REACH-OUT: Chicago Children's Diabetes Prevention Program (REACH-OUT)
Обзор исследования
Статус
Условия
Подробное описание
This is a prevention study that evaluates a community-based, family oriented intervention called Reach-Out. The University of Chicago will partner with community organizations including the Women, Infants and Children [WIC] Clinic at the Chicago Department of Public Health Roseland Clinic, South Side YMCA, the Chicago Park District and the Southside Faith-Based Wellness Network of churches to deliver the intervention. Families will be recruited from the high risk population of patients in the University of Chicago Diabetes database and the Chicago Childhood Diabetes Registry; and La Rabida Children's Hospital; and from the broader south side African-American community ("outreach" population). Families will be randomized to behavioral intervention (Reach-Out Program, hands on nutrition and exercise) or control group(Reach-In Program, standard of care consultation).
All who participate in this study will be seen at the University of Chicago GCRC (General Clinical Research Center). They will be asked to come in at the beginning of the study, after 14 weeks, afer 1 year and after 2 years.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60637
- University of Chicago GCRC (General Clinical Research Center)
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Overweight (>85th percentile BMI for age and gender) African American child age 9-12 with family history of type 2 diabetes in a first or second degree relative. Parents are secondary subjects.
Exclusion Criteria:
- Inability to give informed consent or unwillingness to be randomized
- Prior diagnosis of diabetes in the child planning to participate
- Pregnancy (women who become pregnant during the study will be omitted from the analysis. Pregnant women will not participate in the exercise sessions).
- Uncontrolled hypertension (SBP> 160 or DBP>100) (JNC V, 1993)
- Uncontrolled dyslipidemia by NCEP III criteria (NCEP, 2001)
- Evidence of significant cardiovascular, pulmonary disease, or other serious illness
- Evidence of alcohol or drug abuse (identified by self-report)
- Musculoskeletal disease serious enough to prevent participation in exercise sessions
- Known or suspected major psychiatric disorder
- Inability to participate in aerobic exercise activities
- Inability to comply with a calorie or fat restricted diet
- Age over 65 years
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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Экспериментальный: Group 1
Reach-Out Program, Nutritional and Exercise Intervention
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This group will participate in the Reach-Out nutritional and exercise program. This includes 14 weekly, group sessions involving both parents and children. During these sessions, participants will receive hands-on education regarding food and exercise habits. Sample nutrition activities include learning to read nutrition labels on foods, a tour of a grocery store and practicing a recipe substituting low fat for high fat ingredients. Exercise activities involve physical activities appropriate for children and adults, respectively. Session leaders will help subjects set personal goals in the areas of nutrition and physical activity, and follow up on subjects' progress each week at sessions and with telephone calls between sessions. At the end of the 14-week program, subjects will be asked to attend four bi-monthly and 18 monthly follow-up sessions in which subjects will continue to meet as a group to work on goals in the areas of nutrition and exercise. |
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Активный компаратор: Group 2
Reach-In Program, Standard of Care
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This group will participate in the Reach-Out nutritional and exercise program. This includes 14 weekly, group sessions involving both parents and children. During these sessions, participants will receive hands-on education regarding food and exercise habits. Sample nutrition activities include learning to read nutrition labels on foods, a tour of a grocery store and practicing a recipe substituting low fat for high fat ingredients. Exercise activities involve physical activities appropriate for children and adults, respectively. Session leaders will help subjects set personal goals in the areas of nutrition and physical activity, and follow up on subjects' progress each week at sessions and with telephone calls between sessions. At the end of the 14-week program, subjects will be asked to attend four bi-monthly and 18 monthly follow-up sessions in which subjects will continue to meet as a group to work on goals in the areas of nutrition and exercise.
This group will received standard medical care for their health condition.
This includes meeting individually with a dietician to learn about diet, exercise and diabetes.
This also includes developing an individualized meal plan.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Временное ограничение: 14 weeks, 1 year, 2 years
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14 weeks, 1 year, 2 years
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Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Временное ограничение: 14 weeks, 1 year, 2 years
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14 weeks, 1 year, 2 years
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
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Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Временное ограничение: 14 weeks, 1 year, 2 years
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14 weeks, 1 year, 2 years
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Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Временное ограничение: At two weekly meetings
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At two weekly meetings
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Deborah Burnet, MD, University of Chicago
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 11113B
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. .
Клинические исследования Reach-Out Program, nutritional and exercise program
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Northwestern UniversityWomen and Infants Hospital of Rhode IslandРекрутингПеринатальная депрессияСоединенные Штаты