RECRUITING

Assessing Better Bottles for Babies

Conditions

Pediatric Obesity Weight Gain Trajectory Infant Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain.

Official Title

Assessing Better Bottles for Babies (AB3)

Quick Facts

Study Start:2025-02-01

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06357299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Days to 1 Month

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Child is 3 days old to 1 month old * Greater than 37 weeks gestational age at birth * Birth weight greater than 3% for sex-specific WHO growth standard * Caregiver must plan to use local clinic as infant's primary medical home for first 6 months of life * Caregiver must speak English or Spanish as primary preferred language * Caregiver age 18 years or older * Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period	* Multiple gestation * Significant congenital anomaly or acquired or inherited condition directly affecting feeding, physiology, metabolism, or growth * Feeding with soy-based, hydrolyzed, lactose-reduced, or elemental formula * Weight loss greater than 95% for population reference in the first two weeks of life

Inclusion Criteria

Exclusion Criteria

* Child is 3 days old to 1 month old
* Greater than 37 weeks gestational age at birth
* Birth weight greater than 3% for sex-specific WHO growth standard
* Caregiver must plan to use local clinic as infant's primary medical home for first 6 months of life
* Caregiver must speak English or Spanish as primary preferred language
* Caregiver age 18 years or older
* Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period

* Multiple gestation
* Significant congenital anomaly or acquired or inherited condition directly affecting feeding, physiology, metabolism, or growth
* Feeding with soy-based, hydrolyzed, lactose-reduced, or elemental formula
* Weight loss greater than 95% for population reference in the first two weeks of life

Contacts and Locations

Study Contact

Janna B Howard, MPH

CONTACT

919-620-4793

janna.howard@duke.edu

Principal Investigator

Charles T Wood, MD, MPH

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University

Durham, North Carolina, 27704

United States

Collaborators and Investigators

Sponsor: Duke University

Charles T Wood, MD, MPH, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-02-01

Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

Pediatric Obesity
Weight Gain Trajectory
Infant Obesity