Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
Part of paid clinical trials in Kannapolis, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT05741125
- Status
- Recruiting
Conditions
- Binge Eating
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- DSME + ASE intervention (Centering Appetite) — BEHAVIORALThe intervention will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app.
Study Details
The purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Intervention participants will receive type 2 diabetes education and web-based lessons on appetite self-regulation. Participants will also receive a Fitbit to monitor daily physical activity. The investigators will follow up with participants at six months.
Key Dates
- Start date
- Jan 22, 2025
- Status verified
- Jun 2025
- Primary completion
- Feb 1, 2026
- Completion
- Feb 1, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)The Diabetes Self-Management Education and Support (DSMES) + Appetite Self-Regulation (ASE) intervention includes two, 45-60-minute group sessions delivered via telehealth. These sessions will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app.
- No Intervention: ControlControl group participants will attend two remotely delivered DSMES sessions that will offer content commonly. They will also receive weekly emails providing content from the American Association of Diabetes Educators.
Primary Outcome Measure
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline [ Time Frame: Baseline ]
Central Contacts
- Ramine Alexander, PhD, MPH704-250-5093
- Rachel Goode, PhD, MPH, LCSW919-962-6429
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rachel W. Goode | Kannapolis | North Carolina | 28081 | |
| UNC Nutrition Research Institute | Kannapolis | North Carolina | 28081 | Ramine Alexander, PhD, MPH Rachel Goode, PhD, MPH, MSW (PRINCIPAL_INVESTIGATOR) |
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