RESTORE - Phase II

Enrolling by invitation · Not applicable

Conditions studied: Maternal Health

In brief

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 facts

Study ID

NCT06349070

Run by

NYU Langone Health

People needed

1050

Starts

2024-01-26

Expected to finish

2027-03-30

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

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

Where it is running

• NYC Health + Hospitals/Bellevue — New York, New York, United States
• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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