Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT05104073
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 1 Month
Healthy Volunteers
Accepted

Interventions

  • Intervention — BEHAVIORAL
    Provided with educational materials, guidelines and instructions.

Study Details

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.

Key Dates

Start date
Jan 20, 2022
Status verified
May 2025
Primary completion
May 30, 2024
Completion
May 30, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    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
  • No Intervention: Control
    The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria

Primary Outcome Measure

Conditional Weight Gain Difference Between Study Groups [ Time Frame: Between birth and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-

Find similar trials in Hershey, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Penn State Milton S. Hershey Medical Center· Hershey, PA

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