Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Provided with educational materials, guidelines and instructions.<br>|
| No Intervention: Control<br>The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conditional Weight Gain Difference Between Study Groups |  | Between birth and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of Infants with Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) |  | 1 time point at age 6 months |