Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
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ClinicalTrials.gov Identifier: NCT06230510 |
Recruitment Status :
Not yet recruiting
First Posted : January 30, 2024
Last Update Posted : January 30, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Behavioral: Introduction of Milk Type Behavioral: Child Nutrition Counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 625 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants will be randomly assigned to one of two groups in parallel for one year. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole Versus Low-fat Milk on Child Adiposity, Health and Development |
Estimated Study Start Date : | January 2024 |
Estimated Primary Completion Date : | August 2027 |
Estimated Study Completion Date : | June 30, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Whole Milk
Whole Milk consumption for one year
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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 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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 23 Months to 30 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06230510
Contact: Lorrene Ritchie, PhD | (510) 987-0523 | lritchie@ucanr.edu |
Principal Investigator: | Lorrene Ritchie, PhD | Nutrition Policy Institute |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT06230510 |
Other Study ID Numbers: |
R01DK131217 ( U.S. NIH Grant/Contract ) |
First Posted: | January 30, 2024 Key Record Dates |
Last Update Posted: | January 30, 2024 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |