Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cow Milk Fat Obesity pRevention Trial (CoMFORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03914807
Recruitment Status : Not yet recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Jonathon L Maguire, The Hospital for Sick Children

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Other: Whole (3.25%) cow's milk recommendation Other: Reduced (1%) fat milk Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Superiority cohort embedded 2 arm pragmatic randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cow Milk Fat Obesity pRevention Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2024

Arm Intervention/treatment
Active Comparator: Whole (3.25%) milk Other: Whole (3.25%) cow's milk recommendation
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.

Active Comparator: Reduced fat (1%) milk Other: Reduced (1%) fat milk
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.




Primary Outcome Measures :
  1. weight [ Time Frame: Measured 24 months post-study entry ]
    kilograms; measured using a Healthometer stadiometer

  2. height [ Time Frame: Measured 24 months post-study entry ]
    metres; measured using a Healthometer statiometer

  3. 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


Secondary Outcome Measures :
  1. serum 25-hydroxyvitamin D [ Time Frame: Measured 24 months post-study entry ]
    measured in nmol/L

  2. serum glucose [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  3. blood pressure [ Time Frame: measured 24 months post-study entry ]
    systolic and diastolic

  4. serum insulin [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  5. serum triglycerides [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  6. serum total cholesterol [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  7. serum high density lipoprotein cholesterol [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  8. serum low density lipoprotein cholesterol [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  9. serum non-high density lipoprotein cholesterol [ Time Frame: measured 24 months post-study entry ]
    measured in mmol/L

  10. serum highly sensitive c-reactive protein [ Time Frame: measured 24 months post-study entry ]
    measured in mg/L

  11. height z-score [ Time Frame: measured 24 months post-study entry ]
    measured by a trained research assistant according to the World Health Organization guidelines

  12. waist circumference [ Time Frame: measured 24 months post-study entry ]
    measured by a trained research assistant

  13. lean body mass [ Time Frame: measured 24 months post-study entry ]
    measured in kg, % body weight

  14. fat mass [ Time Frame: measured 24 months post-study entry ]
    measured in kg, % body weight

  15. school readiness [ Time Frame: measured 24 months post-study entry ]
    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

  16. cognitive development [ Time Frame: measured 24 months post-study entry ]
    measured using the Ages and Stages Questionnaire (ASQ)

  17. dietary intake [ Time Frame: measured 24 months post-study entry ]
    measured using the Automated Multiple Pass Self Administered 24 hour recall (ASA24) tool

  18. carotid intima media thickness (cIMT) [ Time Frame: measured 24 months post-study entry ]
    measured by ultrasound

  19. restrained and emotional eating [ Time Frame: measured 24 months post-study entry ]
    measured using the 3-factor eating questionnaire

  20. nutritional risk [ Time Frame: measured 24 months post-study entry ]
    measured using NutriSTEP preschooler

  21. physical activity (minutes per day) [ Time Frame: measured 24 months post-study entry ]
    questionnaire data and accelerometry

  22. sleep time (hours per night) [ Time Frame: measured 24 months post-study entry ]
    questionnaire data and accelerometry

  23. healthcare service utilization [ Time Frame: measured 24 months post-study entry ]
    information accessed through OHIP linkage

  24. upper respiratory tract infection incidence [ Time Frame: measured 24 months post-study entry ]
    information accessed through OHIP linkage

  25. growth trajectories [ Time Frame: measured 24 months post-study entry ]
    zBMI growth rates

  26. head circumference [ Time Frame: measured 24 months post-study entry ]
    measured by a trained research assistant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy by parental report;
  • 1.5 to 2.99 years of age
  • involved in a TARGet Kids! academic pediatric or family medicine group.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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): NCT03914807


Contacts
Layout table for location contacts
Contact: Jonathon L Maguire, MD, FRCPC (416) 867-3655 jonathon.maguire@utoronto.ca

Locations
Layout table for location information
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
The Hospital for Sick Children
St. Michael's Hospital, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Jonathon L Maguire, MD, FRCPC St. Michael's Hospital, Toronto

Layout table for additonal information
Responsible Party: Jonathon L Maguire, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03914807     History of Changes
Other Study ID Numbers: 18-369
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathon L Maguire, The Hospital for Sick Children:
milk
fat
cohort-embedded

Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms