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.
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
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
Single group
Weight loss
BehavioralA 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 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
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
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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
