Nutrition Recommendation Intervention trialS in Children's Healthcare
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Childcare Navigator, Lactation Consultant, Lactation Consultant Support and Childcare Navigator Support, Control Group.
- Who it may be relevant to
- Registry conditions: Obesity, Childhood, Nutrition, Health Risk Behaviors, Breastfeeding. Basic parameters: 1 Day — 1 Week · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Childcare Navigator
Participants will be contacted by the CN to assist with access to centre-based childcare after enrolment. The CN will: a) educate the family on the benefits of centre based childcare; b) facilitate placement of the child on waiting lists for funding and centre based childcare placement in their neighbourhood with the aim of having full-time centre based childcare start at 1 year of age; and c) work with the family to overcome barriers to childcare placement prior to and during childcare. It is e - Other Lactation Consultant
Participants will be contacted by the LC on the same day as their first primary healthcare visit. They will also receive age-appropriate nutrition recommendations according to the Rourke Baby Record. The LC will be an International Board Certified Lactation Consultant (IBCLC) who will provide scheduled and on-call visits, along with phone calls, video conferencing, and text messaging as needed to support exclusive breastfeeding (using virtual care modalities as appropriate during COVID-19). The - Other Lactation Consultant Support and Childcare Navigator Support
This intervention is a combination of the two interventions described above. - Other Control Group
All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.
Primary outcome measures
- zBMI [Time frame: 2-year primary healthcare visit]
Secondary outcome measures (12)
- breastfeeding self-efficacy [Time frame: 6 months]
- exclusive breastfeeding duration [Time frame: 6 months]
- Childcare attendance [Time frame: 2 years of age]
- cognitive development [Time frame: 2 years of age]
- maternal mental health [Time frame: 2 years of age]
- mental health [Time frame: 2 years of age]
- blood pressure [Time frame: 2 years of age]
- non-HDL [Time frame: 2 years of age]
- LDL [Time frame: 2 years of age]
- triglyceride [Time frame: 2 years of age]
- HDL [Time frame: 2 years of age]
- TC [Time frame: 2 years of age]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05477628 · 3606