Assessing Better Bottles for Babies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2026-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Supporting Baby Behavior Through Pediatric Offices

NCT02438878

Infant Behavior Feeding Behavior Breastfeeding +1 more

COMPLETED NA

Feeding My Baby - A National WIC Study

NCT02031978

Breast Feeding Infant Nutrition Childhood Obesity +3 more

UNKNOWN

Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain

NCT05990439

Obesity, Childhood

COMPLETED NA

Coordination of Care Between Pediatricians and Women Infants & Children Nutritionists

NCT03482908

Childhood Obesity

COMPLETED NA

Healthy Babies Through Infant Centered Feeding

NCT01816516

Overweight Obesity Infant Overnutrition +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Obesity Weight Gain Trajectory Infant Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 factorial design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard, Clear

This group will receive standard-sized clear bottles

Group Type EXPERIMENTAL

Standard Bottle Size

Intervention Type BEHAVIORAL

Standard sized bottle

Clear Bottle

Intervention Type BEHAVIORAL

Clear bottle

Standard, Opaque

This group will receive standard-sized opaque bottles

Group Type EXPERIMENTAL

Standard Bottle Size

Intervention Type BEHAVIORAL

Standard sized bottle

Opaque Bottle

Intervention Type BEHAVIORAL

Opaque bottle

Small, Clear

This group will receive small-sized clear bottles

Group Type EXPERIMENTAL

Small Bottle Size

Intervention Type BEHAVIORAL

Small sized bottle

Clear Bottle

Intervention Type BEHAVIORAL

Clear bottle

Small, Opaque

This group will receive small-sized opaque bottles

Group Type EXPERIMENTAL

Small Bottle Size

Intervention Type BEHAVIORAL

Small sized bottle

Opaque Bottle

Intervention Type BEHAVIORAL

Opaque bottle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Small Bottle Size

Small sized bottle

Intervention Type BEHAVIORAL

Standard Bottle Size

Standard sized bottle

Intervention Type BEHAVIORAL

Clear Bottle

Clear bottle

Intervention Type BEHAVIORAL

Opaque Bottle

Opaque bottle

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Days

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No