Nutrition Recommendation Intervention trialS in Children's Healthcare
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity, Childhood
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 620
- Primary Endpoint
- zBMI
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jonathon L Maguire
Principal Investigator
The Hospital for Sick Children
Eligibility Criteria
Inclusion Criteria
- •Healthy by parental report
- •\<32 weeks gestation
- •0-1 week of age
- •First birth /first time parents
Exclusion Criteria
- •Children with a syndrome associated with obesity or developmental delay
Outcomes
Primary Outcomes
zBMI
Time Frame: 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.
Secondary Outcomes
- 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)