Clinical Trial

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

Recruiting
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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
Trial Details
NCT Number NCT07254065
Lead Sponsor Northwell Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Feasibility and Acceptability, Prevention Childhood Obesity
Enrollment 130 participants
Start Date 2025-11-14
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-28