Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial

NCT ID: NCT06486922

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2026-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Child Obesity; Breast Feeding; Feeding Behavior; Nutrition, Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

StEP OUT Intervention

See intervention description

Group Type: EXPERIMENTAL

StEP OUT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Diminished mental capacity
• Serious medical or psychiatric illness
• Serious fetal illness

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Michelle Katzow

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle W Katzow, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michelle W Katzow, MD, MS

Role: CONTACT

mkatzow@northwell.edu

516-465-4377

Facility Contacts

Michelle W Katzow, MD, MS

Role: primary

mkatzow@northwell.edu

5164654377

Other Identifiers

21-1078 Aim 2

Identifier Type: -

Identifier Source: org_study_id