Peer-Led Healthy Lifestyle Program in Supportive Housing
Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
This goal of this randomized controlled effectiveness trial is to compare the effectiveness of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in supportive housing agencies in New York City and Philadelphia serving diverse clients with serious mental illness who are overweight or obese. The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been shown to help people achieve clinically significant weight loss (equal to or greater than 5% weight loss of initial weight). The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).
We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI equal to or greater than 25) from our two supportive housing agencies. Clients will be randomized to either the Peer-led healthy lifestyle intervention or usual care conditions. The primary outcome for this study is achieving clinically significant weight loss (equal to or greater than 5% weight loss from baseline weight) at 12 and 18 months post randomization. The secondary outcomes for this study include overall reductions in weight, waist circumference, blood pressure, and improvements in physical activity, self-efficacy, recovery and health-related quality of life. Repeated assessments will be at baseline, 6, 12 and 18 month post randomization.
Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18 months than UC participants.
Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant reductions in average weight, waist circumference, blood pressure, and significant improvements in physical activity, self-efficacy, recovery, and health-related quality of life in Peer GLB compared to UC.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Missouri
-
Saint Louis, Missouri, Stati Uniti, 63130
- Washington University in St. Louis
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Peer-led Group Lifestyle Balance
Group-based behavioral healthy lifestyle program
|
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.).
The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.
|
|
Comparatore attivo: Usual Care Services
Usual wellness and health care services offered to clients at the two supportive housing agencies.
|
The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinically Significant Weight Loss
Lasso di tempo: 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
|
Baseline to 18 Months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
Lasso di tempo: 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).
|
At study endpoint (18 months).
|
|
Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
Lasso di tempo: 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.
|
At study endpoint (18 months).
|
|
Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
Lasso di tempo: 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.
|
At study endpoint (18 months).
|
|
Self-Efficacy for Exercise
Lasso di tempo: 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.
|
At study endpoint (18 months).
|
|
Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
Lasso di tempo: 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.
|
At study endpoint (18 months).
|
|
Health-related Quality of Life
Lasso di tempo: 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.
|
At study endpoint (18-months).
|
|
6-Minutes Walking Test
Lasso di tempo: 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.
|
At study endpoint (18-months).
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Leopoldo J Cabassa, Ph. D., Washington University School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- AAAN5207
- 1R01MH104574-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Peer-Led Group Lifestyle Balance
-
University of NebraskaNational Institute of Nursing Research (NINR)Completato
-
Memorial Sloan Kettering Cancer CenterAckerman Institute for FamilyAttivo, non reclutanteSostegno alla famiglia come sistema di curaStati Uniti