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OpenTrials
Active, not recruiting

NCT Number: NCT06848244

Preventing Type 2 Diabetes in Black Emergent Adult

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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Mellitus Binge Eating Binge-Eating Disorder Body Weight Bulimia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Feeding and Eating Disorders Glucose Metabolism Disorders Hyperphagia Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Appetite Awareness Training (AAT)

Behavioral

Participants 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)

Behavioral

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

Primary outcomes

  1. Change in number of Binge Eating Episodes from Baseline to Month 6

    Time frame: Baseline, 6 months

    Participants will self-monitor and complete surveys on binge eating episodes.

  2. Change from Baseline to Month 6 in weight regain

    Time frame: 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 outcomes

  1. Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6

    Time frame: Baseline, 6 months

    Participants will provide plasma samples to examine the risk for type 2 diabetes mellitus.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 26, 2025
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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