Cow Milk Fat Obesity pRevention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy by parental report;
- •1.5 to 2.99 years of age
- •involved in a TARGet Kids! academic pediatric or family medicine group.
排除标准
- •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.
结局指标
主要结局
weight
时间窗: Measured 24 months post-study entry
kilograms; measured using a Healthometer stadiometer
height
时间窗: Measured 24 months post-study entry
metres; measured using a Healthometer statiometer
body mass index z-score (zBMI)
时间窗: Measured 24 months post-study entry
BMI calculated by weight (kg)/height (m\^2); zBMI determined according to the World Health Organization guidelines
次要结局
- nutritional risk(measured 24 months post-study entry)
- healthcare service utilization(measured 24 months post-study entry)
- serum 25-hydroxyvitamin D(Measured 24 months post-study entry)
- serum glucose(measured 24 months post-study entry)
- serum insulin(measured 24 months post-study entry)
- serum highly sensitive c-reactive protein(measured 24 months post-study entry)
- waist circumference(measured 24 months post-study entry)
- lean body mass(measured 24 months post-study entry)
- cognitive development(measured 24 months post-study entry)
- serum triglycerides(measured 24 months post-study entry)
- serum total cholesterol(measured 24 months post-study entry)
- serum low density lipoprotein cholesterol(measured 24 months post-study entry)
- serum non-high density lipoprotein cholesterol(measured 24 months post-study entry)
- height z-score(measured 24 months post-study entry)
- dietary intake(measured 24 months post-study entry)
- restrained and emotional eating(measured 24 months post-study entry)
- blood pressure(measured 24 months post-study entry)
- serum high density lipoprotein cholesterol(measured 24 months post-study entry)
- physical activity (minutes per day)(measured 24 months post-study entry)
- growth trajectories(measured 24 months post-study entry)
- head circumference(measured 24 months post-study entry)
- fat mass(measured 24 months post-study entry)
- school readiness(measured 24 months post-study entry)
- sleep time (hours per night)(measured 24 months post-study entry)
- carotid intima media thickness (cIMT)(measured 24 months post-study entry)
- upper respiratory tract infection incidence(measured 24 months post-study entry)
- cost effectiveness(measured 24 months post-study entry)
研究者
Jonathon L Maguire
Principal Investigator
The Hospital for Sick Children