Cow Milk Fat Obesity pRevention Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimizes excess adiposity and optimizes child nutrition and development. CoMFORT will be a parallel group randomized controlled trial among children aged 2 to 4 years participating in the TARGet Kids! practice-based research network. Children will be randomized to receive one of two usual care nutritional recommendations: 1) a recommendation to consume whole milk, or 2) a recommendation to consume reduced (1%) fat milk. The primary outcome is Body Mass Index z-score (zBMI); secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores (serum 25-hydroxyvitamin D), cardiometabolic health (glucose, hsCRP, non-HDL, LDL, triglyceride, HDL and total cholesterol, insulin, and diastolic and systolic blood pressure) and sugar sweetened beverage intake (measured by 24-hour dietary recall). Outcomes will be measured 24 months post-randomization and compared using ANCOVA, adjusting for baseline measures. This trial will contribute to nutrition policy for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 5
Healthy Volunteers: t
View:

• healthy by parental report;

• 1.5 to 2.99 years of age

• involved in a TARGet Kids! academic pediatric or family medicine group.

Locations
Other Locations
Canada
St. Michael's Hospital
RECRUITING
Toronto
Contact Information
Primary
Jonathon L Maguire, MD, FRCPC
jonathon.maguire@utoronto.ca
(416) 867-3655
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 534
Treatments
Active_comparator: Whole (3.25%) milk
Active_comparator: Reduced fat (1%) milk
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children
Collaborators: Unity Health Toronto

This content was sourced from clinicaltrials.gov