Obesity, Childhood
Conditions
Keywords
milk, fat, cohort-embedded
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.
Interventions
OTHERWhole (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.
OTHERReduced (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.
Sponsors
Unity Health Toronto
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Superiority cohort embedded 2 arm pragmatic randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Months to 60 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight | Measured 24 months post-study entry | kilograms; measured using a Healthometer stadiometer |
| height | Measured 24 months post-study entry | metres; measured using a Healthometer statiometer |
| body mass index z-score (zBMI) | Measured 24 months post-study entry | BMI calculated by weight (kg)/height (m\^2); zBMI determined according to the World Health Organization guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | measured 24 months post-study entry | systolic and diastolic |
| serum insulin | measured 24 months post-study entry | measured in mmol/L |
| serum triglycerides | measured 24 months post-study entry | measured in mmol/L |
| serum total cholesterol | measured 24 months post-study entry | measured in mmol/L |
| serum low density lipoprotein cholesterol | measured 24 months post-study entry | measured in mmol/L |
| serum non-high density lipoprotein cholesterol | measured 24 months post-study entry | measured in mmol/L |
| serum highly sensitive c-reactive protein | measured 24 months post-study entry | measured in mg/L |
| height z-score | measured 24 months post-study entry | measured by a trained research assistant according to the World Health Organization guidelines |
| waist circumference | measured 24 months post-study entry | measured by a trained research assistant |
| lean body mass | measured 24 months post-study entry | measured in kg, % body weight |
| fat mass | measured 24 months post-study entry | measured in kg, % body weight |
| school readiness | 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 |
| serum high density lipoprotein cholesterol | measured 24 months post-study entry | measured in mmol/L |
| dietary intake | measured 24 months post-study entry | measured using the Automated Multiple Pass Self Administered 24 hour recall (ASA24) tool |
| carotid intima media thickness (cIMT) | measured 24 months post-study entry | measured by ultrasound |
| restrained and emotional eating | measured 24 months post-study entry | measured using the 3-factor eating questionnaire |
| nutritional risk | measured 24 months post-study entry | measured using NutriSTEP preschooler |
| physical activity (minutes per day) | measured 24 months post-study entry | questionnaire data and accelerometry |
| sleep time (hours per night) | measured 24 months post-study entry | questionnaire data and accelerometry |
| healthcare service utilization | measured 24 months post-study entry | information accessed through OHIP linkage |
| upper respiratory tract infection incidence | measured 24 months post-study entry | information accessed through OHIP linkage |
| growth trajectories | measured 24 months post-study entry | zBMI growth rates |
| head circumference | measured 24 months post-study entry | measured by a trained research assistant |
| cost effectiveness | measured 24 months post-study entry | 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. |
| cognitive development | measured 24 months post-study entry | measured using the Ages and Stages Questionnaire (ASQ) |
| serum 25-hydroxyvitamin D | Measured 24 months post-study entry | measured in nmol/L |
| serum glucose | measured 24 months post-study entry | measured in mmol/L |
Countries
Canada
Contacts
Primary ContactJonathon L Maguire, MD, FRCPC
Outcome results
None listed