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NCT Number: NCT06174389

ADAPT Study: Assessing Diet, Appetite and Physiology Throughout Weight Loss Study)

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch Cancer Center, Seattle, Washington, United States

Loading trial locations.

About this study

Participants will be asked to enroll for 18-months. Each participant will complete 3 in-person study visits, then participate an a 6-month weight loss program delivered remotely. Some participants may be invited to complete 3 additional in-person visits. Study Visit activities include questionnaires, blood draws, brain MRIs, body measurement and dual energy x-ray absorptiometry (DXA) scan for body composition measurement, a breathing test, and biopsies of muscle and fat tissue. Each participant will be provided a fitness tracker and body weight scale to use throughout the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral weight loss program

Behavioral

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

Primary outcomes

  1. 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).

    Mitochondrial maximal respiratory capacity will be measured in fasting samples from peripheral blood mononuclear cells.

  2. 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).

    fMRI BOLD signal to visual food cues within a priori brain regions of interest pre and post consuming a standardized meal. Meal-induced change will be calculated by post-pre meal BOLD signal.

  3. Entry into involuntary weight loss plateau

    Time frame: throughout 18-month enrollment

    binary outcome (Y/N) and time from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

ADAPT Study

CONTACT

[email protected]

206-616-6360

ADAPT Study

CONTACT

[email protected]

206-685-1532

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Physiological Changes Underlying the Weight Loss Plateau in Human

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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