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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH104574-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer-led Group Lifestyle Balance | Experimental | Group-based behavioral healthy lifestyle program |
|
| Usual Care Services | Active Comparator | Usual wellness and health care services offered to clients at the two supportive housing agencies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-Led Group Lifestyle Balance | 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.). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo J Cabassa, Ph. D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26329472 | Background | Cabassa LJ, Stefancic A, O'Hara K, El-Bassel N, Lewis-Fernandez 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. | |
| 34417635 | Derived | Tuda D, Stefancic A, Hawes M, Wang X, Guo S, Cabassa LJ. Correlates of Attendance in a Peer-Led Healthy Lifestyle Intervention for People with Serious Mental Illness Living in Supportive Housing. Community Ment Health J. 2022 May;58(4):761-769. doi: 10.1007/s10597-021-00881-y. Epub 2021 Aug 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services | Posted | Count of Participants | Participants | Baseline to 18 Months |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired Immunodeficiency Syndrome | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leopoldo J. Cabassa, Associate Professor | Washington Universtiy in St. Louis | 314-935-2829 | ljcabassa@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2019 | Oct 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Usual Care Services | Behavioral | The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness. |
|
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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 33657843 | Derived | Stefancic A, Bochicchio L, Tuda D, Harris Y, DeSomma K, Cabassa LJ. Strategies and Lessons Learned for Supporting and Supervising Peer Specialists. Psychiatr Serv. 2021 May 1;72(5):606-609. doi: 10.1176/appi.ps.202000515. Epub 2021 Mar 4. |
| 33657839 | Derived | Stefancic A, Bochicchio L, Tuda D, Gurdak K, Cabassa LJ. Participant Experiences With a Peer-Led Healthy Lifestyle Intervention for People With Serious Mental Illness. Psychiatr Serv. 2021 May 1;72(5):530-538. doi: 10.1176/appi.ps.202000311. Epub 2021 Mar 4. |
| 33385266 | Derived | Stefancic A, Bochicchio L, Svehaug K, Alvi T, Cabassa LJ. "We Die 25 Years Sooner:" Addressing Physical Health Among Persons with Serious Mental Illness in Supportive Housing. Community Ment Health J. 2021 Aug;57(6):1195-1207. doi: 10.1007/s10597-020-00752-y. Epub 2021 Jan 1. |
| 33334158 | Derived | Cabassa LJ, Stefancic A, Lewis-Fernandez R, Luchsinger J, Weinstein LC, Guo S, Palinkas L, Bochicchio L, Wang X, O'Hara K, Blady M, Simiriglia C, Medina McCurdy M. Main Outcomes of a Peer-Led Healthy Lifestyle Intervention for People With Serious Mental Illness in Supportive Housing. Psychiatr Serv. 2021 May 1;72(5):555-562. doi: 10.1176/appi.ps.202000304. Epub 2020 Dec 18. |
| Withdrawal by Subject |
|
| Discharged from Supportive Housing Agenc |
|
| Developed Contraindicated Condition |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Pounds |
|
| OG001 | 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. |
|
|
|
| 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). | 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). | Posted | Mean | Standard Deviation | lb | 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. | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. | Posted | Mean | Standard Deviation | centimeters (CM) | 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. | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | 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. | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. | Posted | Mean | Standard Deviation | Score on a scale | 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. | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants enrolled in the trial and randomized to either Peer-led Group Lifestyle Balance or Usual Care Services. | Posted | Mean | Standard Error | meters | At study endpoint (18-months). |
|
|
|
|
| 3 |
| 157 |
| 21 |
| 157 |
| 0 |
| 157 |
| EG001 | 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. | 4 | 157 | 21 | 157 | 0 | 157 |
| Kidney Infection | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Stroke | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Transient Ischemic Attack | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | Resulted in Death |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Wound Decomposition | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Stab Wound | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Foreign Body | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Dyspnoaea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chronic Obstrucive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | Resulted in Death |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hernia Repair | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Cyst Removal | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Adverse Drug Reaction | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Death NOS | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Brain Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Liver Disorder | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment | Resulted in Death |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |