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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230510
• Other study ID #: R01DK131217
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: University of California, Davis
• Contact: Lorrene Ritchie, PhD
• Phone: (510) 987-0523
• Email: lritchie[@]ucanr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The prevalence of child obesity in the U.S. has tripled since the 1970s and excess weight gain - even in young children - is a precursor to adult obesity and associated co-morbidities. 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. However, surprisingly few rigorous trials to support recommendations on optimal milk type have been conducted and existing observational studies paradoxically suggest that lower fat milk consumption is associated with increased adiposity in children. The effects of the types of fat found in milk on cardiometabolic disease risk have also been questioned. This randomized controlled trial will evaluate the effect of consumption of whole versus 1% milk on child adiposity and other health and developmental outcomes beginning after toddlers have successfully transitioned from breastmilk and/or formula to cow's milk at 2 years of age. 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). Our primary aim is to determine how milk fat type (whole versus 1%) consumed from age 2 to 3 years affects change in adiposity as measured by waist-to-height ratio (primary outcome), body mass index, tri-ponderal mass index, and waist circumference. Secondary aims are to evaluate how milk type consumed from age 2 to 3 years affects changes in milk, total and saturated fat, added sugars, and total energy intake and overall diet quality, as well as blood lipids and vitamin D status, and neurocognitive development. Results from the Milk-TOT Study can help pediatric health care providers give evidence-based dietary recommendations to improve child weight and health, and can inform the types of milk provided to participants in the federal nutrition programs which collectively provide milk to over half of all young children in the U.S.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 625
• Est. completion date: June 30, 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Months to 30 Months

Eligibility

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 smartphone and a tablet, laptop or computer with internet and email at home, 3) ability to speak and read English 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 SF 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 >30 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 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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Introduction of Milk Type
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in body mass index z-score	BMI z-scores will be determined using measured height in m and weight in kg to calculate kg/m^2, and CDC growth curves.	Baseline and 12-months after the start of the study.
Secondary	Change in tri-ponderal mass index	TMI will be determined using measured height in m and weight in kg to calculate kg/m^3.	Baseline and 12-months after the start of the study.
Secondary	Change in waist circumference z-score	Waist circumference z-scores will be determined using measured waist circumference and CDC growth curves.	Baseline and 12-months after the start of the study.
Secondary	Change in dietary intake	Energy (kcals/day), milk (cups/day and %kcals), total dairy (cups/day and %kcals), total fat (g/day and %kcals), saturated fat (g/day and %kcals), added sugars (g/day and %kcals) and calcium (mg/day) intake will be measured using 24-hour recalls.	Baseline and 12-months after the start of the study.
Secondary	Change in diet quality	Diet quality will be measured using the healthy eating index-2020 from 24-hour recalls.	Baseline and 12-months after the start of the study.
Secondary	Change in blood measures	Lipid concentrations, glucoregulatory indices, and 25(OH)D concentrations will be measured in a morning blood draw.	Baseline and 12-months after the start of the study.
Secondary	Change in brain growth	Head circumference z-scores will be determined using measured head circumference in cm and CDC growth curves.	Baseline and 12-months after the start of the study.
Secondary	Change in neurocognitive development	Cognitive, communication and physical development scores will be determined using the Developmental Assessment of Young Children-2 tool.	Baseline and 12-months after the start of the study.