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

NCT05741125 | Recruiting

• 1 other identifier: 22-2237
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes; Binge Eating

Keywords

Bing Eating; Type 2 Diabetes; African Americans; Digital

Outcome Measures

Primary Outcomes (6)

• Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at 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

  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

  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

  Percentage of participants retained in the study following enrollment.

  Month 6

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

  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

  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 Outcomes (4)

• Changes in HbA1C

  Baseline, Month 6

• Changes in Weight

  Baseline, Month 6

• Changes in Blood Pressures (Systolic and Diastolic pressure)

  Baseline, Month 6

• Changes in Binge Eating Episodes

  Baseline, Month 6

Study Arms (2)

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

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Improving Appetite Self-Regulation in African American Adults with Type 2 Diabetes

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Diabetes Association: collaborator

Study Sites (2)

Rachel W. Goode

Kannapolis, North Carolina, 28081, United States

NOT YET RECRUITING

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Bulimia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Goode, PhD, MPH, LCSW

  University of North Carolina at Chapel Hil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramine Alexander, PhD, MPH

CONTACT

704-250-5093; raminea@unc.edu

Rachel Goode, PhD, MPH, LCSW

CONTACT

919-962-6429; rwgoode@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: January 22, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)