Actively Recruiting
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
Led by Northwell Health · Updated on 2025-11-28
130
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with a single baby between 24 and 32 weeks estimated gestational age
- Self-identify as Hispanic/Latinx
- Speak fluent English or Spanish
- At least 18 years of age
- Have a phone or device to participate in video calls
- Receiving or eligible to receive New York State Medicaid benefits
You will not qualify if you...
- Diminished mental capacity
- Serious medical or psychiatric illness
- Fetal condition expected to substantially influence infant feeding, such as an anatomic abnormality (e.g., cleft lip or palate) or a condition requiring surgery within the first six months of life
- Chromosomal abnormalities such as Down's syndrome or other trisomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwell Health
New Hyde Park, New York, United States, 11040
Actively Recruiting
Research Team
M
Michelle W Katzow, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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