Preventing Type 2 Diabetes in Black Emergent Adult

Официальное название

Preventing Type 2 Diabetes in Black Emergent Adult Women At-Risk for Binge-Eating Disorder

Обзор

Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).

Подробное описание

Aim 1. Use formative research to gather recommendations to Tailor AAT+DPP to Black Emergent Adult (EA) Women (Year 1).

Aim 2. Utilize community-engaged and user-centered design methods to adapt a mobile intervention to prevent T2DM in Black women at risk for BED (Year 2).

Aim 3. Conduct a pilot randomized trial to examine the feasibility and acceptability, and preliminary efficacy of the adapted AAT+ DPP intervention (Years 3-4; Analysis Year 5).

Вмешательства

• Поведенческое Appetite Awareness Training (AAT)
  Partcipants will receive the AAT delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.
• Поведенческое Diabetes Prevention Program (DPP)
  Partcipants will receive the DPP delivered as 16 core sessions over six months as well as six maintenance sessions over the course of 12 months.

Первичные конечные точки

• Change in number of Binge Eating Episodes from Baseline to Month 6 [Срок оценки: Baseline, 6 months]
• Change from Baseline to Month 6 in weight regain [Срок оценки: Baseline, 6 months]

Вторичные конечные точки (1)

• Change in Inflammatory Biomarkers for T2DM from Baseline to Month 6 [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

• Black women
• between 18-25 years of age
• BMI ≥ 25 kg/m\^2
• At least one binge eating episode weekly
• Prediabetic
• Have access to a smartphone

Критерии исключения

• Have no internet access
• Currently type 2 diabetic
• Currently pregnant
• Are in substance use treatment
• Have received prior or planned bariatric surgery

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

Скрининг

Центры проведения

США · 1 центр

• UNC-Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06848244 · 25-0125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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