Obesity, ChildhoodCoMFORTNCT03914807
Cow Milk Fat Obesity pRevention Trial
A study testing Whole (3.25%) cow's milk recommendation and Reduced (1%) fat milk in people with Obesity, Childhood, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Whole (3.25%) cow's milk recommendation and Reduced (1%) fat milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy by parental report;
- 1.5 to 2.99 years of age
- involved in a TARGet Kids! academic pediatric or family medicine group.
Who cannot join
- Prader-Willi syndrome or other syndrome associated with obesity
- severe development delay
- children who are from families without verbal communication in English or French
- failure to thrive (with zBMI values ≤ -2 are unlikely to benefit from obesity prevention)
- siblings of trial participants as families may share milk
- will not consume cow's milk by choice, lactose intolerance or allergy.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Jonathon L Maguire, MD, FRCPC, (416) 867-3655, jonathon.maguire@utoronto.ca
About this study
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.
- Conditions
- Obesity, Childhood
- Being tested
- Whole (3.25%) cow's milk recommendation, Reduced (1%) fat milk
- Keywords
- milk, fat, cohort-embedded
- Medical subject headings
- Pediatric Obesity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole (3.25%) cow's milk recommendationOther
Children randomized to the whole milk recommendation will receive a recommendation a primary care recommendation to consume 500 mL of whole fat (3.25%) milk instead of transitioning to reduced fat (1%) milk at 2 years of age. The primary care physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children in the whole milk recommendation group will be provided with the same age-appropriate nutritional recommendations as children in the reduced fat recommendation group as part of routine healthcare according to the Rourke Baby Record.
Reduced (1%) fat milkOther
Children randomized to the reduced fat group will receive a primary care recommendation to transition from whole milk to 500 mL reduced fat (1%) milk daily once the child is two years of age (consistent with current guidelines). The physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children who receive the reduced fat recommendation will be provided with the same age-appropriate nutritional recommendations as children who receive the whole fat recommendation as part of routine healthcare according to the Rourke Baby Record.
| Study group | Role | What they receive |
|---|---|---|
| Whole (3.25%) milk | Active comparator | Not described Receives: Other: Whole (3.25%) cow's milk recommendation |
| Reduced fat (1%) milk | Active comparator | Not described Receives: Other: Reduced (1%) fat milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
kilograms; measured using a Healthometer stadiometer
Measured: Measured 24 months post-study entry
height
metres; measured using a Healthometer statiometer
Measured: Measured 24 months post-study entry
body mass index z-score (zBMI)
BMI calculated by weight (kg)/height (m^2); zBMI determined according to the World Health Organization guidelines
Measured: Measured 24 months post-study entry
Secondary outcomes (27)
serum 25-hydroxyvitamin D
measured in nmol/L
Measured: Measured 24 months post-study entry
serum glucose
measured in mmol/L
Measured: measured 24 months post-study entry
blood pressure
systolic and diastolic
Measured: measured 24 months post-study entry
serum insulin
measured in mmol/L
Measured: measured 24 months post-study entry
serum triglycerides
measured in mmol/L
Measured: measured 24 months post-study entry
serum total cholesterol
measured in mmol/L
Measured: measured 24 months post-study entry
serum high density lipoprotein cholesterol
measured in mmol/L
Measured: measured 24 months post-study entry
serum low density lipoprotein cholesterol
measured in mmol/L
Measured: measured 24 months post-study entry
serum non-high density lipoprotein cholesterol
measured in mmol/L
Measured: measured 24 months post-study entry
serum highly sensitive c-reactive protein
measured in mg/L
Measured: measured 24 months post-study entry
height z-score
measured by a trained research assistant according to the World Health Organization guidelines
Measured: measured 24 months post-study entry
waist circumference
measured by a trained research assistant
Measured: measured 24 months post-study entry
lean body mass
measured in kg, % body weight
Measured: measured 24 months post-study entry
fat mass
measured in kg, % body weight
Measured: measured 24 months post-study entry
school readiness
measured using the Early Development Instrument (EDI); children scoring at or below the 25th percentile of children in their province are considered at risk for continuing on the low achievement and health trajectory, and are more likely to fall behind in academic achievement in later grades
Measured: measured 24 months post-study entry
cognitive development
measured using the Ages and Stages Questionnaire (ASQ)
Measured: measured 24 months post-study entry
dietary intake
measured using the Automated Multiple Pass Self Administered 24 hour recall (ASA24) tool
Measured: measured 24 months post-study entry
carotid intima media thickness (cIMT)
measured by ultrasound
Measured: measured 24 months post-study entry
restrained and emotional eating
measured using the 3-factor eating questionnaire
Measured: measured 24 months post-study entry
nutritional risk
measured using NutriSTEP preschooler
Measured: measured 24 months post-study entry
physical activity (minutes per day)
questionnaire data and accelerometry
Measured: measured 24 months post-study entry
sleep time (hours per night)
questionnaire data and accelerometry
Measured: measured 24 months post-study entry
healthcare service utilization
information accessed through OHIP linkage
Measured: measured 24 months post-study entry
upper respiratory tract infection incidence
information accessed through OHIP linkage
Measured: measured 24 months post-study entry
growth trajectories
zBMI growth rates
Measured: measured 24 months post-study entry
head circumference
measured by a trained research assistant
Measured: measured 24 months post-study entry
cost effectiveness
All costs, parameter estimates and ranges will be derived from study data and will be obtained using medical record extraction. Publicly available Ontario costing sources will be used to cost resource utilisation parameters.
