The Bottle Optimization Testing Tiny Little Eaters Study

NCT07665983 | Recruiting

• 2 other identifiers: HUM002785381K99HD112517-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Infant growth; Responsive feeding; Satiation cues; Milk intake

Outcome Measures

Primary Outcomes (1)

• Change in milk/formula intake (Δ^(S-T))

  Calculated as intake (pre-weight minus post-weight divided by infant body weight) during each slower-flow feeding minus the mean intake across the three baseline feedings

  From baseline to the end of the slower flow feeding phase (approximately 4 days later)

Secondary Outcomes (7)

• Change in suck effect (Δ^(S-T))

  From baseline to the end of the slower flow feeding phase (approximately 4 days later)

• Change in peak tongue pressure ((Δ^(S-T))

  From baseline to the end of the slower flow feeding phase (approximately 4 days later)

• Change in sucking frequency (Δ^(S-T))

  From baseline to the end of the slower flow feeding phase (approximately 4 days later)

• Change in sucking smoothness ((Δ^(S-T))

  From baseline to the end of the slower flow feeding phase (approximately 4 days later)

• Change in feeding Interval for each of the 12-hour segments post-introduction of the Slower-Flow bottle nipple

  From baseline to the end of the slower flow feeding phase (approximately 4 days later)

Study Arms (1)

Mother-infant dyad

EXPERIMENTAL

Each mother-infant dyad serves as its own control.

Behavioral: Feeding

Interventions

Feeding BEHAVIORAL

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).

Mother-infant dyad

Eligibility Criteria

• Age: 4 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Crandall, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryanne Caldwell

CONTACT

734-647-8100; bmcaldwe@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 24, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available by August 2029 and the researchers will leave it up a minimum of 3 years.
• Access Criteria: "All data in the repository are available for anyone to download without restriction." The data not in the repository, ideo-recordings and raw sucking data, University investigators pending approval of data sharing agreement.

Locations

US (1)