Investigating factors affecting weight loss plateaus in obesity
Physiological Changes Underlying the Weight Loss Plateau in Human
This study is trying to understand why people with obesity hit weight loss plateaus and will involve participants in an 18-month program with check-ins and various health tests to help find answers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT06174389 on ClinicalTrials.gov |
What this trial studies
This study examines the physiological and metabolic changes that contribute to involuntary weight loss plateaus in individuals with obesity. Participants will engage in an 18-month program that includes three in-person visits and a six-month remote weight loss intervention. During the study, participants will undergo various assessments, including questionnaires, blood draws, brain MRIs, body composition scans, and muscle and fat biopsies. They will also receive a fitness tracker and scale to monitor their progress throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a BMI between 30.0 and 50.0 kg/m2 who can attend study visits and have access to food preparation facilities.
Not a fit: Patients with type 2 diabetes, significant cognitive impairments, or those currently participating in other weight loss programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into overcoming weight loss plateaus, leading to more effective weight management strategies for patients with obesity.
How similar studies have performed: Other studies have explored similar behavioral weight loss interventions, but this specific investigation into metabolic and brain changes during weight loss plateaus is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seattle, Washington and 1 other locations
- Fred Hutch Cancer Center — Seattle, Washington, United States (Not_yet_recruiting)
- University of Washington - South Lake Union — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Ellen Schur, MD, MS — University of Washington
- Study coordinator: ADAPT Study
- Email: uwadaptstudy@uw.edu
- Phone: 206-616-6360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.