Preventing Type 2 Diabetes in Black Emergent Adult

NCT06848244 | Recruiting

• 1 other identifier: 25-0125
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6

  Baseline, 6 months

Study Arms (2)

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

EXPERIMENTAL

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

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

Diabetes Prevention Program (DPP) only

EXPERIMENTAL

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

Behavioral: Diabetes Prevention Program (DPP)

Interventions

Appetite Awareness Training (AAT) 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.

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

Diabetes Prevention Program (DPP) 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.

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Diabetes Association: collaborator

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight

Study Officials

• Rachel Goode, PhD,MPH,LCSW

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyisha Harper- Cooks, MBA

CONTACT

704-250-5085; tyharper@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 26, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)