Feasibility and AcceptabilityNCT07254065
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Pilot RCT
A study testing StEP OUT and Infant Safety Education in people with Feasibility and Acceptability and Prevention Childhood Obesity, run by Northwell Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Feasibility and Acceptability, Prevention Childhood Obesity
- What is being tested?
- StEP OUT and Infant Safety Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health
New Hyde Park, New York, 11040
Michelle W Katzow, MD, MS, 516-465-4377, mkatzow@northwell.edu
Michelle W Katzow, MD, MS
About this study
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:
Read more
- 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
Read the detailed description
Our objective is to conduct a pilot RCT to evaluate the acceptability, feasibility, and preliminary effectiveness of StEP OUT.
Hypothesis: The intervention and control conditions of StEP OUT will be acceptable to families and feasible, as measured by recruitment, randomization, retention, usability, and fidelity. H3b (exploratory): Families exposed to StEP OUT will have improved obesity-related outcomes (knowledge, styles, practices, and infant adiposity) compared to controls.
- Being tested
- StEP OUT, Infant Safety Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StEP OUTBehavioural
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.
Infant Safety EducationBehavioural
This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.
| Study group | Role | What they receive |
|---|---|---|
| StEP OUT | Experimental | Online nutrition education and parenting support with group chat. Receives: Behavioral: StEP OUT |
| Infant Safety Education | Active comparator | Periodic text messages with links to prenatal and infant health and safety resources. Receives: Behavioral: Infant Safety Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.
Measured: From enrollment through the end of the study after child age 6 months
Secondary outcomes (1)
Feasibility
Feasibility assessment will include measures of recruitment (number enrolled of those eligible), retention (number who attend all scheduled sessions of those enrolled), fidelity (number of curriculum components delivered of those planned), and attendance (1. Attendance rate: number of participants who attend each sessions of those scheduled to attend; 2. Program dose: number of sessions attended for each participant)
Measured: From enrollment to study completion after infant age 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start14 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility and AcceptabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254065
- Sponsor's protocol ID
- 21-1078 Aim 3
- Other IDs
- K23HL159326
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD underlying the primary outcomes will be shared. Sensitive variables (e.g., location-based identifiers, audio/video files, free-text fields) will not be shared. A data dictionary, protocol, and SAP will be provided.