Obesity, ChildhoodNuRISHNCT05477628
Nutrition Recommendation Intervention trialS in Children's Healthcare
A study testing Childcare Navigator, Lactation Consultant and Lactation Consultant Support and Childcare Navigator Support in people with Obesity, Childhood and Nutrition, run by The Hospital for Sick Children.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Nutrition, Health Risk Behaviors
- What is being tested?
- Childcare Navigator, Lactation Consultant and Lactation Consultant Support and Childcare Navigator Support
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy by parental report
- <32 weeks gestation
- 0-1 week of age
- First birth /first time parents
Who cannot join
- Children with a syndrome associated with obesity or developmental delay
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Obesity, Childhood, Nutrition, Health Risk Behaviors, Breastfeeding, Exclusive Breastfeeding, Diabetes
- Being tested
- Childcare Navigator, Lactation Consultant, Lactation Consultant Support and Childcare Navigator Support, Control Group
- 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
- Medical subject headings
- Pediatric Obesity, Health Risk Behaviors, Breast Feeding, Diabetes Mellitus, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childcare NavigatorOther
Also called (CN)
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.
Lactation ConsultantOther
Also called (LC)
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.
Lactation Consultant Support and Childcare Navigator SupportOther
Also called LC+CN
This intervention is a combination of the two interventions described above.
Control GroupOther
All children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Participants who are randomized to the control group will receive usual care from their health care practitioners. Receives: 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. Receives: Other: Childcare Navigator; Other: Lactation Consultant; Other: Lactation Consultant Support and Childcare Navigator Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-year primary healthcare visit
Secondary outcomes (16)
breastfeeding self-efficacy
change in breastfeeding self-efficacy measured by lactation consultant logs
Measured: 6 months
exclusive breastfeeding duration
change in exclusive breastfeeding duration
Measured: 6 months
Childcare attendance
change in centre-based childcare attendance measured by attendance logs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years of age
blood pressure
change in cardiovascular risk factors for the child
Measured: 2 years of age
non-HDL
change in cardiovascular risk factors for the child
Measured: 2 years of age
LDL
change in cardiovascular risk factors for the child
Measured: 2 years of age
triglyceride
change in cardiovascular risk factors for the child
Measured: 2 years of age
HDL
change in cardiovascular risk factors for the child
Measured: 2 years of age
TC
change in cardiovascular risk factors for the child
Measured: 2 years of age
glucose
change in cardiovascular risk factors for the child
Measured: 2 years of age
hsCRP
change in cardiovascular risk factors for the child
Measured: 2 years of age
HbA1C
change in cardiovascular risk factors for the child
Measured: 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
Measured: 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Feb 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Public Health, University of Toronto, Unity Health Toronto, Applied Health Research Centre, McMaster University, Pediatric Alliance of Ontario, Canadian Paediatric Society, Queen Mary University of London
- Responsible party
- Principal investigator, Jonathon L Maguire, The Hospital for Sick Children
- Investigators
- Jonathon Maguire, MD,FRCPC,MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477628
- Sponsor's protocol ID
- 3606
- Acronym
- NuRISH
- Status last verified
- Nov 2023
- First submitted
- 2 Jun 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Recommendation Intervention trialS in Children's Healthcare
- ClinicalTrials.gov ID
- NCT05477628
- Acronym / sponsor ID
- NuRISH / 3606
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Toronto Public Health, University of Toronto, Unity Health Toronto, Applied Health Research Centre, McMaster University, Pediatric Alliance of Ontario, Canadian Paediatric Society, Queen Mary University of London
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control GroupParticipants who are randomized to the control group will receive usual care from their health care practitioners. |
| Intervention Group | Experimental | Other: Childcare Navigator, Other: Lactation Consultant, Other: Lactation Consultant Support and Childcare Navigator SupportParticipants 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. |
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy by parental report
- <32 weeks gestation
- 0-1 week of age
- First birth /first time parents
Key exclusion criteria (1 listed)
- Children with a syndrome associated with obesity or developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Childcare NavigatorAlso: (CN)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. | Other | Intervention Group |
| Lactation ConsultantAlso: (LC)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. | Other | Intervention Group |
| Lactation Consultant Support and Childcare Navigator SupportAlso: LC+CNThis intervention is a combination of the two interventions described above. | Other | Intervention Group |
| Control GroupAll children randomized to the control condition will receive age-appropriate nutritional recommendations as part of routine healthcare. | Other | Control Group |
Primary outcome
zBMI
Time frame: 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.
16 secondary outcomes
breastfeeding self-efficacy
Time frame: 6 months
exclusive breastfeeding duration
Time frame: 6 months
Childcare attendance
Time frame: 2 years of age
cognitive development
Time frame: 2 years of age
maternal mental health
Time frame: 2 years of age
mental health
Time frame: 2 years of age
blood pressure
Time frame: 2 years of age
non-HDL
Time frame: 2 years of age
LDL
Time frame: 2 years of age
triglyceride
Time frame: 2 years of age
HDL
Time frame: 2 years of age
TC
Time frame: 2 years of age
glucose
Time frame: 2 years of age
hsCRP
Time frame: 2 years of age
HbA1C
Time frame: 2 years of age
Dietary Quality
Time frame: 2 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathon Maguire, MD,FRCPC,MSc principal investigator
The Hospital for Sick Children
Questions about this trial
What is this clinical trial studying?
A study testing Childcare Navigator, Lactation Consultant and Lactation Consultant Support and Childcare Navigator Support in people with Obesity, Childhood and Nutrition, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Mitchell, BA (4165255417, michelle.mitchell@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zBMI (time frame: 2-year primary healthcare visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.