History of Changes for Study: NCT06230510

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			January 19, 2024	None (earliest Version on record)
2			May 9, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	R01DK131217
Brief Title:	Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
Official Title:	Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole Versus Low-fat Milk on Child Adiposity, Health and Development
Secondary IDs:

Study Status


Record Verification:	December 2023
Overall Status:	Not yet recruiting
Study Start:	January 2024
Primary Completion:	August 2027 [Anticipated]
Study Completion:	June 30, 2028 [Anticipated]

First Submitted:	December 11, 2023
First Submitted that Met QC Criteria:	January 19, 2024
First Posted:	January 30, 2024 [Actual]

Last Update Submitted that Met QC Criteria:	January 19, 2024
Last Update Posted:	January 30, 2024 [Actual]

Sponsor/Collaborators


Sponsor:	University of California, Davis
Responsible Party:	Sponsor
Collaborators:	Stanford University

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

Detailed 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.

Conditions


Conditions:	Obesity
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	Participants will be randomly assigned to one of two groups in parallel for one year.
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	625 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Whole Milk

Whole Milk consumption for one year

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.

Behavioral: 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.

Experimental: 1% Milk

1% Milk consumption for one year

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.

Behavioral: Child Nutrition Counseling

Outcome Measures


Primary Outcome Measures:
1.	Change in waist-to-height ratio [ Time Frame: Baseline 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.
Secondary Outcome Measures:
1.	Change in body mass index z-score [ Time Frame: Baseline and 12-months after the start of the study. ] BMI z-scores will be determined using measured height in m and weight in kg to calculate kg/m^2, and CDC growth curves.
2.	Change in tri-ponderal mass index [ Time Frame: Baseline and 12-months after the start of the study. ] TMI will be determined using measured height in m and weight in kg to calculate kg/m^3.
3.	Change in waist circumference z-score [ Time Frame: Baseline and 12-months after the start of the study. ] Waist circumference z-scores will be determined using measured waist circumference and CDC growth curves.
4.	Change in dietary intake [ Time Frame: Baseline and 12-months after the start of the study. ] 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.
5.	Change in diet quality [ Time Frame: Baseline and 12-months after the start of the study. ] Diet quality will be measured using the healthy eating index-2020 from 24-hour recalls.
6.	Change in blood measures [ Time Frame: Baseline and 12-months after the start of the study. ] Lipid concentrations, glucoregulatory indices, and 25(OH)D concentrations will be measured in a morning blood draw.
7.	Change in brain growth [ Time Frame: Baseline and 12-months after the start of the study. ] Head circumference z-scores will be determined using measured head circumference in cm and CDC growth curves.
8.	Change in neurocognitive development [ Time Frame: Baseline and 12-months after the start of the study. ] Cognitive, communication and physical development scores will be determined using the Developmental Assessment of Young Children-2 tool.

Eligibility


Minimum Age:	23 Months
Maximum Age:	30 Months
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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 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.

Contacts/Locations


Central Contact Person:	Lorrene Ritchie, PhD Telephone: (510) 987-0523 Email: lritchie@ucanr.edu
Study Officials:	Lorrene Ritchie, PhD Principal Investigator Nutrition Policy Institute
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: