomized controlled trial of an intervention designed to reduce the strength of misconceptions in patients after a first MI. The primary outcome was the degree of change in misconceptions and the secondary outcomes were: exercise, smoking status, return to work and mood (anxiety and depression). Patients in the intervention condition (n = 60) were compared with a control group (n = 67) receiving usual care. Both groups were evaluated at baseline and 4, 8 and 12 months after hospital discharge. There was a significant time-by-group interaction for the total score of cardiac misconceptions. Patients in the intervention group significantly decreased their total score of cardiac misconceptions at 4 months compared with the control group and this difference was sustained over time. Patients in the intervention group were also more likely to exercise at the follow-up period after MI than the control group. This intervention was effective in reducing the strength of cardiac misconceptions in MI patients and had a positive impact on health behaviour outcomes. These results support the importance of misconceptions in health behaviours and the utility of belief change interventions in promoting health in patients with Myocardial Infarction.
Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors
Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year , coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious
Full Text Available BACKGROUND: Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes, increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA during work hours. METHODS: A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864 was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19, 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14, pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29, computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. RESULTS: For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006 and during work hours (-1.7%, p = 0.014 and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005 and during work hours (0.72, p = 0.015; there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012 and MVPA on work days (0.6%, p = 0.012. CONCLUSIONS: This study explored novel ways to modify work practices to reduce occupational sedentary behaviour
Daly, Niamh; Farren, Maria; McKeating, Aoife; OʼKelly, Ruth; Stapleton, Mary; Turner, Michael J
To evaluate whether an intensive, medically supervised exercise intervention improved maternal glycemia and gestational weight gain in obese pregnant women when compared with routine prenatal care. This randomized controlled trial compared a medically supervised exercise intervention with routine prenatal care. The primary outcome was a reduction in mean maternal fasting plasma glucose in the intervention group by 6.9 mg/dL at the time of a 75-g oral glucose tolerance test at 24-28 weeks of gestation. Secondary outcomes included excessive gestational weight gain. The intervention consisted of 50-60 minutes of exercise: warm-up, resistance or weights, aerobic exercises, and cool-down. All women received routine prenatal care. Power calculation determined that 24 women were required per group to detect a difference of 6.9 mg/dL in fasting plasma glucose between groups based on an independent-sample t test for statistical power of 80% at a type I error rate of 0.05. A sample size of 44 per group was planned to allow a dropout rate of 33%. From November 2013 through August 2015, 88 women were randomized: 44 each to the exercise and control groups. Eight women in the control group and 11 in the intervention group did not complete the trial at 6 weeks postpartum (P=.61), but 43 in each group attended the 24- to 28-week glucose screen. There were no baseline maternal differences between groups. Classes commenced at a mean of 13 4/7±1 2/7 weeks of gestation. In early pregnancy, 51.1% (n=45/88) had an elevated fasting plasma glucose (92-125 mg/dL). There was no difference in the mean fasting plasma glucose at 24-28 weeks of gestation: 90.0±9.0 mg/dL (n=43) compared with 93.6±7.2 mg/dL (n=43) (P=.13) or in the incidence of gestational diabetes mellitus at 24-28 weeks of gestation: 48.8% (n=21/43) compared with 58.1% (n=25/43) (P=.51) in the control and exercise groups, respectively. At 36 weeks of gestation, excessive gestational weight gain greater than 9.1 kg was lower
Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny
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. The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was
Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.
Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19
Guillemont, Juliette; Cogordan, Chloé; Nalpas, Bertrand; Nguyen-Thanh, Vi?t; Richard, Jean-Baptiste; Arwidson, Pierre
This study aims to evaluate the effectiveness of a web-based intervention to reduce alcohol consumption among hazardous drinkers. A two-group parallel randomized controlled trial was conducted among adults identified as hazardous drinkers according to the Alcohol Use Disorders Identification Test. The intervention delivers personalized normative…
Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.
Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…
Bogaerts, A.F.L.; Devlieger, R.; Nuyts, E.; Witters, I.; Gyselaers, W.; Van den Bergh, B.R.H.
Objective: Lifestyle intervention could help obese pregnant women to limit their weight gain during pregnancy and improve their psychological comfort, but has not yet been evaluated in randomized controlled trials. We evaluated whether a targeted antenatal lifestyle intervention programme for obese
Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.
This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous…
Gautam, M. R.; Acharya, K.
Water availability and occurrence of water induced disasters are impacted by both natural and human centric drivers. Climate change is considered to be one of the noted drivers in this regard. Human interventions through land use/land cover change, stream and floodplain regulations via dams, weirs, and embankments could be other equally important group of drivers. Unlike developed countries that have both resources and capabilities to adapt and mitigate the impact of such drivers, developing countries are increasingly at more risk. Identifying roles of such drivers are fundamental to the formulation of any adaptation and mitigation plans for their impacts for developing countries. In this study, we present a few examples from three regions of Nepal- a developing country in South Asia generally considered as a water rich country. Through results of modeling and statistical analyses, we show which driver is in control in different watersheds. Preliminary results show that climate change impact appears to be more prominent in large snow-fed river basins. In the smaller non-snow-fed watersheds originating from the middle hill, the impacts are not explicit despite perception of local people about changes in the water availability. In the southern belt bordering India, the impacts of river regulation on downstream areas are found to be the principal cause of flooding/inundation.
Full Text Available Abstract Background Recent years have seen publication of a considerable number of clinical trials of preventive interventions against clinical malaria in children. There has been variability in the specification of end-points, case definitions, analysis methods and reporting and the relative lack of standardization complicates the ability to make comparative evaluations between trials. Methods To prepare for a WHO consultation on design issues in malaria vaccine trials, controlled trials of preventive interventions against malaria in children in endemic countries were identified in which clinical malaria, or death, had been one of the main end-points. Trials were included that evaluated the impact of vaccines, insecticide-treated bed nets (ITN, intermittent presumptive or preventive therapy in infants (IPTi or, in one instance, vitamin A supplementation. Methods that had been used in these trials were summarized and compared in order to identify issues that were directly relevant to the design of malaria vaccine trials. Results 29 controlled trials of preventive malaria interventions were identified, of which eight were vaccine trials. Vaccine trials that were designed to detect an effect on clinical malaria all reported the incidence rate of first episodes of clinical malaria as their primary endpoint. Only one trial of a preventive intervention (of ITN was identified that was designed to detect an effect on severe malaria. A group of larger trials were designed to detect an effect of impregnated bed nets or curtains on all-cause mortality as the primary end-point. Key methodological and reporting differences between trials are noted in the text. Two issues have been identified that are of some concern. Firstly, the choice of primary endpoint is not stated in the reports of a number of the trials and, secondly, the relationship between pre-specified analysis plans and trial reports is rarely made clear. Conclusion This article reports an
Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for
McRury, Jonna M; Zolotor, Adam J
To evaluate the efficacy of videotaped instruction of a behavioral intervention to reduce crying among newborns. Mothers of healthy, full-term newborns were recruited from the postpartum unit of a large community hospital for a prospective, randomized, controlled trial of an intervention to reduce infant crying. Mothers participating in the intervention viewed a videotape with instructions involving swaddling, side positioning, white noise, jiggling, and sucking. Mothers in the control group viewed a videotape with instructions for normal newborn care. Intervention was assessed by mean hours per day of infant total crying (fussing, crying, and unsoothable crying) and sleeping as recorded in a diary 3 days a week during the 1st, 4th, 6th, 8th, and 12th weeks of age; the Parenting Stress Index was also used during the 6th and 12th weeks. Fifty-one mother-infant pairs were recruited; 35 completed the study (18 intervention and 17 controls). Sixteen were lost to follow-up. There were no statistically significant differences between the groups in the hours of mean daily total crying or sleeping during the 1st, 4th, 6th, 8th, or 12th weeks of age. For example, during the 6th week of age mean daily total crying was 1.9 hours for infants in the control group versus 2.2 hours for infants in the intervention group (P = .4); sleep was 14.5 hours for infants in the control group versus 14.4 hours for infants in the intervention group (P = .8). During the 12th week mean daily total crying was 1.2 hours for infants in the control group versus 1.8 hours for infants in the intervention group (P = .8) and sleep was 14.1 hours for infants in the control group versus 14.0 hours for infants in the intervention group (P = 1.0). There was no difference between the groups in the Parenting Stress Index during the 6th week of age. The behavioral intervention, when provided via videotape, does not seem to be efficacious in decreasing total crying among normal infants.
Marc A Adams
Full Text Available 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.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.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.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.The adaptive intervention outperformed the static intervention for increasing
Mark W. Vander Weg
Full Text Available Abstract Background Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes. Methods This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age = 56.8 years; 87 % male; mean number of cigarettes/day = 24.7. The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months. Results Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored = 39 %; Quitline Referral = 25 %; odds ratio [OR]; 95 % confidence interval [CI] = 1.90; 0.56, 5.57. Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI = 1.05; 0.35, 3.12. Satisfaction with the Tailored tobacco intervention was high. Conclusions Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes. Trial registration ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.
Crawford, Jennifer J; Vallance, Jeff K; Holt, Nicholas L; Bell, Gordon J; Steed, Helen; Courneya, Kerry S
To examine the feasibility and preliminary efficacy of an eight-week supervised climbing intervention for gynecologic cancer survivors (GCSs). . A pilot randomized, controlled trial. . The Wilson Climbing Center in Edmonton, Alberta, Canada. . 35 GCSs who had completed cancer therapy. . GCSs were randomized to an eight-week (16 session) supervised wall climbing intervention (WCI) (n = 24) or usual care (UC) (n = 11). . Feasibility outcomes included recruitment rate, adherence rate, skill performance, and safety. Preliminary efficacy outcomes were objective health-related and functional fitness assessed before and after the eight-week intervention using the Senior Fitness Test. . Median adherence to the WCI was 13.5 of 16 sessions. Most GCSs were proficient on 16 of 24 skill assessment items. No serious adverse events were reported. Based on intention-to-treat analyses, the WCI group was superior to the UC group for the 6-minute walk, 30-second chair stand, 30-second arm curls, sit and reach, 8-foot up-and-go, grip strength-right, and grip strength-left assessments. . The Gynecologic Cancer Survivors Wall Climbing for Total Health (GROWTH) Trial demonstrated that an eight-week supervised WCI was safe, feasible, and improved functional fitness in GCSs. Phase II and III trials are warranted to further establish the safety, feasibility, and efficacy of WCIs in cancer survivors. . Oncology nurses may consider a climbing wall as an alternative type of physical activity for improving functional fitness in GCSs.
Karen J. Campbell
Full Text Available Abstract Background Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. Methods/Design The Infant Feeding Activity and Nutrition Trial (InFANT Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month and enhanced (use of web-based materials, and Facebook® engagement, version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. Discussion This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. Trial registration ACTRN12611000386932 . Registered 13 April 2011.
Messiah, Antoine; Constant, Aymery; Contrand, Benjamin; Felonneau, Marie-Line; Lagarde, Emmanuel
Prevention tools are challenged by risky behaviors that follow their adoption. Speed increase following helmet use adoption was analyzed among bicyclists enrolled in a controlled intervention trial. Speed and helmet use were assessed by video (2621 recordings, 587 participants). Speeds were similar among helmeted and nonhelmeted female cyclists (16.5 km/h and 16.1 km/h, respectively) but not among male cyclists (helmeted: 19.2 km/h, nonhelmeted: 16.8 km/h). Risk compensation, observed only among male cyclists, was moderate, thus unlikely to offset helmet preventive efficacy.
Danielle E Clarkesmith
Full Text Available BACKGROUND: Stroke prevention in atrial fibrillation (AF, most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0 and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its treatment may contribute to the patient's willingness to adhere to recommendations. METHOD: A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients utilising an "expert-patient" focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605 against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD 72.0 (8.2, 67.4% men, or usual care (n=51, mean age (SD 73.7 (8.1, 62.7% men, stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR; secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions. MAIN FINDINGS: Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035; at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44. Knowledge increased significantly across time (F (3, 47 = 6.4; p<0.01, but there were no differences between groups (F (1, 47 = 3.3; p = 0.07. At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04. Patients' scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months. CONCLUSIONS: A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients' understanding of the
Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne
Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected
Reynolds, Joanna; DiLiberto, Deborah; Mangham-Jefferies, Lindsay; Ansah, Evelyn K; Lal, Sham; Mbakilwa, Hilda; Bruxvoort, Katia; Webster, Jayne; Vestergaard, Lasse S; Yeung, Shunmay; Leslie, Toby; Hutchinson, Eleanor; Reyburn, Hugh; Lalloo, David G; Schellenberg, David; Cundill, Bonnie; Staedke, Sarah G; Wiseman, Virginia; Goodman, Catherine; Chandler, Clare I R
There is increasing recognition among trialists of the challenges in understanding how particular 'real-life' contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted. A collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection. From our experiences of the realities of conducting these evaluations, we identified six key 'lessons learned' about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the evaluation to aid interpretation of outcomes; and
Allen Kelli D
Full Text Available Abstract Background Osteoarthritis (OA of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers. Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection, based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function, and
Brendbekken, Randi; Eriksen, Hege R; Grasdal, Astrid; Harris, Anette; Hagen, Eli M; Tangen, Tone
This randomized clinical trial was performed to compare the effect of a new multidisciplinary intervention (MI) programme to a brief intervention (BI) programme on return to work (RTW), fully and partly, at a 12-month and 24-month follow-up in patients on long-term sick leave due to musculoskeletal pain. Patients (n = 284, mean age 41.3 years, 53.9 % women) who were sick-listed with musculoskeletal pain and referred to a specialist clinic in physical rehabilitation were randomized to MI (n = 141) or BI (n = 143). The MI included the use of a visual educational tool, which facilitated patient-therapist communication and self-management. The MI also applied one more profession, more therapist time and a comprehensive focus on the psychosocial factors, particularly the working conditions, compared to a BI. The main features of the latter are a thorough medical, educational examination, a brief cognitive assessment based on the non-injury model, and a recommendation to return to normal activity as soon as possible. The number of patients with full-time RTW developed similarly in the two groups. The patients receiving MI had a higher probability to partly RTW during the first 7 months of the follow-up compared to the BI-group. There were no differences between the groups on full-time RTW during the 24 months. However, the results indicate that MI hastens the return to work process in long-term sick leave through the increased use of partial sick leave. http://www.clinicaltrials.gov with the registration number NCT01346423.
Locher, JL; Vickers, KS; Buys, DR; Ellis, A; Lawrence, JC; Newton, LE; Roth, DL; Ritchie, CS; Bales, CW
Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and effica...
Tan, Pey June; Khoo, Ee Ming; Chinna, Karuthan; Hill, Keith D; Poi, Phillip JH; Tan, Maw Pin
Background In line with a rapidly ageing global population, the rise in the frequency of falls will lead to increased healthcare and social care costs. This study will be one of the few randomized controlled trials evaluating a multifaceted falls intervention in a low-middle income, culturally-diverse older Asian community. The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adult...
Munro, Cindy L; Cairns, Paula; Ji, Ming; Calero, Karel; Anderson, W McDowell; Liang, Zhan
Explore the effect of an automated reorientation intervention on ICU delirium in a prospective randomized controlled trial. Delirium is common in ICU patients, and negatively affects outcomes. Few prevention strategies have been tested. Thirty ICU patients were randomized to 3 groups. Ten received hourly recorded messages in a family member's voice during waking hours over 3 ICU days, 10 received the same messages in a non-family voice, and 10 (control) did not receive any automated reorientation messages. The primary outcome was delirium free days during the intervention period (evaluated by CAM-ICU). Groups were compared by Fisher's Exact Test. The family voice group had more delirium free days than the non-family voice group, and significantly more delirium free days (p = 0.0437) than the control group. Reorientation through automated, scripted messages reduced incidence of delirium. Using identical scripted messages, family voice was more effective than non-family voice. Copyright © 2017 Elsevier Inc. All rights reserved.
Harder-Lauridsen, Nina Majlund; Birk, Nina Marie; Ried-Larsen, Mathias
BACKGROUND: Obesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance...... intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group. METHODS: School children from Copenhagen were randomly....../day, and fat mass. In addition, similar beneficial metabolic effects were found in the children as shown in adults, e.g. increase in peripheral insulin sensitivity. TRIAL REGISTRATION: Clinicaltrials.gov Identifier number NCT01660789....
Smith, Gregory C.; Strieder, Frederick; Greenberg, Patty; Hayslip, Bert; Montoro-Rodriguez, Julian
The authors used Andersen’s (2008) behavior model to investigate patterns of enrollment and treatment engagement among 343 custodial grandmothers who participated in a randomized clinical trial of three psychosocial interventions:(a) a behavioral parenting program, (b) a cognitive behavioral coping program, or (c) an information-only condition. Treatment completion was superior to that typically found with birth parents, even though the grandmothers and their target grandchildren both had high levels of mental and physical health challenges. Compliance did not differ significantly by condition but was higher among grandmothers who self-reported less positive affect, were older, and were using mental health professionals. Treatment satisfaction was highest in grandmothers who attended more treatment sessions, reported lower annual family income, had a health problem, and were using mental health professionals. The practice and policy implications of these findings are discussed, especially in terms of strategies for enhancing the engagement of custodial grandfamilies in future psychoeducational interventions. PMID:27667888
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.
Soto-Rodríguez, Anxela; García-Soidán, José Luís; de Toro-Santos, Manuel; Rodríguez-González, Manuel; Arias-Gómez, M Jesús; Pérez-Fernández, María Reyes
To assess whether an educational intervention in women in perimenopausal age with diabetes mellitus, hypertension and/or dyslipidemia could improve aspects of quality of life and exercise. A randomized clinical trial. physical activity, quality of life and weight in women aged 45-60 years (n = 320) at time 0 and 12 months after surgery. intervention group (IG): 3 interactive workshops on cardiovascular disease prevention and control group (CG): information by mail. The IG obtained better scores on the mental component of quality of life one year later (p cardiovascular risk factor improves aspects of quality of life and of healthy habits such as physical activity. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.
Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J.
Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees? dietary intakes, nutri...
Arnold, Shelley S; Barton, Belinda; McArthur, Genevieve; North, Kathryn N; Payne, Jonathan M
To examine the efficacy of a phonics-training program in children with neurofibromatosis type 1 (NF1) and reading difficulties. Thirty children (7-12 years of age) with NF1 completed a double-baseline, 24-week intervention trial. Literacy outcome measures were assessed at 4 time points: (1) at baseline; (2) after an 8-week no-treatment period; (3) immediately post-treatment; and (4) at follow-up 8 weeks post-treatment. Repeated-measures ANOVA were conducted to examine change over time for all outcome measures, and significant main effects were explored with planned comparisons. Predictors of treatment effects were examined by linear regressions. Ninety percent of participants completed the intervention. Intervention-specific improvements were observed across a range of literacy outcomes, including reading accuracy (nonword reading, Cohen d = 1.10; regular-word reading, Cohen d = 0.32), letter-sound knowledge (Cohen d = 0.80), blending (Cohen d = 0.88), repetition of nonsense words (Cohen d = 0.94), phonemic decoding fluency (Cohen d = 0.55), and reading comprehension (Cohen d = 0.31). Improvements were maintained 8 weeks post-treatment. Age (P = .03) and working memory (P = .02) significantly influenced efficacy, with greatest improvements observed in older children with stronger verbal working memory capacity. Home-based, computerized reading intervention was effective in improving the reading and reading-related abilities of children with NF1 and reading difficulty. Australian and New Zealand Clinical Trials Registry: ACTRN12611000779976. Copyright © 2016 Elsevier Inc. All rights reserved.
Adamo, Kristi B; Ferraro, Zachary M; Goldfield, Gary; Keely, Erin; Stacey, Dawn; Hadjiyannakis, Stasia; Jean-Philippe, Sonia; Walker, Mark; Barrowman, Nicholas J
Maternal obesity and/or high gestational weight gain (GWG) are associated with downstream child obesity. Pregnancy represents a critical period for prevention as women are highly motivated and more receptive to behavior change. This pilot study was developed to test the feasibility of intervening with the mother, specifically keeping her GWG within the Institute of Medicine (IOM) limits, with the intended target of preventing obesity in her child downstream. We are testing the practicality of delivering a structured physical activity and nutrition intervention to pregnant women during gestation and then following mom and baby to 24 months of age. This study is a two-arm, parallel group, randomized controlled trial being conducted in Ottawa. Pregnant women, with pregravid BMI >18.5, between 12 and 20 weeks gestation are randomized to one of two groups: intervention (n=30) who receive the MOM trial Handbook (guide to healthy gestation) plus a structured physical activity and nutrition program, or a standard clinical care control group (n=30). The intervention lasts 25-28 weeks (6 months) depending on anticipated delivery date, with follow-up assessment on mother and child at 3, 6, 12 and 24 months post-delivery. Pregnancy, a critical time of growth, development and physiological change, provides an opportunity for early lifestyle intervention. The goal of identifying an effective lifestyle program for the gestational period that leads to healthy fetal development and subsequently normal weight offspring, less likely to develop obesity and its co-morbidities, is unique and could possibly attenuate the inter-generational cycle of obesity. Copyright © 2013 Elsevier Inc. All rights reserved.
Johns, David J; Hartmann-Boyce, Jamie; Jebb, Susan A; Aveyard, Paul
Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12-month mean weight change using baseline observation carried forward. Meta-regression was conducted in STATA v12. Thirty studies met the inclusion criteria, twenty-nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was -0.8 kg (95% CI -1.1 to -0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of -0.53 kg (95% CI -0.96 to -0.09). Also in an unadjusted model, each additional weigh-in was associated with a weight change of -0.42 kg (95% CI -0.81 to -0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh-ins was associated with weight change. Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow-up. © 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).
Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A
Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: email@example.com.
Lee, Hee; Ghebre, Rahel; Le, Chap; Jang, Yoo Jeong; Sharratt, Monica; Yee, Douglas
Despite the increasing breast cancer incidence and mortality rates, Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States. Mobile health (mHealth), defined as the delivery of health care information or services through mobile communication devices, has been utilized to successfully improve a variety of health outcomes. This study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women, an underserved community. Using a randomized controlled trial design, 120 Korean American women aged 40 to 77 years were recruited and randomly assigned to either the mMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group (n=60) to receive a printed brochure. Outcome measures included knowledge, attitudes, and beliefs about breast cancer screening, readiness for mammography, and mammogram receipt. The feasibility and acceptability of the mMammogram intervention was also assessed. The intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines (P=.01). The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group. A significantly higher proportion of women who received the mMammogram intervention (75%, 45/60) completed mammograms by the 6-month follow-up compared with the control group (30%, 18/60; Phttps://clinicaltrials.gov/show/NCT01972048 (Archived by WebCite at https://clinicaltrials.gov/archive/NCT01972048/2013_10_29).
