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Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05104073
Recruitment Status : Recruiting
First Posted : November 2, 2021
Last Update Posted : March 16, 2023
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
Information provided by (Responsible Party):
Ian M. Paul, MD, Milton S. Hershey Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Intervention Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth
Actual Study Start Date : January 20, 2022
Estimated Primary Completion Date : December 2, 2023
Estimated Study Completion Date : December 2, 2023
Arms and Interventions
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Arm Intervention/treatment
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
 Behavioral: Intervention
Provided with educational materials, guidelines and instructions.
No Intervention: Control
The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria


Outcome Measures
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Primary Outcome Measures :
  1. Conditional Weight Gain Difference Between Study Groups [ Time Frame: Between birth and 6 months ]

Secondary Outcome Measures :
  1. Conditional Weight Gain Difference Between Study Groups [ Time Frame: During the intervention period spanning Ages 1-6 Months ]
  2. Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards [ Time Frame: 1 time point at age 6 Months ]
  3. Growth Trajectory (repeated measures of weight-for-length on World Health Organization Child growth standards) during the intervention period [ Time Frame: Spanning ages 1-6 months ]
  4. Proportion of Infants with Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) [ Time Frame: 1 time point at age 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05104073


Contacts
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Contact: Courtney Byrnes, BS 717-531-0003 ext 322458 cbyrnes@pennstatehealth.psu.edu
Contact: Ellen Stoute, MPH 717-531-1260 estoute@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Courtney Byrnes, BS    717-531-0003 ext 322458    cbyrnes@pennstatehealth.psu.edu   
Contact: Ellen Stoute, MPH    717-531-1260    estoute@pennstatehealth.psu.edu   
Principal Investigator: Ian M Paul, MD, MSc         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
Investigators
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Principal Investigator: Ian Paul, MD, MSc Penn State College of Medicine
More Information
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Responsible Party: Ian M. Paul, MD, Staff Physician Department of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT05104073    
Other Study ID Numbers: STUDY00018788
1R21HD104028-01 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2021    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This may change in the future depending on results, although all individual participant data will be de-identified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight