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

NCT05748158 | Recruiting DMC

• 4 other identifiers: STUDY21120046U24DK128125UH3DK128302UH3DK128298
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Obesity; Weight loss; Weight change trajectory; Lifestyle intervention

Outcome Measures

Primary Outcomes (2)

• Weight change from end of weight stabilization following at least 7 percent weight loss to 52 weeks after weight stabilization following at least 7 percent weight loss

  Percentage of lost weight that is regained

  End of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss

• Weight change from end of weight stabilization following at least 7 percent weight loss to 52 weeks after weight stabilization following at least 7 percent weight loss

  Weight regained

  End of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss

Study Arms (1)

Weight loss

OTHER

A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity.

Behavioral: Weight loss

Interventions

Weight loss BEHAVIORAL

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.

Weight loss

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 25 - \<60 years
• BMI: 30 - \<40 kg/m2 at the first screening visit
• Within 5% of current weight, for the past 6 months at the first screening visit
• Able to participate in ergometry testing
• Has a smart phone, tablet or computer with access to the internet

You may not qualify if:

• If 25-29 years old, \> 5% deviation from maximum weight (excluding weights while pregnant) since age 25 years
• If at least 30 years old, \> 5% deviation from maximum weight (excluding weights while pregnant) in last 5 years or ≥ 10% deviation from maximum weight (excluding weights while pregnant) since age 30 years
• History of pulmonary embolus in the past 6 months
• Cardiovascular disease (e.g. myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack) within the past 6 months
• Current major depressive disorder or history of major depressive disorder within 2 years
• Any regular tobacco or nicotine use in the past year
• Currently engaging in intense physical training or training for a sports event including, but not limited to, a marathon or body building
• Currently pregnant, or less than one-year post-partum or actively planning to become pregnant within the next two years
• Presently classified as being in New York Heart Association Class II or greater or dysrhythmia
• Diabetes (type 1 or 2 - HbA1c ≥ 6.5%, fasting glucose ≥ 126 mg/dL) or currently taking a glucose lowering medication
• Thyroid disease requiring hormones or medication or TSH \< 0.5 or \> 5 mIU/L
• Renal disease requiring dialysis
• Known HIV infection
• ALT or AST greater than 5 times the upper limit of normal or active gall bladder disease
• Significant anemia (Hgb \< 10 g/dL) or thrombocytopenia (platelet count \< 60,000 /mm3)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Tufts University: collaborator
• Columbia University: collaborator
• New York State Psychiatric Institute: collaborator
• Drexel University: collaborator
• University of Pennsylvania: collaborator
• Dartmouth College: collaborator

Study Sites (3)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Links

• The Physiology of the Weight Reduced State (POWERS) study website

MeSH Terms

Conditions

Obesity; Weight Loss; Body-Weight Trajectory

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven Belle, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Dympna Gallagher, EdD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Susan Roberts, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Pelesko, BS

CONTACT

412-383-9584; ajp67@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: September 29, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following the end of data collection. Time frame is determined by the NIDDK.
• Access Criteria: Access to the data for approved ancillary studies will be through the data coordinating center. Access to the data at the NIDDK-repository will be through the NIDDK data repository's process.

Locations

US (3)