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NCT Number: NCT05104073

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.

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Key information

Conditions

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

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

Provided with educational materials, guidelines and instructions.

Primary outcomes

  1. Conditional Weight Gain Difference Between Study Groups

    Time frame: Between birth and 6 months

    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.

Secondary outcomes

  1. Conditional Weight Gain Difference Between Study Groups

    Time frame: During the intervention period spanning Ages 1-6 Months

    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.

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

    Time frame: 1 time point at age 6 Months

    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

  3. Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period

    Time frame: Spanning ages 1-6 months

    repeated measures analysis of weight-for-length

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

    Time frame: 1 time point at age 6 months

    % overweight by study group

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of California, Los Angeles

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2021
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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