Measured: measured 24 months post-study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Superiority cohort embedded 2 arm pragmatic randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Jonathon L Maguire, The Hospital for Sick Children
- Investigators
- Jonathon L Maguire, MD, FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914807
- Sponsor's protocol ID
- 18-369
- Acronym
- CoMFORT
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2019
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanderhout SM, Aglipay M, Birken C, Li P, O'Connor DL, Thorpe K, Constantin E, Davis MA, Feldman M, Ball GDC, Janus M, Juni P, Junker A, Laupacis A, L'Abbe M, Manson H, Moretti ME, Persaud N, Omand JA, Relton C, Wong P, Yamashiro H, Tavares E, Weir S, Maguire JL. 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. BMJ Open. 2020 May 7;10(5):e035241. doi: 10.1136/bmjopen-2019-035241.
PubMed 32385063
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cow Milk Fat Obesity pRevention Trial
- ClinicalTrials.gov ID
- NCT03914807
- Acronym / sponsor ID
- CoMFORT / 18-369
- Conditions
- Obesity, Childhood
- Keywords
- milk, fat, cohort-embedded
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Apr 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Superiority cohort embedded 2 arm pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Whole (3.25%) milk | Active comparator | Other: Whole (3.25%) cow's milk recommendation |
| Reduced fat (1%) milk | Active comparator | Other: Reduced (1%) fat milk |
Who may qualify
- Ages
- 18 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy by parental report;
- 1.5 to 2.99 years of age
- involved in a TARGet Kids! academic pediatric or family medicine group.
Key exclusion criteria (6 listed)
- Prader-Willi syndrome or other syndrome associated with obesity
- severe development delay
- children who are from families without verbal communication in English or French
- failure to thrive (with zBMI values ≤ -2 are unlikely to benefit from obesity prevention)
- siblings of trial participants as families may share milk
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 |
|---|---|---|
| Whole (3.25%) cow's milk recommendationChildren randomized to the whole milk recommendation will receive a recommendation a primary care recommendation to consume 500 mL of whole fat (3.25%) milk instead of transitioning to reduced fat (1%) milk at 2 years of age. The primary care physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children in the whole milk recommendation group will be provided with the same age-appropriate nutritional recommendations as children in the reduced fat recommendation group as part of routine healthcare according to the Rourke Baby Record. | Other | Whole (3.25%) milk |
| Reduced (1%) fat milkChildren randomized to the reduced fat group will receive a primary care recommendation to transition from whole milk to 500 mL reduced fat (1%) milk daily once the child is two years of age (consistent with current guidelines). The physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children who receive the reduced fat recommendation will be provided with the same age-appropriate nutritional recommendations as children who receive the whole fat recommendation as part of routine healthcare according to the Rourke Baby Record. | Other | Reduced fat (1%) milk |
Primary outcome
weight
Time frame: Measured 24 months post-study entry
kilograms; measured using a Healthometer stadiometer
height
Time frame: Measured 24 months post-study entry
metres; measured using a Healthometer statiometer
body mass index z-score (zBMI)
Time frame: Measured 24 months post-study entry
BMI calculated by weight (kg)/height (m^2); zBMI determined according to the World Health Organization guidelines
27 secondary outcomes
serum 25-hydroxyvitamin D
Time frame: Measured 24 months post-study entry
serum glucose
Time frame: measured 24 months post-study entry
blood pressure
Time frame: measured 24 months post-study entry
serum insulin
Time frame: measured 24 months post-study entry
serum triglycerides
Time frame: measured 24 months post-study entry
serum total cholesterol
Time frame: measured 24 months post-study entry
serum high density lipoprotein cholesterol
Time frame: measured 24 months post-study entry
serum low density lipoprotein cholesterol
Time frame: measured 24 months post-study entry
serum non-high density lipoprotein cholesterol
Time frame: measured 24 months post-study entry
serum highly sensitive c-reactive protein
Time frame: measured 24 months post-study entry
height z-score
Time frame: measured 24 months post-study entry
waist circumference
Time frame: measured 24 months post-study entry
lean body mass
Time frame: measured 24 months post-study entry
fat mass
Time frame: measured 24 months post-study entry
school readiness
Time frame: measured 24 months post-study entry
cognitive development
Time frame: measured 24 months post-study entry
dietary intake
Time frame: measured 24 months post-study entry
carotid intima media thickness (cIMT)
Time frame: measured 24 months post-study entry
restrained and emotional eating
Time frame: measured 24 months post-study entry
nutritional risk
Time frame: measured 24 months post-study entry
physical activity (minutes per day)
Time frame: measured 24 months post-study entry
sleep time (hours per night)
Time frame: measured 24 months post-study entry
healthcare service utilization
Time frame: measured 24 months post-study entry
upper respiratory tract infection incidence
Time frame: measured 24 months post-study entry
growth trajectories
Time frame: measured 24 months post-study entry
head circumference
Time frame: measured 24 months post-study entry
cost effectiveness
Time frame: measured 24 months post-study entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 32385063Vanderhout SM, Aglipay M, Birken C, Li P, O'Connor DL, Thorpe K, Constantin E, Davis MA, Feldman M, Ball GDC, Janus M, Juni P, Junker A, Laupacis A, L'Abbe M, Manson H, Moretti ME, Persaud N, Omand JA, Relton C, Wong P, Yamashiro H, Tavares E, Weir S, Maguire JL. 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. BMJ Open. 2020 May 7;10(5):e035241. doi: 10.1136/bmjopen-2019-035241.
- 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. This study is not recruiting at the moment.
Jonathon L Maguire, MD, FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole (3.25%) cow's milk recommendation and Reduced (1%) fat milk in people with Obesity, Childhood, run by The Hospital for Sick Children at 1 site in Canada.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathon L Maguire, MD, FRCPC ((416) 867-3655, jonathon.maguire@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: Measured 24 months post-study entry). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914807, which also lists 1 linked publication.
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 13 Dec 2023.