ObesityNCT06174389
ADAPT Study: Assessing Diet, Appetite and Physiology Throughout Weight Loss Study)
A study testing Behavioral Weight Loss Program in people with Obesity, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Fred Hutch Cancer Center
Seattle, Washington, 98109
Diana Lowry, dlowry@fredhutch.org
- Recruiting
University of Washington - South Lake Union
Seattle, Washington, 98109
Mary Webb, uwadaptstudy@uw.edu
About this study
Official title: Physiological Changes Underlying the Weight Loss Plateau in Human
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.
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss Program
- Keywords
- Gloisis, Weight Change
- Medical subject headings
- Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss ProgramBehavioural
Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss | Experimental | Participants will undergo a behavioral weight loss program. Receives: Behavioral: Behavioral Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
binary outcome (Y/N) and time from baseline
Measured: throughout 18-month enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Oct 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen Schur, MD, MS, Principal investigator, University of WashingtonMarian Neuhouser, PhD, RD, Principal investigator, Fred Hutch Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174389
- Sponsor's protocol ID
- STUDY00017667
- Other IDs
- R01DK134417
- Status last verified
- May 2025
- First submitted
- 13 Nov 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melhorn SJ, Valencia AP, Schenk JM, Garcia JM, Beatty SJ, Konchan A, Brandao AF, Acosta-Vega NL, Marcinek DJ, Tong J, Neuhouser ML, Schur EA. Assessing the physiology of weight loss based on real-time weight monitoring: The ADAPT behavioral weight loss study protocol. PLoS One. 2026 Aug 25;21(8):e0354678. doi: 10.1371/journal.pone.0354678. eCollection 2026.
PubMed 42640961
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Changes Underlying the Weight Loss Plateau in Human
- ClinicalTrials.gov ID
- NCT06174389
- Acronym / sponsor ID
- STUDY00017667
- Conditions
- Obesity
- Keywords
- Gloisis, Weight Change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss | Experimental | Behavioral: Behavioral Weight Loss ProgramParticipants will undergo a behavioral weight loss program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Weight Loss ProgramBehavioral Weight Loss Program is a modified version of the Diabetes Prevention Program. | Behavioural | Behavioral Weight Loss |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 42640961Melhorn SJ, Valencia AP, Schenk JM, Garcia JM, Beatty SJ, Konchan A, Brandao AF, Acosta-Vega NL, Marcinek DJ, Tong J, Neuhouser ML, Schur EA. Assessing the physiology of weight loss based on real-time weight monitoring: The ADAPT behavioral weight loss study protocol. PLoS One. 2026 Aug 25;21(8):e0354678. doi: 10.1371/journal.pone.0354678. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Schur, MD, MS principal investigator
University of Washington
Marian Neuhouser, PhD, RD principal investigator
Fred Hutch Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss Program in people with Obesity, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ADAPT Study (206-616-6360, uwadaptstudy@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.