Centering Appetite: a digital program to improve appetite control and blood sugar in African American adults with type 2 diabetes
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention
NA · University of North Carolina, Chapel Hill · NCT05741125
This 6-month program will try a digital diabetes education plus appetite self-regulation tools to improve A1c and reduce binge eating in African American adults with type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 2 sites (Kannapolis, North Carolina and 1 other locations) |
| Trial ID | NCT05741125 on ClinicalTrials.gov |
What this trial studies
This randomized 6-month trial will enroll 60 African American adults with type 2 diabetes who report uncontrolled eating and have A1c >7.5. Participants will be assigned to the Centering Appetite intervention—with two core sessions, monthly booster sessions, weekly messages, web-based lessons on appetite self-regulation, diabetes education, and a Fitbit—or to a control group receiving two sessions and weekly nutrition tutorials. Investigators will track feasibility metrics (recruitment, attendance, retention, adherence, and satisfaction) and clinical outcomes including HbA1c and binge eating at baseline and six months. The program is delivered digitally but requires participants to have a working smartphone and attend site visits in Kannapolis, North Carolina for assessments.
Who should consider this trial
Good fit: Ideal candidates are non-Hispanic African American adults over 18 with type 2 diabetes, A1c >7.5, a working smartphone, and signs of uncontrolled or binge eating.
Not a fit: Patients with major end-organ diabetes complications, a history of weight-loss surgery, current pregnancy, active substance use treatment, participation in another weight-reduction program, or without a smartphone may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could offer a convenient digital way to lower A1c and reduce binge eating for African American adults with type 2 diabetes.
How similar studies have performed: Digital diabetes self-management and appetite-regulation programs have shown modest improvements in blood sugar and eating behaviors in other populations, but this specific combination tailored to African American adults with binge eating is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Individuals are eligible if they * identify as a Non-Hispanic, AA * are over 18 years of age * have an A1c value \> 7.5 * have a working Smartphone * complete binge eating screening Exclusion Criteria: Individuals will be excluded if they: * have major end-organ type 2 diabetes mellitus complications * have a history of weight loss surgery * are currently pregnant * in substance use treatment or are involved in another weight reduction program.
Where this trial is running
Kannapolis, North Carolina and 1 other locations
- Rachel W. Goode — Kannapolis, North Carolina, United States (NOT_YET_RECRUITING)
- UNC Nutrition Research Institute — Kannapolis, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Rachel Goode, PhD, MPH, LCSW — University of North Carolina at Chapel Hil
- Study coordinator: Ramine Alexander, PhD, MPH
- Email: raminea@unc.edu
- Phone: 704-250-5093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Binge Eating, Bing Eating, African Americans, Digital