protocolSection identificationModule nctId: NCT06349070, orgStudyIdInfo id: 23-00404, briefTitle: RESTORE - Phase II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2027-01-30, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule 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., conditionsModule conditions: Maternal Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Low Touch - Text Messaging Implementation Strategy, interventions name: High Touch - Community Health Worker (CHW) Implementation Strategy, outcomesModule primaryOutcomes measure: Percent adoption of the program, secondaryOutcomes measure: Mean number of videos viewed, secondaryOutcomes measure: Mean number of sessions completed, secondaryOutcomes measure: Level of adherence, secondaryOutcomes measure: Adequacy of Prenatal Care Utilization Index Score, secondaryOutcomes measure: Number of postpartum follow-up visits attended, secondaryOutcomes measure: Number of subjects who had a pre-term delivery, secondaryOutcomes measure: Number of subjects with post-partum depression, secondaryOutcomes measure: Mean gestational weight gain, secondaryOutcomes measure: Percent sustainability (continued adoption) following the M-CHW implementation period, secondaryOutcomes measure: Program Costs, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYC Health + Hospitals/Bellevue, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False