Preventing Type 2 Diabetes in Black Emergent Adult

Preventing Type 2 Diabetes in Black Emergent Adult Women At-Risk for Binge-Eating Disorder

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Type 2 Diabetes Mellitus; Binge-Eating Disorder; Binge Eating
• Intervention / Treatment: Behavioral: Appetite Awareness Training (AAT); Behavioral: Diabetes Prevention Program (DPP)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tyisha Harper- Cooks, MBA; Phone Number: 704-250-5085; Email: tyharper@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC-Chapel Hill
      • Contact: Rachel Goode, PhD,MPH,LCSW
      • Principal Investigator: Rachel Goode, PhD,MPH,LCSW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; 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.
Experimental: Diabetes Prevention Program (DPP) only; Participants are randomized into the DPP group and will be able to access the program's content.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of Binge Eating Episodes from Baseline to Month 6	Participants will self-monitor and complete surveys on binge eating episodes.	Baseline, 6 months
Change from Baseline to Month 6 in weight regain	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.	Baseline, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Rachel Goode, PhD,MPH,LCSW, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Hyperphagia; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Bulimia; Diabetes Mellitus, Type 2; Diabetes Mellitus; Binge-Eating Disorder; Feeding and Eating Disorders
• Other Study ID Numbers: 25-0125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No