Infant Behavior, Obesity; Familial, Pregnancy Related
Conditions
Brief summary
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
Detailed description
The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.
Interventions
BEHAVIORALTypical Nipple
Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple.
BEHAVIORALChallenging Nipple
Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery).
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers.
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible to participate in this study... Mother -Current or previous participation in the PLAN study resulting in a live birth. Child * Mother participated in PLAN study during child's gestation * Infant birth weight (From PLAN study records) appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set (Oken et al, BMC Pediatrics 2003). * Infant is 3.0 to 6.0 months old at Consent. * Biological mother is legal guardian by maternal report. * Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time). * Infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report. * Stated willingness by mother to comply with all study procedures and availability for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suck effect | Up to 6 weeks | Sucking will be measured with the NFANT® Feeding Solution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sucking pressure | Up to 6 weeks | Sucking will be measured with the NFANT® Feeding Solution |
| Sucking frequency | Up to 6 weeks | Sucking will be measured with the NFANT® Feeding Solution |
| Milk/Formula intake | Up to 6 weeks | — |
| Milk/Formula consumption rate | Up to 6 weeks | — |
| Number of Feedings Over 24 Hours | Up to 6 weeks | — |
| Total Hours of Sleep per 24 Hours within 24 hours of intervention | Up to 6 weeks | — |
| Total Night Wake-ups within 24 hours of intervention | Up to 6 weeks | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmanda Crandall, PhD
University of Michigan
PRINCIPAL_INVESTIGATORJulie Lumeng, MD
University of Michigan
Outcome results
None listed