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.
Healthy by parental report
<32 weeks gestation
0-1 week of age
First birth /first time parents
Children with a syndrome associated with obesity or developmental delay
Factorial
Childcare Navigator
Other interventionParticipants 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 expected that the child will be in full-time centre-based childcare for a minimum of 12 months. Control: All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare according to the Rourke Baby Record.
Lactation Consultant
Other interventionParticipants 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 LC will contact the family once per week for the first 4 weeks to support breastfeeding technique and help with breastfeeding problems such as latching difficulties, painful nursing, and low milk production, monthly thereafter and provide on-call support as required to support exclusive breastfeeding through 6 months of age. Control: All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.
Lactation Consultant Support and Childcare Navigator Support
Other interventionThis intervention is a combination of the two interventions described above.
Control Group
Other interventionAll children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.
zBMI
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.
breastfeeding self-efficacy
change in breastfeeding self-efficacy measured by lactation consultant logs
exclusive breastfeeding duration
change in exclusive breastfeeding duration
Childcare attendance
change in centre-based childcare attendance measured by attendance logs
cognitive development
To capture child's development, the Ages and Stages Questionnaire will be administered. The Ages and Stages Questionnaire identifies infants, toddlers and preschool aged children at risk of a developmental delay in five developmental domains: Communication, Gross Motor, Fine Motor, Problem Solving and Personal Social Behaviour. Each domain consists of six questions about important age-specific developmental milestones. If a child scores between 1 and 2 below the normative mean on any domain, rescreening is recommended. When a child scores 1 below the normative mean on two or more domains, or 2 below the normative mean on at least one domain, a referral to a health care professional is recommended.
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
Toronto Public Health
Collaborator
University of Toronto
Collaborator
Unity Health Toronto
Collaborator
Applied Health Research Centre
Collaborator
McMaster University
Collaborator
Pediatric Alliance of Ontario
Collaborator
Canadian Paediatric Society
Collaborator
Queen Mary University of London
Collaborator
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