Recruiting

Observational Study

Sponsor:

Rush University Medical Center

Code:

NCT05326477

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Behavioral weight loss treatment

Study Details

Brief summary:

Socioceconomically disadvantaged individuals typically have poor outcomes in behavioral weight loss interventions, but the reasons for this are unknown. This project will characterize the mechanisms through which adverse daily experiences and present bias -- a cognitive adaptation to harsh and unpredictable environments -- account for disparities in weight loss outcomes.

Conditions

Obesity

Study ID

NCT05326477

Start date

May 26, 2023

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age ≥18 years old
2. Obesity (body mass index ≥30 kg/m2)
3. Meets criteria for either the lower SES or higher SES cohort

Exclusion Criteria:

1. Not fluent in English
2. Change in income or financial assets exceeding ±75% of federal poverty guideline within the past 12 months, or expected in the next 6 months, if this change would result in reclassification on SES.
3. Previous or planned bariatric surgery, or concurrent engagement in other behavioral or pharmacological treatment for obesity
4. Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period
5. Body mass index ≥60 kg/m2, due to increased injury risk with exercise
6. History of bariatric surgery, or current engagement in another weight loss therapy
7. Lack of reliable access to cell or landline phone
8. Medical contraindications to treatment, including osteoporosis, cognitive impairment (Montreal Cognitive Assessment ≤25), active substance abuse based on the World Health Organization's ASSIST screener, lack of physician clearance for participation, or serious medical illness (e.g., stage 3 or 4 heart failure, cancer, renal failure, etc.)

Study Design

Enrollment

230 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Standard-of-care behavioral weight loss treatment

6-months of group-based behavioral weight loss treatment following the Centers for Disease Control and Prevention Prevent T2 curriculum.

Interventions

Behavioral weight loss treatment

The weight loss intervention consists of the first 6 months of the Centers for Disease Control and Prevention's Prevent T2 program.

Primary outcome measure

  • Weight change [ Time Frame: Months 2, 4, and 6 ]

Central Contacts and Locations

Central contacts

Bradley M Appelhans, PHD

312-942-3477brad_appelhans@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Michele Li, MS, RD

312-942-8260

Principal Investigator:

Bradley M Appelhans, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-03-11.