NCT07254065Recruiting
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 14 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Northwell Health
- Diseases
- Obesity
- NCT number
- NCT07254065
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 14 Nov 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.)
Other
- Diminished mental capacity
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwell Health Coordinator of this site? Confirm its status | New Hyde Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.