NCT07665983 The Bottle Optimization Testing Tiny Little Eaters Study
| NCT ID | NCT07665983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2026-06-26 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2026-06-26 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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). 2. Maternal age: Mother is ≥18 years old. 3. Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions. 4. Gestational age: Infant was born at 37.0-42.0 weeks gestation. 5. Birthweight: Infant's birthweight was appropriate for gestational age. 6. Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week. 7. 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. 8. Infant age: Infant is 4.0-6.0 months old at enrollment. Exclusion Criteria: 1. Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions. 2. Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development. 3. History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support. 4. Current weight-for-age below the 10th percentile or significant history of poor weight gain. 5. Infant already typically uses a slower-flow nipple (flow rate \< 5 mL/min).
Contact & Investigator
Amanda Crandall, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07665983 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07665983 currently recruiting?
Yes, NCT07665983 is actively recruiting participants. Contact the research team at bmcaldwe@umich.edu for enrollment information.
Where is the NCT07665983 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07665983 clinical trial?
NCT07665983 is sponsored by University of Michigan. The principal investigator is Amanda Crandall, PhD at University of Michigan. The trial plans to enroll 440 participants.
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