Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Clinically Significant Weight Loss
研究概览
简要总结
This goal of this randomized controlled effectiveness trial is to compare the effectiveness of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in supportive housing agencies in New York City and Philadelphia serving diverse clients with serious mental illness who are overweight or obese. The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been shown to help people achieve clinically significant weight loss (equal to or greater than 5% weight loss of initial weight). The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).
We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI equal to or greater than 25) from our two supportive housing agencies. Clients will be randomized to either the Peer-led healthy lifestyle intervention or usual care conditions. The primary outcome for this study is achieving clinically significant weight loss (equal to or greater than 5% weight loss from baseline weight) at 12 and 18 months post randomization. The secondary outcomes for this study include overall reductions in weight, waist circumference, blood pressure, and improvements in physical activity, self-efficacy, recovery and health-related quality of life. Repeated assessments will be at baseline, 6, 12 and 18 month post randomization.
Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18 months than UC participants.
Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant reductions in average weight, waist circumference, blood pressure, and significant improvements in physical activity, self-efficacy, recovery, and health-related quality of life in Peer GLB compared to UC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female,18 years of age or older, of any race/ethnicity, who are English and/or Spanish speakers.
- •Chart diagnosis of a serious mental illness (SMI; e.g., schizophrenia, bipolar disorder, schizoaffective disorders, major depression).
- •Overweight/obese as determined by a Body Mass Index (BMI) equal to or greater than 25 (kg/m2) at the time of recruitment.
- •Able and willing to give informed consent and participate in the intervention.
- •Received a medical clearance from a primary care or medical provider to participate in light-to-moderate physical activity (e.g., 150 minutes a week of brisk walking).
排除标准
- •Need for detoxification services at the time of recruitment.
- •Pose a danger to self or others at the time of recruitment.
- •Have medical conditions that contraindicate their participation in a healthy lifestyle program focusing on weight loss and physical activity, such as active cancer treatment, liver failure, history of anorexia nervosa, cardiovascular event [e.g., unstable angina, myocardial infraction] within the past 6 months, untreated exercise- induced asthma, walking limitations preventing participation in exercise, and pregnant or planning a pregnancy during study period.
- •Fail a capacity-to-consent questionnaire.
- •Cognitive impairment as detected by the Mini-Cog Examination
结局指标
主要结局
Clinically Significant Weight Loss
时间窗: Baseline to 18 Months
Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months
次要结局
- Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months(At study endpoint (18 months).)
- Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).(At study endpoint (18 months).)
- Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months(At study endpoint (18 months).)
- 6-Minutes Walking Test(At study endpoint (18-months).)
- Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months(At study endpoint (18 months).)
- Self-Efficacy for Exercise(At study endpoint (18 months).)
- Health-related Quality of Life(At study endpoint (18-months).)
研究者
Leopoldo J. Cabassa
Associate Professor
Washington University School of Medicine