ObesityNCT06230510
Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
A study testing Introduction of Milk Type and Child Nutrition Counseling in people with Obesity, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Introduction of Milk Type and Child Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nutrition Policy Institute, University of California Agriculture and Natural Resources
Oakland, California, 94607
Kassandra Bacon, 510-987-9023, Milktotstudy@ucanr.edu
Ryan Williams, 510-987-9023, Milktotstudy@ucanr.edu
About this study
Official title: Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole Versus Low-fat Milk on Child Adiposity, Health and Development
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.
Read the 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
- Obesity
- Being tested
- Introduction of Milk Type, Child Nutrition Counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction of Milk TypeBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole Milk | Experimental | Whole Milk consumption for one year Receives: Behavioral: Introduction of Milk Type; Behavioral: Child Nutrition Counseling |
| 1% Milk | Experimental | 1% Milk consumption for one year Receives: Behavioral: Introduction of Milk Type; Behavioral: Child Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist-to-height ratio
Waist-to-height ratios will be calculated using measured height in m and waist circumference in m.
Measured: Baseline and 12-months after the start of the study.
Secondary outcomes (8)
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 Centers for Disease Control and Prevention (CDC) growth curves.
Measured: Baseline and 12-months after the start of the study.
Change in tri-ponderal mass index
Try-ponderal mass index (TMI) will be determined using measured height in m and weight in kg to calculate kg/m^3.
Measured: Baseline and 12-months after the start of the study.
Change in waist circumference z-score
Waist circumference z-scores will be determined using measured waist circumference and CDC growth curves.
Measured: Baseline and 12-months after the start of the study.
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.
Measured: Baseline and 12-months after the start of the study.
Change in diet quality
Diet quality will be measured using the healthy eating index-2020 from 24-hour recalls.
Measured: Baseline and 12-months after the start of the study.
Change in blood measures
Lipid concentrations, glucoregulatory indices, and 25(OH)D concentrations will be measured in a morning blood draw.
Measured: Baseline and 12-months after the start of the study.
Change in brain growth
Head circumference z-scores will be determined using measured head circumference in cm and CDC growth curves.
Measured: Baseline and 12-months after the start of the study.
Change in neurocognitive development
Cognitive, communication and physical development scores will be determined using the Developmental Assessment of Young Children-2 tool.
Measured: Baseline and 12-months after the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start15 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups in parallel for one year.
- Masking
- None (open label)
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Lorrene Ritchie, PhD, Principal investigator, Nutrition Policy Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230510
- Sponsor's protocol ID
- 1757040
- Other IDs
- R01DK131217
- Status last verified
- May 2026
- First submitted
- 11 Dec 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole Versus Low-fat Milk on Child Adiposity, Health and Development
- ClinicalTrials.gov ID
- NCT06230510
- Acronym / sponsor ID
- 1757040
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups in parallel for one year.
| Arm | Type | Receives |
|---|---|---|
| Whole Milk | Experimental | Behavioral: Introduction of Milk Type, Behavioral: Child Nutrition CounselingWhole Milk consumption for one year |
| 1% Milk | Experimental | Behavioral: Introduction of Milk Type, Behavioral: Child Nutrition Counseling1% Milk consumption for one year |
Who may qualify
- Ages
- 23 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introduction of Milk TypeBeginning at approximately age 2, milk (equivalent to 2 cups/day) will be provided at no cost to the family for one year. | Behavioural | 1% Milk, Whole Milk |
| Child Nutrition CounselingParent/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. | Behavioural | 1% Milk, Whole Milk |
Primary outcome
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.
8 secondary outcomes
Change in body mass index z-score
Time frame: 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.
Change in waist circumference z-score
Time frame: 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.
Change in diet quality
Time frame: 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.
Change in brain growth
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorrene Ritchie, PhD principal investigator
Nutrition Policy Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introduction of Milk Type and Child Nutrition Counseling in people with Obesity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorrene Ritchie, PhD ((510) 987-0523, lritchie@ucanr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in waist-to-height ratio (time frame: Baseline and 12-months after the start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.