Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT

NCT07254065 | Recruiting

• 2 other identifiers: 21-1078 Aim 3K23HL159326
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Acceptability

  We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.

  From enrollment through the end of the study after child age 6 months

Secondary Outcomes (1)

• Feasibility

  From enrollment to study completion after infant age 6 months.

Study Arms (2)

StEP OUT

EXPERIMENTAL

Online nutrition education and parenting support with group chat.

Behavioral: StEP OUT

Infant Safety Education

ACTIVE COMPARATOR

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

Behavioral: Infant Safety Education

Interventions

StEP OUT BEHAVIORAL

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.

StEP OUT

Infant Safety Education BEHAVIORAL

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

Infant Safety Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Northwell Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwell Health

New Hyde Park, New York, 11040, United States

RECRUITING

Central Study Contacts

Michelle W Katzow, MD, MS

CONTACT

516-465-4377; mkatzow@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 12 months after publication for 5 years.
• Access Criteria: Access requires a proposal and a data use agreement.

Locations

US (1)