RESTORE - Phase II

Not Applicable

Recruiting

• Conditions: Maternal Health
• Interventions: Behavioral: Low Touch - Text Messaging Implementation Strategy; Behavioral: High Touch - Community Health Worker (CHW) Implementation Strategy

• Registration Number: NCT06349070
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Primary Completion: 2027-01-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Technology supported (Low Touch) Strategy	Low Touch - Text Messaging Implementation Strategy	During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.
Community Health Worker (High Touch Group)	High Touch - Community Health Worker (CHW) Implementation Strategy	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 Measures

Name	Time	Method
Percent adoption of the program	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 Outcome Measures

Name	Time	Method
Adequacy of Prenatal Care Utilization Index Score	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.
Mean gestational weight gain	12 weeks postpartum	This outcome measure will be collected from the electronic health record.
Number of subjects with post-partum depression	12 weeks postpartum	This outcome measure will be collected from the electronic health record.
Mean number of videos viewed	Month 12
Level of adherence	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.
Number of postpartum follow-up visits attended	12 weeks postpartum	This outcome measure will be collected from the electronic health record.
Number of subjects who had a pre-term delivery	12 weeks postpartum	This outcome measure will be collected from the electronic health record.
Mean number of sessions completed	Month 12
Percent sustainability (continued adoption) following the M-CHW implementation period	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.
Program Costs	End of study (up to 5 years)	Costs of each implementation stage will be calculated by calculating comparative resources associated with implementation

Trial Locations

Locations (2)

NYU Langone Health; 🇺🇸 New York, New York, United States

NYC Health + Hospitals/Bellevue; 🇺🇸 New York, New York, United States