McKenzie, Lara B; Roberts, Kristin J; Kaercher, Roxanne M; Collins, Christy L; Comstock, R Dawn; Fernandez, Soledad; Abdel-Rasoul, Mahmoud; Casavant, Marcel J; Mihalov, Leslie
Although non-fire-related carbon monoxide (CO) poisoning is almost entirely preventable, over 400 people die and 20 000 people are injured each year in the USA from unintentional CO poisoning. Thus, there is a critical need for evidence-based interventions for preventing CO poisoning and increasing the proper use and installation of CO detectors. A randomised, controlled trial (Project CODE, a Carbon Monoxide Detector Education intervention) with 2-week and 6-month follow-up home observations was conducted in 299 parents of children aged ≤18 years recruited in the emergency department of a level 1 paediatric trauma centre. The intervention group received an educational tool, a spiral-bound, laminated booklet that resembled a CO detector containing theory-based safety messages based on the precaution adoption process model, a plug-in CO detector and 9 V battery. The control group received a one page flyer on CO poisoning prevention. Although the difference was not statistically significant, mean CO knowledge score increased at a greater rate for the intervention group than the control group. Intervention group parents were more likely to exhibit 'safe' CO detector use than control group parents at the 2-week follow-up (RR: 2.75; 95% CI 2.06 to 3.69) and 6-month follow-up (RR: 2.78; 95% CI 2.06 to 3.76), after adjusting for self-reported CO detector use behaviour at enrolment and annual per capita income. An emergency department-delivered intervention containing a theory-based educational tool paired with a CO detector can be an effective method for increasing knowledge about CO poisoning, for prevention and for appropriate use of a CO detector. NCT00959478. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Pace, Emma J; Somerville, Nicholas J; Enyioha, Chineme; Allen, Joseph P; Lemon, Latrina C; Allen, Claudia W
Increasing attention is being paid to patients’ experience of hospitalization. BATHE (a brief psychosocial intervention that addresses Background, Affect, Trouble, Handling, and Empathy) has been found to improve patients’ outpatient experiences but has not yet been studied in inpatient settings. This randomized controlled trial (RCT) examined whether daily administration of BATHE would improve patients’ satisfaction with their hospital experience. BATHE is a brief psychosocial intervention designed to reduce distress and strengthen the physician-patient relationship. In February through March 2015 and February through March 2016, 25 patients admitted to the University of Virginia Family Medicine inpatient service were randomized to usual care or to the BATHE intervention. Participants completed a baseline measure of satisfaction at enrollment. Those in the intervention group received the BATHE intervention daily for five days or until discharge. At completion, participants completed a patient satisfaction measure. Daily administration of BATHE had strong effects on patients’ likelihood of endorsing their medical care as “excellent.” BATHE did not improve satisfaction by making patients feel more respected, informed or attended to. Rather, effects on satisfaction were mediated by patients’ perception that their physician showed “a genuine interest in me as a person." Our study suggests that patients are more satisfied with their hospitalization experience when physicians take a daily moment to check in with the patient “as a person” and not just as a medical patient. The brevity of the BATHE intervention indicates that this check-in need not be lengthy or overly burdensome for the already busy inpatient physician.
Karjalainen, Kaija; Malmivaara, Antti; Pohjolainen, Timo; Hurri, Heikki; Mutanen, Pertti; Rissanen, Pekka; Pahkajärvi, Helena; Levon, Heikki; Karpoff, Hanna; Roine, Risto
Randomized controlled trial. To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.
Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M
A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.
Clanchy, Kelly M; Tweedy, Sean M; Trost, Stewart G
Individuals with brain impairment (BI) are less active than the general population and have increased risk of chronic disease. This controlled trial evaluated the efficacy of a physical activity (PA) intervention for community-dwelling adults with BI. A total of 43 adults with BI (27 male, 16 female; age 38.1 ± 11.9 years; stage of change 1-3) who walked as their primary means of locomotion were allocated to an intervention (n = 23) or control (n = 20) condition. The intervention comprised 10 face-to-face home visits over 12 weeks, including a tailored combination of stage-matched behavior change activities, exercise prescription, community access facilitation, and relapse prevention strategies. The control group received 10 face-to-face visits over 12 weeks to promote sun safety, healthy sleep, and oral health. Primary outcomes were daily activity counts and minutes of moderate-to-vigorous-intensity PA (MVPA) measured with the ActiGraph GT1M at baseline (0 weeks), postintervention (12 weeks) and follow-up (24 weeks). Between-group differences were evaluated for statistical significance using repeated-measures ANOVA. MVPA for the intervention group increased significantly from baseline to 12 weeks (20.8 ± 3.1 to 31.2 ± 3.1 min/d; P = .01), but differences between baseline and 24 weeks were nonsignificant (20.8 ± 3.1 to 25.3 ± 3.2 min/d; P = .28). MVPA changes for the control group were negligible and nonsignificant. Between-group differences for change in MVPA were significant at 12 weeks (P = .03) but not at 24 weeks (P = .49). The 12-week intervention effectively increased adoption of PA in a sample of community-dwelling adults with BI immediately after the intervention but not at follow-up. Future studies should explore strategies to foster maintenance of PA participation. © The Author(s) 2016.
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.
Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine
To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.
Osman, Hibah; Saliba, Matilda; Chaaya, Monique; Naasan, Georges
The postpartum period can be a challenging time particularly for first-time mothers. This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers. Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut, Lebanon after delivery. The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline. Participants were randomized to one of four study arms to receive either the postpartum support film, the hotline service, both interventions, or a music CD (control). Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale (PSS-10). Of the 632 eligible women, 552 (88%) agreed to participate in the study. Of those, 452 (82%) completed the study. Mean PSS-10 scores of mothers who received the film alone (15.76) or the film with the hotline service (15.86) were significantly lower than that of the control group (18.93) (p-value reduced stress in the postpartum period in first-time mothers. These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers. The trial was registered with clinicaltrials.gov (identifier # NCT00857051) on March 5, 2009.
Elgmark Andersson, E; Emanuelson, I; Björklund, R; Stålhammar, D A
Positive results from early clinical intervention of mild traumatic brain injury (MTBI) patients by rehabilitation specialists have been reported. Various treatments have been used, but few controlled studies are published. We hypothesised that early rehabilitation of selected MTBI patients would reduce long term sequelae. A randomised controlled trial with one year follow-up. Among 1719 consecutive patients with MTBI, 395 individuals, 16-60 years of age, met the MTBI definition. Exclusion criteria were: previous clinically significant brain disorders and/or a history of substance abuse. The control group (n = 131) received regular care. The intervention group (n = 264) was examined by a rehabilitation specialist. 78 patients were mainly referred to an occupational therapist. The problems were identified in daily activities and in terms of post-concussion symptoms (PCS), an individualised, tailored treatment was given. Primary endpoint was change in rate of PCS and in life satisfaction at one-year follow-up between the groups. No statistical differences were found between the intervention and control groups. Patients who experienced few PCS two to eight weeks after the injury and declined rehabilitation recovered and returned to their pre-injury status. Patients who suffered several PCS and accepted rehabilitation did not recover after one year. In this particular MTBI sample, early active rehabilitation did not change the outcome to a statistically-significant degree. Further studies should focus on patients with several complaints during the first 1-3 months and test various types of interventions.
Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes
Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents.
