NCT06174389

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
15mo left

Started Oct 2023

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2023Jul 2027

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

August 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3.8 years

First QC Date

November 13, 2023

Last Update Submit

August 22, 2025

Conditions

Obesity

Keywords

GloisisWeight Change

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Behavioral Weight Loss

EXPERIMENTAL

Participants will undergo a behavioral weight loss program.

Behavioral: Behavioral Weight Loss Program

Interventions

Behavioral Weight Loss ProgramBEHAVIORAL

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

Behavioral Weight Loss

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

NOT YET RECRUITING

University of Washington - South Lake Union

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

ObesityBody Weight Changes

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ellen Schur, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Marian Neuhouser, PhD, RD

    Fred Hutch Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ADAPT Study

CONTACT

206-616-6360uwadaptstudy@uw.edu

ADAPT Study

CONTACT

206-685-1532uwadaptstudy@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor: School of Medicine

Study Record Dates

First Submitted

November 13, 2023

First Posted

December 18, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

August 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)