Cow Milk Fat Obesity pRevention Trial

Obesity, Childhood Clinical Trial

— CoMFORT  

Official title:

Cow Milk Fat Obesity pRevention Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914807
• Other study ID #: 18-369
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: The Hospital for Sick Children
• Contact: Jonathon L Maguire, MD, FRCPC
• Phone: (416) 867-3655
• Email: jonathon.maguire[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 534
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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