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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03396653
Other study ID # H17-099
Secondary ID 1R01DK111232-01A
Status Completed
Phase N/A
First received
Last updated
Start date February 19, 2018
Est. completion date March 21, 2023

Study information

Verified date April 2023
Source University of Connecticut
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 849
Est. completion date March 21, 2023
Est. primary completion date March 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
United States UConn's Weight Management Research Group Hartford Connecticut
United States Institute for Collaboration on Health, Intervention and Policy Storrs Connecticut

Sponsors (4)

Lead Sponsor Collaborator
University of Connecticut National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Change (kg) 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. Baseline to 18-months
Secondary Blood pressure (mmHg) 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. Baseline to 18-months
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