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Enrolling by Invitation

NCT Number: NCT06349070

RESTORE - Phase II

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.

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Key information

Conditions

Maternal Health

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYC Health + Hospitals/Bellevue, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Percent adoption of the program

    Time frame: End of study (up to 5 years)

    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

Secondary outcomes

  1. Mean number of videos viewed

    Time frame: Month 12

  2. Mean number of sessions completed

    Time frame: Month 12

  3. Level of adherence

    Time frame: Month 12

    Adherence to the program will measure the extent to which the program was implemented per the protocol. This will assess whether components of the program (i.e. identify, counsel, treat, refer and the 5A's) were implemented as intended using data from checklists completed by the training facilitators. Each component will be rated on a 3-point scale: 1=The component was fully implemented and/or modified with permission, as per protocol; 2=The component was partially implemented; and 3=The component was not implemented, as per protocol.

  4. Adequacy of Prenatal Care Utilization Index Score

    Time frame: Month 12

    This outcome measure will be collected from electronic health record. Adequacy is measured using the Adequacy of Prenatal Care Utilization Index, which classifies prenatal care received into 1 of 4 categories (Inadequate (received less than 50% of expected visits), Intermediate (50%-79%), Adequate (80%-109%), Adequate Plus (110% or more)) by combining information about the timing of prenatal care, the number of visits, and the infant's gestational age.

  5. Number of postpartum follow-up visits attended

    Time frame: 12 weeks postpartum

    This outcome measure will be collected from the electronic health record.

  6. Number of subjects who had a pre-term delivery

    Time frame: 12 weeks postpartum

    This outcome measure will be collected from the electronic health record.

  7. Number of subjects with post-partum depression

    Time frame: 12 weeks postpartum

    This outcome measure will be collected from the electronic health record.

  8. Mean gestational weight gain

    Time frame: 12 weeks postpartum

    This outcome measure will be collected from the electronic health record.

  9. Percent sustainability (continued adoption) following the M-CHW implementation period

    Time frame: End of study (up to 5 years)

    Sustainability is measured as the number of those correctly referred and enrolled offset by the denominator of subjects screened.

  10. Program Costs

    Time frame: End of study (up to 5 years)

    Costs of each implementation stage will be calculated by calculating comparative resources associated with implementation

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 5, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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