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

June 13, 2025 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ramine Alexander, PhD, MPH
  • Phone Number: 704-250-5093
  • Email: raminea@unc.edu

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • Recruiting
        • UNC Nutrition Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachel Goode, PhD, MPH, MSW
      • Kannapolis, North Carolina, United States, 28081
        • Not yet recruiting
        • Rachel W. Goode
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: DSME + 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.
Other Names:
  • Improving Appetite Self-Regulation in African American Adults with Type 2 Diabetes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline
Time Frame: Baseline
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Baseline
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6
Time Frame: Month 6
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Month 6
Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session
Time Frame: Month 6
The number of potential participants who attended intervention sessions versus the number of persons who enrolled in the study and did not attend intervention sessions.
Month 6
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
Time Frame: Month 6
Percentage of participants retained in the study following enrollment.
Month 6
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
Time Frame: Month 6
Percentage of participants who adheres to study protocol.
Month 6
Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention
Time Frame: Month 6
Participant satisfaction will be measured using a self-report scale at month 6. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM). This is a 4-item scale with 1 being the lowest measure and 5 being the highest measure.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HbA1C
Time Frame: Baseline, Month 6
Participant HbA1C will be measured using a glycohemoglobin analyzer.
Baseline, Month 6
Changes in Weight
Time Frame: Baseline, Month 6
Participant body weight will be measured by trained research staff using a calibrated digital scale.
Baseline, Month 6
Changes in Blood Pressures (Systolic and Diastolic pressure)
Time Frame: Baseline, Month 6
Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.
Baseline, Month 6
Changes in Binge Eating Episodes
Time Frame: Baseline, Month 6
Participant binge eating episodes will be measured using the Binge Eating Scale (BES). This is a 16-item psychological self-assessment tool used to assess the severity of binge eating behavior. Minimum values are: 0-17 which indicates non-binge eating, and the maximum values are anything greater than 27, which indicates severe binge eating.
Baseline, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Rachel Goode, PhD, MPH, LCSW, University of North Carolina at Chapel Hil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-2237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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