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New treatment option for Childhood Obesity
Official title The Bottle Optimization Testing Tiny Little Eaters Study
ClinicalTrials.gov ID: NCT07665983
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study...
- 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).
See the full eligibility criteria
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 months and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.