Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06230510

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age23 Months to 48 Months
SexAll
Healthy volunteersAccepted
ConditionObesity

Full registry 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.

Treatments and study arms

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.

Primary outcomes

Change in waist-to-height ratioBaseline and 12-months after the start of the study.

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nutrition Policy Institute, University of California Agriculture and Natural Resources🇺🇸 Oakland, California, United States
Kassandra BaconContact
Ryan WilliamsContact
Lorrene Ritchie, PhDPrincipal Investigator