Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will 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. N=30 meeting inclusion/exclusion criteria	Behavioral: Intervention; Provided with educational materials, guidelines and instructions.
No Intervention: Control; The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditional Weight Gain Difference Between Study Groups	Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at birth, with length for age at birth and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values.	Between birth and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditional Weight Gain Difference Between Study Groups	Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at 1 month, with length for age at 1 month and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values.	During the intervention period spanning Ages 1-6 Months
Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards	Weight-for-Length Z-score is based on values from the World Health Organization Growth Standards. A z-score of 0 represents the population mean. Positive values represent values above the population mean. Negative values represent values below the population mean	1 time point at age 6 Months
Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period	repeated measures analysis of weight-for-length	Spanning ages 1-6 months
Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards)	% overweight by study group	1 time point at age 6 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, Los Angeles
• Investigators: Principal Investigator: Ian Paul, MD, MSc, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: STUDY00018788; 1R21HD104028-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This may change in the future depending on results, although all individual participant data will be de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No