The Bottle Optimization Testing Tiny Little Eaters Study
Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 4 Months and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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).
Study sites (1)
MI
- University of Michigan · Ann Arbor, MI 48109Bryanne Caldwell · Study contact · 734-647-8100 · bmcaldwe@umich.eduAmanda Crandall, PhD · Principal investigatorMore trials in Ann Arbor