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Peer-Led Healthy Lifestyle Program in Supportive Housing

This study is currently recruiting participants.
Verified September 2017 by Leopoldo J. Cabassa, Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02175641
First Posted: June 26, 2014
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Leopoldo J. Cabassa, Washington University School of Medicine
  Purpose

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 Intervention
Obesity Behavioral: Peer-Led Group Lifestyle Balance Behavioral: Usual Care Services

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies

Resource links provided by NLM:


Further study details as provided by Leopoldo J. Cabassa, Washington University School of Medicine:

Primary Outcome Measures:
  • 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, 6, 12 and 18th months ]

Secondary Outcome Measures:
  • Overall reduction in weight in lb from baseline to 6, 12 and 18 months [ Time Frame: baseline, 6, 12 and 18 months ]
  • Overall reduction in waist circumference measures to the nearest cm from baseline to 6, 12 and 18 months [ Time Frame: baseline, 6, 12 and 18 months ]
  • Overall reductions in blood pressure from basline, 6, 12 and 18 months [ Time Frame: baseline, 6, 12 and 18 months ]
  • Change from baseline on three self efficacy scales (self-efficacy exercise scale, eating habits scale and the weight efficacy lifestyle scale). [ Time Frame: baseline, 6, 12 and 18 months ]
  • Change from baseline in the physical activity on the International Physical Activity Questionnaire (IPAQ) short form. [ Time Frame: baseline, 6, 12 and 18 months ]
  • Change from baseline in recovery using the recovery assessment scale (RAS). [ Time Frame: baseline, 6, 12, and 18 months ]
  • Change from baseline on health-related quality of life using the 12-Item Short-Form Health Survey (SF-12) [ Time Frame: baseline, 6, 12 and 18 months ]
  • Change from baseline on 6-minutes walking test [ Time Frame: baseline, 6, 12 and 18 months ]

Estimated Enrollment: 300
Study Start Date: July 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175641


Contacts
Contact: Leopoldo J. Cabassa, Ph.D. 314-935-2829 ljcabassa@wustl.edu

Locations
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Principal Investigator: Leopoldo J. Cabassa, Ph. D.         
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
  More Information

Publications:
Responsible Party: Leopoldo J. Cabassa, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02175641     History of Changes
Other Study ID Numbers: AAAN5207
1R01MH104574-01 ( U.S. NIH Grant/Contract )
First Submitted: June 24, 2014
First Posted: June 26, 2014
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Leopoldo J. Cabassa, Washington University School of Medicine:
Healthy lifestyle Intervention
Serious Mental Illness
Effectiveness trial
Supportive housing
Racial and Ethnic Health Disparities