ObesityNCT02175641
Peer-Led Healthy Lifestyle Program in Supportive Housing
A study testing Peer-Led Group Lifestyle Balance in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This goal of this randomized controlled effectiveness trial is to compare the effectiveness of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in supportive housing agencies in New York City and Philadelphia serving diverse clients with serious mental illness who are overweight or obese. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Peer-Led Group Lifestyle Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Peer-Led Group Lifestyle Balance, Usual Care Services
- Keywords
- Healthy lifestyle Intervention, Serious Mental Illness, Effectiveness trial, Supportive housing, Racial and Ethnic Health Disparities
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Led Group Lifestyle BalanceBehavioural
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 ServicesBehavioural
The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.
| Study group | Role | What they receive |
|---|---|---|
| Peer-led Group Lifestyle Balance | Experimental | Group-based behavioral healthy lifestyle program Receives: Behavioral: Peer-Led Group Lifestyle Balance; Behavioral: Usual Care Services |
| Usual Care Services | Active comparator | Usual wellness and health care services offered to clients at the two supportive housing agencies. Receives: Behavioral: Usual Care Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 18 Months
Secondary outcomes (7)
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).
Measured: At study endpoint (18 months).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study endpoint (18-months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2015
- Primary completionFeb 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Leopoldo J. Cabassa, Washington University School of Medicine
- Investigators
- Leopoldo J Cabassa, Ph. D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175641
- Sponsor's protocol ID
- AAAN5207
- Other IDs
- 1R01MH104574-01
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2014
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26329472Tuda 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.
PubMed 34417635Stefancic 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.
PubMed 33657843Stefancic 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.
PubMed 33657839Stefancic 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.
PubMed 33385266Cabassa 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.
PubMed 33334158
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
- ClinicalTrials.gov ID
- NCT02175641
- Acronym / sponsor ID
- AAAN5207
- Conditions
- Obesity
- Keywords
- Healthy lifestyle Intervention, Serious Mental Illness, Effectiveness trial, Supportive housing, Racial and Ethnic Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-led Group Lifestyle Balance | Experimental | Behavioral: Peer-Led Group Lifestyle Balance, Behavioral: Usual Care ServicesGroup-based behavioral healthy lifestyle program |
| Usual Care Services | Active comparator | Behavioral: Usual Care ServicesUsual wellness and health care services offered to clients at the two supportive housing agencies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Led Group Lifestyle BalanceThe 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.). | Behavioural | Peer-led Group Lifestyle Balance |
| Usual Care ServicesThe usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness. | Behavioural | Peer-led Group Lifestyle Balance, Usual Care Services |
Primary outcome
Clinically Significant Weight Loss
Time frame: 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
7 secondary outcomes
Overall Reduction in Weight in lb From Baseline to 6, 12 and 18 Months
Time frame: At study endpoint (18 months).
Overall Reduction in Waist Circumference Measures to the Nearest cm From Baseline to 6, 12 and 18 Months
Time frame: At study endpoint (18 months).
Overall Reductions in Systolic Blood Pressure From Baseline, 6, 12 and 18 Months
Time frame: At study endpoint (18 months).
Self-Efficacy for Exercise
Time frame: At study endpoint (18 months).
Change From Baseline in Recovery Using the Recovery Assessment Scale (RAS).
Time frame: At study endpoint (18 months).
Health-related Quality of Life
Time frame: At study endpoint (18-months).
6-Minutes Walking Test
Time frame: At study endpoint (18-months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26329472Cabassa 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.
- Derived from this study: PubMed 34417635Tuda 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.
- Derived from this study: PubMed 33657843Stefancic 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.
- Derived from this study: PubMed 33657839Stefancic 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.
- Derived from this study: PubMed 33385266Stefancic 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.
- Derived from this study: PubMed 33334158Cabassa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo J Cabassa, Ph. D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Led Group Lifestyle Balance in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Weight Loss (time frame: Baseline to 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175641, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.