Nutrition Recommendation Intervention trialS in Children's Healthcare
- Conditions
- NutritionDiabetesHealth Risk BehaviorsBreastfeedingExclusive BreastfeedingObesity, Childhood
- Interventions
- Other: Control GroupOther: Childcare NavigatorOther: Lactation ConsultantOther: Lactation Consultant Support and Childcare Navigator Support
- Registration Number
- NCT05477628
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 620
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Control Group Control Group Participants who are randomized to the control group will receive usual care from their health care practitioners. Intervention Group Childcare Navigator 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. Intervention Group Lactation Consultant 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. Intervention Group Lactation Consultant Support and Childcare Navigator Support 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.
- Primary Outcome Measures
Name Time Method zBMI 2-year primary healthcare visit 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.
- Secondary Outcome Measures
Name Time Method Childcare attendance 2 years of age change in centre-based childcare attendance measured by attendance logs
HDL 2 years of age change in cardiovascular risk factors for the child
breastfeeding self-efficacy 6 months change in breastfeeding self-efficacy measured by lactation consultant logs
exclusive breastfeeding duration 6 months change in exclusive breastfeeding duration
cognitive development 2 years of age 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.
mental health 2 years of age Child's mental health captured by the Strengths and Difficulties Questionnaire. The questionnaire consists of 25 items subdivided into four difficulties scales, emotional symptoms, conduct problems, inattention-hyperactivity and peer problems, and a separate fifth strength scale, prosocial behavior. All subscales have five questions. Each item has to be scored on a 3-point scale with 0 = 'not true', 1 = 'somewhat true' and 2 = 'certainly true'. A higher score indicates more emotional and behavioral problems.
blood pressure 2 years of age change in cardiovascular risk factors for the child
TC 2 years of age change in cardiovascular risk factors for the child
HbA1C 2 years of age change in cardiovascular risk factors for the child
maternal mental health 2 years of age change in maternal mental health, measured by the Edinburgh Postnatal Depression Scale at 2 years of age. The scale was developed for screening postpartum women in outpatient, home visiting settings, or at the 6 -8 week postpartum examination. Consisting of 10 questions, each response is scored 0, 1, 2, or 3 according to increased severity of the symptom. Items marked with an asterisk (\*) are reverse scored (i.e., 3, 2, 1, and 0). The total score is determined by adding together the scores for each of the 10 items. A woman scoring 9 or more points or indicating any suicidal ideation - that is she scores 1 or higher on question #10 - should be referred immediately for follow-up. Even if a woman scores less than 9, if the clinician feels the client is suffering from depression, an appropriate referral should be made.
non-HDL 2 years of age change in cardiovascular risk factors for the child
LDL 2 years of age change in cardiovascular risk factors for the child
triglyceride 2 years of age change in cardiovascular risk factors for the child
glucose 2 years of age change in cardiovascular risk factors for the child
hsCRP 2 years of age change in cardiovascular risk factors for the child
Dietary Quality 2 years of age total caloric intake captured through the Automated Self-Administered 24-hour Dietary Assessment Tool of the child and mother at 2 years of age