- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01923350
Avoiding Diabetes After Pregnancy Trial (ADAPT)
Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the effectiveness of interventions that potentially increase the adoption of Diabetes Prevention Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).
The study was conducted as an integrated trial with two separate arms: one to facilitate weight reduction and the other to increase diabetes testing.
There were two hypotheses:
- Women in the testing intervention will be more likely to have received a diabetes test within the 6 months post-intervention than women in the control group.
- Women in the weight reduction intervention will have lost more weight at the 6-month and 9-month follow-up than women in the control group.
The primary study aim was to determine the efficacy of a system of interactive technology-based supports to prompt women with a history of gestational diabetes to take steps to prevent diabetes. The secondary aims were focused on women's engagement:
- To evaluate the impact of the weight reduction intervention in terms of participant engagement with the interactive technology-based supports.
- To evaluate changes in the women's perception of their personal diabetes risk following after exposure to information about diabetes risk following a pregnancy with GDM.
- To identify the determinants and motivators of and barriers to diabetes testing in the 6- to 12-week postpartum period and thereafter, using the Health Belief model to guide the study.
There was an additional secondary aim involving metformin:
- To evaluate the impact of the diabetes risk reduction intervention in terms of women seeking out their physician's advice on metformin treatment and receiving a metformin prescription, if appropriate.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Maryland
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Silver Spring, Maryland, Соединенные Штаты, 20910
- Social & Scientific Systems Inc.
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
General
- History of GDM in the previous 6 months to 4.5 years
- Access to the internet and text messages or phone messages
- Current patient of Harvard Vanguard Medical Associates
- 18 years of age or older
- Able to read in English
Weight Reduction Group
- Overweight or obese
- Capable of performing moderate physical activity
Diabetes Testing Group
- Had not competed a diabetes test (OGTT or fasting blood sugar at 6-12 weeks postpartum or OGTT, fasting blood sugar or hemoglobin A1c after 12 weeks postpartum)
Exclusion Criteria:
General:
- Diabetes diagnosis
- Psychotic disorder diagnosis
- Enrolled in a research study
Weight Reduction Group
- Taking prescription medications for weight loss
- Engaged in a formal weight reduction program
Diabetes Testing Group
- History of postpartum OGTT, fasting plasma glucose or hemoglobin A1c (after 6 weeks postpartum)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Weight Reduction Intervention
|
The weight trial intervention components were:
|
Активный компаратор: Weight Reduction Control Arm
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Participants received an initial brochure about managing diabetes risk, a digital scale to use in entering their weights in online questionnaires, and monthly emailed wellness messages unrelated to diabetes.
|
Активный компаратор: Tested for diabetes
|
Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a sub-sample of those tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
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Активный компаратор: Not tested for diabetes
|
Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a subsample of those not tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
For participants in weight group, weight reduction from baseline to 6 months
Временное ограничение: 6 months
|
Participants reported their weights online at baseline, 3 months, 6 months, and 9 months, and the difference in weight from baseline to 6 months was the primary measure of the intervention's success.
|
6 months
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In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
Временное ограничение: 6 months
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The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
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6 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Weight intervention participant engagement with the interactive technology-based supports
Временное ограничение: 9 months
|
Measured by separate scores for taking part in behavioral support (coaching calls) and electronic feedback (women responding on goal performance via daily text messaging (SMS)or weekly IVR, chosen by the participant).
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9 months
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Success of participants in weight intervention arm in achieving behavior change goals.
Временное ограничение: 9 months
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Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
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9 months
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Weight change from baseline to 9 months
Временное ограничение: 9 months
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Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
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9 months
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Weight change from 6 to 9 months
Временное ограничение: 3 months
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Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.
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3 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Susan J Griffey, DPh, BSN, Social & Scientific Systems Inc.
Публикации и полезные ссылки
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
- NDEP-GDM GS10F0381L
- GS10F0381L (Другой номер гранта/финансирования: GSA)
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. .
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