Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

NCT05104073 | Completed Results

• 2 other identifiers: STUDY000187881R21HD104028-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Conditional Weight Gain Difference Between Study Groups

  During the intervention period spanning Ages 1-6 Months

• Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards

  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

  Spanning ages 1-6 months

• Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards)

  1 time point at age 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria

Interventions

Intervention BEHAVIORAL

Provided with educational materials, guidelines and instructions.

Intervention

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Ian Paul, MD
• Organization: Penn State College of Medicine

ipaul@pennstatehealth.psu.edu

7175318006

Study Officials

• Ian Paul, MD, MSc

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician Department of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 2, 2021
• Study Start: January 20, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)