NCT07254065 · Northwell Health
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
StEP OUT
The program consists of five interactive, virtual, group sessions (two prenatal, three post-natal) with a registered dietician/lactation counselor and other women/families of similar gestational age/infant age. Participants discuss maternal nutrition, responsive feeding techniques (breast and bottle), infant feeding cues, and non-feeding soothing methods. Participants are also invited to participate in a moderated WhatsApp Chat with each other to foster additional social engagement and connection. They participate in the program until the baby turns 6 months.
BEHAVIORAL
Infant Safety Education
This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.
Primary outcome measures
Acceptability
Time frame: From 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New Hyde Park, New York
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations