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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiological Changes Underlying the Weight Loss Plateau in Human

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral Weight Loss Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Weight Loss<br>Participants will undergo a behavioral weight loss program. | Behavioral: Behavioral Weight Loss Program<br>* Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | throughout 18-month enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gloisis, Weight Change