Starting Early to Prevent Obesity Using Telehealth (StEP OUT) for pregnant Latino families
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
This trial will test whether an online program (StEP OUT) can teach healthy pregnancy and infant feeding habits to pregnant Hispanic/Latinx people to help prevent early childhood obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New Hyde Park, New York) |
| Trial ID | NCT07254065 on ClinicalTrials.gov |
What this trial studies
This is a pilot randomized trial comparing the StEP OUT telehealth program to an infant safety education control for pregnant people who identify as Hispanic/Latinx. Participants are enrolled at 24–32 weeks gestation and randomized to receive either group text chats and video calls with StEP OUT content or periodic text-based safety tips. Investigators will track feasibility and acceptability (recruitment, retention, engagement, usability, and fidelity) and collect preliminary outcome data on parental knowledge, feeding practices, and infant adiposity. Most study activities are delivered remotely, with enrollment and oversight run by Northwell Health in New Hyde Park, NY.
Who should consider this trial
Good fit: Ideal candidates are pregnant people (≥18 years) with a singleton pregnancy at 24–32 weeks who self-identify as Hispanic/Latinx, speak English or Spanish, have a phone or device for video calls, and are receiving or eligible for New York State Medicaid.
Not a fit: People with diminished mental capacity, serious medical or psychiatric illness, fetal conditions expected to substantially affect feeding, or those not meeting the demographic or device/Medicaid eligibility criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could improve parental feeding knowledge and practices and reduce early childhood obesity risk among participating Latino families.
How similar studies have performed: Prior pilot telehealth and parent-education programs have shown promising effects on feeding knowledge and behaviors, but evidence that such interventions reduce infant adiposity is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
New Hyde Park, New York
- Northwell Health — New Hyde Park, New York, United States (Recruiting)
Study contacts
- Study coordinator: Michelle W Katzow, MD, MS
- Email: mkatzow@northwell.edu
- Phone: 516-465-4377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.