Trial Outcomes & Findings for Peer-Led Healthy Lifestyle Program in Supportive Housing (NCT NCT02175641)
NCT ID: NCT02175641
Last Updated: 2021-08-31
Results Overview
Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
314 participants
Primary outcome timeframe
Baseline to 18 Months
Results posted on
2021-08-31
Participant Flow
Participant milestones
| Measure |
Peer-led Group Lifestyle Balance
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 Care Services
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.
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
157
|
|
Overall Study
6-month Follow up
|
144
|
149
|
|
Overall Study
12-month Follow up
|
129
|
136
|
|
Overall Study
18-month Follow up
|
122
|
130
|
|
Overall Study
COMPLETED
|
122
|
130
|
|
Overall Study
NOT COMPLETED
|
35
|
27
|
Reasons for withdrawal
| Measure |
Peer-led Group Lifestyle Balance
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 Care Services
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Discharged from Supportive Housing Agenc
|
13
|
15
|
|
Overall Study
Developed Contraindicated Condition
|
8
|
0
|
Baseline Characteristics
Peer-Led Healthy Lifestyle Program in Supportive Housing
Baseline characteristics by cohort
| Measure |
Peer-led Group Lifestyle Balance
n=157 Participants
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 Care Services
n=157 Participants
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
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.50 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
48.81 years
STANDARD_DEVIATION 11.60 • n=7 Participants
|
48.65 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
104 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Weight
|
225.75 Pounds
STANDARD_DEVIATION 58.07 • n=5 Participants
|
211.84 Pounds
STANDARD_DEVIATION 48.83 • n=7 Participants
|
218.79 Pounds
STANDARD_DEVIATION 54.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 MonthsPopulation: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services
Percentage of participants that achieve equal to or greater than 5% weight loss in lb from baseline at 12 and 18th months
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=122 Participants
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 Care Services
n=130 Participants
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.
|
|---|---|---|
|
Clinically Significant Weight Loss
|
39 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At study endpoint (18 months).Population: 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).
Weight (in pounds) was measured by a trained research assistant with a calibrated digital scale (participants wore indoor clothing without shoes).
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=122 Participants
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 Care Services
n=130 Participants
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.
|
|---|---|---|
|
Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
|
226.04 lb
Standard Deviation 62.81
|
209.51 lb
Standard Deviation 50.41
|
SECONDARY outcome
Timeframe: At study endpoint (18 months).Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
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.
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=121 Participants
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 Care Services
n=128 Participants
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.
|
|---|---|---|
|
Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
|
114.61 centimeters (CM)
Standard Deviation 18.84
|
110.38 centimeters (CM)
Standard Deviation 16.91
|
SECONDARY outcome
Timeframe: At study endpoint (18 months).Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
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.
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=113 Participants
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 Care Services
n=127 Participants
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.
|
|---|---|---|
|
Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
|
129.52 Millimeters of mercury (mmHg)
Standard Deviation 17.70
|
128.28 Millimeters of mercury (mmHg)
Standard Deviation 19.13
|
SECONDARY outcome
Timeframe: At study endpoint (18 months).Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
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.
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=120 Participants
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 Care Services
n=130 Participants
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.
|
|---|---|---|
|
Self-Efficacy for Exercise
|
6.73 Score on a scale
Standard Deviation 2.58
|
6.89 Score on a scale
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: At study endpoint (18 months).Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
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.
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=120 Participants
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 Care Services
n=129 Participants
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.
|
|---|---|---|
|
Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
|
4.26 score on a scale
Standard Deviation 0.64
|
4.26 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: At study endpoint (18-months).Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
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.
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=118 Participants
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 Care Services
n=129 Participants
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.
|
|---|---|---|
|
Health-related Quality of Life
|
44.81 score on a scale
Standard Deviation 10.36
|
45.71 score on a scale
Standard Deviation 10.26
|
SECONDARY outcome
Timeframe: At study endpoint (18-months).Population: Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services.
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.
Outcome measures
| Measure |
Peer-led Group Lifestyle Balance
n=117 Participants
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 Care Services
n=126 Participants
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.
|
|---|---|---|
|
6-Minutes Walking Test
|
315.83 meters
Standard Error 95.97
|
318.16 meters
Standard Error 93.38
|
Adverse Events
Peer-led Group Lifestyle Balance
Serious events: 21 serious events
Other events: 0 other events
Deaths: 3 deaths
Usual Care Services
Serious events: 21 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Peer-led Group Lifestyle Balance
n=157 participants at risk
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 Care Services
n=157 participants at risk
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.
|
|---|---|---|
|
Immune system disorders
Acquired Immunodeficiency Syndrome
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Renal and urinary disorders
Kidney Infection
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Vascular disorders
Hypotension
|
1.3%
2/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Vascular disorders
Stroke
|
0.00%
0/157 • 18 months
|
1.9%
3/157 • 18 months
|
|
Vascular disorders
Transient Ischemic Attack
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
2/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Nervous system disorders
Epilepsy
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Injury, poisoning and procedural complications
Wound Decomposition
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoaea
|
0.00%
0/157 • 18 months
|
1.3%
2/157 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
2/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstrucive Pulmonary Disease
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Surgical and medical procedures
Hernia Repair
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Surgical and medical procedures
Cyst Removal
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
General disorders
Adverse Drug Reaction
|
1.3%
2/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
General disorders
Death NOS
|
1.3%
2/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.64%
1/157 • 18 months
|
0.00%
0/157 • 18 months
|
|
Hepatobiliary disorders
Liver Disorder
|
0.00%
0/157 • 18 months
|
0.64%
1/157 • 18 months
|
Other adverse events
Adverse event data not reported
Additional Information
Leopoldo J. Cabassa, Associate Professor
Washington Universtiy in St. Louis
Phone: 314-935-2829
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place