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

NCT06230510 | Recruiting DMC

• 2 other identifiers: 1757040R01DK131217
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in waist-to-height ratio

  Waist-to-height ratios will be calculated using measured height in m and waist circumference in m.

  Baseline and 12-months after the start of the study.

Secondary Outcomes (8)

• Change in body mass index z-score

  Baseline and 12-months after the start of the study.

• Change in tri-ponderal mass index

  Baseline and 12-months after the start of the study.

• Change in waist circumference z-score

  Baseline and 12-months after the start of the study.

• Change in dietary intake

  Baseline and 12-months after the start of the study.

• Change in diet quality

  Baseline and 12-months after the start of the study.

Study Arms (2)

Whole Milk

EXPERIMENTAL

Whole Milk consumption for one year

Behavioral: Introduction of Milk Type; Behavioral: Child Nutrition Counseling

1% Milk

EXPERIMENTAL

1% Milk consumption for one year

Behavioral: Introduction of Milk Type; Behavioral: Child Nutrition Counseling

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.

1% Milk; Whole Milk

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.

1% Milk; Whole Milk

Eligibility Criteria

• Age: 23 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Stanford University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Nutrition Policy Institute, University of California Agriculture and Natural Resources

Oakland, California, 94607, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorrene Ritchie, PhD

  Nutrition Policy Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorrene Ritchie, PhD

CONTACT

(510) 987-0523; lritchie@ucanr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups in parallel for one year.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 30, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)