Peer-Led Healthy Lifestyle Program in Supportive Housing

NCT02175641 | Completed Results DMC

• 2 other identifiers: AAAN52071R01MH104574-01
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Healthy lifestyle Intervention; Serious Mental Illness; Effectiveness trial; Supportive housing; Racial and Ethnic Health Disparities

Outcome Measures

Primary Outcomes (1)

• Clinically Significant Weight Loss

  Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months

  Baseline to 18 Months

Secondary Outcomes (7)

• Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months

  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).

• 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).

• Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).

  At study endpoint (18 months).

Study Arms (2)

Peer-led Group Lifestyle Balance

EXPERIMENTAL

Group-based behavioral healthy lifestyle program

Behavioral: Peer-Led Group Lifestyle Balance; Behavioral: Usual Care Services

Usual Care Services

ACTIVE COMPARATOR

Usual wellness and health care services offered to clients at the two supportive housing agencies.

Behavioral: Usual Care Services

Interventions

Peer-Led Group Lifestyle Balance BEHAVIORAL

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.).

Peer-led Group Lifestyle Balance

Usual Care Services BEHAVIORAL

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

Peer-led Group Lifestyle Balance; Usual Care Services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Related Publications (6)

• 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.

  PMID: 26329472 BACKGROUND

• 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.

  PMID: 34417635 DERIVED

• 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.

  PMID: 33657843 DERIVED

• 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.

  PMID: 33657839 DERIVED

• 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.

  PMID: 33385266 DERIVED

• 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.

  PMID: 33334158 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leopoldo J. Cabassa, Associate Professor
• Organization: Washington Universtiy in St. Louis

ljcabassa@wustl.edu

314-935-2829

Study Officials

• Leopoldo J Cabassa, Ph. D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2019
• Last Updated: August 31, 2021
• Results First Posted: August 31, 2021

Record last verified: 2021-08

Locations

US (1)