Peer-Led Healthy Lifestyle Program in Supportive Housing

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02175641
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 314
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Peer-Led Group Lifestyle Balance; Behavioral: Usual Care Services	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 314 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer-led Group Lifestyle Balance Group-based behavioral healthy lifestyle program	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.).; 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.
Active Comparator: Usual Care Services Usual wellness and health care services offered to clients at the two supportive housing agencies.	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.

Outcome Measures

Primary Outcome Measures

1. Clinically Significant Weight Loss [Baseline to 18 Months]

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

Secondary Outcome Measures

1. Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months [At study endpoint (18 months).]

   Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes).

2. Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months [At study endpoint (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.

3. Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months [At study endpoint (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.

4. Self-Efficacy for Exercise [At study endpoint (18 months).]

   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.

5. Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS). [At study endpoint (18 months).]

   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.

6. Health-related Quality of Life [At study endpoint (18-months).]

   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.

7. 6-Minutes Walking Test [At study endpoint (18-months).]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis	Saint Louis	Missouri	United States	63130

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Leopoldo J Cabassa, Ph. D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2019

More Information

Publications

• 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.

• Responsible Party: Leopoldo J. Cabassa, Associate Professor, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02175641
• Other Study ID Numbers: AAAN5207; 1R01MH104574-01
• First Posted: Jun 26, 2014
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Leopoldo J. Cabassa, Associate Professor, Washington University School of Medicine: Healthy lifestyle Intervention; Serious Mental Illness; Effectiveness trial; Supportive housing; Racial and Ethnic Health Disparities

Study Results

Participant Flow

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Period Title: Overall Study
STARTED	157	157
6-month Follow up	144	149
12-month Follow up	129	136
18-month Follow up	122	130
COMPLETED	122	130
NOT COMPLETED	35	27

Baseline Characteristics

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services	Total
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.	Total of all reporting groups
Overall Participants	157	157	314
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.50 (11.56)	48.81 (11.60)	48.65 (11.56)
Sex: Female, Male (Count of Participants)
Female	67 42.7%	66 42%	133 42.4%
Male	90 57.3%	91 58%	181 57.6%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	28 17.8%	29 18.5%	57 18.2%
Non-Hispanic Black	104 66.2%	77 49%	181 57.6%
Hispanic	13 8.3%	26 16.6%	39 12.4%
Other	12 7.6%	25 15.9%	37 11.8%
Weight (Pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pounds]	225.75 (58.07)	211.84 (48.83)	218.79 (54.01)

Outcome Measures

1. Primary Outcome

Title	Clinically Significant Weight Loss
Description	Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months
Time Frame	Baseline to 18 Months

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	122	130
Count of Participants [Participants]	39 24.8%	40 25.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Generalized linear mixed-effects models with a logistic link
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
Description	Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes).
Time Frame	At study endpoint (18 months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. Results presented are weight at the study endpoint (18-months).

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	122	130
Mean (Standard Deviation) [lb]	226.04 (62.81)	209.51 (50.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Mixed effect models controlling for study site.
Statistical Test of Hypothesis	p-Value	0.804
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Time by treatment interaction coefficien
	Estimated Value	0.15
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.59
	Estimation Comments

3. Secondary Outcome

Title	Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
Description	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.
Time Frame	At study endpoint (18 months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	121	128
Mean (Standard Deviation) [centimeters (CM)]	114.61 (18.84)	110.38 (16.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Time*treatment interaction coefficient
	Estimated Value	0.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

4. Secondary Outcome

Title	Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
Description	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.
Time Frame	At study endpoint (18 months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	113	127
Mean (Standard Deviation) [Millimeters of mercury (mmHg)]	129.52 (17.70)	128.28 (19.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Mixed effect models controlling for study site.
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	time*treatment interaction coefficient
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.74
	Estimation Comments

5. Secondary Outcome

Title	Self-Efficacy for Exercise
Description	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.
Time Frame	At study endpoint (18 months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	120	130
Mean (Standard Deviation) [Score on a scale]	6.73 (2.58)	6.89 (2.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Mixed effect models controlling for study site.
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Time*treatment interaction coefficient
	Estimated Value	0.08
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
Description	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.
Time Frame	At study endpoint (18 months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	120	129
Mean (Standard Deviation) [score on a scale]	4.26 (0.64)	4.26 (0.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Mixed effect models controlling for study site.
Statistical Test of Hypothesis	p-Value	0.39
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Time*treatment interaction coefficient
	Estimated Value	0.02
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments

7. Secondary Outcome

Title	Health-related Quality of Life
Description	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.
Time Frame	At study endpoint (18-months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	118	129
Mean (Standard Deviation) [score on a scale]	44.81 (10.36)	45.71 (10.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Mixed effect models controlling for study site.
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Time*treatment interaction coefficient
	Estimated Value	0.23
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.37
	Estimation Comments

8. Secondary Outcome

Title	6-Minutes Walking Test
Description	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.
Time Frame	At study endpoint (18-months).

