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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05741125
• Other study ID #: 22-2237
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Ramine Alexander, PhD, MPH
• Phone: 704-250-5093
• Email: raminea[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 T2DM complications

• have a history of weight loss surgery

• are currently pregnant

• in substance use treatment or are involved in another weight reduction program.

Related Conditions & MeSH terms

• Binge Eating
• Bulimia
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Rachel W. Goode	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6	Percentage of participants retained in the study following enrollment.	Month 6
Primary	Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol	Percentage of participants who adheres to study protocol.	Month 6
Primary	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	Changes in HbA1C	Participant HbA1C will be measured using a glycohemoglobin analyzer.	Baseline, Month 6
Secondary	Changes in Weight	Participant body weight will be measured by trained research staff using a calibrated digital scale.	Baseline, Month 6
Secondary	Changes in Blood Pressures (Systolic and Diastolic pressure)	Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.	Baseline, Month 6
Secondary	Changes in Binge Eating Episodes	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