nctId: NCT06349070 id: 23-00404 briefTitle: RESTORE - Phase II overallStatus: RECRUITING date: 2024-01-26 date: 2027-01-30 date: 2027-03-30 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: 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. conditions: Maternal Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The study is a hybrid type III implementation-effectiveness trial using a longitudinal cluster-randomized trial with a modified stepped wedge design. In Year 1, all 10 clinics start with the low touch strategy, followed by randomization of clinics in Year 2 to either low touch (5 clinics) or high touch (5 clinics), and finally in Year 3, all 10 clinics will transition to the high touch strategy. Starting in Year 2, we will enroll a subsample of subjects into the a prospective cohort of pregnant persons who will participate in surveys at baseline and postpartum. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 900 type: ESTIMATED name: Low Touch - Text Messaging Implementation Strategy name: High Touch - Community Health Worker (CHW) Implementation Strategy measure: Percent adoption of the program measure: Mean number of videos viewed measure: Mean number of sessions completed measure: Level of adherence measure: Adequacy of Prenatal Care Utilization Index Score measure: Number of postpartum follow-up visits attended measure: Number of subjects who had a pre-term delivery measure: Number of subjects with post-partum depression measure: Mean gestational weight gain measure: Percent sustainability (continued adoption) following the M-CHW implementation period measure: Program Costs sex: FEMALE minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYC Health + Hospitals/Bellevue status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False