Clinical trial NCT05477628: Nutrition Recommendation Intervention trialS in Children's Healthcare
Official title: Nutrition Recommendation Intervention trialS in Children's Healthcare
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Nutrition
Health Risk Behaviors
Breastfeeding
Exclusive Breastfeeding
Diabetes
Keywords: Lower adiposity
Higher breastfeeding self-efficacy
Higher centre-based childcare attendance
Improved child development and mental health
Lower cardiovascular risk factors
Better dietary quality
Lower healthcare and overall societal costs
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Toronto Public Health
name: University of Toronto
name: Unity Health Toronto
name: Applied Health Research Centre
name: McMaster University
name: Pediatric Alliance of Ontario
name: Canadian Paediatric Society
name: Queen Mary University of London
First posted: 2022-07-28
Enrollment: 620
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This will be a pragmatic, randomized, longitudinal factorial Trials within Cohorts (TwiCs) clinical trial. This study will be a direct comparison of two HCP prescriptions provided randomly at the individual level: 1) Optimal breastfeeding with mobile lactation consultant support vs. usual care and 2) High-quality childcare starting at 1 year of age vs. usual care. We will combine TwiCs methods with a longitudinal factorial design to enhance the integration of cohort study and factorial trial designs.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: zBMI
timeFrame: 2-year primary healthcare visit
Secondary outcomes:
measure: breastfeeding self-efficacy
timeFrame: 6 months
measure: exclusive breastfeeding duration
timeFrame: 6 months
measure: Childcare attendance
timeFrame: 2 years of age
measure: cognitive development
timeFrame: 2 years of age
measure: maternal mental health
timeFrame: 2 years of age
measure: mental health
timeFrame: 2 years of age
measure: blood pressure
timeFrame: 2 years of age
measure: non-HDL
timeFrame: 2 years of age
measure: LDL
timeFrame: 2 years of age
measure: triglyceride
timeFrame: 2 years of age
measure: HDL
timeFrame: 2 years of age
measure: TC
timeFrame: 2 years of age
measure: glucose
timeFrame: 2 years of age
measure: hsCRP
timeFrame: 2 years of age
measure: HbA1C
timeFrame: 2 years of age
measure: Dietary Quality
timeFrame: 2 years of age
Other outcomes:
Locations:
Study officials:
affiliation: The Hospital for Sick Children
name: Jonathon Maguire, MD,FRCPC,MSc
role: PRINCIPAL_INVESTIGATOR
References: