Cow Milk Fat Obesity pRevention Trial
- Conditions
- Obesity, Childhood
- Interventions
- Other: Reduced (1%) fat milkOther: Whole (3.25%) cow's milk recommendation
- Registration Number
- NCT03914807
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 534
- healthy by parental report;
- 1.5 to 2.99 years of age
- involved in a TARGet Kids! academic pediatric or family medicine group.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reduced fat (1%) milk Reduced (1%) fat milk - Whole (3.25%) milk Whole (3.25%) cow's milk recommendation -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method cognitive development measured 24 months post-study entry measured using the Ages and Stages Questionnaire (ASQ)
nutritional risk measured 24 months post-study entry measured using NutriSTEP preschooler
healthcare service utilization measured 24 months post-study entry information accessed through OHIP linkage
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
serum insulin 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
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
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
height z-score measured 24 months post-study entry measured by a trained research assistant according to the World Health Organization guidelines
dietary intake measured 24 months post-study entry measured using the Automated Multiple Pass Self Administered 24 hour recall (ASA24) tool
restrained and emotional eating measured 24 months post-study entry measured using the 3-factor eating questionnaire
blood pressure measured 24 months post-study entry systolic and diastolic
serum high density lipoprotein cholesterol measured 24 months post-study entry measured in mmol/L
physical activity (minutes per day) measured 24 months post-study entry questionnaire data and accelerometry
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
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
sleep time (hours per night) measured 24 months post-study entry questionnaire data and accelerometry
carotid intima media thickness (cIMT) measured 24 months post-study entry measured by ultrasound
upper respiratory tract infection incidence measured 24 months post-study entry information accessed through OHIP linkage
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.
Trial Locations
- Locations (1)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada