Nutrition Recommendation Intervention trialS in Children's Healthcare

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutrition Recommendation Intervention trialS in Children's Healthcare

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

Intervention / Treatment
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* Other: Childcare Navigator
* Other: Lactation Consultant
* Other: Lactation Consultant Support and Childcare Navigator Support
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This will be a pragmatic, randomized, longitudinal factorial Trials within Cohorts (TwiCs) clinical trial. This study will be a direct comparison of two HCP prescriptions provided randomly at the individual level: 1) Optimal breastfeeding with mobile lactation consultant support vs. usual care and 2) High-quality childcare starting at 1 year of age vs. usual care. We will combine TwiCs methods with a longitudinal factorial design to enhance the integration of cohort study and factorial trial designs.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Participants who are randomized to the control group will receive usual care from their health care practitioners. | Other: Control Group<br>* All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.<br>|
| Experimental: Intervention Group<br>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. | Other: Childcare Navigator<br>* 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.<br>* Other names: (CN);Other: Lactation Consultant<br>* 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.<br>* Other names: (LC);Other: Lactation Consultant Support and Childcare Navigator Support<br>* This intervention is a combination of the two interventions described above.<br>* Other names: LC+CN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2-year primary healthcare visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breastfeeding self-efficacy | change in breastfeeding self-efficacy measured by lactation consultant logs | 6 months | 
| exclusive breastfeeding duration | change in exclusive breastfeeding duration | 6 months | 
| Childcare attendance | change in centre-based childcare attendance measured by attendance logs | 2 years of age | 
| 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. | 2 years of age | 
| maternal mental health | 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. | 2 years of age | 
| mental health | 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. | 2 years of age | 
| blood pressure | change in cardiovascular risk factors for the child | 2 years of age | 
| non-HDL | change in cardiovascular risk factors for the child | 2 years of age | 
| LDL | change in cardiovascular risk factors for the child | 2 years of age | 
| triglyceride | change in cardiovascular risk factors for the child | 2 years of age | 
| HDL | change in cardiovascular risk factors for the child | 2 years of age | 
| TC | change in cardiovascular risk factors for the child | 2 years of age | 
| glucose | change in cardiovascular risk factors for the child | 2 years of age | 
| hsCRP | change in cardiovascular risk factors for the child | 2 years of age | 
| HbA1C | change in cardiovascular risk factors for the child | 2 years of age | 
| Dietary Quality | total caloric intake captured through the Automated Self-Administered 24-hour Dietary Assessment Tool of the child and mother at 2 years of age | 2 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower adiposity, Higher breastfeeding self-efficacy, Higher centre-based childcare attendance, Improved child development and mental health, Lower cardiovascular risk factors, Better dietary quality, Lower healthcare and overall societal costs