Effects of whole vs. nonfat milk on children's body composition
Official title: Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
Run by Boston Children's Hospital · NCT05464186 · Data updated 2026-11-12
This study is testing whether kids aged 9 to 12 who drink whole milk instead of nonfat milk gain less weight and eat healthier foods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 9 Years to 12 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | December 28, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT05464186 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 9 to 12 years with a BMI at or above the 75th percentile living in the Greater Boston area.
✕Probably not a fit
Patients with major medical illnesses, eating disorders, or milk allergies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates how consuming whole milk compared to nonfat milk affects body composition, cardiometabolic disease risk factors, and dietary quality in children aged 9 to 12 years with a BMI at or above the 75th percentile. The research aims to determine if whole milk consumption leads to less weight gain and improved dietary quality by reducing the intake of lower quality foods. Participants will be recruited from the Greater Boston area and will consume either whole or nonfat milk as part of their diet during the study period.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations that help reduce obesity and related health risks in children.
How similar studies have gone: Previous observational studies have suggested that whole milk may be associated with less weight gain and lower cardiometabolic disease risk, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 9 to 12 years * BMI ≥75th percentile for sex and age * Residence in the Greater Boston catchment area Exclusion Criteria: * Aversion to nonfat or whole milk * Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided) * Plans to move away from the Greater Boston catchment area during the study period * Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation) * Change in body weight exceeding 10% during prior year * Recent adherence to a special diet * Chronic use of any medication or dietary supplement that could affect study outcomes * Another member of the family (first degree relative) or household participating in the study
Where it's running
-
New Balance Foundation Obesity Prevention Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Cara B Ebbeling, PhD — Boston Children's Hospital
- Study coordinator: Donna L Lesperance, MA, MPH
- Email: Donna.Lesperance@childrens.harvard.edu
- Phone: 617-919-7305
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.