Clinical trial NCT02175641: Peer-Led Healthy Lifestyle Program in Supportive Housing
Official title: Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Healthy lifestyle Intervention
Serious Mental Illness
Effectiveness trial
Supportive housing
Racial and Ethnic Health Disparities
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-06-26
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinically Significant Weight Loss
timeFrame: Baseline to 18 Months
Secondary outcomes:
measure: Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
timeFrame: At study endpoint (18 months).
measure: Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
timeFrame: At study endpoint (18 months).
measure: Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
timeFrame: At study endpoint (18 months).
measure: Self-Efficacy for Exercise
timeFrame: At study endpoint (18 months).
measure: Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
timeFrame: At study endpoint (18 months).
measure: Health-related Quality of Life
timeFrame: At study endpoint (18-months).
measure: 6-Minutes Walking Test
timeFrame: At study endpoint (18-months).
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Leopoldo J Cabassa, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabassa LJ, Stefancic A, O'Hara K, El-Bassel N, Lewis-Fernandez R, Luchsinger JA, Gates L, Younge R, Wall M, Weinstein L, Palinkas LA. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial. Trials. 2015 Sep 2;16:388. doi: 10.1186/s13063-015-0902-z.
citation: Tuda D, Stefancic A, Hawes M, Wang X, Guo S, Cabassa LJ. Correlates of Attendance in a Peer-Led Healthy Lifestyle Intervention for People with Serious Mental Illness Living in Supportive Housing. Community Ment Health J. 2022 May;58(4):761-769. doi: 10.1007/s10597-021-00881-y. Epub 2021 Aug 20.
citation: Stefancic A, Bochicchio L, Tuda D, Harris Y, DeSomma K, Cabassa LJ. Strategies and Lessons Learned for Supporting and Supervising Peer Specialists. Psychiatr Serv. 2021 May 1;72(5):606-609. doi: 10.1176/appi.ps.202000515. Epub 2021 Mar 4.
citation: Stefancic A, Bochicchio L, Tuda D, Gurdak K, Cabassa LJ. Participant Experiences With a Peer-Led Healthy Lifestyle Intervention for People With Serious Mental Illness. Psychiatr Serv. 2021 May 1;72(5):530-538. doi: 10.1176/appi.ps.202000311. Epub 2021 Mar 4.
citation: Stefancic A, Bochicchio L, Svehaug K, Alvi T, Cabassa LJ. "We Die 25 Years Sooner:" Addressing Physical Health Among Persons with Serious Mental Illness in Supportive Housing. Community Ment Health J. 2021 Aug;57(6):1195-1207. doi: 10.1007/s10597-020-00752-y. Epub 2021 Jan 1.
citation: Cabassa LJ, Stefancic A, Lewis-Fernandez R, Luchsinger J, Weinstein LC, Guo S, Palinkas L, Bochicchio L, Wang X, O'Hara K, Blady M, Simiriglia C, Medina McCurdy M. Main Outcomes of a Peer-Led Healthy Lifestyle Intervention for People With Serious Mental Illness in Supportive Housing. Psychiatr Serv. 2021 May 1;72(5):555-562. doi: 10.1176/appi.ps.202000304. Epub 2020 Dec 18.