Peer-Led Healthy Lifestyle Program in Supportive Housing

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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RECRUITING PHASE4

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Peer-led Group Lifestyle Balance

Group-based behavioral healthy lifestyle program

Group Type EXPERIMENTAL

Peer-Led Group Lifestyle Balance

Intervention Type 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.).

Usual Care Services

Intervention Type BEHAVIORAL

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

Usual Care Services

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

Group Type ACTIVE_COMPARATOR

Usual Care Services

Intervention Type BEHAVIORAL

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

Interventions

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Peer-Led Group Lifestyle Balance

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.).

Intervention Type BEHAVIORAL

Usual Care Services

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No