Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
Northwell Health
130 participants
Nov 14, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to test an online program that teaches healthy habits during pregnancy and infant to prevent early child obesity in Latino families. Specifically, this pilot trial will determine how well we can deliver and test the effects of the program, and how acceptable it is to participants. The main question it aims to answer are: • Is a randomized controlled trial of StEP OUT versus infant safety education control feasible to conduct and acceptable to participants? Researchers will compare StEP OUT to infant safety education control to see if participants enroll in and engage with the program, complete surveys, and learn the content we are teaching. Participants will: * Be assigned to receive StEP OUT or Infant Safety Education * If receiving StEP OUT, they will participant in group text chats and video calls * If receiving Infant Safety Education, they will receive periodic text messages with helpful links and tips * Respond to periodic surveys
Eligibility
Inclusion Criteria6
- Pregnant with singleton of 24 to 32 weeks estimated gestational age
- Self-identify as Hispanic/Latinx
- Speak fluent English or Spanish
- At least 18 years of age
- Has a phone or device to participate in video calls
- Receiving or eligible to receive New York State Medicaid benefits
Exclusion Criteria3
- Diminished mental capacity
- Serious medical or psychiatric illness
- Fetal condition expected to substantially influence infant feeding (anatomic abnormality, such as cleft lip/palate or one that will require surgery within the first six months of life, chromosomal abnormality, such as Down's syndrome or other trisomy, etc.)
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Interventions
The program consists of five interactive, virtual, group sessions (two prenatal, three post-natal) with a registered dietician/lactation counselor and other women/families of similar gestational age/infant age. Participants discuss maternal nutrition, responsive feeding techniques (breast and bottle), infant feeding cues, and non-feeding soothing methods. Participants are also invited to participate in a moderated WhatsApp Chat with each other to foster additional social engagement and connection. They participate in the program until the baby turns 6 months.
This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07254065