Peer-Led Healthy Lifestyle Program in Supportive Housing
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | July 2015 |
| End Date: | June 2019 |
Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
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.
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.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Leopoldo J. Cabassa, Ph. D.
Click here to add this to my saved trials
