RESTORE - Phase II

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06349070
Status
Enrolling By Invitation

Conditions

  • Maternal Health

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Low Touch - Text Messaging Implementation Strategy — BEHAVIORAL
    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 to keep them engaged and reinforce the video content delivered. The StEP curriculum is guideline concordant and includes sessions delivered during pregnancy coordinated with prenatal visits. The sessions delivered during pregnancy aim to improve diet, physical activity and stress management, enhance prenatal breastfeeding support, and build social support. The StEP curriculum was adapted into brief videos (\<5 minutes), and an additional module on Sleep Health was added.
  • High Touch - Community Health Worker (CHW) Implementation Strategy — BEHAVIORAL
    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 stress management during pregnancy, enhance prenatal breastfeeding support, and build social support and are anchored by the same brief videos developed for the low touch strategy.

Study Details

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.

Key Dates

Start date
Jan 26, 2024
Status verified
Feb 2026
Primary completion
Jan 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
1,050 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Technology supported (Low Touch) Strategy
    During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.
  • Experimental: Community Health Worker (High Touch Group)
    During the intervention period (high touch) asynchronous and synchronous learning whereby content will be delivered by trained M-CHWs who are equipped to directly address social determinants of health-related needs and barriers to prenatal care.

Primary Outcome Measure

Percent adoption of the program [ Time Frame: End of study (up to 5 years) ]

Locations (2)

FacilityCityStateZIPSite coordinators
NYC Health + Hospitals/BellevueNew YorkNew York10016-
NYU Langone HealthNew YorkNew York10016-

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By research site
NYC Health + Hospitals/Bellevue· New York, NYNYU Langone Health· New York, NY

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