Recruiting

Whole vs. Nonfat Milk

Sponsor:

Boston Children's Hospital

Code:

NCT05464186

Conditions

Obesity

Diabetes

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 9 - 12

Healthy Volunteers: Accepted

Interventions

Whole milk

Nonfat milk

Study Details

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

Study ID

NCT05464186

Start date

Dec 28, 2022

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 12

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Whole milk

3 cups a day of whole milk for 1 year

experimental: Nonfat milk

3 cups a day of nonfat milk for 1 year

Interventions

Whole milk

Weekly home delivery of whole milk, daily text messages, monthly virtual visits

Nonfat milk

Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits

Primary outcome measure

  • Fat mass [ Time Frame: Change from start of trial (time of randomization) through end of trial (12 months) ]

Central Contacts and Locations

Central contacts

Donna L Lesperance, MA, MPH

617-919-7305Donna.Lesperance@childrens.harvard.edu

Locations

New Balance Foundation Obesity Prevention Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Donna L Lesperance, MA, MPH

617-919-7305Donna.Lesperance@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 8, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-08.