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?

This trial explores whether whole milk or reduced-fat milk better manages and prevents obesity in young children. Researchers aim to determine which type of milk helps maintain a healthy weight and supports overall nutrition and development. Ideal candidates are healthy children aged 1.5 to 2.99 years who are part of the TARGet Kids! network. By comparing the effects of these two milk types, the trial seeks to inform improved dietary guidelines for children. As an unphased trial, it offers participants a unique opportunity to contribute to significant nutritional research that could shape future dietary recommendations for children.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both whole milk and reduced-fat milk are generally safe for children. Studies have found that drinking whole milk does not increase the risk of becoming overweight or obese. In fact, some evidence suggests that children who drink whole milk might be less likely to be overweight compared to those who drink reduced-fat milk.

International guidelines often recommend reduced-fat milk to lower obesity risk, but current research does not strongly support this. Most studies have not found that reduced-fat milk helps reduce obesity risk. Additionally, switching from whole to reduced-fat milk has not been shown to improve heart and metabolic health.

Overall, both types of milk seem well-tolerated by children, with no significant reports of serious side effects. This suggests that either option is likely safe for kids from a health perspective, based on current research findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of different types of milk on childhood obesity, potentially offering a simple dietary modification as a preventive strategy. Unlike traditional treatments for obesity that often involve medication, surgery, or intensive lifestyle changes, this trial focuses on the type of milk children consume—either whole milk (3.25% fat) or reduced-fat milk (1%). The unique aspect of this approach is its accessibility and ease of implementation, making it feasible for families to adopt. By understanding the effects of milk fat content on obesity, researchers hope to provide clearer dietary guidelines that could help manage or prevent childhood obesity more effectively.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare the effects of whole (3.25%) milk and reduced-fat (1%) milk on childhood obesity. Research has shown that children who drink whole milk are less likely to be overweight or obese compared to those who drink reduced-fat milk. Specifically, one study found that children drinking whole milk had a 39% lower chance of being overweight or obese than those drinking reduced-fat milk. This suggests that whole milk might help children maintain a healthier weight. Although health guidelines often recommend reduced-fat milk, some research suggests that whole milk could be better for managing children's weight. ^{1 2 5 6 7}

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

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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31851302/

Whole milk compared with reduced-fat milk and childhood ... Among children who consumed whole (3.25% fat) compared with reduced-fat (0.1-2%) milk, the OR of overweight or obesity was 0.61 (95% CI: 0.52, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6997094/

Whole milk compared with reduced-fat milk and childhood ... Children aged >2 y are recommended to consume reduced-fat (0.1–2%) cow-milk to lower the risk of obesity. Objectives. To evaluate the relation ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03914807

NCT03914807 | Cow Milk Fat Obesity pRevention Trial Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1%) fat milk at age 2 years, recent epidemiological evidence ...

4. cdc.gov cdc.gov/mmwr/preview/mmwrhtml/mm5903a2.htm

Effects of Switching from Whole to Low-Fat/Fat-Free Milk in ... DOE determined that reducing consumption of whole milk and increasing consumption of fat-free or low-fat milk could help decrease students' fat ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/10/5/e035241

Cow's Milk Fat Obesity pRevention Trial (CoMFORT) Observational evidence supports that children who consume whole milk have a lower risk of overweight or obesity relative to children who consume reduced (0.1%–2 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322003180

Whole-Fat or Reduced-Fat Dairy Product Intake, Adiposity, ... Most studies have not found the consumption of whole-fat dairy products to be associated with increased cardiometabolic or adiposity risk.

7. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)00060-0/fulltext

Association of cow's milk intake in early childhood with ... Early childhood consumption of higher-fat milk (compared with lower-fat milk) was not associated with adverse cardiometabolic outcomes. The frequency of cow's ...