Peer-Led Healthy Lifestyle Program in Supportive Housing

Obesity Clinical Trial

Official title:

Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175641
• Other study ID #: AAAN5207
• Secondary ID: 1R01MH104574-01
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2019

Study information

• Verified date: August 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: July 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.).
• 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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cabassa LJ, Stefancic A, O'Hara K, El-Bassel N, Lewis-Fernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months	Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes).	At study endpoint (18 months).
Secondary	Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months	Waist circumference measured by a trained research assistant to the nearest 0.1 cm with an anthropometric tape, in a horizontal plane 1 cm above the navel in light indoor clothing.	At study endpoint (18 months).
Secondary	Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months	Blood pressure assessed on the right arm of participants after they rest quietly in a seated position for at least 5 minutes, using a validated automated sphygmomanometer.	At study endpoint (18 months).
Secondary	Self-Efficacy for Exercise	Self-efficacy for exercise was measured with a three-item scale assessing a person's confidence that they can engage in physical activity. The scores from this scale range from 1 to 10 with higher scores indicating higher self-efficacy.	At study endpoint (18 months).
Secondary	Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).	The Recovery Assessment Scale is a 24-item measure that captures different aspects of recovery and produces a total recovery score ranging from 1 to 5 with higher scores indicating higher recovery.	At study endpoint (18 months).
Secondary	Health-related Quality of Life	The 12-Item Short-Form Health Survey (SF-12) was used to capture participants health-related quality of life. The Physical Composite Score derived from the SF-12 is an indicator of health-related quality of life with scores that range from 0 to 100 with higher scores indicating higher health-related quality of life.	At study endpoint (18-months).
Secondary	6-Minutes Walking Test	The 6-minutes Walking Test is an objective measure of functional exercise capacity that captures the distance (in meters) that participants walk at a normal pace along a flat and straight course for 6 minutes.	At study endpoint (18-months).