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Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

ABSTRACT: The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese.The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial.This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI.www.clinicaltrials.gov; NCT02175641, registered 24 June 2014.

SUBMITTER: Cabassa LJ

PROVIDER: S-EPMC4557630 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

Cabassa Leopoldo J LJ Stefancic Ana A O'Hara Kathleen K El-Bassel Nabila N Lewis-Fernández Roberto R Luchsinger José A JA Gates Lauren L Younge Richard R Wall Melanie M Weinstein Lara L Palinkas Lawrence A LA

Trials 20150902

<h4>Background</h4>The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight ...[more]

PMID: 26329472

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Project description:INTRODUCTION:Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS:The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION:This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001288314.

Project description:BackgroundPermanent supportive housing (PSH)-subsidized housing paired with support services such as case management-is a key part of national strategic plans to end homelessness. PSH tenants face high overdose risk due to a confluence of individual and environmental risk factors, yet little research has examined overdose prevention in PSH.MethodsWe describe the protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial (RCT) of overdose prevention practice implementation in PSH. We adapted evidence-based overdose prevention practices and implementation strategies for PSH using input from stakeholder focus groups. The trial will include 20 PSH buildings (with building size ranging from 20 to over 150 tenants) across New York City and New York's Capital Region. Buildings will be randomized to one of four 6-month intervention waves during which they will receive a package of implementation support including training in using a PSH Overdose Prevention (POP) Toolkit, time-limited practice facilitation, and learning collaboratives delivered to staff and tenant implementation champions appointed by each building. The primary outcome is building-level fidelity to a defined list of overdose prevention practices. Secondary and exploratory implementation and effectiveness outcomes will be examined using PSH staff and tenant survey questionnaires, and analysis of tenant Medicaid data. We will explore factors related to implementation success, including barriers and facilitators, using qualitative interviews with key stakeholders. The project is being conducted through an academic-community partnership, and an Advisory Board including PSH tenants and other key stakeholders will be engaged in all stages of the project.DiscussionWe describe the protocol for a hybrid type 3 stepped-wedge cluster RCT of overdose prevention practice implementation in PSH. This study will be the first controlled trial of overdose prevention implementation in PSH settings. The research will make a significant impact by testing and informing future implementation strategies to prevent overdose for a population at particularly high risk for overdose mortality. Findings from this PSH-focused research are expected to be broadly applicable to other housing settings and settings serving people experiencing homelessness.Trial registrationClinicalTrials.gov, NCT05786222 , registered 27 March 2023.

Project description:BackgroundExtending contact with participants after initial, intensive intervention may support maintenance of weight loss and related behaviors.ObjectiveThis community-wide trial evaluated a text message (short message service, SMS)-delivered, extended contact intervention ('Get Healthy, Stay Healthy' (GHSH)), which followed on from a population-level, behavioral telephone coaching program.MethodsThis study employed a parallel, randomized controlled trial: GHSH compared with no continued contact (standard practice). Participants (n=228) were recruited after completing a 6-month lifestyle telephone coaching program: mean age = 53.4 (standard deviation (SD)=12.3) years; 66.7% (152/228) female; mean body mass index (BMI) upon entering GHSH=29.5 kg/m2 (SD = 6.0). Participants received tailored text messages over a 6-month period. The message frequency, timing, and content of the messages was based on participant preference, ascertained during two tailoring telephone calls. Primary outcomes of body weight, waist circumference, physical activity (walking, moderate, and vigorous sessions/week), and dietary behaviors (fruit and vegetable serves/day, cups of sweetened drinks per day, takeaway meals per week; fat, fiber and total indices from the Fat and Fiber Behavior Questionnaire) were assessed via self-report before (baseline) and after (6-months) extended contact (with moderate-vigorous physical activity (MVPA) also assessed via accelerometry).ResultsSignificant intervention effects, all favoring the intervention group, were observed at 6-months for change in weight (-1.35 kg, 95% confidence interval (CI): -2.24, -0.46, P=.003), weekly moderate physical activity sessions (0.56 sessions/week, 95% CI: 0.15, 0.96, P=.008) and accelerometer-assessed MVPA (24.16 minutes/week, 95% CI: 5.07, 43.25, P=.007). Waist circumference, other physical activity outcomes and dietary outcomes, did not differ significantly between groups.ConclusionsThe GHSH extended care intervention led to significantly better anthropometric and physical activity outcomes than standard practice (no contact). This evidence is useful for scaling up the delivery of GHSH as standard practice following the population-level telephone coaching program.

