Recruiting

StEP OUT vs. Infant Safety Education

Sponsor:

Northwell Health

Code:

NCT07254065

Conditions

Feasibility and Acceptability

Prevention Childhood Obesity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

StEP OUT

Infant Safety Education

Study Details

Brief 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

Conditions

Feasibility and Acceptability

Prevention Childhood Obesity

Study ID

NCT07254065

Start date

Nov 14, 2025

Status verified date

Nov, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.)

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: StEP OUT

Online nutrition education and parenting support with group chat.

active comparator: Infant Safety Education

Periodic text messages with links to prenatal and infant health and safety resources.

Interventions

StEP OUT

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.

Infant Safety Education

This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.

Primary outcome measure

  • Acceptability [ Time Frame: From enrollment through the end of the study after child age 6 months ]

Central Contacts and Locations

Central contacts

Michelle W Katzow, MD, MS

516-465-4377mkatzow@northwell.edu

Locations

Northwell Health

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Michelle W Katzow, MD, MS

516-465-4377mkatzow@northwell.edu

Principal Investigator:

Michelle W Katzow, MD, MS

More Information

Sponsor

Northwell Health

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-11-28.