Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DSME + ASE intervention (Centering Appetite).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Binge Eating. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention
Overview
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.
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]
- Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6 [Time frame: Month 6]
- Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session [Time frame: Month 6]
- Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6 [Time frame: Month 6]
- Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol [Time frame: Month 6]
- Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention [Time frame: Month 6]
Secondary outcome measures (4)
- Changes in HbA1C [Time frame: Baseline, Month 6]
- Changes in Weight [Time frame: Baseline, Month 6]
- Changes in Blood Pressures (Systolic and Diastolic pressure) [Time frame: Baseline, Month 6]
- Changes in Binge Eating Episodes [Time frame: Baseline, Month 6]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Rachel W. Goode — Kannapolis
- UNC Nutrition Research Institute — Kannapolis
Identifiers
NCT: NCT05741125 · 22-2237