Childhood ObesityBOTTLENCT07665983
The Bottle Optimization Testing Tiny Little Eaters Study
A study testing Feeding in people with Childhood Obesity, run by University of Michigan at 1 site in United States.
Trial summary
The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep. Read more about this study
- Who is it for?
- Ages 4 months and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody).
- Maternal age: Mother is ≥18 years old.
- Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions.
- Gestational age: Infant was born at 37.0-42.0 weeks gestation.
- Birthweight: Infant's birthweight was appropriate for gestational age.
- Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week.
- Residence: Family lives within approximately one hours driving distance of Ann Arbor, Michigan to participate in an at- home appointment or is willing to drive to the U-M North Campus research site.
- Infant age: Infant is 4.0-6.0 months old at enrollment.
Who cannot join
- Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions.
- Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development.
- History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support.
- Current weight-for-age below the 10th percentile or significant history of poor weight gain.
- Infant already typically uses a slower-flow nipple (flow rate < 5 mL/min).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Bryanne Caldwell, 734-647-8100, bmcaldwe@umich.edu
Amanda Crandall, PhD
About this study
Official title: Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.
Read the detailed description
The study will enroll 220 mother-infant dyads.
- Conditions
- Childhood Obesity
- Being tested
- Feeding
- Keywords
- Infant growth, Responsive feeding, Satiation cues, Milk intake
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedingBehavioural
Following a baseline day (Day 1) in which infants are fed with their typical nipple, infants are exposed to a commercially available nipple with a 30 percent reduced flow rate for three consecutive days (Days 2-4).
| Study group | Role | What they receive |
|---|---|---|
| Mother-infant dyad | Experimental | Each mother-infant dyad serves as its own control. Receives: Behavioral: Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in milk/formula intake (Δ^(S-T))
Calculated as intake (pre-weight minus post-weight divided by infant body weight) during each slower-flow feeding minus the mean intake across the three baseline feedings
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Secondary outcomes (7)
Change in suck effect (Δ^(S-T))
Measured with smart bottles and defined as the area under the sucking curve across a single feeding.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in peak tongue pressure ((Δ^(S-T))
Measured with smart bottles and defined as the average peak of the sucking curves across a single feeding.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in sucking frequency (Δ^(S-T))
Measured with smart bottles and defined as the average number of full suck cycles per second across a single feeding.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in sucking smoothness ((Δ^(S-T))
Measured with smart bottles and defined as the average number of sucking pattern peaks in the speed profile of a suck across a single feeding.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in feeding Interval for each of the 12-hour segments post-introduction of the Slower-Flow bottle nipple
Calculated as the mean Feeding Interval during the given 12-hour segment on the Slower Flow day minus the mean Feeding Interval during the matching 12-hour segment Typical nipple day.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in satiation signaling (Δ^(S-T))
Coded set of behaviors from video recordings of feeding interactions associated with infant disengagement from the bottle or caregiver.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in dyadic mutuality between infant and caregiver (Δ^(S-T))
Coded from video-recordings of feeding interactions, based on behaviors associated with strong communication, warmth, and synchrony of the dyad.
Measured: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start26 Jun 2026
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amanda Kinney Crandall, University of Michigan
- Investigators
- Amanda Crandall, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665983
- Sponsor's protocol ID
- HUM00278538
- Other IDs
- 1K99HD112517-01
- Acronym
- BOTTLE
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers will upload the study data to Deep Blue Data. Video-recordings and raw sucking data will not be included in the archived data on Deep Blue Data and will only be shared under appropriate data use agreements. "Deep Blue Data provides access to digital research data that were developed or used in the support of research activities at U-M. All data in the repository are available for anyone to download without restriction." https://www.lib.umich.edu/collections/deep-blue-repositories
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
- ClinicalTrials.gov ID
- NCT07665983
- Acronym / sponsor ID
- BOTTLE / HUM00278538
- Conditions
- Childhood Obesity
- Keywords
- Infant growth, Responsive feeding, Satiation cues, Milk intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Jun 2026 (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.
The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.
Detailed description
The study will enroll 220 mother-infant dyads.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-infant dyad | Experimental | Behavioral: FeedingEach mother-infant dyad serves as its own control. |
Who may qualify
- Ages
- 4 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody).
- Maternal age: Mother is ≥18 years old.
- Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions.
- Gestational age: Infant was born at 37.0-42.0 weeks gestation.
- Birthweight: Infant's birthweight was appropriate for gestational age.
Key exclusion criteria (5 listed)
- Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions.
- Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development.
- History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support.
- Current weight-for-age below the 10th percentile or significant history of poor weight gain.
- Infant already typically uses a slower-flow nipple (flow rate < 5 mL/min).
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 |
|---|---|---|
| FeedingFollowing a baseline day (Day 1) in which infants are fed with their typical nipple, infants are exposed to a commercially available nipple with a 30 percent reduced flow rate for three consecutive days (Days 2-4). | Behavioural | Mother-infant dyad |
Primary outcome
Change in milk/formula intake (Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Calculated as intake (pre-weight minus post-weight divided by infant body weight) during each slower-flow feeding minus the mean intake across the three baseline feedings
7 secondary outcomes
Change in suck effect (Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in peak tongue pressure ((Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in sucking frequency (Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in sucking smoothness ((Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in feeding Interval for each of the 12-hour segments post-introduction of the Slower-Flow bottle nipple
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in satiation signaling (Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in dyadic mutuality between infant and caregiver (Δ^(S-T))
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. The researchers will upload the study data to Deep Blue Data. Video-recordings and raw sucking data will not be included in the archived data on Deep Blue Data and will only be shared under appropriate data use agreements. "Deep Blue Data provides access to digital research data that were developed or used in the support of research activities at U-M. All data in the repository are available for anyone to download without restriction." https://www.lib.umich.edu/collections/deep-blue-repositories
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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.
Amanda Crandall, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding in people with Childhood Obesity, run by University of Michigan 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryanne Caldwell (734-647-8100, bmcaldwe@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in milk/formula intake (Δ^(S-T)) (time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)). 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 1 Jul 2026.