Clinical trial NCT05104073: Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
Official title: Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of California, Los Angeles
First posted: 2021-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care.
Primary purpose: PREVENTION

Brief summary: The purpose of this voluntary research study is to determine if calibrated formula feeding recommendations can promote optimal growth for the first 6 months after birth for mothers with a pre-pregnancy body mass index of 25 or more.

Detailed description: This pilot study seeks to determine if formula feeding recommendations that are calibrated using age and weight specific caloric intake recommendations can prevent excessive infant weight gain and reduce overweight in the first 6 months after birth among infants born to mothers with overweight prior to pregnancy electing to exclusively formula feed their infants. Calibrated formula feeding refers to adjusting the recommended daily caloric formula intake to account for weight status. A cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care. Intervention group parents will also be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. The investigators hypothesize that the calibrated formula intake intervention will reduce rapid infant gain and overweight during infancy resulting in lower weight-for-length at age 6 months.

Eligibility criteria: Inclusion Criteria:

* Term or Early Term (≥37 weeks), singleton infants
* Infant birthweight ≥50th percentile based on the 2013 Fenton Growth Charts (which account for sex of child and gestational age at birth)
* Infant without substantial neonatal morbidity that would affect feeding or weight gain (e.g. known chromosomal abnormality, metabolic disorder, cleft lip/palate, etc.)
* Infant age ≤1 month
* Mothers with pre-pregnancy body mass index ≥25 kg/m2
* Mothers ≥18 years old
* Parental plan to exclusively feed infant 19-20 kcal/ounce formula upon delivery or by the start of the intervention period \~1 month after delivery
* Parental intention to have infant well child visits through age 6 months at a Division of Academic General Pediatrics practice site (Hope Drive, Elizabethtown, Nyes Road)
* English speaking parent

Exclusion Criteria:

* Infants who weigh less than their birthweight 21 days after delivery

Primary outcomes:
measure: Conditional Weight Gain Difference Between Study Groups
timeFrame: Between birth and 6 months
Secondary outcomes:
measure: Conditional Weight Gain Difference Between Study Groups
timeFrame: During the intervention period spanning Ages 1-6 Months
measure: Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards
timeFrame: 1 time point at age 6 Months
measure: Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period
timeFrame: Spanning ages 1-6 months
measure: Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards)
timeFrame: 1 time point at age 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Ian Paul, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: