Impact of Whole Versus Low-fat Milk on Child Health

Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole Versus Low-fat Milk on Child Adiposity, Health and Development

This study tests whether whole milk or low-fat milk is better for the health and weight of toddlers aged 2 to 3 years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 625 (estimated)
• Ages: 23 Months to 48 Months
• Sex: All
• Sponsor: University of California, Davis (Academic / other)
• Locations: 1 site (Oakland, California)
• Trial ID: NCT06230510 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of whole cow's milk compared to 1% low-fat milk on child obesity and health outcomes in toddlers aged 2 to 3 years. It aims to determine how different milk fat types influence adiposity, measured by waist-to-height ratio and other metrics. The study will recruit 625 parents and randomly assign their toddlers to either milk group for one year, with a focus on understanding the implications of milk fat on early childhood growth and development.

Who should consider this trial

Good fit: Ideal candidates are parents of toddlers aged 2 to 3 years who are willing to participate in the milk intervention and meet the study's eligibility criteria.

Not a fit: Patients with specific medical conditions affecting growth or feeding, or those outside the age range of 23 to 48 months, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence to guide dietary recommendations for preventing obesity in young children.

How similar studies have performed: While few rigorous trials have focused on this specific question, existing observational studies suggest a complex relationship between milk fat consumption and child adiposity, indicating that this approach may yield novel insights.

Eligibility criteria

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), 6) current participation in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) (which provides milk as part of benefits), 7) 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.

Where this trial is running

Oakland, California

• Nutrition Policy Institute, University of California Agriculture and Natural Resources — Oakland, California, United States (Recruiting)

Study contacts

• Principal investigator: Lorrene Ritchie, PhD — Nutrition Policy Institute
• Study coordinator: Lorrene Ritchie, PhD

Conditions Obesity