Recipient Organization
Bellevue Hospital Center
New York University School of Medicine
New York,NY 10016
Performing Department
(N/A)
Non Technical Summary
High rates of nutrition related chronic diseases such as obesity, diabetes and hypertension among pregnant women and children highlight the need to identify protective strategies during these critical life cycle periods. In 2011, with USDA funding, our RCT of the original Starting Early Program (StEP) child obesity prevention intervention enrolled women in the third trimester of pregnancy and continued through child age 3 years. The StEP intervention includes individual and group support for healthy diet and lifestyle practices provided by registered dietitians, coordinated with prenatal and pediatric health care visits. Our StEP:prenatal single arm trial, enrolled women in the first trimester and was transitioned to remote delivery in 2020 due to the COVID-19 pandemic.Mobile health (mHealth) interventions can significantly impact diet and lifestyle behaviors linked to nutrition related chronic diseases, and may have advantages in terms of attendance and cost. Although over 80% of pregnant patients in safety-net prenatal clinics receive WIC, and have high rates of nutrition related pregnancy risk factors, existing interventions have not synchronized counseling across prenatal care and WIC.We plan an RCT of remote delivery of Step:prenatal in an urban safety-net prenatal clinic with extension into an affiliated WIC program and mHealth support. Participants will be enrolled at their first prenatal visit and randomized to control vs intervention groups. WIC nutritionists will incorporate StEP:prenatal content in pregnancy certification visits. Outcomes will include diet, physical activity and pregnancy outcomes, changes in nutrition knowledge among families and nutrition providers, and access and use of StEP:prenatal materials.
Animal Health Component
100%
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Goals / Objectives
SPECIFIC AIMSResearch - Aim 1: Determine the efficacy of remotely delivered StEP:Prenatal on diet, lifestyle behaviors, SDoH and pregnancy outcomes.Hypothesis 1a: Compared to standard prenatal care, women receiving remote StEP:Prenatal will:Have healthier diet and lifestyle behaviors.Demonstrate improvements in SDoH (e.g., social support, depressive symptoms)Have healthier pregnancy outcomes (e.g., optimal GWG, reduced GDM).Hypothesis 1b: Higher StEP:Prenatal attendance and website use will lead to greater impacts.Education - Aim 2: To disseminate knowledge of prenatal healthy diet/lifestyle behaviors.Hypothesis 2: Compared to women receiving standard prenatal nutritional counseling, participants receiving StEP:Prenatal will demonstrate greater improvements in knowledge.Education - Aim 3: Educate nutrition students, dietetic interns and health care trainees, through supervised practice and experiential learning opportunities.Aim 3a: To provide experiential learning opportunities and research activities for undergraduate and graduate nutrition students.Aim 3b: To provide supervised practice opportunities for dietetic interns and health care trainees.Hypothesis 3a: Compared to pre-experience, students, interns, and trainees will build scientific literacy and leadership skills on obesity prevention for high-risk groups.Hypotheses 3b: Undergraduate and graduate nutrition students, dietetic interns, and trainees will successfully complete educational programs and deliver appropriate research outputs.Extension - Aim 4: Extend StEP:Prenatal into WIC by incorporating StEP:Prenatal content into standard counseling during pregnancy.Extension - Aim 5: Collaborate with New York City Health + Hospitals (NYC H+H), the nation's largest provider of health care for low-income families, to disseminate evidence-based interventions for stakeholders in nutrition and health care, and build opportunities for scaling and sustainability of virtual and evidence-based interventions.
Project Methods
Overall design: We will conduct a Randomized Controlled Trial (RCT) of remote StEP:Prenatal, which will be delivered to a cohort of women enrolled at their first prenatal visits in the Bellevue prenatal clinic. Participants will be randomized to either standard prenatal care control vs. StEP:Prenatal intervention groups. Intervention will be delivered from enrollment in pregnancy through the birth of the infant. Assessments of weight and health status, diet, lifestyle (physical activity, sleep and sedentary time) and socio-demographic data at baseline, third trimester, and infant age 3 months (post-partum) will be performed.Needs assessment and stakeholder engagement: The current project will begin with assessment of needs around nutrition and lifestyle counseling during pregnancy with prenatal care and WIC providers. Semi-structured interviews will be conducted among prenatal care and WIC nutrition providers. Prenatal care providers will include Ob-Gyn physicians, Certified Nurse Midwives (CNMs) and nutritionists. WIC providers include nutritionists and lactation peer counselors. The goals of these sessions are: 1) to assess the needs among the multiple stakeholders and promote cooperation and engagement; and 2) to harmonize nutrition counseling content and messaging across prenatal care and WIC.StEP:Prenatal setting: Enrollment will occur virtually and in the prenatal clinics at Bellevue Hospital, a large urban public hospital in New York City, part of NYC Health + Hospitals (NYC H+H), the nation's largest public health care system, serving a diverse low-income population, with many immigrant families. There are over 1,100 births and ~1,200 new prenatal care patients yearly at Bellevue; 70% identify as Latinx, 15% Black, 15% Asian and 15% White; Spanish is the primary language for 60%, English for 15%, and 80% qualify for WIC. The most common pregnancy health risk factors identified by providers are obesity, diabetes and hypertension; food and housing insecurity and depressive symptoms were the most common SDoH identified.Sampling: A consecutive sample of pregnant women presenting to Bellevue prenatal clinic in their first trimester will be assessed for eligibility. We estimate 10 to 15 eligible participants per week, and this will be sufficient to enroll 250 over a 15-month period assuming ~65-70% acceptance rate, based on prior RCT experience.Eligibility criteria: Inclusion: English/Spanish speaking, singleton pregnancy, intended prenatal and pediatric care at Bellevue. Exclusion (to prevent confounder imbalance): severe illness (e.g., uncontrolled neurologic disease, psychosis). Diabetes, hypertension, depression are not excluded.Enrollment and randomization: Enrollment will include screening of eligibility, informed consent and completion of baseline assessments. Once baseline assessments are completed, randomization will be conducted using a computerized random number generator to Control (n~125) and StEP:Prenatal (n~125).Receipt of routine medical care/services: Families in both groups will receive routine prenatal and post-partum primary care, on-site WIC and referral for additional services as needed (e.g., women with poor weight gain, obesity, or diabetes may be offered additional RD visits).Intervention: As described above, StEP is a health care-based intervention based on elements of Social Cognitive Theory,in which registered dietitians with additional certified lactation counselor training (RD/CLC) provide individual and group-based support for healthy nutrition and GWG, physical activity, lifestyle behaviors and stress reduction. StEP:Prenatal will be delivered remotely by the StEP RD/CLC using methods developed during the feasibility trial, and informed by stakeholder input during the needs assessment. There are 8 sessions, coordinated with scheduled prenatal care visits and designed to be offered from the first trimester of pregnancy through delivery (see session content above Table 1). Participants enrolling in the 2nd trimester will receive summaries and handouts of earlier sessions.Extension of the intervention context into WIC: Three trimester specific summaries of StEP prenatal content will be developed, informed by the needs assessment. WIC staff will deliver the appropriate trimester summary for nutrition counseling of pregnant clients. The StEP dietitian and WIC staff will refer patients to the mHealth materials described below.Retention plan: The research team has extensive experience maintaining retention of participants. Substantial efforts will be made to minimize attrition by: 1) keeping frequent contact; 2) retaining accurate contact information; 3) providing incentives; and 4) conducting assessments on evenings/weekends. We will track prenatal care appointments for all groups and reschedule those missed to balance attention and facilitate comparable receipt of care across groups.