Skip to content

Preventing Type 2 Diabetes in Black Emergent Adult

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06848244
Enrollment
100
Registered
2025-02-26
Start date
2025-06-30
Completion date
2030-12-01
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

BEHAVIORALAppetite Awareness Training (AAT)

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.

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.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER
American Diabetes Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in number of Binge Eating Episodes from Baseline to Month 6Baseline, 6 monthsParticipants will self-monitor and complete surveys on binge eating episodes.
Change from Baseline to Month 6 in weight regainBaseline, 6 monthsParticipant 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

MeasureTime frameDescription
Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6Baseline, 6 monthsParticipants will provide plasma samples to examine the risk for type 2 diabetes mellitus.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRachel Goode, PhD,MPH,LCSW

University of North Carolina, Chapel Hill

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026