The Bottle Optimization Testing Tiny Little Eaters Study
ConditionChildhood Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorUniversity of Michigan
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Feeding
Treatment groups
440 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Michigan
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov