Predictors of Behavioral Obesity Treatment Outcomes

NCT05326477 | Recruiting

• 1 other identifier: 20042007
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Weight change

  Weight change, reported as a percentage of baseline weight

  Months 2, 4, and 6

Secondary Outcomes (3)

• Adherence to dietary self-monitoring

  Months 2, 4, and 6

• Adherence to physical activity recommendations

  Months 2, 4, and 6

• Frequency of dietary lapses

  Months 2, 4, and 6

Study Arms (1)

Standard-of-care behavioral weight loss treatment

OTHER

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

Behavioral: Behavioral weight loss treatment

Interventions

Behavioral weight loss treatment BEHAVIORAL

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

Standard-of-care behavioral weight loss treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not fluent in English
• 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.
• Previous or planned bariatric surgery, or concurrent engagement in other behavioral or pharmacological treatment for obesity
• Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period
• Body mass index ≥60 kg/m2, due to increased injury risk with exercise
• History of bariatric surgery, or current engagement in another weight loss therapy
• Lack of reliable access to cell or landline phone
• 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.)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bradley M Appelhans, PHD

CONTACT

312-942-3477; brad_appelhans@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: May 26, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)