Project description:BackgroundA significant proportion of Canadian adults is impacted by chronic noncommunicable diseases. These conditions may be improved by peer-led health promotion interventions that target modifiable risk factors; however, to date, there is mixed evidence on the effectiveness of these interventions. Unlike other health promotion programs, Hans Kai is grounded in a holistic model of health that simultaneously addresses multiple determinants of health at different levels of human ecology. In Hans Kai, a set of informational sessions that are delivered in a group setting by healthcare professionals are followed by regular peer-led group meetings in a self-governed support group setting that is designed to promote implementation of newly learned health competences. The Hans Kai trial described here aims to evaluate the efficacy of the Hans Kai program in promoting the health and wellbeing of its participants and investigate the experiences of the Hans Kai participants and facilitators.MethodsThis research will involve a mixed methods trial combining an experimental component with a qualitative component. The experimental component will involve a 6-month 2-group parallel superiority randomized controlled trial (RCT) in which 105 participants will be randomly assigned to two conditions, an intervention group (n = 70) that will participate in the Hans Kai program and a control group (n = 35) that will have access to standard care using a computer-generated random sequence; blinding will not occur. The RCT will test the impact of the program on several health outcomes and will be followed by a 12-18-month observational follow-up study that will provide data on the long-term durability of the 6-month RCT health outcomes. The qualitative component will investigate the experiences of program participants (n = 30) and facilitators (n = 15) to identify the main strengths and limitations of Hans Kai, uncover potential implementation issues, and elucidate the mechanisms through which the program works. The population of interest will include adults aged 18 + with or without chronic health conditions who self-report an interest in taking control of their own health and improving their lifestyle. In the RCT, all outcomes of interest will be measured using a multi-method approach, involving self-report questionnaires and objective indicators, and within-subject mean changes in outcomes over time between the two groups will be compared to address the RCT aims. Similarly, in the qualitative component, a multi-method approach, involving in-depth individual interviews, photovoice, and online surveys, will be used to reach a deeper and more nuanced understanding of the program strengths, how the program works, and for which people it is more effective. Adaptable components of the program will also be investigated and modified according to the feedback provided by the RCT participants. In the mixed methods integration of evidence, the qualitative findings will be used to explain the quantitative RCT results.DiscussionThe RCT findings will help support the further development and use of Hans Kai as well as other peer-led health promotion interventions.Trial registrationUnited Stated Clinical Trial Registry ClinicalTrials.gov (registration# NCT03949725; Protocol version 2, June 22nd, 2022).

Project description:BackgroundFormerly chronically homeless adults who live in permanent supportive housing (PSH) have high prevalence of smoking. It is uncommon to find smoke-free policies in PSH because of the concern that such policies contradict PSH's harm reduction framework and could increase homelessness should residents lose their housing because of the policy. However, in the absence of such policies, non-smoking PSH residents face the harmful effects of secondhand smoke exposure while residents who smoke see increased risks from high rates of smoking throughout their residence. Our pilot work highlighted the feasibility and acceptability of an intervention designed to promote voluntary adoption of a smoke-free home. Here we report a protocol for a cluster randomized controlled trial of the smoke-free home intervention for formerly chronically homeless residents in PSH.MethodsThe smoke-free home intervention provides face-to-face counseling and instruction to PSH residents on how to adopt a smoke-free home and offers training for PSH staff on how to refer residents to tobacco cessation services. We will randomize 20 PSH sites in the San Francisco Bay Area to either the intervention or wait-list control arms. We will enroll 400 PSH residents who smoke cigarettes in their housing unit and 120 PSH staff who work at the sites. At baseline, three- and six-months follow-up, we will ask residents to report their tobacco use and cessation behaviors and adoption of smoke-free homes. We will ask staff to answer questions on their knowledge, attitudes, practices, and barriers related to supporting residents' smoking cessation. The primary outcome for PSH residents is adoption of smoke-free homes for 90 days or more at six-months follow-up, and the secondary outcome is point prevalence tobacco abstinence. The primary outcome for PSH staff is change in Smoking Knowledge Attitudes Practices survey score.DiscussionVoluntary adoption of smoke-free homes is a promising approach for reducing exposure to secondhand smoke and reducing tobacco use among a population facing high rates of tobacco-related disease, and is aligned with PSH's harm reduction framework. Findings from this study have the potential to inform adoption of tobacco control policies among vulnerable populations most at risk for smoking-related harms.Trial registrationThis study was registered with the U.S. National Institute of Health Clinical Trials register on April 22, 2021: NCT04855357.

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Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

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Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

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