Preventing Type 2 Diabetes in Black Emergent Adult

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Black women

between 18-25 years of age

BMI ≥ 25 kg/m²

At least one binge eating episode weekly

Disqualifiers

Have no internet access

Currently type 2 diabetic

Currently pregnant

Are in substance use treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP)Experimental treatment 2 interventions
Group B: Diabetes Prevention Program (DPP) onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Baseline, 6 months
2

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.

Time frame
Baseline, 6 months

Secondary outcomes

1

Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6

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

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

American Diabetes Association

Collaborator