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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline [Срок оценки: Baseline]
• Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6 [Срок оценки: Month 6]
• Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session [Срок оценки: Month 6]
• Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6 [Срок оценки: Month 6]
• Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol [Срок оценки: Month 6]
• Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention [Срок оценки: Month 6]

Вторичные конечные точки (4)

• Changes in HbA1C [Срок оценки: Baseline, Month 6]
• Changes in Weight [Срок оценки: Baseline, Month 6]
• Changes in Blood Pressures (Systolic and Diastolic pressure) [Срок оценки: Baseline, Month 6]
• Changes in Binge Eating Episodes [Срок оценки: Baseline, Month 6]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Rachel W. Goode — Kannapolis
• UNC Nutrition Research Institute — Kannapolis

Идентификаторы

NCT: NCT05741125 · 22-2237

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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