Nutrition Recommendation Intervention trialS in Children's Healthcare

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.

Conditions

• Obesity, Childhood
• Nutrition
• Health Risk Behaviors
• Breastfeeding
• Exclusive Breastfeeding
• Diabetes

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 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.

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 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.

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.

Sponsors & Collaborators

• Toronto Public Health

  collaborator OTHER_GOV

• University of Toronto

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Applied Health Research Centre

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Pediatric Alliance of Ontario

  collaborator UNKNOWN

• Canadian Paediatric Society

  collaborator OTHER

• Queen Mary University of London

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Jonathon Maguire, MD,FRCPC,MSc · The Hospital for Sick Children

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

1 Day

Max Age

1 Week

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2027-12-31

Completion

2027-12-31