ClinicalTrials.gg
RecruitingNCT06174389Updated Aug 29, 2025

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

An interventional study of Behavioral Weight Loss Program in Obesity, sponsored by University of Washington. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by University of Washington · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Obesity

Keywords

  • Gloisis
  • Weight Change
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 90 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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 (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Behavioral Weight Loss

    Participants will undergo a behavioral weight loss program.

    Behavioral: Behavioral Weight Loss Program

Interventions

  • BehavioralBehavioral Weight Loss Program

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

06

What researchers measure

Primary outcomes

  1. Change in maximal respiratory capacity (oxygen consumption rate) in peripheral blood mononuclear cells

    Mitochondrial maximal respiratory capacity will be measured in fasting samples from 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).

  2. Change in fMRI BOLD signal

    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.

    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).

  3. Entry into involuntary weight loss plateau

    binary outcome (Y/N) and time from baseline

    Time frame: throughout 18-month enrollment

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Jul 2027, 45 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 45 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2023
First posted
Dec 18, 2023
StartActual
Oct 1, 2023
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Aug 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06174389
Responsible party
Ellen Schur, MD, MS (Professor: School of Medicine, University of Washington) — Principal investigator
First posted
Dec 18, 2023
Start date
Oct 1, 2023
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Aug 29, 2025

Study contacts

ADAPT Study
Contact
uwadaptstudy@uw.edu
206-616-6360
ADAPT Study
Contact
uwadaptstudy@uw.edu
206-685-1532
Ellen Schur, MD, MS
principal investigator · University of Washington
Marian Neuhouser, PhD, RD
principal investigator · Fred Hutch Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion