Preventing Type 2 Diabetes in Black Emergent Adult

NCT ID: NCT06848244

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2030-12-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Appetite Awareness Training (AAT)

Intervention Type: BEHAVIORAL

Partcipants will receive the AAT delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.

Diabetes Prevention Program (DPP)

Intervention Type: BEHAVIORAL

Partcipants will receive the DPP delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.

Diabetes Prevention Program (DPP) only

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

Group Type: EXPERIMENTAL

Diabetes Prevention Program (DPP)

Intervention Type: BEHAVIORAL

Partcipants will receive the DPP delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.

Interventions

Appetite Awareness Training (AAT)

Partcipants will receive the AAT delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.

Intervention Type: BEHAVIORAL

Diabetes Prevention Program (DPP)

Partcipants will receive the DPP delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Goode, PhD,MPH,LCSW

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tyisha Harper- Cooks, MBA

Role: CONTACT

tyharper@unc.edu

704-250-5085

Facility Contacts

Rachel Goode, PhD,MPH,LCSW

Role: primary

Other Identifiers

25-0125

Identifier Type: -

Identifier Source: org_study_id