Actively Recruiting
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
Led by Northwell Health · Updated on 2025-05-08
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention, an online group-based program designed to support nutrition and parenting to help prevent obesity. This study focuses on Hispanic/Latinx families starting in the third trimester of pregnancy and continuing through the first four to six months after birth. The goal is to optimize the program for feasibility and acceptability using participant and community feedback. The StEP OUT intervention is delivered by a registered dietician and certified lactation counselor through the Long Island Jewish Medical Center WIC program. The program includes five formal group sessions conducted mainly via remote videoconference, with individual sessions available based on participant preference. Each session includes educational content, interactive discussions, skill practice, and feedback discussions to guide program improvements. The study will enroll three to four consecutive cohorts and may add more if needed to reach intervention goals. Participants will attend sessions during pregnancy and early infancy, providing feedback after each session and at the end of the program. Researchers will collect data on how acceptable and feasible the intervention is, aiming for high participant satisfaction and program fidelity. The study follows participants from enrollment through their child’s age of at least four months. The total duration varies depending on when participants join during pregnancy and how long they continue through infancy.
CONDITIONS
Brief Title
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with at least 14 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 WIC benefits
You will not qualify if you...
- Diminished mental capacity
- Serious medical or psychiatric illness
- Serious fetal illness
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Approximately 5 to 8 months
Participants receive the StEP OUT intervention, an online, group-based nutrition education and parenting support program starting in the third trimester of pregnancy and continuing through the first four to six months of infancy. Sessions are primarily delivered via remote videoconference with opportunities for interactive discussions and skill practice.
5 formal sessions primarily via remote videoconference
Duration - Up to 6 months after intervention completion
Participants provide feedback and data on intervention acceptability and feasibility through the end of the study after the child reaches 4 months of age.
Assessments conducted remotely at study end
Trial Site Locations
Total: 1 location
1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
Research Team
M
Michelle W Katzow, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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