Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
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- STATUS
- Recruiting
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- End date
- Jan 2, 2023
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- participants needed
- 60
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- sponsor
- Milton S. Hershey Medical Center
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.
Details
| Condition | Overweight and Obesity |
|---|---|
| Treatment | Intervention |
| Clinical Study Identifier | NCT05104073 |
| Sponsor | Milton S. Hershey Medical Center |
| Last Modified on | 21 March 2022 |
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