- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07560969
Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans
The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.
The main questions it aims to answer are:
- Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?
- How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?
Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.
Participants will
- Attend DPP sessions delivered in community settings (e.g., churches)
- Receive lifestyle education focused on diet, physical activity, and weight loss
- Engage in physical activity (including in-class exercise sessions [E-DPP only] and community-based options)
- Receive support for healthy eating, including food deliveries ([E-DPP only]), food selection guidance, and referrals to food assistance programs
- Receive information and support for accessing community resources for food and physical activity
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study is a cluster-randomized clinical trial designed to evaluate the effectiveness of an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) compared to a standard culturally tailored DPP (S-DPP) among African American adults with prediabetes residing in low-income, socially vulnerable communities. The trial will enroll approximately 408 participants across 12 community-based sites (churches), which will be randomized to deliver either S-DPP or E-DPP to minimize contamination across intervention conditions.
Both intervention arms are grounded in the evidence-based DPP lifestyle intervention and incorporate cultural tailoring strategies to improve relevance and acceptability in African American communities. The enhanced intervention builds upon this foundation by explicitly addressing multilevel social determinants that influence engagement in healthy eating and physical activity. Specifically, E-DPP integrates structural supports to improve access to healthy foods and safe, low-cost physical activity opportunities, alongside strategies to address social stigma related to obesity, poverty, and food insecurity.
The E-DPP includes additional components delivered during and between sessions. These include provision of fruits and vegetables during sessions, experiential activities focused on healthy food selection and budgeting, and facilitated linkage to community food resources such as food pantries and assistance programs. Physical activity support includes structured in-session exercise and guidance on accessing community-based physical activity programs. Participants in the E-DPP arm will also receive tailored text messaging designed to reinforce behavior change, promote utilization of community resources, and reduce stigma-related barriers to engagement.
The intervention is delivered over a 12-month period, with assessments conducted at baseline, 6 months, and 12 months. A community-engaged approach informs intervention design and implementation, ensuring alignment with local context and resources. The study is guided by theoretical frameworks that emphasize the role of social and structural determinants in shaping health behaviors and outcomes.
In addition to evaluating intervention effects, the study will examine potential mediators and moderators of weight loss, including social determinant-related stressors, access to resources, and psychosocial factors. A concurrent process evaluation will assess intervention fidelity, dose, participant engagement, acceptability, and feasibility, as well as cost-related considerations. These data will inform identification of key intervention components and support future scalability and dissemination of the enhanced program in underserved communities.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jenifer E Allsworth, PhD
- Номер телефона: 816-235-1781
- Электронная почта: allsworthj@umkc.edu
Учебное резервное копирование контактов
- Имя: Jannette E Berkley-Patton, PhD
- Номер телефона: 816-235-1781
- Электронная почта: berkleypattonj@umkc.edu
Места учебы
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Missouri
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Kansas City, Missouri, Соединенные Штаты, 64108
- University of Missouri-Kansas City
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Контакт:
- Jenifer E Allsworth, PhD
- Номер телефона: 816-235-1781
- Электронная почта: allsworthj@umkc.edu
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Members of a participating church or user of a participating church's outreach services
- Age 18 years or older
- Prediabetic (score of 5 or higher in the National Diabetes Prevention Program Risk Score or ([body mass index > 24 or history of gestational diabetes] and (5.7-6.4 A1v, 100-125 mg/dL fasting plasma glucose, or 140-149 mg/dL oral glucose tolerance test)
Exclusion Criteria:
- Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year
- Individuals with unsafe blood pressure levels (160 systolic or higher or 100 diastolic or higher) without a medical clearance firn
- Individuals who are not able to engage in low-impact physical activity
- Individuals who do not speak English
- Individuals who live in a household with a participant in this study at a different church
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Standard Diabetes Prevention Program (S-DPP)
Standard DPP (S-DPP) is a 12-month, in-person lifestyle intervention based on the CDC PreventT2 curriculum, delivered by community peer coaches across 22 sessions (16 core, 6 maintenance).
Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers.
