Clinical trial NCT06848244: Preventing Type 2 Diabetes in Black Emergent Adult
Official title: Preventing Type 2 Diabetes in Black Emergent Adult Women At-Risk for Binge-Eating Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Binge-Eating Disorder
Binge Eating
Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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

Primary outcomes:
measure: Change in number of Binge Eating Episodes from Baseline to Month 6
timeFrame: Baseline, 6 months
measure: Change from Baseline to Month 6 in weight regain
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rachel Goode, PhD,MPH,LCSW
role: PRINCIPAL_INVESTIGATOR
References: