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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Prevention Childhood Obesity; Feasibility and Acceptability
• Intervention / Treatment: Behavioral: StEP OUT; Behavioral: Infant Safety Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle W Katzow, MD, MS; Phone Number: 516-465-4377; Email: mkatzow@northwell.edu

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Northwell Health
      • Contact: Michelle W Katzow, MD, MS; Phone Number: 516-465-4377; Email: mkatzow@northwell.edu
      • Principal Investigator: Michelle W Katzow, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: StEP OUT; Online nutrition education and parenting support with group chat.	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.
Active Comparator: Infant Safety Education; Periodic text messages with links to prenatal and infant health and safety resources.	Behavioral: Infant Safety Education; This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.	From enrollment through the end of the study after child age 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From enrollment to study completion after infant age 6 months.

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21-1078 Aim 3; K23HL159326 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 12 months after publication for 5 years.
• IPD Sharing Access Criteria: Access requires a proposal and a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No