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Recruiting NCT06848244

Preventing Type 2 Diabetes in Black Emergent Adult

No phase Interventional Type 2 Diabetes Mellitus Binge-Eating Disorder Binge Eating Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Appetite Awareness Training (AAT), Diabetes Prevention Program (DPP).
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus, Binge-Eating Disorder, Binge Eating, Obesity. Basic parameters: 18 years — 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Change in number of Binge Eating Episodes from Baseline to Month 6 [Time frame: Baseline, 6 months]
  • Change from Baseline to Month 6 in weight regain [Time frame: Baseline, 6 months]
Secondary outcome measures (1)
  • Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6 [Time frame: Baseline, 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • UNC-Chapel Hill — Chapel Hill

Identifiers

NCT: NCT06848244 · 25-0125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