Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT06174389

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Behavioral Weight Loss Program

Study Details

Brief summary:

Behavioral weight loss programs for obesity can result in weight loss and health benefits. However, behavioral weight loss often stops despite efforts to continue losing weight, this can be called an involuntarily weight loss plateau. This study investigates changes in metabolism and/or the brain that contribute to the occurrence of an involuntary weight loss plateau.

Conditions

Obesity

Study ID

NCT06174389

Start date

Oct 1, 2023

Status verified date

May, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • BMI 30.0 - 50.0 kg/m2
  • Able to attend study intervention classes and study visits/assessments
  • Independently living with access to food preparation facilities

Exclusion Criteria:

  • Current smoker or regular use of nicotine containing products and/or cannabis
  • Heavy alcohol use (≥2 drinks/d for females, ≥3 drinks/d for males) or drug use
  • Known cognitive impairments or h/o stroke
  • Type 2 diabetes (known diagnosis or by screening A1c (≥6.5%))
  • Medical conditions (chronic diseases, cancer, MS) or labs limiting ability to participate
  • Females: currently pregnant (or 6-months postpartum of full-term pregnancy) and/or current breastfeeding
  • Use of medications with significant effects on appetite (e.g., weight loss medications, atypical antipsychotics, stimulants) and/or chronic use of anticoagulants
  • History of bariatric surgery
  • History of eating disorder
  • Current participation in a formal weight loss program
  • Prior or current participation in a research study involving weight loss
  • Weight-reduced by >10% within past year
  • Weight > 330 pounds (MRI limit)
  • Allergy or intolerance to or unwillingness to consume study foods provided at visit
  • MRI contraindication (e.g., implanted metal, claustrophobia)
  • Do not have a phone compatible with activity tracker or access to videoconferencing platform that will be used for the dietary intervention or other appropriate technology needed to complete study procedures
  • Any condition(s) found by the study team and confirmed with the PI(s) that make it unsafe to participate

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Behavioral Weight Loss

Participants will undergo a behavioral weight loss program.

Interventions

Behavioral Weight Loss Program

Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program.

Primary outcome measure

  • Change in maximal respiratory capacity (oxygen consumption rate) in peripheral blood mononuclear cells [ Time Frame: From baseline to active weight loss (at least 21 days of weight loss equivalent or greater than 0.5 pounds per week) and from baseline to weight loss plateau (after active weight loss, at least 21 days of halted weight loss, or +/- 0.25 pounds/week). ]
  • Change in fMRI BOLD signal [ Time Frame: From baseline to a weight loss plateau (after active weight loss, at least 21 days of halted weight loss, or +/- 0.25 pounds/week). ]
  • Entry into involuntary weight loss plateau [ Time Frame: throughout 18-month enrollment ]

Central Contacts and Locations

Central contacts

ADAPT Study

206-616-6360uwadaptstudy@uw.edu

ADAPT Study

206-685-1532uwadaptstudy@uw.edu

Locations

University of Washington - South Lake Union

Recruiting

Seattle, Washington, United States, 98109

Contacts

Mary Webb

uwadaptstudy@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Aug 29, 2025

Last verified

May, 2025

Keywords

  • Gloisis
  • Weight Change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-08-29.