Nutrition Recommendation Intervention trialS in Children's Healthcare (NuRISH)

The Hospital for Sick Children

Status: Not yet enrolling

Conditions: Exclusive Breastfeeding; Diabetes; Obesity, Childhood; Nutrition; Health Risk Behaviors; Breastfeeding

Treatments: Other: Lactation Consultant; Other: Control Group; Other: Lactation Consultant Support and Childcare Navigator Support; Other: Childcare Navigator

Study type: Interventional

Funder types: Other

Identifiers

NCT05477628

3606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 620 estimated patients

Sex: All

Ages: 1 day to 1 week old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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620 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Participants who are randomized to the control group will receive usual care from their health care practitioners.

Treatment:

Other: Control Group

Intervention Group

Experimental group

Description:

Participants who are randomized to Intervention Group will receive one of three possible "scenarios": 1) Childcare Navigator Support, 2) Breastfeeding support via Lactation Consultant, 3) both Childcare Navigator Support and Breastfeeding support via Lactation.

Treatment:

Other: Childcare Navigator

Other: Lactation Consultant Support and Childcare Navigator Support

Other: Lactation Consultant