A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program

Summary

The goal of this clinical trial is to determine the physiological basis for the differences in weight regain among adults (25-59 years old) with obesity following participation in a behavioral weight loss program. Eligible participants will undergo a baseline evaluation after which they will enter an up to 20 week behavioral weight loss program with the goal of losing at least 7 percent of their baseline weight within 35 weeks. Participants who meet the weight loss goal will be asked to remain weight stable for 2 weeks after which they will undergo a clinical examination. They will then be observed for 1 year during which they will undergo 2 additional clinical examinations, one 4 months after completing the weight loss program, and the other 12 months after completing the weight loss program.

Conditions

• Obesity

Interventions

BEHAVIORAL

Weight loss

A behavioral lifestyle program, up to 20 weeks in duration, based on interventions shown to be successful for weight loss such as the Diabetes Prevention Program (DPP), Action for Health in Diabetes (Look AHEAD), and Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Study (CALERIE). Weekly sessions, led by experienced interventionists, will provide education and behavioral strategies for weight loss focused an energy-reduced diet and physical activity. Participants must meet the following milestones to continue in the study: * ≥ 2% weight loss anytime between 28 and 34 days after the start of the intervention * ≥ 5% weight loss anytime between 140 and 146 days after the start of the intervention * ≥ 7% weight loss by the end of 35 weeks After achieving ≥7% weight loss followed by weight stability, participants are observed, without further intervention, for 52 weeks.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Tufts University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• New York State Psychiatric Institute

  collaborator OTHER

• Drexel University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Dartmouth College

  collaborator OTHER

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Susan Roberts, PhD · Dartmouth College

• Steven Belle, PhD · University of Pittsburgh

• Dympna Gallagher, EdD · Columbia University

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-29

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations