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

NCT06486922 | Recruiting

• 1 other identifier: 21-1078 Aim 2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 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)

  From enrollment to study completion after infant age 4 months.

Study Arms (1)

StEP OUT Intervention

EXPERIMENTAL

See intervention description

Behavioral: StEP OUT

Interventions

StEP OUT 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.

StEP OUT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Breast Feeding; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Study Officials

• Michelle W Katzow, MD, MS

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle W Katzow, MD, MS

CONTACT

516-465-4377; mkatzow@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sequential, single arm, intervention development study.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 5, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)