Outcome Measure Data

Analysis Population Description

Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.

Arm/Group Title	Peer-led Group Lifestyle Balance	Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.	Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
Measure Participants	117	126
Mean (Standard Error) [meters]	315.83 (95.97)	318.16 (93.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer-led Group Lifestyle Balance, Usual Care Services
	Comments
	Type of Statistical Test	Other
	Comments	Mixed effect models controlling for study site.
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Time*treatment interaction coefficient
	Estimated Value	3.83
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.28
	Estimation Comments

Adverse Events

Time Frame	18 months
Arm/Group Title	Peer-led Group Lifestyle Balance		Usual Care Services
Arm/Group Description	Group-based behavioral healthy lifestyle program 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.		Usual wellness and health care services offered to clients at the two supportive housing agencies. 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.
All Cause Mortality
	Peer-led Group Lifestyle Balance		Usual Care Services
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/157 (1.9%)		4/157 (2.5%)
Serious Adverse Events
	Peer-led Group Lifestyle Balance		Usual Care Services
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/157 (13.4%)		21/157 (13.4%)
Blood and lymphatic system disorders
Anaemia	1/157 (0.6%)		0/157 (0%)
Cardiac disorders
Cardiac Arrest	0/157 (0%)		1/157 (0.6%)
Myocardial Infarction	2/157 (1.3%)		0/157 (0%)
Gastrointestinal disorders
Pancreatitis	1/157 (0.6%)		0/157 (0%)
Gastroenteritis	1/157 (0.6%)		0/157 (0%)
General disorders
Adverse Drug Reaction	2/157 (1.3%)		0/157 (0%)
Death NOS	2/157 (1.3%)		1/157 (0.6%)
Hepatobiliary disorders
Liver Disorder	0/157 (0%)		1/157 (0.6%)
Immune system disorders
Acquired Immunodeficiency Syndrome	1/157 (0.6%)		0/157 (0%)
Infections and infestations
Wound Infection	0/157 (0%)		1/157 (0.6%)
Injury, poisoning and procedural complications
Rib Fracture	0/157 (0%)		1/157 (0.6%)
Wound Decomposition	0/157 (0%)		1/157 (0.6%)
Stab Wound	1/157 (0.6%)		0/157 (0%)
Foreign Body	1/157 (0.6%)		0/157 (0%)
Drug Toxicity	1/157 (0.6%)		0/157 (0%)
Accidental Overdose	1/157 (0.6%)		0/157 (0%)
Injury	0/157 (0%)		1/157 (0.6%)
Metabolism and nutrition disorders
Hyperglycaemia	1/157 (0.6%)		0/157 (0%)
Musculoskeletal and connective tissue disorders
Joint Swelling	1/157 (0.6%)		0/157 (0%)
Arthritis	0/157 (0%)		1/157 (0.6%)
Spinal Osteoarthritis	0/157 (0%)		1/157 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic	1/157 (0.6%)		0/157 (0%)
Nervous system disorders
Epilepsy	1/157 (0.6%)		0/157 (0%)
Renal and urinary disorders
Kidney Infection	0/157 (0%)		1/157 (0.6%)
Cystitis	0/157 (0%)		1/157 (0.6%)
Respiratory, thoracic and mediastinal disorders
Dyspnoaea	0/157 (0%)		2/157 (1.3%)
Asthma	2/157 (1.3%)		0/157 (0%)
Bronchitis	0/157 (0%)		1/157 (0.6%)
Chronic Obstrucive Pulmonary Disease	0/157 (0%)		1/157 (0.6%)
Upper Respiratory Tract Infection	0/157 (0%)		1/157 (0.6%)
Skin and subcutaneous tissue disorders
Cellulitis	0/157 (0%)		1/157 (0.6%)
Surgical and medical procedures
Hernia Repair	0/157 (0%)		1/157 (0.6%)
Cyst Removal	1/157 (0.6%)		0/157 (0%)
Vascular disorders
Hypotension	2/157 (1.3%)		1/157 (0.6%)
Stroke	0/157 (0%)		3/157 (1.9%)
Transient Ischemic Attack	0/157 (0%)		1/157 (0.6%)
Other (Not Including Serious) Adverse Events
	Peer-led Group Lifestyle Balance		Usual Care Services
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/157 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.