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

RecruitingNAAges 18 Years - anyFemaleNorthwell Health
NCT07254065 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.)
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What it tests

  • StEP OUT
  • Infant Safety Education
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Where

1 site
Northwell Health
New Hyde Park, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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