NCT06230510 Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
| NCT ID | NCT06230510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 625 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 625 participants in total. It began in 2024-08-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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), 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.
Contact & Investigator
Lorrene Ritchie, PhD
PRINCIPAL INVESTIGATOR
Nutrition Policy Institute
Frequently Asked Questions
Who can join the NCT06230510 clinical trial?
This trial is open to participants of all sexes, aged 23 Months or older, up to 48 Months, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06230510 currently recruiting?
Yes, NCT06230510 is actively recruiting participants. Contact the research team at lritchie@ucanr.edu for enrollment information.
Where is the NCT06230510 trial being conducted?
This trial is being conducted at Oakland, United States.
Who is sponsoring the NCT06230510 clinical trial?
NCT06230510 is sponsored by University of California, Davis. The principal investigator is Lorrene Ritchie, PhD at Nutrition Policy Institute. The trial plans to enroll 625 participants.
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