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NCT Number: NCT05741125

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

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.

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Key information

Conditions

Type 2 Diabetes Binge Eating Bulimia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperphagia Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rachel W. Goode, Kannapolis, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Improving Appetite Self-Regulation in African American Adults with Type 2 Diabetes

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol

    Time frame: Month 6

    Percentage of participants who adheres to study protocol.

  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.

Secondary outcomes

  1. Changes in HbA1C

    Time frame: Baseline, Month 6

    Participant HbA1C will be measured using a glycohemoglobin analyzer.

  2. Changes in Weight

    Time frame: Baseline, Month 6

    Participant body weight will be measured by trained research staff using a calibrated digital scale.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Goode, PhD, MPH, LCSW

CONTACT

[email protected]

919-962-6429

Ramine Alexander, PhD, MPH

CONTACT

[email protected]

704-250-5093

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2023
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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