RESTORE - Phase II

NYU Langone Health

Status: Invitation-only

Conditions: Maternal Health

Treatments: Behavioral: Low Touch - Text Messaging Implementation Strategy; Behavioral: High Touch - Community Health Worker (CHW) Implementation Strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06349070

23-00404

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,050 participants in 2 patient groups

Technology supported (Low Touch) Strategy

Active Comparator group

Description:

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

Treatment:

Behavioral: Low Touch - Text Messaging Implementation Strategy

Community Health Worker (High Touch Group)

Experimental group

Description:

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.

Treatment:

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