Preventing Type 2 Diabetes in Black Emergent Adult

University of North Carolina (UNC)

Status: Enrolling

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

Treatments: Behavioral: Appetite Awareness Training (AAT); Behavioral: Diabetes Prevention Program (DPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06848244

25-0125

Details and patient eligibility

About

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).

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP)

Experimental group

Description:

Participants are randomized into the AAT and DPP groups and receive content from both programs for 12 months.

Treatment:

Behavioral: Diabetes Prevention Program (DPP)

Behavioral: Appetite Awareness Training (AAT)

Diabetes Prevention Program (DPP) only

Experimental group

Description:

Participants are randomized into the DPP group and will be able to access the program's content.

Treatment:

Behavioral: Diabetes Prevention Program (DPP)