RESTORE - Phase II

NCT06349070 | Enrolling By Invitation DMC

• 1 other identifier: 23-00404
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Percent adoption of the program

  Adoption of the program will be measured as the number of patients correctly referred and enrolled offset by the number of eligible pregnant subjects screened

  End of study (up to 5 years)

Secondary Outcomes (10)

• Mean number of videos viewed

  Month 12

• Mean number of sessions completed

  Month 12

• Level of adherence

  Month 12

• Adequacy of Prenatal Care Utilization Index Score

  Month 12

• Number of postpartum follow-up visits attended

  12 weeks postpartum

Study Arms (2)

Technology supported (Low Touch) Strategy

ACTIVE COMPARATOR

During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.

Behavioral: Low Touch - Text Messaging Implementation Strategy

Community Health Worker (High Touch Group)

EXPERIMENTAL

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.

Behavioral: High Touch - Community Health Worker (CHW) Implementation Strategy

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.

Technology supported (Low Touch) Strategy

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.

Community Health Worker (High Touch Group)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

NYC Health + Hospitals/Bellevue

New York, New York, 10016, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Natasha Williams, EdD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: January 26, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to erinn.hade@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)