NCT06174389 · University of Washington
ADAPT Study: Assessing Diet, Appetite and Physiology Throughout Weight Loss Study)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Behavioral Weight Loss Program
Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program.
Primary outcome measures
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.
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.
Entry into involuntary weight loss plateau
Time frame: throughout 18-month enrollment
binary outcome (Y/N) and time from baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 29, 2025 · Source of record for eligibility and locations