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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-59
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Weight loss

Treatment groups

205 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

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