Nutrition Recommendation Intervention trialS in Children's Healthcare

NCT05477628 | Not Yet Recruiting

• 1 other identifier: 3606
• Study Type: interventional
• Target: 620
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• breastfeeding self-efficacy

  6 months

• exclusive breastfeeding duration

  6 months

• Childcare attendance

  2 years of age

• cognitive development

  2 years of age

• maternal mental health

  2 years of age

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Other: Control Group

Intervention Group

EXPERIMENTAL

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; Other: Lactation Consultant; Other: Lactation Consultant Support and Childcare Navigator Support

Interventions

Childcare Navigator OTHER

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.

Also known as: (CN)

Intervention Group

Lactation Consultant OTHER

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.

Also known as: (LC)

Intervention Group

Lactation Consultant Support and Childcare Navigator Support OTHER

This intervention is a combination of the two interventions described above.

Also known as: LC+CN

Intervention Group

Control Group OTHER

All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.

Control Group

Eligibility Criteria

• Age: 1 Day - 1 Week
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with a syndrome associated with obesity or developmental delay

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Toronto Public Health: collaborator
• University of Toronto: collaborator
• Unity Health Toronto: collaborator
• Applied Health Research Centre: collaborator
• McMaster University: collaborator
• Pediatric Alliance of Ontario: collaborator
• Canadian Paediatric Society: collaborator
• Queen Mary University of London: collaborator

MeSH Terms

Conditions

Pediatric Obesity; Health Risk Behaviors; Breast Feeding; Diabetes Mellitus; Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Feeding Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jonathon Maguire, MD,FRCPC,MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Mitchell, BA

CONTACT

4165255417; michelle.mitchell@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To reduce the risk of bias, all research assistants who collect baseline and outcome data will be blinded. All other study personnel, including data analysts, will also be blinded to group allocation. Due to the nature of the intervention, children and parents cannot be blinded, but they will be blinded to trial hypotheses. Healthcare providers who provide the interventions also cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 28, 2022
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share