Cow Milk Fat Obesity pRevention Trial (CoMFORT)

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 Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Whole (3.25%) cow's milk recommendation; Other: Reduced (1%) fat milk

• Study Type: Interventional
• Enrollment (Estimated): 534
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathon L Maguire, MD, FRCPC; Phone Number: (416) 867-3655; Email: jonathon.maguire@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Jonathon L Maguire, MD, FRCPC; Phone Number: (416) 867-3655; Email: jonathon.maguire@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	kilograms; measured using a Healthometer stadiometer	Measured 24 months post-study entry
height	metres; measured using a Healthometer statiometer	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 24 months post-study entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum 25-hydroxyvitamin D	measured in nmol/L	Measured 24 months post-study entry
serum glucose	measured in mmol/L	measured 24 months post-study entry
blood pressure	systolic and diastolic	measured 24 months post-study entry
serum insulin	measured in mmol/L	measured 24 months post-study entry
serum triglycerides	measured in mmol/L	measured 24 months post-study entry
serum total cholesterol	measured in mmol/L	measured 24 months post-study entry
serum high density lipoprotein cholesterol	measured in mmol/L	measured 24 months post-study entry
serum low density lipoprotein cholesterol	measured in mmol/L	measured 24 months post-study entry
serum non-high density lipoprotein cholesterol	measured in mmol/L	measured 24 months post-study entry
serum highly sensitive c-reactive protein	measured in mg/L	measured 24 months post-study entry
height z-score	measured by a trained research assistant according to the World Health Organization guidelines	measured 24 months post-study entry
waist circumference	measured by a trained research assistant	measured 24 months post-study entry
lean body mass	measured in kg, % body weight	measured 24 months post-study entry
fat mass	measured in kg, % body weight	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 24 months post-study entry
cognitive development	measured using the Ages and Stages Questionnaire (ASQ)	measured 24 months post-study entry
dietary intake	measured using the Automated Multiple Pass Self Administered 24 hour recall (ASA24) tool	measured 24 months post-study entry
carotid intima media thickness (cIMT)	measured by ultrasound	measured 24 months post-study entry
restrained and emotional eating	measured using the 3-factor eating questionnaire	measured 24 months post-study entry
nutritional risk	measured using NutriSTEP preschooler	measured 24 months post-study entry
physical activity (minutes per day)	questionnaire data and accelerometry	measured 24 months post-study entry
sleep time (hours per night)	questionnaire data and accelerometry	measured 24 months post-study entry
healthcare service utilization	information accessed through OHIP linkage	measured 24 months post-study entry
upper respiratory tract infection incidence	information accessed through OHIP linkage	measured 24 months post-study entry
growth trajectories	zBMI growth rates	measured 24 months post-study entry
head circumference	measured by a trained research assistant	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 24 months post-study entry

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Jonathon L Maguire, MD, FRCPC, Unity Health Toronto

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: milk; fat; cohort-embedded
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 18-369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No