RecruitingNot ApplicableNCT05464186
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
Sponsor
Boston Children's Hospital
Enrollment
200 participants
Start Date
Dec 28, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Eligibility
Min Age: 9 YearsMax Age: 12 Years
Inclusion Criteria3
- Aged 9 to 12 years
- BMI ≥75th percentile for sex and age
- Residence in the Greater Boston catchment area
Exclusion Criteria8
- 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
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Interventions
BEHAVIORALWhole milk
Weekly home delivery of whole milk, daily text messages, monthly virtual visits
BEHAVIORALNonfat milk
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05464186
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