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

Northwell Health

Status: Enrolling

Conditions: Feasibility and Acceptability; Prevention Childhood Obesity

Treatments: Behavioral: Infant Safety Education; Behavioral: StEP OUT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07254065

K23HL159326 (U.S. NIH Grant/Contract)

21-1078 Aim 3

Details and patient eligibility

About

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

Full description

Our objective is to conduct a pilot RCT to evaluate the acceptability, feasibility, and preliminary effectiveness of StEP OUT.

Hypothesis: The intervention and control conditions of StEP OUT will be acceptable to families and feasible, as measured by recruitment, randomization, retention, usability, and fidelity. H3b (exploratory): Families exposed to StEP OUT will have improved obesity-related outcomes (knowledge, styles, practices, and infant adiposity) compared to controls.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Diminished mental capacity
• Serious medical or psychiatric illness
• Fetal condition expected to substantially influence infant feeding (anatomic abnormality, such as cleft lip/palate or one that will require surgery within the first six months of life, chromosomal abnormality, such as Down's syndrome or other trisomy, etc.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

StEP OUT

Experimental group

Description:

Online nutrition education and parenting support with group chat.

Treatment:

Behavioral: StEP OUT

Infant Safety Education

Active Comparator group

Description:

Periodic text messages with links to prenatal and infant health and safety resources.

Treatment:

Behavioral: Infant Safety Education