Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02175641 · ClinicalTrials.gov registry record · NA
Peer-Led Healthy Lifestyle Program in Supportive Housing
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 314
- Enrollment target
NCT02175641 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 314 participants.
The verdict
NCT02175641, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 314 participants
- Enrollment target
Study 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 1
Interventions
- BEHAVIORAL Peer-Led Group Lifestyle Balance
- BEHAVIORAL Usual Care Services
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02175641
The ClinicalTrials.gov registry entry for NCT02175641 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Peer-Led Group Lifestyle Balance is the first listed.
NCT02175641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02175641 about?
NCT02175641 is a clinical study titled "Peer-Led Healthy Lifestyle Program in Supportive Housing". 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 o...
What is the current status of trial NCT02175641?
This trial is currently completed. It is a NA study. The enrollment target is 314 participants. The study started on 2015-07. Estimated completion is 2019-07.
What interventions are being tested in trial NCT02175641?
The interventions under investigation include: Peer-Led Group Lifestyle Balance (BEHAVIORAL), Usual Care Services (BEHAVIORAL).
Who is sponsoring clinical trial NCT02175641?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.