N/A
N=60
Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05104073 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Conditional Weight Gain Difference Between Study Groups — 0.27; -0.12 Conditional Weight Gain score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conditional Weight Gain Difference Between Study Groups |
0.28; -0.14 | — |
| SECONDARY Conditional Weight Gain Difference Between Study Groups |
0.28; -0.14 | — |
| SECONDARY Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards |
0.73; 0.65 | — |
| SECONDARY Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period |
12.4; 12.1 | — |
| SECONDARY Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) |
4; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05104073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.