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

Not Applicable

Not yet recruiting

• Conditions: Binge Eating; Type 2 Diabetes
• Interventions: Behavioral: DSME + ASE intervention (Centering Appetite)

• Registration Number: NCT05741125
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Study Start: 2024-12-03
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)	DSME + ASE intervention (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.

Primary Outcome Measures

Name	Time	Method
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline	Baseline	The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6	Month 6	Percentage of participants retained in the study following enrollment.
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6	Month 6	The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention	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.
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol	Month 6	Percentage of participants who adheres to study protocol.
Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session	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.

Secondary Outcome Measures

Name	Time	Method
Changes in HbA1C	Baseline, Month 6	Participant HbA1C will be measured using a glycohemoglobin analyzer.
Changes in Weight	Baseline, Month 6	Participant body weight will be measured by trained research staff using a calibrated digital scale.
Changes in Binge Eating Episodes	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.
Changes in Blood Pressures (Systolic and Diastolic pressure)	Baseline, Month 6	Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.

Trial Locations

Locations (1)

Rachel W. Goode; 🇺🇸 Kannapolis, North Carolina, United States