Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- NYU Langone Health
- Enrollment
- 1,050
- Locations
- 2
- Primary Endpoint
- Percent adoption of the program
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Technology supported (Low Touch) Strategy
During the control period (low touch), asynchronous videos summarizing healthy lifestyle content will be delivered via text messaging.
Intervention: Low Touch - Text Messaging Implementation Strategy (Behavioral)
Community Health Worker (High Touch Group)
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.
Intervention: High Touch - Community Health Worker (CHW) Implementation Strategy (Behavioral)
Outcomes
Primary Outcomes
Percent adoption of the program
Time Frame: 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 Outcomes
- Adequacy of Prenatal Care Utilization Index Score(Month 12)
- Mean gestational weight gain(12 weeks postpartum)
- Number of subjects with post-partum depression(12 weeks postpartum)
- Mean number of videos viewed(Month 12)
- Level of adherence(Month 12)
- Number of postpartum follow-up visits attended(12 weeks postpartum)
- Number of subjects who had a pre-term delivery(12 weeks postpartum)
- Mean number of sessions completed(Month 12)
- Percent sustainability (continued adoption) following the M-CHW implementation period(End of study (up to 5 years))
- Program Costs(End of study (up to 5 years))