Clinical Trials Directory

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RecruitingNCT05741125

Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes

Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

Using a randomized clinical trial design examine the feasibility and acceptability of a 6-month digital diabetes self-management education program plus an appetite self-regulation intervention for (n=60) African Americans (AA) with type 2 diabetes who report uncontrolled eating in North Carolina. Sixty AAs will be randomized to the Centering Appetite intervention or the control group. Over the 6 months, Centering Appetite participants will have two intervention sessions supplemented by monthly booster sessions and weekly messages related to the program. The control group will also receive two intervention sessions and weekly nutrition tutorials. The study will examine the following: recruitment feasibility, attendance/retention, treatment adherence, intervention, HbA1c, and binge eating.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDSME + ASE intervention (Centering Appetite)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.

Timeline

Start date
2025-01-22
Primary completion
2026-02-01
Completion
2026-02-01
First posted
2023-02-23
Last updated
2025-06-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05741125. Inclusion in this directory is not an endorsement.