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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • DSME + ASE intervention (Centering Appetite) — BEHAVIORAL
    The 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: Control
    Control 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

Locations (2)

FacilityCityStateZIPSite coordinators
Rachel W. GoodeKannapolisNorth Carolina28081
Rachel Goode, PhD, MPH, LCSW
919-962-6429
UNC Nutrition Research InstituteKannapolisNorth Carolina28081
Tyisha Harper-Cooks, MBA
7042505093
Ramine Alexander, PhD, MPH
Rachel Goode, PhD, MPH, MSW (PRINCIPAL_INVESTIGATOR)

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