Clinical trial NCT06174389: ADAPT Study: Assessing Diet, Appetite and Physiology Throughout Weight Loss Study)
Official title: Physiological Changes Underlying the Weight Loss Plateau in Human
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Gloisis
Weight Change
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-12-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

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

Primary outcomes:
measure: Change in maximal respiratory capacity (oxygen consumption rate) in peripheral blood mononuclear cells
timeFrame: 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).
measure: Change in fMRI BOLD signal
timeFrame: From baseline to a weight loss plateau (after active weight loss, at least 21 days of halted weight loss, or +/- 0.25 pounds/week).
measure: Entry into involuntary weight loss plateau
timeFrame: throughout 18-month enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch Cancer Center
state: Washington
city: Seattle
country: United States
facility: University of Washington - South Lake Union
state: Washington
Study officials:
affiliation: University of Washington
name: Ellen Schur, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch Cancer Center
name: Marian Neuhouser, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington/VA Puget Sound
name: Jenny Tong, MD
role: PRINCIPAL_INVESTIGATOR
References: