Trial comparing whole milk and reduced fat milk for preventing obesity in young children
Cow Milk Fat Obesity pRevention Trial
This study is testing whether whole milk or reduced fat milk can help prevent obesity in young children aged 2 to 4 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 534 (estimated) |
| Ages | 18 Months to 60 Months |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03914807 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of whole cow's milk versus reduced fat milk on obesity prevention in children aged 2 to 4 years. It is a parallel group randomized controlled trial conducted within the TARGet Kids! practice-based research network. Participants will be assigned to receive either whole milk or reduced fat milk recommendations, with the primary outcome being the Body Mass Index z-score (zBMI). Secondary outcomes include assessments of cognitive development and vitamin D levels.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 1.5 to 2.99 years who are part of the TARGet Kids! network.
Not a fit: Children with obesity-related syndromes, severe developmental delays, or those who cannot consume cow's milk will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide evidence-based dietary recommendations to help prevent obesity in young children.
How similar studies have performed: Previous studies have suggested a potential link between whole milk consumption and lower adiposity, indicating that this approach may have merit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy by parental report; * 1.5 to 2.99 years of age * involved in a TARGet Kids! academic pediatric or family medicine group. Exclusion Criteria: * Prader-Willi syndrome or other syndrome associated with obesity * severe development delay * children who are from families without verbal communication in English or French * failure to thrive (with zBMI values ≤ -2 are unlikely to benefit from obesity prevention) * siblings of trial participants as families may share milk * will not consume cow's milk by choice, lactose intolerance or allergy.
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jonathon L Maguire, MD, FRCPC — Unity Health Toronto
- Study coordinator: Jonathon L Maguire, MD, FRCPC
- Email: jonathon.maguire@utoronto.ca
- Phone: (416) 867-3655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.