Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health

Part of paid clinical trials in Oakland, California.

Sponsor
University of California, Davis
Study ID
NCT06230510
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
23 Months - 48 Months
Healthy Volunteers
Accepted

Interventions

  • Introduction of Milk Type — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
625 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Whole Milk
    Whole Milk consumption for one year
  • Experimental: 1% Milk
    1% Milk consumption for 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

Locations (1)

FacilityCityStateZIPSite coordinators
Nutrition Policy Institute, University of California Agriculture and Natural ResourcesOaklandCalifornia94607
Kassandra Bacon
[email protected]
510-987-9023
Ryan Williams
[email protected]
510-987-9023
Lorrene Ritchie, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oakland, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Nutrition Policy Institute, University of California Agriculture and Natural Resources· Oakland, CA

Related Studies