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Peer-Led Healthy Lifestyle Program in Supportive Housing

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ClinicalTrials.gov Identifier: NCT02175641
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Leopoldo J. Cabassa, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 24, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
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, 12 and 18th months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peer-Led Healthy Lifestyle Program in Supportive Housing
Official Title  ICMJE Peer-Led Healthy Lifestyle Program in Supportive Housing Agencies
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Peer-led Group Lifestyle Balance
    Group-based behavioral healthy lifestyle program
    Interventions:
    • Behavioral: Peer-Led Group Lifestyle Balance
    • Behavioral: Usual Care Services
  • Active Comparator: Usual Care Services
    Usual wellness and health care services offered to clients at the two supportive housing agencies.
    Intervention: Behavioral: Usual Care Services
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
314
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2014)
300
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02175641
Other Study ID Numbers  ICMJE AAAN5207
1R01MH104574-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Leopoldo J. Cabassa, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Leopoldo J Cabassa, Ph. D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP