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Studies

Interventional Recruiting

NCT05464186 on ClinicalTrials.gov

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children

Official title: Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT

  • Sponsor: Boston Children's Hospital
  • Enrollment: 200 (Estimated)
  • Study start: 2022-12-28 (Actual)
  • Primary completion: 2026-12-01 (Estimated)
  • Study completion: 2026-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Participants will be randomly assigned for 1 year to receive home delivery of: 1) Whole milk, 3 cups a day or 2) Nonfat milk, 3 cups a day.
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief Summary

This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

Conditions

  • Obesity
  • Diabetes
  • Cardiovascular Diseases

Intervention / Treatment

  • Behavioral: Whole milk
  • Behavioral: Nonfat milk

Primary Outcome Measures

  • Fat mass (Change from start of trial (time of randomization) through end of trial (12 months))
    Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)

Countries

United States

Locations and Investigators

  • New Balance Foundation Obesity Prevention Center, Boston, United States (Recruiting)
    • Donna L Lesperance, MA, MPH

Study Officials