An interventional study of StEP OUT in Child Obesity, Breast Feeding and Feeding Behavior, sponsored by Northwell Health. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Northwell Health · Not applicable, Interventional, and Prevention
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.
This intervention development study will enroll three to four consecutive cohorts to receive Starting Early to Prevent Obesity Using Telehealth (StEP OUT), an online, group-based nutrition education and parenting support program beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy. It is tailored to Hispanic/Latinx families. StEP OUT will be delivered by a registered dietician/certified lactation counselor in coordination with the Long Island Jewish Medical Center Special Supplemental Nutrition Program for Women, Infants, and Children (LIJ WIC). The StEP OUT curriculum is based on the Starting Early Program (StEP), which uses didactic instruction, reflective discussion, interactive demonstrations, and hands-on practicing of skills to support prenatal nutrition and healthy early infant feeding practices. The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and our Community Advisory Board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. Each session will conclude with a structured feedback discussion designed to elicit targets and strategies for further program adaptation. We will collect feasibility and acceptability data after each session and at the end of the five-session program for each cohort. The iterative intervention adaptation process will be complete once all participants rate the intervention as "acceptable" or higher and fidelity is 90% or higher. We anticipate meeting this benchmark after 3 cohorts but may need to recruit an additional cohort to test subsequent adaptations, if necessary.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 49 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
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Exclusion Criteria:
See intervention description
Behavioral: StEP OUT
The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and the community advisory board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. All sessions are designed to be supportive, educational, and interactive, with opportunities to practice skills and discuss feeding and parenting concerns.
Acceptability
We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.
Time frame: From enrollment through the end of the study after child age 4 months.
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 curriculun 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)
Time frame: From enrollment to study completion after infant age 4 months.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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