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Whole vs Reduced-Fat Milk for Childhood Obesity (CoMFORT Trial)

N/A

Recruiting

Led By Jonathon L Maguire, MD, FRCPC

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

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

Must have

1.5 to 2.99 years of age

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured 24 months post-study entry

Awards & highlights

CoMFORT Trial Summary

This trial will determine whether it is better for children to drink whole milk or reduced-fat milk in order to minimize excess adiposity and optimize child nutrition and development.

Who is the study for?

This trial is for healthy children aged 1.5 to almost 3 years who are part of the TARGet Kids! network, can communicate in English or French, and regularly consume cow's milk. It excludes those with certain medical conditions like Prader-Willi syndrome, severe developmental delays, lactose intolerance or allergy to cow's milk.Check my eligibility

What is being tested?

The CoMFORT study tests whether whole (3.25% fat) or reduced (1% fat) cow's milk affects childhood obesity over a two-year period. Children will be randomly assigned to one of these two dietary recommendations and their growth, cognitive development, vitamin D levels, heart health markers and diet will be monitored.See study design

What are the potential side effects?

Since this trial involves dietary recommendations rather than medication, there are no direct side effects from interventions being tested; however changes in diet may affect each child differently.

CoMFORT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 1.5 and 3 years old.

CoMFORT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured 24 months post-study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured 24 months post-study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 24 months post-study entry for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

body mass index z-score (zBMI)

height

weight

Secondary outcome measures

blood pressure

carotid intima media thickness (cIMT)

cognitive development

+24 more

CoMFORT Trial Design

2Treatment groups

Active Control

Group I: Whole (3.25%) milkActive Control1 Intervention

Group II: Reduced fat (1%) milkActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

689 Previous Clinical Trials

6,944,887 Total Patients Enrolled

Unity Health TorontoOTHER

538 Previous Clinical Trials

447,329 Total Patients Enrolled

Jonathon L Maguire, MD, FRCPCPrincipal InvestigatorUnity Health Toronto

Media Library

Reduced (1%) fat milk (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03914807 — N/A

Childhood Obesity Research Study Groups: Whole (3.25%) milk, Reduced fat (1%) milk

Childhood Obesity Clinical Trial 2023: Reduced (1%) fat milk Highlights & Side Effects. Trial Name: NCT03914807 — N/A

Reduced (1%) fat milk (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03914807 — N/A

Frequently Asked Questions

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

Does this trial include geriatric patients?

"This clinical trial permits the enrollment of patients as young as 18 months and no older than 60 months, in accordance with its eligibility criteria."

Answered by AI

What is the ultimate objective of this clinical research?

"Primarily, the aim of this research is to investigate changes in weight over 24 months. Additionally, serum 25-hydroxyvitamin D (measured in nmol/L), low density lipoprotein cholesterol (mmol/L) and waist circumference (as recorded by a qualified researcher) will be taken into consideration."

Answered by AI

What is the current estimated enrollment of this trial?

"Affirmative. The information on clinicaltrials.gov denotes that this medical experiment is presently enrolling participants, which was initially posted on 1/1/2020 and most recently revised on 9/20/2021. This trial seeks to recruit 534 individuals from a single location."

Answered by AI

Do I meet the criteria for enrolment in this experiment?

"To be eligible, applicants ought to have obesity and must fall within the 18-month to 60-month age range. This trial is aiming for a total of 534 participants."

Answered by AI

Are there vacancies available in this research project?

"Affirmative. Clinicaltrials.gov shows that this experiment is still enrolling patients, having been first posted on January 1st 2020 and last updated September 20th 2021. The research requires 534 persons to be recruited from a single site."

Answered by AI

Recent research and studies

BMJ OpenJournal

Cow’s Milk Fat Obesity Prevention Trial (comfort): A Primary Care Embedded Randomised Controlled Trial Protocol to Determine the Effect of Cow’s Milk Fat on Child Adiposity

Vanderhout, Shelley M, Mary Aglipay, Catherine Birken, Patricia Li, Deborah L O'Connor, Kevin Thorpe, Evelyn Constantin, et al.. 2020. “Cow’s Milk Fat Obesity Prevention Trial (comfort): A Primary Care Embedded Randomised Controlled Trial Protocol to Determine the Effect of Cow’s Milk Fat on Child Adiposity”. BMJ Open. BMJ. doi:10.1136/bmjopen-2019-035241.

clinicaltrials.govStudy

Cow Milk Fat Obesity pRevention Trial

Jonathon L Maguire 2020. "Cow Milk Fat Obesity pRevention Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03914807.