Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Overweight and Obesity Clinical Trial

Official title:

Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104073
• Other study ID #: STUDY00018788
• Secondary ID: 1R21HD104028-01
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Intervention
Provided with educational materials, guidelines and instructions.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conditional Weight Gain Difference Between Study Groups		Between birth and 6 months
Secondary	Conditional Weight Gain Difference Between Study Groups		During the intervention period spanning Ages 1-6 Months
Secondary	Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards		1 time point at age 6 Months
Secondary	Growth Trajectory (repeated measures of weight-for-length on World Health Organization Child growth standards) during the intervention period		Spanning ages 1-6 months
Secondary	Proportion of Infants with Overweight (Weight-for-Length =95th Percentile on World Health Organization Child Growth Standards)		1 time point at age 6 months