Nutrition Recommendation Intervention trialS in Children's Healthcare

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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
• Другое Lactation Consultant Support and Childcare Navigator Support
  This intervention is a combination of the two interventions described above.
• Другое Control Group
  All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.

Первичные конечные точки

• zBMI [Срок оценки: 2-year primary healthcare visit]

Вторичные конечные точки (12)

• breastfeeding self-efficacy [Срок оценки: 6 months]
• exclusive breastfeeding duration [Срок оценки: 6 months]
• Childcare attendance [Срок оценки: 2 years of age]
• cognitive development [Срок оценки: 2 years of age]
• maternal mental health [Срок оценки: 2 years of age]
• mental health [Срок оценки: 2 years of age]
• blood pressure [Срок оценки: 2 years of age]
• non-HDL [Срок оценки: 2 years of age]
• LDL [Срок оценки: 2 years of age]
• triglyceride [Срок оценки: 2 years of age]
• HDL [Срок оценки: 2 years of age]
• TC [Срок оценки: 2 years of age]

Критерии участия

Критерии включения

• Healthy by parental report
• <32 weeks gestation
• 0-1 week of age
• First birth /first time parents

Критерии исключения

• Children with a syndrome associated with obesity or developmental delay

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05477628 · 3606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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