- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02963428
Teaching Appropriate Gestational Weight Gain (TAGG)
Обзор исследования
Подробное описание
The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.
The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Pennsylvania
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Danville, Pennsylvania, Соединенные Штаты, 17822
- Geisinger Health System
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
- Less than 16 weeks gestation
- Gestational weight gain (GWG) less than < 11 pounds from their pre-pregnancy weight to time of potential study enrollment
- Singleton gestation
- Access to a phone
Exclusion Criteria:
- BMI less than 30 kg/m2
- Gestational age greater than or equal to 16 weeks
- Active diagnosis of cancer on their electronic health record problem list
- Acquired immunodeficiency syndrome (AIDS)
- Palliative medicine patients
- Multiple gestations
- GWG in excess of 11 pounds prior to study enrollment
- Patients with Non-Geisinger prenatal care providers
- Vegan diet
- Malabsorptive conditions
- Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
- Non-English Speaking
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 |
---|---|
Без вмешательства: Standard of Care (SOC)
Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.
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Экспериментальный: Enhanced Care (EC)
In addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. |
In addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Gestational weight gain, adjusting for time in the study
Временное ограничение: at delivery
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at delivery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Patient knowledge and expectations factors
Временное ограничение: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Attitude on pregnancy weight gain
Временное ограничение: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Self-efficacy of healthy eating
Временное ограничение: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Eating, sleeping and physical activity behavior
Временное ограничение: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Patient-experience and involvement in care
Временное ограничение: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Delivery of large for gestational age infants
Временное ограничение: At Delivery
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This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data.
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At Delivery
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Diagnosis of gestational diabetes mellitus
Временное ограничение: Baseline through 4-12 Weeks Postpartum
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This measure will be obtained using EHR data and analyzed utilizing clinic data points.
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Baseline through 4-12 Weeks Postpartum
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Neonatal intensive care unit (NICU) admissions
Временное ограничение: At Delivery
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At Delivery
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Cost of Treatment
Временное ограничение: Baseline through 4-12 Weeks Postpartum
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Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost.
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Baseline through 4-12 Weeks Postpartum
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Mode of delivery
Временное ограничение: At Delivery
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Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest.
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At Delivery
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Rate of gestational weight gain
Временное ограничение: Baseline through 4-12 weeks postpartum
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Baseline through 4-12 weeks postpartum
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Perceived stress measured via Perceived Stress Scale
Временное ограничение: Baseline through 4-12 weeks postpartum
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Perceived Stress will be measured using the Perceived Stress Scale by Cohen et.
al.
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Baseline through 4-12 weeks postpartum
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Psychological factors measured via Pregnancy Weight Gain Attitude Scale
Временное ограничение: Baseline through 4-12 Weeks postpartum
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Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et.
al.
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Baseline through 4-12 Weeks postpartum
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Awathif D Mackeen, MD, MPH, Geisinger Clinic
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 (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2016-0205
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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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