Assessing Better Bottles for Babies

NCT06357299 | Recruiting

• 1 other identifier: Pro00115060
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Obesity; Weight Gain Trajectory; Infant Obesity

Outcome Measures

Primary Outcomes (1)

• Conditional weight gain z-score changes (CWGz)

  CWGz scores will be calculated for each participant as the residual of the actual weight-for-age z-score at 4 months minus its predicted z-score from linear regression of the 4 month z-score on birth weight z-score. Intent-to-treat analyses will include regression models, stratified by sex, with CWGz score as the outcome.

  Birth to 4 months

Secondary Outcomes (2)

• Formula volume per feed

  Birth to 4 months

• Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)

  Birth to 4 months

Study Arms (4)

Standard, Clear

EXPERIMENTAL

This group will receive standard-sized clear bottles

Behavioral: Standard Bottle Size; Behavioral: Clear Bottle

Standard, Opaque

EXPERIMENTAL

This group will receive standard-sized opaque bottles

Behavioral: Standard Bottle Size; Behavioral: Opaque Bottle

Small, Clear

EXPERIMENTAL

This group will receive small-sized clear bottles

Behavioral: Small Bottle Size; Behavioral: Clear Bottle

Small, Opaque

EXPERIMENTAL

This group will receive small-sized opaque bottles

Behavioral: Small Bottle Size; Behavioral: Opaque Bottle

Interventions

Small Bottle Size BEHAVIORAL

Small sized bottle

Small, Clear; Small, Opaque

Standard Bottle Size BEHAVIORAL

Standard sized bottle

Standard, Clear; Standard, Opaque

Clear Bottle BEHAVIORAL

Clear bottle

Small, Clear; Standard, Clear

Opaque Bottle BEHAVIORAL

Opaque bottle

Small, Opaque; Standard, Opaque

Eligibility Criteria

• Age: 3 Days - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27704, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Body-Weight Trajectory

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles T Wood, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janna B Howard, MPH

CONTACT

919-620-4793; janna.howard@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: May 28, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)