CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 314 enrolled
Drug / intervention
Peer-Led Group Lifestyle Balance +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02175641
NCT02175641N/ACompleted

Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies

Washington University School of Medicine·interventional·Posted Jun 26, 2014·Updated Aug 31, 2021

In Brief

A clinical study evaluating Peer-Led Group Lifestyle Balance and Usual Care Services for Obesity. Completed, enrolled 314 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 26, 2014
Enrollment StartJul 1, 2015
Primary CompletionFeb 1, 2018
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.0 years ago

Interventions

Peer-Led Group Lifestyle Balancebehavioral

The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and 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.).

Usual Care Servicesbehavioral

The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.