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Peer Support for Weight Loss Maintenance

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ClinicalTrials.gov Identifier: NCT03396653
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
The Miriam Hospital
Information provided by (Responsible Party):
Tricia Leahey, University of Connecticut

Brief Summary:
The primary aim of this study is to test the efficacy of patient-provided treatment for weight-loss maintenance.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Peer-delivered Weight Maintenance Behavioral: Professionally-Delivered Weight Maintenance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peer Support for Weight Loss Maintenance
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Peer-Delivered Weight Maintenance
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).
Behavioral: Peer-delivered Weight Maintenance
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).

Active Comparator: Professionally-Delivered Weight Maintenance
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
Behavioral: Professionally-Delivered Weight Maintenance
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.




Primary Outcome Measures :
  1. Weight Change (kg) [ Time Frame: Baseline to 18-months ]
    Weight change (measured on a digital scale to the nearest 0.1-kilogram) from the end of the Phase I weight loss program to the end of the Phase II maintenance program, which is 18 months long.


Secondary Outcome Measures :
  1. Blood pressure (mmHg) [ Time Frame: Baseline to 18-months ]
    Blood pressure (mmHg) from the end of the Phase I weight loss program to the end of the Phase II maintenance program, which is 18 months long.

  2. Cholesterol (mg/dL) [ Time Frame: Baseline to 18-months ]
    Cholesterol (mg/dL) from the end of the Phase I weight loss program to the end of the phase II maintenance program, which is 18 months long.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-75
  • Body Mass Index between 25-50
  • English Speaking

Exclusion Criteria:

  • Report being unable to walk 2 blocks without stopping
  • Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
  • Are pregnant or plan to become pregnant within 1 year
  • Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
  • Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
  • Have no Internet access.

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): NCT03396653


Contacts
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Contact: Tricia Leahey, PhD 860-380-2987 tricia.leahey@uconn.edu
Contact: Zeely Denmat, BS zeely.denmat@uconn.edu

Locations
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United States, Connecticut
UConn's Weight Management Research Group Recruiting
Hartford, Connecticut, United States, 06103
Contact: Zeely Denmat       zeely.denmat@uconn.edu   
Principal Investigator: Tricia Leahey, PhD         
Sub-Investigator: Amy Gorin, PhD         
Institute for Collaboration on Health, Intervention and Policy Recruiting
Storrs, Connecticut, United States, 06269
Contact: Zeely Denmat       zeely.denmat@uconn.edu   
Principal Investigator: Tricia Leahey, PhD         
Sub-Investigator: Amy Gorin, PhD         
Sponsors and Collaborators
University of Connecticut
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
The Miriam Hospital

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Responsible Party: Tricia Leahey, Associate Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT03396653     History of Changes
Other Study ID Numbers: H17-099
1R01DK111232-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tricia Leahey, University of Connecticut:
weight loss
weight maintenance
weight control
peer support
patient-provided care
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms