Effects of whole vs. nonfat milk on children's body composition
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 9 Years to 12 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05464186 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with major medical illnesses, eating disorders, or milk allergies may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
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.