Clinical trial NCT05741125: Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
Official title: Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Binge Eating
Keywords: Bing Eating
Type 2 Diabetes
African Americans
Digital
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2023-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline
timeFrame: Baseline
measure: Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6
timeFrame: Month 6
measure: Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session
timeFrame: Month 6
measure: Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
timeFrame: Month 6
measure: Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
timeFrame: Month 6
measure: Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention
timeFrame: Month 6
Secondary outcomes:
measure: Changes in HbA1C
timeFrame: Baseline, Month 6
measure: Changes in Weight
timeFrame: Baseline, Month 6
measure: Changes in Blood Pressures (Systolic and Diastolic pressure)
timeFrame: Baseline, Month 6
measure: Changes in Binge Eating Episodes
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Rachel W. Goode
state: North Carolina
city: Kannapolis
country: United States
facility: UNC Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hil
name: Rachel Goode, PhD, MPH, LCSW
role: PRINCIPAL_INVESTIGATOR
References: