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

NCT07254065 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Infant Safety Education

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Northwell Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254065 on ClinicalTrials.gov