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StEP OUT: Preventing Childhood Obesity in Latino Families

This study, called StEP OUT, is testing an online program designed to help prevent childhood obesity in Latino families. The program involves five virtual group sessions (two during pregnancy, three after birth) led by a dietitian/lactation counselor. These sessions cover topics like healthy eating for mothers and responsive feeding for infants. You would also receive text messages with health and safety information. This pilot study aims to see if this program is easy to deliver, if families find it acceptable, and if it can effectively teach healthy habits. To join, you must be a pregnant woman (24-32 weeks gestational age) carrying one baby, identify as Hispanic/Latinx, speak English or Spanish, be at least 18 years old, have a device for video calls, and be eligible for New York State Medicaid. The study is currently unclear on its recruitment status.

Study design
This is an interventional pilot randomized controlled trial, meaning participants will be randomly assigned to either the StEP OUT program or an infant safety education group. The study plans to enroll 130 women.
What's involved
You would participate in five interactive, virtual group sessions and receive periodic text messages (about every two weeks). The study will last from enrollment until your child is 6 months old.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment through the end of the study after the child reaches 6 months of age.

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NCT07254065

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

Recruiting
NAAges 18+InterventionalPrevention
Northwell Health
~130 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:StEP OUTInfant Safety Education

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability
Measured over From enrollment through the end of the study after child age 6 months

Conditions

Feasibility and Acceptability
Prevention Childhood Obesity

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
New York1

Who to contact

Michelle W Katzow, MD, MS
[email protected]
516-465-4377
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.)

What this trial measures

  • AcceptabilityFrom enrollment through the end of the study after child age 6 months

    We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.