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

Conditions

• Feasibility and Acceptability
• Prevention Childhood Obesity

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• StEP OUT — BEHAVIORAL
  The program consists of five interactive, virtual, group sessions (two prenatal, three post-natal) with a registered dietician/lactation counselor and other women/families of similar gestational age/infant age. Participants discuss maternal nutrition, responsive feeding techniques (breast and bottle), infant feeding cues, and non-feeding soothing methods. Participants are also invited to participate in a moderated WhatsApp Chat with each other to foster additional social engagement and connection. They participate in the program until the baby turns 6 months.
• Infant Safety Education — BEHAVIORAL
  This intervention consists of periodic text messages (approximately every 2 weeks) with links to prenatal health and infant safety information.

Study Details

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

Key Dates

Start date

Nov 14, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: StEP OUT
  Online nutrition education and parenting support with group chat.
• Active Comparator: Infant Safety Education
  Periodic text messages with links to prenatal and infant health and safety resources.

Primary Outcome Measure

Acceptability [ Time Frame: From enrollment through the end of the study after child age 6 months ]

Central Contacts

• Michelle W Katzow, MD, MS
  516-465-4377
  [email protected]

Locations (1)

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