Assessing Better Bottles for Babies (AB3)

Assessing Better Bottles for Babies (AB3)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Obesity; Infant Obesity; Weight Gain Trajectory
• Intervention / Treatment: Behavioral: Standard Bottle Size; Behavioral: Clear Bottle; Behavioral: Opaque Bottle; Behavioral: Small Bottle Size

Detailed Description

Infants who gain weight rapidly have over 4 times higher odds of developing obesity as a child or adult; infants who are predominantly bottle-fed are at higher risk for excessive infancy weight gain and childhood obesity, yet there are not effective interventions to reduce excessive weight gain among infants who are bottle-fed. The investigators' preliminary work suggest that two novel intervention strategies are feasible and may reduce excessive infancy weight gain: reducing bottle size; and increasing bottle opacity. The investigators aim to test the independent and joint efficacy of these two intervention components among exclusively bottle-fed infants in a randomized, full factorial clinical trial. The investigators' primary objective is to measure the change in conditional weight gain z-score (CWGz) from birth to four months by study group. 4 groups are composed of two conditions: smaller bottles and opaque bottles, independently and in combination, via a 2x2 factorial trial design.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard, Clear; This group will receive standard-sized clear bottles	Behavioral: Standard Bottle Size; Standard sized bottle; Behavioral: Clear Bottle; Clear bottle
Experimental: Standard, Opaque; This group will receive standard-sized opaque bottles	Behavioral: Standard Bottle Size; Standard sized bottle; Behavioral: Opaque Bottle; Opaque bottle
Experimental: Small, Clear; This group will receive small-sized clear bottles	Behavioral: Clear Bottle; Clear bottle; Behavioral: Small Bottle Size; Small sized bottle
Experimental: Small, Opaque; This group will receive small-sized opaque bottles	Behavioral: Opaque Bottle; Opaque bottle; Behavioral: Small Bottle Size; Small sized bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula volume per feed	At the time of in-home video recordings, the volume per feed will be measured from the pre- and post-weight of bottles by a food-grade scale calibrated and accurate to the nearest 0.01g.	Birth to 4 months
Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)	The Nursing Child Assessment Feeding Scale (NCAFS) measures discrete behaviors scored as "presence" or "absence" of each behavior/item. We will calculate feeding behavior scores on the "Sensitivity to Cues" subscale (score range 0 to 16) and "Responsiveness to Caregiver" subscale (score range 0 to 11). Score of 0 on a subscale means that none of the behaviors/items were observed, higher scores indicate more behaviors on the subscale were observed.	Birth to 4 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Charles T Wood, MD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Body-Weight Trajectory; Pediatric Obesity
• Other Study ID Numbers: Pro00115060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No