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Calibrated Formula Feeding for Obesity

N/A

Waitlist Available

Led By Ian Paul, MD, MSc

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mothers with pre-pregnancy body mass index ≥25 kg/m2

English speaking parent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up spanning ages 1-6 months

Awards & highlights

Study Summary

This trial will study whether mothers who are overweight can better match their baby's formula feedings to their needs, promoting optimal growth in the first 6 months.

Who is the study for?

This study is for infants born at or after 37 weeks, weighing in the ≥50th percentile without major health issues affecting feeding/weight gain. It's also for mothers with a pre-pregnancy BMI of 25 or more, who are over 18 and plan to feed their baby formula. Infants must be no older than one month and not weigh less than birth weight by day 21.Check my eligibility

What is being tested?

The Califormula Study tests whether special formula feeding recommendations can help babies grow optimally during their first six months. The study involves parents following these calibrated feeding guidelines provided by researchers.See study design

What are the potential side effects?

Since this trial involves infant nutrition rather than medication, traditional side effects aren't expected. However, potential risks may include under- or overfeeding leading to poor growth patterns compared to standard formula feeding practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI was 25 or higher before I got pregnant.

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My parent speaks English.

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My baby is 1 month old or younger.

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My baby is healthy with no major health issues affecting feeding or weight gain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ spanning ages 1-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~spanning ages 1-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and spanning ages 1-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Conditional Weight Gain Difference Between Study Groups

Growth Trajectory (repeated measures of weight-for-length on World Health Organization Child growth standards) during the intervention period

Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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

Group II: ControlActive Control1 Intervention

The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention

2011

Completed Phase 4

~73780

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

494 Previous Clinical Trials

2,798,782 Total Patients Enrolled

11 Trials studying Obesity

2,632,946 Patients Enrolled for Obesity

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,670 Total Patients Enrolled

105 Trials studying Obesity

97,072 Patients Enrolled for Obesity

University of California, Los AngelesOTHER

1,529 Previous Clinical Trials

10,277,742 Total Patients Enrolled

28 Trials studying Obesity

25,233 Patients Enrolled for Obesity

Media Library

Calibrated Formula Feeding Clinical Trial Eligibility Overview. Trial Name: NCT05104073 — N/A

Obesity Research Study Groups: Intervention, Control

Obesity Clinical Trial 2023: Calibrated Formula Feeding Highlights & Side Effects. Trial Name: NCT05104073 — N/A

Calibrated Formula Feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104073 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has this trial recruited thus far?

"Affirmative. As evidenced by clinicaltrials.gov, the research initiative initially posted on January 20th 2022 is presently recruiting participants at one site and needs around 60 volunteers to join."

Answered by AI

Might I qualify to participate in this experimental research?

"This clinical trial is seeking 60 neonates between the age of 24 hours and 4 weeks that are already overweight. Potential subjects must also possess no substantial birth complications (e.g chromosomal defects, metabolic issues, cleft lip/palate etc.), be born at a Division of Academic General Pediatrics practice site (Hope Drive, Elizabethtown or Nyes Road), weigh more than 50th percentile according to 2013 Fenton Growth Charts for sex and gestational age at birth, have been delivered full-term (>37 weeks) as singleton infants and their mothers need to be over 18 years old in order to participate in this research project."

Answered by AI

Is this research study still taking on new participants?

"Confirmed. Per the information on clinicaltrials.gov, this research project is currently recruiting volunteers and has been since January 20th 2021 (most recently updated July 21st 2022). 60 participants are required from a single hospital location."

Answered by AI

Is the age eligibility for this medical research restricted to adults aged 45 and under?

"To be included in this trial, infants who are between 1 day and 1 month old must enroll. Additionally, 54 studies cater to children under 18 years of age while 206 trials focus on those 65 or older."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Ian M. Paul, MD 2022. "Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05104073.