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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. 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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Northwell Health
RECRUITING
New Hyde Park
Contact Information
Primary
Michelle W Katzow, MD, MS
mkatzow@northwell.edu
516-465-4377
Time Frame
Start Date: 2025-11-14
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 130
Treatments
Experimental: StEP OUT
Online nutrition education and parenting support with group chat.
Active_comparator: Infant Safety Education
Periodic text messages with links to prenatal and infant health and safety resources.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov