RESTORE - Phase II

Maternal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349070
• Other study ID #: 23-00404
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: March 30, 2027

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Natasha Williams, EdD
• Phone: 646-501-3433
• Email: Natasha.williams2[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 30, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Health

Intervention

Behavioral:
• Low Touch - Text Messaging Implementation Strategy
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
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.

Locations

Country	Name	City	State
United States	NYC Health + Hospitals/Bellevue	New York	New York
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean number of videos viewed		Month 12
Secondary	Mean number of sessions completed		Month 12
Secondary	Level of adherence	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.	Month 12
Secondary	Adequacy of Prenatal Care Utilization Index Score	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.	Month 12
Secondary	Number of postpartum follow-up visits attended	This outcome measure will be collected from the electronic health record.	12 weeks postpartum
Secondary	Number of subjects who had a pre-term delivery	This outcome measure will be collected from the electronic health record.	12 weeks postpartum
Secondary	Number of subjects with post-partum depression	This outcome measure will be collected from the electronic health record.	12 weeks postpartum
Secondary	Mean gestational weight gain	This outcome measure will be collected from the electronic health record.	12 weeks postpartum
Secondary	Percent sustainability (continued adoption) following the M-CHW implementation period	Sustainability is measured as the number of those correctly referred and enrolled offset by the denominator of subjects screened.	End of study (up to 5 years)
Secondary	Program Costs	Costs of each implementation stage will be calculated by calculating comparative resources associated with implementation	End of study (up to 5 years)