Cow Milk Fat Obesity pRevention Trial

Study Overview
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Brief Summary
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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.

Official Title
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Cow Milk Fat Obesity pRevention Trial

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Other: Whole (3.25%) cow's milk recommendation
* Other: Reduced (1%) fat milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Superiority cohort embedded 2 arm pragmatic randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole (3.25%) milk<br> | Other: Whole (3.25%) cow's milk recommendation<br>* 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.<br>|
| Active Comparator: Reduced fat (1%) milk<br> | Other: Reduced (1%) fat milk<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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milk, fat, cohort-embedded