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

Obesity Clinical Trial

Official title:

Physiological Changes Underlying the Weight Loss Plateau in Human

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174389
• Other study ID #: STUDY00017667
• Secondary ID: R01DK134417
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: ADAPT Study
• Phone: 206-616-6360
• Email: uwadaptstudy[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study investigates changes in metabolism and/or the brain that contribute to the occurrence of an involuntary weight loss plateau.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Behavioral Weight Loss Program
Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program.

Locations

Country	Name	City	State
United States	Fred Hutch Cancer Center	Seattle	Washington
United States	University of Washington - South Lake Union	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	Entry into involuntary weight loss plateau	binary outcome (Y/N) and time from baseline	throughout 18-month enrollment