Starting Early to Prevent Obesity Using Telehealth (StEP OUT) for pregnant Latino families
Official title: Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
Run by Northwell Health · NCT07254065 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 130 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New Hyde Park, New York) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07254065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exercise after pregnancy to activate infant brown fat
This study will test if a mother's exercise during pregnancy and after birth changes her breast milk so it increases her infant's brown fat activity and energy use.
-
Digitally delivered obesity prevention for parents in home visiting programs
A digital program for mothers in home visiting is tested to see if it helps prevent obesity in their infants and improve parenting practices.
-
Intervention to prevent childhood obesity through caregiver education
This study is testing two programs to see if teaching caregivers better nutrition and feeding practices can help prevent obesity in infants during their first year of life.
-
Validating measurements of how much energy your body uses
This study tests whether measuring energy expenditure in a whole-room calorimeter gives healthy adults a more accurate guide to how much to eat to keep their weight stable.
-
BETTER4All personalized weight-management pilot
This pilot tests whether a personalized smartphone app plus a smartwatch using AI can monitor daily behaviors and support weight management for adults aged 18–65.
-
Improving team-based biopsychosocial training so clinics can deliver recommended obesity care
This project will test two training methods to help clinic teams (primary care clinicians, behavioral health staff, dietitians, and community health workers) deliver USPSTF-recommended obesity care to patients at Federally Qualified Health Centers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.