Saitz, Richard; Palfai, Tibor P A; Cheng, Debbie M; Alford, Daniel P; Bernstein, Judith A; Lloyd-Travaglini, Christine A; Meli, Seville M; Chaisson, Christine E; Samet, Jeffrey H
The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse, based in part on evidence of efficacy for unhealthy alcohol use. However, it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy. To test the efficacy of 2 brief counseling interventions for unhealthy drug use (any illicit drug use or prescription drug misuse)-a brief negotiated interview (BNI) and an adaptation of motivational interviewing (MOTIV)-compared with no brief intervention. This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice; 528 adult primary care patients with drug use (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] substance-specific scores of ≥4) were identified by screening between June 2009 and January 2012 in Boston, Massachusetts. Two interventions were tested: the BNI is a 10- to 15-minute structured interview conducted by health educators; the MOTIV is a 30- to 45-minute intervention based on motivational interviewing with a 20- to 30-minute booster conducted by master's-level counselors. All study participants received a written list of substance use disorder treatment and mutual help resources. Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months. Secondary outcomes included other self-reported measures of drug use, drug use according to hair testing, ASSIST scores (severity), drug use consequences, unsafe sex, mutual help meeting attendance, and health care utilization. At baseline, 63% of participants reported their main drug was marijuana, 19% cocaine, and 17% opioids. At 6 months, 98% completed follow-up. Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group (incidence rate ratio [IRR], 0.97; 95% CI, 0.77-1.22) and 12
Sharma, Yogesh; Thompson, Campbell; Miller, Michelle; Shahi, Rashmi; Hakendorf, Paul; Horwood, Chris; Kaambwa, Billingsley
Prevalence of malnutrition in older hospitalized patients is 30%. Malnutrition is associated with poor clinical outcomes in terms of high morbidity and mortality and is costly for hospitals. Extended nutrition interventions improve clinical outcomes but limited studies have investigated whether these interventions are cost-effective. In this randomized controlled trial, 148 malnourished general medical patients ≥60 years were recruited and randomized to receive either an extended nutritional intervention or usual care. Nutrition intervention was individualized and started with 24 h of admission and was continued for 3 months post-discharge with a monthly telephone call whereas control patients received usual care. Nutrition status was confirmed by Patient generated subjective global assessment (PG-SGA) and health-related quality of life (HRQoL) was measured using EuroQoL 5D (EQ-5D-5 L) questionnaire at admission and at 3-months follow-up. A cost-effectiveness analysis was conducted for the primary outcome (incremental costs per unit improvement in PG-SGA) while a cost-utility analysis (CUA) was undertaken for the secondary outcome (incremental costs per quality adjusted life year (QALY) gained). Nutrition status and HRQoL improved in intervention patients. Mean per included patient Australian Medicare costs were lower in intervention group compared to control arm (by $907) but these differences were not statistically significant (95% CI: -$2956 to $4854). The main drivers of higher costs in the control group were higher inpatient ($13,882 versus $13,134) and drug ($838 versus $601) costs. After adjusting outcomes for baseline differences and repeated measures, the intervention was more effective than the control with patients in this arm reporting QALYs gained that were higher by 0.0050 QALYs gained per patient (95% CI: -0.0079 to 0.0199). The probability of the intervention being cost-effective at willingness to pay values as low as $1000 per unit
Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui
Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised
van der Kop, Mia L; Muhula, Samuel; Ekström, Anna M; Jongbloed, Kate; Smillie, Kirsten; Abunah, Bonface; Kinagwi, Koki; Kyomuhangi, Lennie B; Gelmon, Lawrence; Ojakaa, David I; Lester, Richard T; Awiti, Patricia O
Background To be consistent with the United Nations' sustainable development goals on gender equality, mobile health (mHealth) programmes should aim to use communications technology to promote the empowerment of women. We conducted a pre-trial analysis of data from the WelTel Retain study on retention in HIV care to assess gender-based differences in phone access, phone sharing and concerns about receiving text messages from a healthcare provider. Methods Between April 2013-June 2015, HIV-positive adults were screened for trial participation at two clinics in urban slums in Nairobi, Kenya. Proportions of men and women excluded from the trial due to phone-related criteria were compared using a chi-square test. Gender-based differences in phone sharing patterns and concerns among trial participants were similarly compared. Results Of 1068 individuals screened, there was no difference in the proportion of men ( n = 39/378, 10.3%) and women ( n = 71/690, 10.3%) excluded because of phone-related criteria ( p-value = 0.989). Among those who shared their phone, women ( n = 52/108, 48.1%) were more likely than men ( n = 6/60, 10.0%) to share with other non-household and household members ( p equally able to participate in a trial of an mHealth intervention. Equitable access in these urban slums may indicate the 'gender digital divide' is narrowing in some settings; however, gender-specific phone sharing patterns and concerns regarding privacy must be fully considered in the development and scale-up of mHealth programmes.
Stow, Ruth; Ives, Natalie; Smith, Christina; Rick, Caroline; Rushton, Alison
Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken. Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months. All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC
Parry, Sharon; Straker, Leon; Gilson, Nicholas D; Smith, Anne J
Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes), increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA) during work hours. A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864) was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years) in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19), 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14), pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29), computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days) determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006) and during work hours (-1.7%, p = 0.014) and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005) and during work hours (0.72, p = 0.015); there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012) and MVPA on work days (0.6%, p = 0.012). This study explored novel ways to modify work practices to reduce occupational sedentary behaviour. Participatory workplace interventions can reduce
view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775
Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep
Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline
Stevenson, Kay; Jackson, Sue; Shufflebotham, Julie; Roddy, Edward; Foster, Nadine E
This paper describes the development, content and delivery of a physiotherapist- led individualised, supervised and progressed exercise programme for use in a factorial randomised controlled trial testing treatments for subacromial impingement syndrome. To develop the intervention, a survey of community physiotherapists and national guidelines provided the basis for a consensus workshop through which a protocol was developed for the SUPPORT trial physiotherapist-led exercise programme (SUPPORT: SUbacromial impingement syndrome and Pain: a randomised controlled trial Of exeRcise and injection). The protocol included three stages of exercise progression: (1) scapular stability and active exercise with no resistance (2) range of motion exercise with scapular control, isometrics and stretches, and (3) through range resistance exercise. A two day training programme was developed for physiotherapists which included the trial background, current evidence and strategies to improve exercise adherence. Twenty physiotherapists were trained to deliver the exercise intervention. In the SUPPORT trial, 128 participants were randomised to physiotherapist-led exercise. Ninety nine (81%) participants had their first physiotherapy session within 2 to 3 weeks and 71 (56%) received six to eight treatment sessions. Frequently-used exercises were: stage 1 scapular setting with glenohumeral joint (GHJ) flexion to 90°, stage 2 GHJ medial rotation stretch, stage 3 scapular setting through lateral rotation, with resistance bands. We combined clinical and research expertise with national guidance in order to develop a physiotherapist-led, individualised, progressed and supervised exercise intervention for use within a randomised trial. The effectiveness of the intervention is being evaluated within the SUPPORT trial. Trial registration number ISRCTN 42399123. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
Full Text Available Abstract Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding and benefit (thrombosis averted were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.
Brady, Marian C; Stott, David J; Norrie, John; Chalmers, Campbell; St George, Bridget; Sweeney, Petrina M; Langhorne, Peter
Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC) intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial. After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered. We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures used to capture impact across a range of components was
Wolfenden, Luke; Nathan, Nicole; Janssen, Lisa M; Wiggers, John; Reilly, Kathryn; Delaney, Tessa; Williams, Christopher M; Bell, Colin; Wyse, Rebecca; Sutherland, Rachel; Campbell, Libby; Lecathelinais, Christophe; Oldmeadow, Chris; Freund, Megan; Yoong, Sze Lin
Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group. The intervention sought to increase implementation of a state-wide healthy canteen policy which required schools to remove unhealthy items (classified as 'red' or 'banned') from regular sale and encouraged schools to 'fill the menu' with healthy items (classified as 'green'). The intervention strategies included allocation of a support officer to assist with policy implementation, engagement of school principals and parent committees, consensus processes with canteen managers, training, provision of tools and resources, academic detailing, performance feedback, recognition and marketing initiatives. Data were collected at baseline (April to September, 2013) and at completion of the implementation period (November, 2014 to April, 2015). Seventy schools participated in the trial. Relative to control, at follow-up, intervention schools were significantly more likely to have menus without 'red' or 'banned' items (RR = 21.11; 95% CI 3.30 to 147.28; p ≤ 0.01) and to have at least 50% of menu items classified as 'green' (RR = 3.06; 95% CI 1.64 to 5.68; p ≤ 0.01). At follow-up, student purchases from intervention school canteens were significantly lower in total fat (difference = -1.51 g; 95% CI -2.84 to -0.18; p = 0.028) compared to controls, but not in energy (difference = -132.32 kJ; 95% CI -280.99 to 16.34; p = 0.080) or sodium (difference = -46
Morris David W
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
Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will
Kooijmans, H.; Post, M. W. M.; van der Woude, L. H. V.; de Groot, S.; Stam, H. J.; Bussmann, J. B. J.
