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OpenTrials
Completed

NCT Number: NCT03396653

Peer Support for Weight Loss Maintenance

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

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn's Weight Management Research Group, Hartford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer-delivered Weight Maintenance

Behavioral

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

Behavioral

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 outcomes

  1. Weight Change (kg)

    Time frame: Baseline to 18-months

    Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

Secondary outcomes

  1. Blood Pressure (mmHg)

    Time frame: Baseline to 18-months

    Blood pressure (mmHg) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Stanford University
  • The Miriam Hospital

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2018
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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