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

University of North Carolina (UNC)

Status: Enrolling

Conditions: Binge Eating; Type 2 Diabetes

Treatments: Behavioral: DSME + ASE intervention (Centering Appetite)

Study type: Interventional

Funder types: Other

Identifiers

NCT05741125

22-2237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)

Experimental group

Description:

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.

Treatment:

Behavioral: DSME + ASE intervention (Centering Appetite)

Control

No Intervention group

Description:

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.