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
The main aim of this thesis was to evaluate the added benefit of applying specific factors in community-based intervention for child witnesses of interparental violence (IPV) and their parents, by means of a randomized controlled trial (RCT). The results of this RCT showed no additional benefits of
Full Text Available Giselle K Perez,1 Dean G Cruess,2 Nicole M Strauss,3 1Department of Psychiatry, Massachusetts General Hospital, Boston, MA, 2Department of Psychology, University of Connecticut, Storrs, CT, 3Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, USA Background: Human papillomavirus (HPV is prevalent among college-aged women. Although HPV vaccines decrease women’s risk for cervical cancer, the vaccination rates remain inadequate. Objective: This study explored the utility of an information–motivation–behavioral skills (IMB intervention in promoting HPV vaccination knowledge, motivation, and intentions among college-aged women. Methods: In Spring/Fall 2012, 62 participants were randomly assigned to a single-session intervention or attention control and were assessed baseline, post-intervention, and at 1 month. Results: The participants demonstrated adequate baseline vaccine knowledge, low HPV/cancer knowledge, and ambivalence about the vaccination. Post-intervention, the IMB arm demonstrated increased HPV/cancer and vaccination knowledge, motivation, and intentions. There were no group differences in vaccination at 1 month; however, the odds of wanting to get vaccinated increased sevenfold in the IMB arm. Conclusion: These results provide preliminary support for an IMB-based intervention in increasing vaccination knowledge, motivation, and intentions among at-risk women. Future research examining the efficacy of longer trials with larger, diverse populations is warranted. Keywords: human papillomavirus, HPV, vaccination, cervical cancer, Gardasil, IMB
Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.
Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568
Hagobian, Todd; Smouse, Allison; Streeter, Mikaela; Wurst, Chloe; Schaffner, Andrew; Phelan, Suzanne
Previous studies have shown that women have higher concentrations of the endocrine disruptor bisphenol A (BPA), but an intervention to reduce BPA is lacking in women. To test the hypothesis that an intervention to reduce BPA would decrease urinary BPA concentrations over 3 weeks, 24 women (mean ± standard deviation [SD]; 22.1 ± 2.8 kg/m2 body mass index, 20.9 ± 1.5 years) were randomly assigned to an intervention or control. The intervention included weekly face-to-face meetings to reduce BPA exposures from food, cosmetics, and other packaged products. Women were provided with BPA-free cosmetics, hygiene, glass food/water containers, and daily self-monitored major sources of BPA. Fasting urine BPA and creatinine concentrations, and weight were assessed at study entry and after 3 weeks. A significant (p = 0.04) treatment × time interaction effect was observed on creatinine-adjusted BPA concentrations. From study entry to 3 weeks, women in the intervention significantly decreased geometric mean creatinine-adjusted urinary BPA by -0.71 ng/m, whereas women in the control significantly increased urinary BPA by 0.32 ng/mL (p = 0.04). Additionally, from study entry to 3 weeks, women in the intervention significantly lost weight -0.28 ± 0.44 kg, whereas women in the control significantly gained weight +1.65 ± 0.74 kg (p = 0.03). Changes in creatinine-adjusted BPA concentrations and weight were not significantly related (p = 0.67). In this pilot study, a 3-week intervention decreased urinary BPA concentrations in women. Future clinical trials are needed to confirm these results and to examine whether a similar BPA intervention positively impacts risk markers in the pathogenesis of cardiovascular disease and diabetes.
Green, Carla A; Yarborough, Bobbi Jo H; Leo, Michael C; Yarborough, Micah T; Stumbo, Scott P; Janoff, Shannon L; Perrin, Nancy A; Nichols, Greg A; Stevens, Victor J
The STRIDE study assessed whether a lifestyle intervention, tailored for individuals with serious mental illnesses, reduced weight and diabetes risk. The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism. The study design was a multisite, parallel two-arm randomized controlled trial in community settings and an integrated health plan. Participants who met inclusion criteria were ≥18 years old, were taking antipsychotic agents for ≥30 days, and had a body mass index ≥27. Exclusions were significant cognitive impairment, pregnancy/breastfeeding, recent psychiatric hospitalization, bariatric surgery, cancer, heart attack, or stroke. The intervention emphasized moderate caloric reduction, the DASH (Dietary Approaches to Stop Hypertension) diet, and physical activity. Blinded staff collected data at baseline, 6 months, and 12 months. Participants (men, N=56; women, N=144; mean age=47.2 years [SD=10.6]) were randomly assigned to usual care (N=96) or a 6-month weekly group intervention plus six monthly maintenance sessions (N=104). A total of 181 participants (90.5%) completed 6-month assessments, and 170 (85%) completed 12-month assessments, without differential attrition. Participants attended 14.5 of 24 sessions over 6 months. Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months (95% CI=-6.96 kg to -1.78 kg) and 2.6 kg more than control participants from baseline to 12 months (95% CI=-5.14 kg to -0.07 kg). At 12 months, fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL. No serious adverse events were study-related; medical hospitalizations were reduced in the intervention group (6.7%) compared with the control group (18.8%). Individuals taking antipsychotic medications can lose
Walker, Marion F; Thomas, Shirley A; Whitehead, Phillip J; Condon, Laura; Fisher, Rebecca J; Kontou, Eirini; Benford, Penny; Cobley, Christine
Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT). Feasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life. Favourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences. ISRCTN
Beukes, Eldré W; Allen, Peter M; Manchaiah, Vinaya; Baguley, David M; Andersson, Gerhard
Managing chronic tinnitus is challenging, and innovative ways to address the resulting health-care burden are required. Internet-based cognitive behavioral therapy (iCBT) for tinnitus shows promise as a cost-effective treatment option. The feasibility and effectiveness of iCBT in the United Kingdom are yet to be explored. Furthermore, it is not known if iCBT can be supported by an audiologist rather than a psychologist. This study aimed to determine the feasibility of guided iCBT using audiological support on tinnitus distress and tinnitus-related comorbidities. Furthermore, it aimed to establish the feasibility of iCBT for tinnitus distress in the United Kingdom, by determining recruitment, attrition, and compliance rates. Finally, it aimed to identify which aspects of the protocol require refinement for subsequent clinical trials. A single-group open trial design was implemented. This study would serve as a prerequisite study, to identify barriers, before undertaking effectiveness trials. Participants consisted of 37 adults (18 males, 19 females), with an age range of between 50 and 59 yr. The mean preintervention tinnitus severity rating was 56.15 (standard deviation = 18.35), which is categorized as "severe tinnitus" as measured by the Tinnitus Functional Index (TFI). Five participants withdrew during the study, and 29 of the remaining participants completed the postintervention questionnaire. The guided iCBT intervention ran over an eight-week period and consisted of 16 obligatory modules and five optional modules. The intervention was designed to be interactive, interesting, and stimulating. A key element was the provision of support from an audiologist throughout the program. Online questionnaires were used throughout the study. These were administered at baseline and postintervention to determine attrition and compliance rates and to facilitate sample size estimates for further clinical trials. Outcome measures for tinnitus severity, hearing handicap
Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias
This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....
