Pediatric ObesityAB3NCT06357299
Assessing Better Bottles for Babies
A study testing Small Bottle Size, Standard Bottle Size and Clear Bottle in people with Pediatric Obesity and Weight Gain Trajectory, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 1 month
- Conditions the study is for
- Pediatric Obesity, Weight Gain Trajectory, Infant Obesity
- What is being tested?
- Small Bottle Size, Standard Bottle Size and Clear Bottle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Obesity, Weight Gain Trajectory, Infant Obesity
- Being tested
- Small Bottle Size, Standard Bottle Size, Clear Bottle, Opaque Bottle
- Medical subject headings
- Pediatric Obesity, Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Bottle SizeBehavioural
Small sized bottle
Standard Bottle SizeBehavioural
Standard sized bottle
Clear BottleBehavioural
Clear bottle
Opaque BottleBehavioural
Opaque bottle
| Study group | Role | What they receive |
|---|---|---|
| Standard, Clear | Experimental | This group will receive standard-sized clear bottles Receives: Behavioral: Standard Bottle Size; Behavioral: Clear Bottle |
| Standard, Opaque | Experimental | This group will receive standard-sized opaque bottles Receives: Behavioral: Standard Bottle Size; Behavioral: Opaque Bottle |
| Small, Clear | Experimental | This group will receive small-sized clear bottles Receives: Behavioral: Small Bottle Size; Behavioral: Clear Bottle |
| Small, Opaque | Experimental | This group will receive small-sized opaque bottles Receives: Behavioral: Small Bottle Size; Behavioral: Opaque Bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth to 4 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Birth to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start28 May 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Charles T Wood, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357299
- Sponsor's protocol ID
- Pro00115060
- Acronym
- AB3
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Better Bottles for Babies (AB3)
- ClinicalTrials.gov ID
- NCT06357299
- Acronym / sponsor ID
- AB3 / Pro00115060
- Conditions
- Pediatric Obesity, Weight Gain Trajectory, Infant Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Standard, Clear | Experimental | Behavioral: Standard Bottle Size, Behavioral: Clear BottleThis group will receive standard-sized clear bottles |
| Standard, Opaque | Experimental | Behavioral: Standard Bottle Size, Behavioral: Opaque BottleThis group will receive standard-sized opaque bottles |
| Small, Clear | Experimental | Behavioral: Small Bottle Size, Behavioral: Clear BottleThis group will receive small-sized clear bottles |
| Small, Opaque | Experimental | Behavioral: Small Bottle Size, Behavioral: Opaque BottleThis group will receive small-sized opaque bottles |
Who may qualify
- Ages
- 3 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Bottle SizeSmall sized bottle | Behavioural | Small, Clear, Small, Opaque |
| Standard Bottle SizeStandard sized bottle | Behavioural | Standard, Clear, Standard, Opaque |
| Clear BottleClear bottle | Behavioural | Small, Clear, Standard, Clear |
| Opaque BottleOpaque bottle | Behavioural | Small, Opaque, Standard, Opaque |
Primary outcome
Conditional weight gain z-score changes (CWGz)
Time frame: Birth to 4 months
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.
2 secondary outcomes
Formula volume per feed
Time frame: Birth to 4 months
Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)
Time frame: Birth to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Pediatric Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruitingObservational study
Investigating the Impact of Obesity on Pubertal Development in Girls
Obesity, Puberty
RecruitingObservational study
Evaluation of Children With Endocrine and Metabolic-Related Conditions
Adrenal Insufficiency, Growth Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles T Wood, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Bottle Size, Standard Bottle Size and Clear Bottle in people with Pediatric Obesity and Weight Gain Trajectory, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditional weight gain z-score changes (CWGz) (time frame: Birth to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.