Childhood Obesity
Conditions
Keywords
Infant growth, Responsive feeding, Satiation cues, Milk intake
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.
Detailed description
The study will enroll 220 mother-infant dyads.
Interventions
BEHAVIORALFeeding
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).
Sponsors
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in milk/formula intake (Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in suck effect (Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | Measured with smart bottles and defined as the area under the sucking curve across a single feeding. |
| Change in peak tongue pressure ((Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | Measured with smart bottles and defined as the average peak of the sucking curves across a single feeding. |
| Change in sucking frequency (Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | Measured with smart bottles and defined as the average number of full suck cycles per second across a single feeding. |
| Change in sucking smoothness ((Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | Measured with smart bottles and defined as the average number of sucking pattern peaks in the speed profile of a suck across a single feeding. |
| 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) | Calculated as the mean Feeding Interval during the given 12-hour segment on the Slower Flow day minus the mean Feeding Interval during the matching 12-hour segment Typical nipple day. |
| Change in satiation signaling (Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | Coded set of behaviors from video recordings of feeding interactions associated with infant disengagement from the bottle or caregiver. |
| Change in dyadic mutuality between infant and caregiver (Δ^(S-T)) | From baseline to the end of the slower flow feeding phase (approximately 4 days later) | Coded from video-recordings of feeding interactions, based on behaviors associated with strong communication, warmth, and synchrony of the dyad. |
Countries
United States
Contacts
CONTACTBryanne Caldwell
PRINCIPAL_INVESTIGATORAmanda Crandall, PhD
University of Michigan
Outcome results
None listed