Preventing Type 2 Diabetes in Black Emergent Adult

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus; Binge-Eating Disorder; Binge Eating; Obesity

• Registration Number: NCT06848244
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).

Detailed Description

Aim 1. Use formative research to gather recommendations to Tailor AAT+DPP to Black Emergent Adult (EA) Women (Year 1).

Aim 2. Utilize community-engaged and user-centered design methods to adapt a mobile intervention to prevent T2DM in Black women at risk for BED (Year 2).

Aim 3. Conduct a pilot randomized trial to examine the feasibility and acceptability, and preliminary efficacy of the adapted AAT+ DPP intervention (Years 3-4; Analysis Year 5).

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Study Start: 2025-06
• Primary Completion: 2030-06
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Black women
• between 18-25 years of age
• BMI ≥ 25 kg/m^2
• At least one binge eating episode weekly
• Prediabetic
• Have access to a smartphone

Exclusion Criteria

• Have no internet access
• Currently type 2 diabetic
• Currently pregnant
• Are in substance use treatment
• Have received prior or planned bariatric surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in number of Binge Eating Episodes from Baseline to Month 6	Baseline, 6 months	Participants will self-monitor and complete surveys on binge eating episodes.
Change from Baseline to Month 6 in weight regain	Baseline, 6 months	Participant body weight will be measured by trained research staff using calibrated digital scales. Participants will be in light indoor clothing, with pockets emptied, and belts and shoes removed.

Secondary Outcome Measures

Name	Time	Method
Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6	Baseline, 6 months	Participants will provide plasma samples to examine the risk for type 2 diabetes mellitus.

Trial Locations

Locations (1)

UNC-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States