The Bottle Optimization Testing Tiny Little Eaters Study

Purpose

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.

Condition

  • Childhood Obesity

Eligibility

Eligible Ages
Over 4 Months
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mother-infant dyad 		Each mother-infant dyad serves as its own control.
  • Behavioral: Feeding
    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).

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Bryanne Caldwell
734-647-8100
bmcaldwe@umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Bryanne Caldwell
734-647-8100
bmcaldwe@umich.edu

Detailed Description

The study will enroll 220 mother-infant dyads.