Clinical trial NCT06349070: RESTORE - Phase II
Official title: Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Health
Keywords: Pregnancy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-05
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study is a hybrid type III implementation-effectiveness trial using a longitudinal cluster-randomized trial with a modified stepped wedge design. In Year 1, all 10 clinics start with the low touch strategy, followed by randomization of clinics in Year 2 to either low touch (5 clinics) or high touch (5 clinics), and finally in Year 3, all 10 clinics will transition to the high touch strategy. Starting in Year 2, we will enroll a subsample of subjects into the a prospective cohort of pregnant persons who will participate in surveys at baseline and postpartum.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Percent adoption of the program
timeFrame: End of study (up to 5 years)
Secondary outcomes:
measure: Mean number of videos viewed
timeFrame: Month 12
measure: Mean number of sessions completed
timeFrame: Month 12
measure: Level of adherence
timeFrame: Month 12
measure: Adequacy of Prenatal Care Utilization Index Score
timeFrame: Month 12
measure: Number of postpartum follow-up visits attended
timeFrame: 12 weeks postpartum
measure: Number of subjects who had a pre-term delivery
timeFrame: 12 weeks postpartum
measure: Number of subjects with post-partum depression
timeFrame: 12 weeks postpartum
measure: Mean gestational weight gain
timeFrame: 12 weeks postpartum
measure: Percent sustainability (continued adoption) following the M-CHW implementation period
timeFrame: End of study (up to 5 years)
measure: Program Costs
timeFrame: End of study (up to 5 years)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC Health + Hospitals/Bellevue
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Natasha Williams, EdD
role: PRINCIPAL_INVESTIGATOR
References: