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

Physiological Changes Underlying the Weight Loss Plateau in Human

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral Weight Loss Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Webb; Phone Number: 206-616-6360; Email: uwadaptstudy@uw.edu
• Study Contact Backup: Name: Roz De Leon; Phone Number: 206-685-1532; Email: uwadaptstudy@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington - South Lake Union
      • Contact: Mary Webb; Email: uwadaptstudy@uw.edu
    • Seattle, Washington, United States, 98109
      • Not yet recruiting
      • Fred Hutch Cancer Center
      • Contact: Diana Lowry; Email: dlowry@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ellen Schur, MD, MS, University of Washington; Principal Investigator: Marian Neuhouser, PhD, RD, Fred Hutch Cancer Center; Principal Investigator: Jenny Tong, MD, University of Washington/VA Puget Sound

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Weight Change; Gloisis
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: STUDY00017667; R01DK134417 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No