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Идёт набор NCT05693896

Treating Binge Eating and Obesity Digitally in Black Women

Без фазы С лечением Binge Eating Binge-Eating Disorder Weight Gain Prevention Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Centering Appetite.
Кому может быть актуально
Состояния в реестре: Binge Eating, Binge-Eating Disorder, Weight Gain Prevention, Obesity. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Treating Binge Eating and Obesity Digitally in Black Women: A Feasibility Study

Обзор

More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.

Подробное описание

Aim 1. Modify and adapt a validated program to be a culturally-relevant digital health tool for binge eating and weight management for Black women (BMI \> 30 kg/m\^2) who binge eat.

Aim 1a. Identify the barriers and facilitators to detecting and treating binge eating in Black women with obesity, and identify strategies for optimizing digital health tools to engage and retain this population.

Aim 1b. Conduct usability testing with a group of stakeholders to guide content and design refinements; refine tool.

Aim 2. In a randomized clinical trial, examine the feasibility and preliminary efficacy of the digital health appetite awareness + behavioral weight program in primary care.

Вмешательства

  • Поведенческое Centering Appetite
    A digital treatment of Appetite Awareness Treatment (AAT) and behavioral weight loss treatment (BWL) over 6 months, delivered remotely using Zoom. The goal of AAT is to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. AAT has been successful in helping participants diagnosed with Binge Eating Disorder (BED) and bulimia nervosa reduce binge eating, overeating, urges to eat in response to non-appetite stimuli, and prevent

Первичные конечные точки

  • Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study [Срок оценки: 3 month]
  • Retention: Percentage of Participants Retained in the Study [Срок оценки: 6 months]
  • Attendance: Percentage of Intervention Sessions Attended [Срок оценки: 6 months]
Вторичные конечные точки (4)
  • Change from Baseline to Month 3 in weight regain [Срок оценки: Baseline, 3 months]
  • Change from Baseline to Month 6 in weight regain [Срок оценки: Baseline, 6 months]
  • Change in number of Binge Eating Episodes from Baseline to Month 3 [Срок оценки: Baseline, 3 months]
  • Change in number of Binge Eating Episodes from Baseline to Month 6 [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

  • Over 18 years of age,
  • BMI ≥ 30 kg/m\^2,
  • have and regularly use a Bluetooth-enabled smartphone,
  • report at least one binge eating episode weekly,
  • work or live within 30 miles of Kannapolis, NC,
  • complete the screening questionnaire

Критерии исключения

  • currently pregnant,
  • in substance abuse treatment,
  • involved in another weight reduction program,
  • have a history of anorexia,
  • are purging,
  • currently in treatment for eating difficulties,
  • are concurrent intravenous drug users
  • consume >4 alcoholic beverages/day

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UNC-Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT05693896 · 21-2718 · 5K23DK129832

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