Clinical trial NCT06087133: Prenatal Starting Early Program mHealth
Official title: Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Prenatal care
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2023-10-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this interventional trial is to test the efficacy of the remote delivery of the StEP:Prenatal intervention compared to standard prenatal care in pregnant individuals planning to receive prenatal and pediatric care at Bellevue Hospital. The primary aims are to determine the efficacy of the remotely delivered StEP:Prenatal intervention on diet, lifestyle behaviors, social determinants of health (SDoH), and pregnancy outcomes.


Eligibility criteria: Inclusion Criteria:

* Currently pregnant in the first trimester (up to 13 weeks, 6 days)
* Speak English or Spanish fluently
* Intent to receive prenatal and pediatric care at Bellevue
* ≥18 years
* Have a smart phone or device with internet access
* Willing and able to provide consent

Exclusion Criteria:

* Severe illness (severe medical or mental health condition e.g. cancer, epilepsy neuromuscular disease, psychosis or bipolar disorder).

Note: Diabetes, hypertension, depression are not excluded.

* Living in a shelter
* Receiving treatment for drug or alcohol use

Primary outcomes:
measure: Daily servings of fruits (cup equivalents)
timeFrame: Week 28-42 (third trimester)
measure: Daily servings of whole grains (ounce equivalents)
timeFrame: Week 28-42 (third trimester)
measure: Daily servings of refined grains (ounce equivalents)
timeFrame: Week 28-42 (third trimester)
measure: Daily servings of dairy (total milk cup equivalents)
timeFrame: Week 28-42 (third trimester)
measure: Daily servings of vegetables (cup equivalents)
timeFrame: Week 28-42 (third trimester)
measure: Number of times 100% pure fruit juice consumed
timeFrame: Week 28-42 (third trimester)
measure: Number of times sugar sweetened beverages (not including 100% fruit juice) consumed
timeFrame: Week 28-42 (third trimester)
measure: Daily servings of protein foods (ounce equivalents)
timeFrame: Week 28-42 (third trimester)
measure: Healthy Eating Index (HEI)-2015 score
timeFrame: Week 28-42 (third trimester)
measure: Daily servings of fruits (cup equivalents)
timeFrame: 3 months (6-14 weeks postpartum)
measure: Daily servings of whole grains (ounce equivalents)
timeFrame: 3 months (6-14 weeks postpartum)
measure: Daily servings of refined grains (ounce equivalents)
timeFrame: 3 months (6-14 weeks postpartum)
measure: Daily servings of dairy (total milk cup equivalents)
timeFrame: 3 months (6-14 weeks postpartum)
measure: Daily servings of vegetables (cup equivalents)
timeFrame: 3 months (6-14 weeks postpartum)
measure: Daily servings of protein foods (ounce equivalents)
timeFrame: 3 months (6-14 weeks postpartum)
measure: Number of times 100% pure fruit juice consumed
timeFrame: 3 months (6-14 weeks postpartum)
measure: Number of times sugar sweetened beverages (not including 100% fruit juice) consumed
timeFrame: 3 months (6-14 weeks postpartum)
measure: Healthy Eating Index (HEI)-2015 score
timeFrame: 3 months (6-14 weeks postpartum)
measure: Total amount of screen time
timeFrame: Week 28-42 (third trimester)
measure: Total amount of physical activity
timeFrame: Week 28-42 (third trimester)
measure: Total amount of screen time
timeFrame: 3 months (6-14 weeks postpartum)
measure: Total amount of physical activity
timeFrame: 3 months (6-14 weeks postpartum)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9) score
timeFrame: Week 28-42 (third trimester)
measure: Patient Health Questionnaire (PHQ-9) score
timeFrame: 3 months (6-14 weeks postpartum)
measure: Generalized Anxiety Disorder-7 score
timeFrame: Week 28-42 (third trimester)
measure: Generalized Anxiety Disorder-7 score
timeFrame: 3 months (6-14 weeks postpartum)
measure: Perceived Stress Scale score
timeFrame: Week 28-42 (third trimester)
measure: Perceived Stress Scale score
timeFrame: 3 months (6-14 weeks postpartum)
measure: Family Resilience score
timeFrame: Week 28-42 (third trimester)
measure: Family Resilience score
timeFrame: 3 months (6-14 weeks postpartum)
measure: Gestational weight gain
timeFrame: 3 months (6-14 weeks postpartum)
measure: Total number of remote StEP:Prenatal sessions attended
timeFrame: 3 months (6-14 weeks postpartum)
measure: Total number of pregnancy care visits attended
timeFrame: 3 months (6-14 weeks postpartum)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC Health + Hospitals/Bellevue
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mary Messito, MD
role: PRINCIPAL_INVESTIGATOR
References: