Milk-Tot Study: 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 23 Months to 48 Months
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Investigators will recruit 625 parents of toddlers and randomly assign 625 toddlers to either whole or 1% milk groups for 1 year (with estimated final sample size of 500)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (1)
CA
- Nutrition Policy Institute, University of California Agriculture and Natural Resources · Oakland, CA 94607Kassandra Bacon · Study contact · 510-987-9023 · Milktotstudy@ucanr.eduRyan Williams · Study contact · 510-987-9023 · Milktotstudy@ucanr.eduLorrene Ritchie, PhD · Principal investigatorMore trials in Oakland