Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Penn State Health

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05104073

1R21HD104028-01 (U.S. NIH Grant/Contract)

STUDY00018788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Intervention

Control

No Intervention group

Description:

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