RESTORE - Phase II

Официальное название

Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II

Обзор

The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.

Вмешательства

• Поведенческое Low Touch - Text Messaging Implementation Strategy
  The low touch strategy is designed as a tool to distill and organize the most important information from the Starting Early Program (StEP) original evidenced-based intervention curriculum. Video links are sent to pregnant subjects via automated SMS messaging. Subjects will receive videos (20 videos total) at least weekly lasting 17 to 31 weeks and the duration is based upon the gestational age at enrollment into the study. Subjects will also receive SMS messages in between videos at least weekly
• Поведенческое High Touch - Community Health Worker (CHW) Implementation Strategy
  The curriculum will be delivered by CHWs. Each subject will be asked to participate in 1-hour live sessions with a CHW. During the sessions, videos are interspersed with open-ended questions and pauses to discuss these open-ended questions. This results in an interactive session that employs principles of active learning. The curriculum includes sessions delivered during pregnancy coordinated with prenatal visits. The sessions delivered during pregnancy aim to improve diet, physical activity and

Первичные конечные точки

• Percent adoption of the program [Срок оценки: End of study (up to 5 years)]

Вторичные конечные точки (10)

• Mean number of videos viewed [Срок оценки: Month 12]
• Mean number of sessions completed [Срок оценки: Month 12]
• Level of adherence [Срок оценки: Month 12]
• Adequacy of Prenatal Care Utilization Index Score [Срок оценки: Month 12]
• Number of postpartum follow-up visits attended [Срок оценки: 12 weeks postpartum]
• Number of subjects who had a pre-term delivery [Срок оценки: 12 weeks postpartum]
• Number of subjects with post-partum depression [Срок оценки: 12 weeks postpartum]
• Mean gestational weight gain [Срок оценки: 12 weeks postpartum]
• Percent sustainability (continued adoption) following the M-CHW implementation period [Срок оценки: End of study (up to 5 years)]
• Program Costs [Срок оценки: End of study (up to 5 years)]

Критерии участия

Inclusion Criteria (Implementation Group (Low Touch and High Touch)):

• Confirmed pregnant and <20 weeks 0 days gestational age
• receiving care at one of the 10 clinics
• ≥18 years old
• able to speak and read English or Spanish
• Has a smartphone or mobile device with a data plan to accept text messages and internet connection to watch videos

Inclusion Criteria (Follow-up Group):

• Enrolled as a subject in the Implementation Group (Low Touch or High Touch) within the first trimester (before the end of the 13th week (13w6d))
• willing and able to provide consent for baseline and follow up surveys

Критерии исключения

• Significant psychiatric or developmental disability as noted in the medical record.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• NYC Health + Hospitals/Bellevue — New York
• NYU Langone Health — New York

Идентификаторы

NCT: NCT06349070 · 23-00404

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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