NCT05741125 · University of North Carolina, Chapel Hill
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
What this study is about
The purpose of this 6-month randomly assigned 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
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.
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.
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.
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
Time frame: Month 6
Percentage of participants who adheres to study protocol.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Kannapolis, North Carolina
Collaborators
American Diabetes Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2025 · Source of record for eligibility and locations