Nutrition Recommendation Intervention trialS in Children's Healthcare
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 620
- 主要终点
- zBMI
研究概览
简要总结
NuRISH is a suite of clinical trials for children from low-income families which will determine whether primary healthcare prescription for: 1) Optimal breastfeeding with support from a mobile lactation consultant vs. usual care and 2) High-quality childcare starting at 1 year vs. usual care can prevent childhood obesity, and improve cardiovascular, developmental and mental health at 2 years of age.
详细描述
Canada's children are falling behind. One in 4 are overweight or obese and more than 1 in 3 have factors that put them at risk for cardiovascular disease as adults. Children from low income families are 70% more likely to be overweight or obese. Research across disciplines has shown that early life nutrition has profound effects on childhood obesity, development, mental health, and lifetime success. Optimizing early life nutrition to reduce inequalities in childhood obesity and its consequences is a promising approach. Through this application, we will be using a longitudinal factorial design within an ongoing cohort study(TARGet Kids!). The longitudinal factorial design involves randomizing the same children to multiple interventions, providing the opportunity to evaluate the effect of individual interventions as well as the multiplicative effects of a combination of interventions over time. This design increases the feasibility and lowers the cost relative to conducting 2 separate trials. This will be a pragmatic, randomized, longitudinal factorial Trials within Cohorts (TwiCs) clinical trial. This study will be a direct comparison of two primary healthcare interventions provided randomly at the individual level: 1) Lactation Consultant (LC) support vs. usual care; 2) Childcare Navigator (CN) support vs. usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
To reduce the risk of bias, all research assistants who collect baseline and outcome data will be blinded. All other study personnel, including data analysts, will also be blinded to group allocation. Due to the nature of the intervention, children and parents cannot be blinded, but they will be blinded to trial hypotheses. Healthcare providers who provide the interventions also cannot be blinded.
入排标准
- 年龄范围
- 1 Day 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy by parental report
- •<32 weeks gestation
- •0-1 week of age
- •First birth /first time parents
排除标准
- •Children with a syndrome associated with obesity or developmental delay
结局指标
主要结局
zBMI
时间窗: 2-year primary healthcare visit
The primary outcome measure will be age and sex standardized BMI z-score (zBMI), which will be measured at the 2-year primary healthcare visit. zBMI is an important outcome that is predictive of adiposity in later childhood, adolescence and adulthood. Data including birthweight and length, and repeated measures of weight and length will be used to calculate zBMI growth trajectories.
次要结局
- Childcare attendance(2 years of age)
- HDL(2 years of age)
- breastfeeding self-efficacy(6 months)
- exclusive breastfeeding duration(6 months)
- cognitive development(2 years of age)
- mental health(2 years of age)
- blood pressure(2 years of age)
- TC(2 years of age)
- HbA1C(2 years of age)
- maternal mental health(2 years of age)
- non-HDL(2 years of age)
- LDL(2 years of age)
- triglyceride(2 years of age)
- glucose(2 years of age)
- hsCRP(2 years of age)
- Dietary Quality(2 years of age)
研究者
Jonathon L Maguire
Principal Investigator
The Hospital for Sick Children