Each session includes weigh-ins with REDCap capture, review of self-monitoring logs for diet, activity, and goals, and guided delivery of the curriculum.
Participants receive Wi-Fi scales and fitness trackers to support weight loss and physical activity tracking.
Certain sessions provide information on local, low- or no-cost food and physical activity resources to support and maintain behavior change.
|
This intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance).
Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery.
Participants use Wi-Fi scales and fitness trackers to support behavior change.
The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability.
|
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Экспериментальный: Enhanced Diabetes Prevention Program (E-DPP)
Enhanced DPP (E-DPP) is a 12-month intervention based on the CDC PreventT2 curriculum that integrates digital tools, community resources, and culturally tailored supports across 22 sessions (16 core, 6 maintenance).
Coaches conduct pre-program outreach and a pre-session addressing diabetes disparities, goal setting, and attendance barriers.
Sessions include weigh-ins with REDCap capture, review of self-monitoring logs, and guided curriculum delivery.
Participants receive Wi-Fi scales and fitness trackers and access tailored text messages with DPP content and resource links.
Coaches provide additional messaging support.
The model also includes in-class healthy food distribution and culturally tailored physical activity sessions, as well as information on local low- or no-cost resources to support sustained behavior change.
|
This intervention adapts the CDC PreventT2 Diabetes Prevention Program into two 12-month delivery models led by community peer coaches with student support across 22 sessions (16 core, 6 maintenance).
Both arms include pre-program outreach, a pre-session addressing diabetes disparities, goal setting and barrier identification, structured sessions with weigh-ins captured in REDCap, review of self-monitoring logs, and guided curriculum delivery.
Participants use Wi-Fi scales and fitness trackers to support behavior change.
The enhanced arm adds tailored text messaging, resource navigation, food access supports, and culturally tailored physical activity to address barriers and improve engagement and sustainability.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Weight loss
Временное ограничение: Baseline, 6 months, 12 months
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Percent weight loss measured as percent change in weight (in pounds) from baseline at 6 and 12 months
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Baseline, 6 months, 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Nutrition security
Временное ограничение: Baseline, 6 months, 12 months
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Self-reported nutrition security
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Baseline, 6 months, 12 months
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Dietary intake
Временное ограничение: Baseline, 6 months, 12 months
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Self-reported dietary quality that assesses alignment with US dietary guidelines
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Baseline, 6 months, 12 months
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DPP Attendance
Временное ограничение: 6 months
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Number of DPP sessions attended
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6 months
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Physical activity (subjective)
Временное ограничение: Baseline, 6 months, 12 months
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Self-reported physical activity
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Baseline, 6 months, 12 months
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Physical activity (objective)
Временное ограничение: Baseline, 6 months
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Physical activity measured by accelerometer
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Baseline, 6 months
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Use of community resources for food access
Временное ограничение: Baseline, 6 months, 12 months
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Self-reported use of food access community resources
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Baseline, 6 months, 12 months
|
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Use of community resources for physical activity
Временное ограничение: Baseline, 6 months, 12 months
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Self-reported use of physical activity community resources
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Baseline, 6 months, 12 months
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Blood pressure
Временное ограничение: Baseline, 6 months, 12 months
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Measured systolic and diastolic blood pressure
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Baseline, 6 months, 12 months
|
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Glycosylated hemoglobin
Временное ограничение: Baseline, 6 months, 12 months
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Measured A1c categorized via American Diabetes Association guidelines
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Baseline, 6 months, 12 months
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Food security
Временное ограничение: Baseline, 6 months, 12 months
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Self-reported measure of household food security
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Baseline, 6 months, 12 months
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Jenifer E Jenifer, PhD, University of Missouri, Kansas City
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Расстройства питания
- Метаболические заболевания
- Переедание
- Масса тела
- Изменения массы тела
- Нарушения метаболизма глюкозы
- Избыточный вес
- Патологические состояния, признаки и симптомы
- Поведение
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Ожирение
- Потеря веса
- Сахарный диабет
- Двигательная активность
Другие идентификационные номера исследования
- 2130354
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .