- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06230510
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lorrene Ritchie, PhD
- Phone Number: (510) 987-0523
- Email: lritchie@ucanr.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole Milk
Whole Milk consumption for one year
|
Beginning at approximately age 2, milk (equivalent to 2 cups/day) will be provided at no cost to the family for one year.
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
|
Beginning at approximately age 2, milk (equivalent to 2 cups/day) will be provided at no cost to the family for one year.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12-months after the start of the study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
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.
|
Baseline and 12-months after the start of the study.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorrene Ritchie, PhD, Nutrition Policy Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01DK131217 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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