Pradeep, Archana; Proudlock, Frank Antony; Awan, Musarat; Bush, Glen; Collier, Jacqueline; Gottlob, Irene
Previous reports suggest that adherence to patching is a major issue in amblyopia treatment. We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed. 62 children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material. Both were prescribed patching 10 h/day, 6 days/week for a fixed period of 12 weeks. The intervention arm received an educational/motivational intervention before patching which included information booklets, video, a cartoon story book, sticker charts and a dedicated session with a researcher. The control arm received the usual clinical information. The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching >4 h/day. Visual outcome, expressed as percentage visual deficit, was measured as secondary outcome. The intervention increased adherence success rate from 45.2% in the control group to 80.6% in the intervention group (p=0.0027). However, visual outcome was not significantly better in the intervention group (p=0.190). Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed. TRIALS REGISTRATION NUMBER: ISRCTN05346737 (International Standard Randomised Controlled Trial Number Register).
Russell, Ailsa; Cooper, Kate; Barton, Stephen; Ensum, Ian; Gaunt, Daisy; Horwood, Jeremy; Ingham, Barry; Kessler, David; Metcalfe, Chris; Parr, Jeremy; Rai, Dheeraj; Wiles, Nicola
IntroductionHigh rates of co-occurring depression are reported in Autism Spectrum Disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group CBT for co-occurring depression, but no randomised trials investigating low intensity psychological interventions as recommended in clinical guidelines f...
Cuc, Andrea V; Locke, Dona E C; Duncan, Noah; Fields, Julie A; Snyder, Charlene Hoffman; Hanna, Sherrie; Lunde, Angela; Smith, Glenn E; Chandler, Melanie
This study aims to provide effect size estimates of the impact of two cognitive rehabilitation interventions provided to patients with mild cognitive impairment: computerized brain fitness exercise and memory support system on support partners' outcomes of depression, anxiety, quality of life, and partner burden. A randomized controlled pilot trial was performed. At 6 months, the partners from both treatment groups showed stable to improved depression scores, while partners in an untreated control group showed worsening depression over 6 months. There were no statistically significant differences on anxiety, quality of life, or burden outcomes in this small pilot trial; however, effect sizes were moderate, suggesting that the sample sizes in this pilot study were not adequate to detect statistical significance. Either form of cognitive rehabilitation may help partners' mood, compared with providing no treatment. However, effect size estimates related to other partner outcomes (i.e., burden, quality of life, and anxiety) suggest that follow-up efficacy trials will need sample sizes of at least 30-100 people per group to accurately determine significance. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
Colford, John M; Saha, Sona R; Wade, Timothy J; Wright, Catherine C; Vu, Mai; Charles, Sandra; Jensen, Peter; Hubbard, Alan; Levy, Deborah A; Eisenberg, Joseph N S
Although immunocompromised persons may be at increased risk for gastrointestinal illnesses, no trials investigating drinking water treatment and gastrointestinal illness in such patients have been published. Earlier results from San Francisco suggested an association (OR 6.76) between tap water and cryptosporidiosis among HIV + persons. The authors conducted a randomized, triple-blinded intervention trial of home water treatment in San Francisco, California, from April 2000 to May 2001. Fifty HIV-positive patients were randomized to externally identical active (N = 24) or sham (N = 26) treatment devices. The active device contained a filter and UV light; the sham provided no treatment. Forty-five (90%) of the participants completed the study and were successfully blinded. Illness was measured using 'highly credible gastrointestinal illness' (HCGI), a previously published measure. There were 31 episodes of HCGI during 1,797 person-days in the sham group and 16 episodes during 1,478 person-days in the active group. The adjusted relative risk was 3.34 (95% CI: 0.99-11.21) times greater in those with the sham device. The magnitude of the point estimate of the risk, its consistency with recently published observational data, and its relevance for drinking water choices by immunocompromised individuals support the need for larger trials.
Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane
When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.
Gaies, Michael G; Morris, Shaine A; Hafler, Janet P; Graham, Dionne A; Capraro, Andrew J; Zhou, Jing; Landrigan, Christopher P; Sandora, Thomas J
Pediatric housestaff are required to learn basic procedural skills and demonstrate competence during training. To our knowledge, an evidenced-based procedural skills curriculum does not exist. To create, implement, and evaluate a modular procedural skills curriculum for pediatric residents. A randomized, controlled trial was performed. Thirty-eight interns in the Boston Combined Residency Program who began their training in 2005 were enrolled and randomly assigned. Modules were created to teach residents bag-mask ventilation, venipuncture, peripheral intravenous catheter (PIV) insertion, and lumbar puncture skills. The curriculum was administered to participants in the intervention group during intern orientation. Interns in the control group learned procedural skills by usual methods. Subjects were evaluated by using a structured objective assessment on simulators immediately after the intervention and 7 months later. Success in performing live-patient procedures was self-reported by subjects. The primary outcome was successful performance of the procedure on the initial assessment. Secondary outcomes included checklist and knowledge examination scores, live-patient success, and qualitative assessment of the curriculum. Participants in the intervention group performed PIV placement more successfully than controls (79% vs 35%) and scored significantly higher on the checklist for PIV placement (81% vs 61%) and lumbar puncture (77% vs 68%) at the initial assessment. There were no differences between groups at month 7, and both groups demonstrated declining skills. There were no statistically significant differences in success on live-patient procedures. Those in the intervention group scored significantly higher on knowledge examinations. Participants in the intervention group were more successful performing certain simulated procedures than controls when tested immediately after receiving the curriculum but demonstrated declining skills thereafter. Future efforts
Knobf, M Tish; Jeon, Sangchoon; Smith, Barbara; Harris, Lyndsay; Thompson, Siobhan; Stacy, Mitchel R; Insogna, Karl; Sinusas, Albert J
Induced premature menopause and cardio-toxic therapy increase cardiovascular disease risk in female cancer survivors. To compare the effects of a 12 month aerobic-resistance fitness center intervention to home based physical activity on cardiovascular function and metabolic risk factors. Subjects (N = 154) who had completed primary and/or adjuvant chemotherapy (past 3 years) were randomized to a fitness center intervention or a home based group. The fitness center intervention was a structured thrice weekly aerobic (30 min brisk walking treadmill in target heart range) combined with resistance (30 min of lower body strength training) exercise program, supervised for the first 6 months. The home based group received national guidelines for 30 min moderate intensity exercise most days of the week. Fasting serum samples were collected at baseline, 6 and 12 months for insulin, glucose, lipids and hemoglobin A-1C. A graded exercise stress test was also performed at baseline and 6 months. The majority of subjects were white (85.7%), had breast cancer (83.1%) and the average age was 51.9 years. Subjects in the fitness center intervention had significantly improved time on treadmill (p = .039), improved heart rate recovery at 1 min (p = .028), greater MET minutes/week (p ≤ .0001), a trend for improved insulin resistance (p = .067) and stable insulin levels (p = .045) compared to the home based physical activity group. Exercise represents a potential cardiac risk reduction intervention for cancer survivors. CLINICAL TRIALS.GOV: NCT01102985. Copyright © 2017. Published by Elsevier Inc.
O'Connor, Thomas G; Matias, Carla; Futh, Annabel; Tantam, Grace; Scott, Stephen
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 learning theory-based treatment promoted change in qualities of parent-child relationship derived from attachment theory. A randomized clinical trial of 174 four- to six-year-olds selected from a high-need urban area and stratified by conduct problems were assigned to a parenting program plus a reading intervention (n = 88) or nonintervention condition (n = 86). In-home observations of parent-child interactions were assessed in three tasks: (a) free play, (b) challenge task, and (c) tidy up. Parenting behavior was coded according to behavior theory using standard count measures of positive and negative parenting, and for attachment theory using measures of sensitive responding and mutuality; children's attachment narratives were also assessed. Compared to the parents in the nonintervention group, parents allocated to the intervention showed increases in the positive behavioral counts and sensitive responding; change in behavioral count measures overlapped modestly with change in attachment-based changes. There was no reliable change in children's attachment narratives associated with the intervention. The findings demonstrate that standard social learning theory-based parenting interventions can change broader aspects of parent-child relationship quality and raise clinical and conceptual questions about the distinctiveness of existing treatment models in parenting research.
La Greca, Annette M; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn
Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Adolescents (N=14; 13-18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths' clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Regarding feasibility, 86% of the adolescents completed the intervention ( M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed.
Thorndike, Anne N; Mills, Sarah; Sonnenberg, Lillian; Palakshappa, Deepak; Gao, Tian; Pau, Cindy T; Regan, Susan
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. 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. 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; 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%, pmonitor 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 intensive hospital-based wellness programs have potential for promoting healthier lifestyles among physicians. Clinicaltrials.gov NCT01287208.
Amiri, Parisa; Hamzavi Zarghani, Najmeh; Nazeri, Pantea; Ghofranipour, Fazlollah; Karimi, Mehrdad; Amouzegar, Atieh; Mirmiran, Parvin; Azizi, Fereidoun
Because of their increased need for iodine, pregnant women are among the high-risk groups for iodine deficiency. The purpose of this study was to evaluate the effectiveness of an educational program on the iodine nutrition status of pregnant women. In this randomized controlled trial, 100 pregnant women were randomly selected from five healthcare centers in the southern region of Tehran, the capital of Iran. In the intervention group, pregnant women received a four-month educational program, which included two face-to-face educational sessions, using a researcher-designed educational pamphlet in the second and third trimesters, and two follow-up telephone calls. Knowledge, attitude, and practice (KAP) scores, urinary iodine concentration (UIC), and salt iodine content were assessed at baseline and four months after the intervention. At baseline, there were significant associations between knowledge and attitude (r = 0.38, p = 0.03) between practice and UIC (r = 0.28, p = 0.01) and between UIC and iodine content of salt (r = 0.24, p = 0.009). Although a significant difference was found in mean KAP scores between the two groups after the educational intervention, scores were significantly higher in the intervention group compared with controls (p educational intervention increasing KAP among women regarding the importance of iodine and iodized salt consumption during pregnancy, their iodine status did not improve. Considering the main socio-environmental determinants of iodine deficiency, in particular, the monitoring of salt fortification, prescribing iodine containing supplements as well as improving health literacy in pregnant women seem essential strategies.
Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in
Ewald, H; Kirby, J; Rees, K; Robertson, W
An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the
Kelly, Stephanie A; Oswalt, Krista; Melnyk, Bernadette Mazurek; Jacobson, Diana
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 health teachers implemented the intervention. To attribute study findings to the intervention, it was vital to know to what degree the intervention was implemented. Therefore, the purposes of this study were to evaluate intervention fidelity and to compare implementation fidelity between the creating opportunities for personal empowerment (COPE) Healthy Lifestyles TEEN (thinking, emotions, exercise, and nutrition) program, the experimental intervention and Healthy Teens, an attention-control intervention, in a randomized controlled trial with 779 adolescents from 11 high schools in the southwest region of the United States. Thirty teachers participated in this study. Findings indicated that the attention-control teachers implemented their intervention with greater fidelity than COPE TEEN teachers. It is possible due to the novel intervention and the teachers' unfamiliarity with cognitive-behavioral skills building, COPE TEEN teachers had less fidelity. It is important to assess novel skill development prior to the commencement of experimental interventions and to provide corrective feedback during the course of implementation. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: email@example.com.
Fernandez, A C; Wood, M D; Laforge, R; Black, J T
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. 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 consequences among incoming college students. This study used a 2 × 2 factorial design to investigate the effects of a two-session brief motivational intervention delivered to students and a handbook-based parent intervention. Interventions were administered to students and parents. Follow-up assessment took place at 10- and 22-months post-baseline. The Transitions Project successfully recruited and retained participants across a major transition period (i.e., entering college), administered and compared two distinct but complementary interventions, and collected and analyzed highly skewed data. The application of a factorial design and two-part latent growth curve modeling allowed us to examine main and interactive intervention effects in terms of both initiation and growth in heavy drinking and alcohol-related problems. While we conducted successful tests of our primary and secondary study hypotheses over a lengthy follow-up period, our study design did not permit full interpretation of null findings. We suggest that researchers carefully consider assessment timing, tests of assessment reactivity, and ensure objective tests of intervention efficacy when conducting clinical trials of motivational interventions. The lessons we learned while conducting this trial have the potential to assist other researchers designing and conducting future preventive interventions targeting parents and college students. The data analytic procedures presented can also help guide trials that plan to analyze
de Souto Barreto, Philipe; Cesari, Matteo; Denormandie, Philippe; Armaingaud, Didier; Vellas, Bruno; Rolland, Yves
To compare the effects of exercise with those of a structured nonphysical intervention on ability to perform activities of daily living (ADLs) and physical and cognitive function of persons with dementia (PWDs) living in nursing homes (NH). Cluster-randomized pilot-controlled trial. Seven French NHs. PWDs living in NHs. NHs were randomized to an exercise group (4 NHs, n = 47) or structured social activity group (3 NHs, n = 50) for a 24-week intervention performed twice per week for 60 minutes per session. The main endpoint was ADL performance (Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease Scale (ADCS-ADL-sev); range 0-54, higher is better); secondary endpoints were overall cognitive function (Mini-Mental State Examination (MMSE)) and performance-based tests of physical function (Short Physical Performance Battery (SPPB), usual gait speed). Ninety-one participants with at least one postbaseline ADL assessment were included in efficacy analysis. Groups differed at baseline in terms of sex, neuropsychiatric symptoms, and nutritional status. Multilevel analysis adjusted for baseline differences between groups found no significant difference between effects of exercise and social activity (group-by-time interaction), with adjusted mean differences at 6 months of 1.9 points for ADCS-ADL-sev and 0.55 points for MMSE favoring social activity and 0.6 points for SPPB and 0.05 m/s favoring exercise. Adverse events did not differ between groups, except that the social activity group had more falls than the exercise group. A larger, longer trial is required to determine whether exercise has greater health benefits than nonphysical interventions for institutionalized PWDs. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.
Sparrow, David; Aloia, Mark; Demolles, Deborah A; Gottlieb, Daniel J
Continuous positive airway pressure (CPAP) is the most widely prescribed treatment for obstructive sleep apnoea syndrome (OSAS). Although it has been shown to improve the symptoms of OSAS, many patients have difficulty adhering to this treatment. The purpose of this study was to investigate the effectiveness of an automated telemedicine intervention to improve adherence to CPAP. A randomised clinical trial was undertaken in 250 patients being started on CPAP therapy for OSAS. Patients were randomly assigned to use a theory-driven interactive voice response system designed to improve CPAP adherence (telephone-linked communications for CPAP (TLC-CPAP), n=124) or to an attention placebo control (n=126) for 12 months. TLC-CPAP monitors patients' self-reported behaviour and CPAP-related symptoms and provides feedback and counselling through a structured dialogue to enhance motivation to use CPAP. A Sleep Symptoms Checklist, the Functional Outcomes of Sleep Questionnaire, the Center for Epidemiological Studies Depression Scale and the Psychomotor Vigilance Task were administered at study entry and at 6-month and 12-month follow-up. Hours of CPAP usage at effective mask pressure were measured by the CPAP device stored in its memory and retrieved at each visit. Median observed CPAP use in patients randomised to TLC-CPAP was approximately 1 h/night higher than in the control subjects at 6 months and 2 h/night higher at 12 months. Using generalised estimating equation modelling, the intervention had a significant effect on CPAP ad