Recruiting

Milk vs. Low-fat Milk

Sponsor:

UCLA

Code:

NCT06230510

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 1 - 4

Healthy Volunteers: Accepted

Interventions

Introduction of Milk Type

Child Nutrition Counseling

Study Details

Brief summary:

In the U.S. it is recommended that children consume whole cow's milk (3.5% fat) from ages 1 to 2 years to support rapid early growth and brain development, and then at age 2 years transition to low-fat (1%) or non-fat milk to reduce saturated fat and calorie intake. To date, few studies have examined the optimal milk type for children to prevent obesity. This randomized controlled trial will evaluate the effect of consumption of whole versus 1% milk on child adiposity.

Conditions

Obesity

Study ID

NCT06230510

Start date

Aug 15, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 4

Healthy Volunteers: Accepted

Inclusion Criteria:

Parents of children: 1) willing to be randomized to provide either only whole or 1% milk to their child for 1 year, 2) access to a smart phone and a tablet, laptop or computer with internet and email at home, 3) ability to speak and read English or Spanish for the purposes of receiving study communications and completing surveys and dietary assessments (to avoid needing to translate all study materials and have research staff fluent in other languages due to budget limits), 4) not planning to move outside of the San Francisco Bay Area or discontinue being child's primary caregiver for the next year (e.g., foster care, parent separation).

Exclusion Criteria:

Children: 1) <23 months or >48 months old at recruitment; 2) condition or medication that affects growth or daily feeding, or cardiometabolic health such as hypopituitarism, growth hormone deficiency, inborn error of metabolism, syndromic obesity, familial hypercholesterolemia, 3) weight-for-length or height below the 2nd percentile, 4) lactose intolerance, milk allergy or other dietary restrictions (e.g., vegan) that impact ability to consume dairy or otherwise limit dietary intake, 5) resides in more than one household (e.g., shared care by separated parents), and 6) not covered by public or private medical insurance (may reduce well-child doctor visits). If two eligible children are in a household, one will be randomly selected to participate.

Study Design

Enrollment

625 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Whole Milk

Whole Milk consumption for one year

experimental: 1% Milk

1% Milk consumption for one year

Interventions

Introduction of Milk Type

Beginning at approximately age 2, milk (equivalent to 2 cups/day) will be provided at no cost to the family for one year.

Child Nutrition Counseling

Parent/caregivers will receive quarterly phone-based counseling by a Registered Dietitian (RD) on how to introduce the toddler to the assigned milk and the importance of continuing to drink the assigned milk for the one year.

Primary outcome measure

  • Change in waist-to-height ratio [ Time Frame: Baseline and 12-months after the start of the study. ]

Central Contacts and Locations

Central contacts

Locations

Nutrition Policy Institute, University of California Agriculture and Natural Resources

Recruiting

Oakland, California, United States, 94607

Contacts

Principal Investigator:

Lorrene Ritchie, PhD

More Information

Sponsor

University of California, Davis

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-05-18.