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

Part of paid clinical trials in New York, New York.

Sponsor
University of Pittsburgh
Study ID
NCT05748158
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 59 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 29, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
205 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Weight loss
    A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity.

Primary Outcome Measure

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 [ Time Frame: End of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Dympna Gallagher, EdD
[email protected]
Rudolph Leibel, MD
[email protected]
Rudolph Leibel, MD (PRINCIPAL_INVESTIGATOR)
Dympna Gallagher, EdD (PRINCIPAL_INVESTIGATOR)
Michael Rosenbaum, MD (PRINCIPAL_INVESTIGATOR)
Laurel Mayer, MD (PRINCIPAL_INVESTIGATOR)
Drexel UniversityPhiladelphiaPennsylvania19104
Michael R Lowe, PhD
[email protected]
Michael R Lowe, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Matthew Hayes, PhD
[email protected]
Kelly Allison, PhD
[email protected]
Matthew Hayes, PhD (PRINCIPAL_INVESTIGATOR)
Kelly Allison, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Columbia University Irving Medical Center· New York, NYDrexel University· Philadelphia, PAUniversity of Pennsylvania· Philadelphia, PA

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