ADAPT Study: Assessing Diet, Appetite and Physiology Throughout Weight Loss Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioral Weight Loss Program.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Physiological Changes Underlying the Weight Loss Plateau in Human
Overview
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.
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).]
- 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).]
- Entry into involuntary weight loss plateau [Time frame: throughout 18-month enrollment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Fred Hutch Cancer Center — Seattle
- University of Washington - South Lake Union — Seattle
Identifiers
NCT: NCT06174389 · STUDY00017667 · R01DK134417