Whole vs Reduced-Fat Milk for Childhood Obesity

(CoMFORT Trial)

Overseen By Jonathon L Maguire, MD, FRCPC

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Prader-Willi, Development delay, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

534 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimizes excess adiposity and optimizes child nutrition and development. CoMFORT will be a parallel group randomized controlled trial among children aged 2 to 4 years participating in the TARGet Kids! practice-based research network. Children will be randomized to receive one of two usual care nutritional recommendations: 1) a recommendation to consume whole milk, or 2) a recommendation to consume reduced (1%) fat milk. The primary outcome is Body Mass Index z-score (zBMI); secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores (serum 25-hydroxyvitamin D), cardiometabolic health (glucose, hsCRP, non-HDL, LDL, triglyceride, HDL and total cholesterol, insulin, and diastolic and systolic blood pressure) and sugar sweetened beverage intake (measured by 24-hour dietary recall). Outcomes will be measured 24 months post-randomization and compared using ANCOVA, adjusting for baseline measures. This trial will contribute to nutrition policy for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is it safe for children to consume whole or reduced-fat milk?

Research suggests that both whole and reduced-fat milk are generally safe for children. However, guidelines recommend whole milk for children under 2 years and reduced-fat milk for older children to help manage obesity risk. Nutrient intake is similar between the two, except for fat content. ^{1 2 3 4 5}

How does the treatment of recommending reduced-fat or whole milk differ from other treatments for childhood obesity?

This treatment is unique because it focuses on the type of milk fat consumed by children, with recent evidence suggesting that whole milk might be linked to lower obesity rates compared to reduced-fat milk, challenging traditional guidelines that recommend low-fat options to prevent obesity. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment of different milk fat recommendations for childhood obesity?

Recent studies suggest that consuming whole fat dairy products, like whole milk, may help protect against severe obesity in children, as seen in a study of Latino children where those who consumed more milk fat were less likely to be severely obese. ^{1 2 3 4 6}

Who Is on the Research Team?

Jonathon L Maguire, MD, FRCPC

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for healthy children aged 1.5 to almost 3 years who are part of the TARGet Kids! network, can communicate in English or French, and regularly consume cow's milk. It excludes those with certain medical conditions like Prader-Willi syndrome, severe developmental delays, lactose intolerance or allergy to cow's milk.

Inclusion Criteria

I am between 1.5 and 3 years old.

involved in a TARGet Kids! academic pediatric or family medicine group

healthy by parental report

Exclusion Criteria

Siblings of trial participants are not allowed to participate because families may share milk.

You have a significant delay in your development.

You have a medical condition that causes obesity, such as Prader-Willi syndrome or other similar syndromes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children are randomized to receive either whole milk or reduced fat milk as part of their usual care nutritional recommendations

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reduced (1%) fat milk
• Whole (3.25%) cow's milk recommendation

Trial Overview The CoMFORT study tests whether whole (3.25% fat) or reduced (1% fat) cow's milk affects childhood obesity over a two-year period. Children will be randomly assigned to one of these two dietary recommendations and their growth, cognitive development, vitamin D levels, heart health markers and diet will be monitored.

How Is the Trial Designed?

Group I: Whole (3.25%) milk Active Control 1 Intervention

Group II: Reduced fat (1%) milk Active Control 1 Intervention

Reduced (1%) fat milk is already approved in Canada, United States for the following indications:

Approved in Canada as Reduced-fat milk for:

• General nutrition for children aged 2 and above

Approved in United States as Reduced-fat milk for:

• General nutrition for children aged 2 and above

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Published Research Related to This Trial

Physicians and parents have differing recommendations and practices regarding cow's milk fat for 2-year-old children, with 36% of parents providing whole milk and 58% offering reduced-fat milk.

Qualitative interviews revealed that both groups have mixed views on the role of cow's milk fat in children's diets, highlighting a need for clearer guidance on its impact on child obesity to support informed dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study to understand parent and physician perspectives about cow's milk fat for children. Vanderhout, SM., Juando-Prats, C., Birken, CS., et al.[2023]

The Cow's Milk Fat Obesity pRevention Trial will involve 534 children aged 2 to 4-5 years to compare the effects of whole milk versus reduced fat milk on body fat and overall health over 24 months.

This study aims to provide evidence on whether whole milk can help minimize excess body fat and improve nutrition in children, potentially influencing future dietary guidelines to combat childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity. Vanderhout, SM., Aglipay, M., Birken, C., et al.[2023]

In a study of 145 Latino preschoolers, higher consumption of milk fat was linked to lower odds of severe obesity, suggesting that whole fat dairy may be protective against obesity in this population.

Severely obese children consumed less milk fat (5.3 g) compared to their non-severely obese peers (8.9 g), indicating that promoting lower fat milk may not be beneficial for preventing obesity in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full fat milk consumption protects against severe childhood obesity in Latinos. Beck, AL., Heyman, M., Chao, C., et al.[2023]

A systematic review of 28 studies involving 20,897 children found that higher consumption of whole cow-milk (3.25% fat) is associated with lower rates of overweight and obesity compared to reduced-fat milk (0.1-2% fat).

Current guidelines recommending reduced-fat milk for children may not effectively reduce the risk of childhood obesity, suggesting a need for randomized trials to identify the optimal cow-milk fat content for minimizing adiposity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole milk compared with reduced-fat milk and childhood overweight: a systematic review and meta-analysis. Vanderhout, SM., Aglipay, M., Torabi, N., et al.[2023]

In a study of 7467 children aged 9 months to 8 years, higher intake of whole cow's milk fat was associated with lower body mass index z-scores (zBMI), suggesting that whole milk may help in maintaining a healthier weight.

Children consuming whole milk had significantly lower odds of being overweight (16% lower) and obese (18% lower) compared to those consuming reduced fat milk, indicating that current guidelines favoring reduced fat milk may not effectively prevent obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cow's milk fat and child adiposity: a prospective cohort study. Vanderhout, SM., Keown-Stoneman, CDG., Birken, CS., et al.[2022]

A significant number of infants in the U.S. were fed low-fat milk, despite recommendations against it, with 32% of 12-month-olds consuming it in 1985, often due to misconceptions about its health benefits.

Infants consuming low-fat milk had similar nutrient intakes to those on whole cow's milk, but both groups exceeded safe levels for sodium, potassium, and chloride, while also falling short on iron intake, highlighting potential dietary risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding low-fat milk during infancy. Ryan, AS., Martinez, GA., Krieger, FW.[2015]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A qualitative study to understand parent and physician perspectives about cow's milk fat for children. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Full fat milk consumption protects against severe childhood obesity in Latinos. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Whole milk compared with reduced-fat milk and childhood overweight: a systematic review and meta-analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Cow's milk fat and child adiposity: a prospective cohort study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Feeding low-fat milk during infancy. [2015]