Nutritional DisordersTARGetKids!NCT01869530
TARGet Kids!: Measuring Nutrition in Young Preschool Children in the Primary Care Practice Setting
An observational study of Nutritional Disorders and Obesity, run by The Hospital for Sick Children at 3 sites in Canada.
Trial summary
TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life exposures to health problems including obesity, micronutrient deficiencies, and developmental problems. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Disorders, Obesity, Development
- How many people
- 14,000 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2008to Jun 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children are recruited from 12 pediatric and family medicine primary care practices in Toronto, Ontario, and Montreal, Quebec, Canada.
Who may be able to join
- Birth to less than 6 years of age
- Parental consent
- Attending a TARGet Kids! research network practice
Who cannot join
- Chronic illness with the exception of asthma
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Melville Pediatric Center
Montreal, Quebec
Patricia Li, MD
Elise Mok, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Jonathon Maguire, MD, MSc, FRCPC, 416-919-3462, jonathon.maguire@utoronto.ca
Jonathon L Maguire, MD, MSc
- Recruiting
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Catherine Birken, MD, M.Sc., FRCPC, 416-813-7654 ext. 301544, catherine.birken@sickkids.ca
Dalah Mason, MPH, 416-813-7654 ext. 302129, dalah.mason@sickkids.ca
About this study
TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life exposures to health problems including obesity, micronutrient deficiencies, and developmental problems.
TARGet Kids! represents an innovative collaboration between child health researchers and children's primary care doctors (pediatricians and family physicians) to promote research that really matters and create solutions to some of the today's biggest health concerns. The results of this collaborative research study are not only improving the quality of children's healthcare but also the health of children across the country. Coordinated by Sick Kids and St. Michael's Hospital with data management services by the Applied Health Research Centre (AHRC), TARGet Kids! is the only primary care research network for children in Canada.
- Conditions
- Nutritional Disorders, Obesity, Development
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Change in BMI over a 10 year follow-up period
Measured: 10 years (yearly measurements)
Secondary outcomes (8)
Nutrition
Nutritional risk
Measured: Yearly measurements
Development
Child development
Measured: Yearly measurements
Mental Health
Mental Health
Measured: Yearly measurements
Lifestyle Factors
Assessment of Lifestyle Factors that contribute to health
Measured: Yearly measurements
Child Behavior
Child behavior
Measured: Yearly measurements
Social Determinants
Social determinants of health
Measured: Yearly measurements
Education
Nutritional factors affects on education
Measured: Yearly measurements
Parenting
Parenting styles
Measured: Yearly measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJul 2008
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Nutritional DisordersStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Birken, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869530
- Sponsor's protocol ID
- 2063
- Acronym
- TARGetKids!
- Status last verified
- Nov 2021
- First submitted
- 28 May 2013
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoshida-Montezuma Y, Keown-Stoneman CDG, Jamnik J, Smith BT, Pabayo R, Kinlin LM, Vanderloo LM, Omand J, Maguire JL, Birken CS, Anderson LN. Changes in obesity and waist circumference in children and parents during the COVID-19 pandemic. Sci Rep. 2026 Jun 20. doi: 10.1038/s41598-026-57151-8. Online ahead of print.
PubMed 42321251Borkhoff CM, Imsirovic H, Bayoumi I, Macarthur C, Nurse KM, To T, Feldman M, Lau E, Knight B, Birken CS, Maguire JL, Parkin PC. Developmental screening at 18 months using the Nipissing District Developmental Screen. Paediatr Child Health. 2025 May 11;30(6):477-485. doi: 10.1093/pch/pxaf023. eCollection 2025 Sep.
PubMed 41049705Kucab MD, Keown-Stoneman CD, Birken CS, Perlman M, Parsons J, D'Annunzio D, Thadani S, Allen CA, Maguire JL; TARGet Kids! Collaboration. Center-Based Childcare in Early Childhood and Nutritional Risk in Later Childhood: A Prospective Cohort Study. J Nutr. 2025 Dec;155(12):4530-4539. doi: 10.1016/j.tjnut.2025.09.028. Epub 2025 Sep 27.
PubMed 41022151Nurse KM, Parkin PC, Keown-Stoneman CDG, Bayoumi I, Birken CS, Maguire JL, Macarthur C, Borkhoff CM. Association Between Family Income and Positive Developmental Screening Using the Infant Toddler Checklist at the 18-Month Health Supervision Visit. J Pediatr. 2024 Jan;264:113769. doi: 10.1016/j.jpeds.2023.113769. Epub 2023 Nov 1.
PubMed 37821023Palumbo AM, Kirkwood D, Borkhoff CM, Keown-Stoneman CDG, Muraca GM, Fuller A, Birken CS, Maguire JL, Brown HK, Anderson LN; TARGet Kids! Collaboration. Validation of Parent-reported Gestational Age Categories for Children Less Than 6 Years of Age. Epidemiology. 2023 Nov 1;34(6):767-773. doi: 10.1097/EDE.0000000000001645. Epub 2023 Sep 26.
PubMed 37757868Braddon KE, Keown-Stoneman CD, Dennis CL, Li X, Maguire JL, O'Connor DL, Omand JA, Simpson JR, Birken CS. Maternal Preconception Body Mass Index and Early Childhood Nutritional Risk. J Nutr. 2023 Aug;153(8):2421-2431. doi: 10.1016/j.tjnut.2023.06.022. Epub 2023 Jun 24.
PubMed 37356500Kucab MD, Keown-Stoneman CDG, Birken CS, Perlman M, Maguire JL; TARGet Kids! Collaboration. Centre-based childcare in early childhood and growth in later childhood: a prospective cohort study. Int J Obes (Lond). 2023 Aug;47(8):724-731. doi: 10.1038/s41366-023-01316-2. Epub 2023 Apr 27.
PubMed 37106078Omand JA, Li X, Keown-Stoneman CDG, Borkhoff CM, Duku E, Lebovic G, Maguire JL, Mamdani MM, Parkin PC, Reid-Westoby C, Randall Simpson J, Tremblay MS, Janus M, Birken CS; TARGet Kids! Study Group. Body Weight at Age Four Years and Readiness to Start School: A Prospective Cohort Study. Child Obes. 2023 Jun;19(4):267-281. doi: 10.1089/chi.2022.0018. Epub 2022 Jul 13.
PubMed 35834646Omand JA, Janus M, Maguire JL, Parkin PC, Aglipay M, Randall Simpson J, Keown-Stoneman CDG, Duku E, Reid-Westoby C, Birken CS. Nutritional Risk in Early Childhood and School Readiness. J Nutr. 2021 Dec 3;151(12):3811-3819. doi: 10.1093/jn/nxab307.
PubMed 34587245Hamid JS, Atenafu EG, Borkhoff CM, Birken CS, Maguire JL, Bohn MK, Adeli K, Abdelhaleem M, Parkin PC. Reference intervals for hemoglobin and mean corpuscular volume in an ethnically diverse community sample of Canadian children 2 to 36 months. BMC Pediatr. 2021 May 19;21(1):241. doi: 10.1186/s12887-021-02709-w.
PubMed 34011305Bayoumi I, Birken CS, Nurse KM, Parkin PC, Maguire JL, Macarthur C, Randall Simpson JA, Borkhoff CM. Screening for marginal food security in young children in primary care. BMC Pediatr. 2021 Apr 23;21(1):196. doi: 10.1186/s12887-021-02674-4.
PubMed 33892660Gunaseelan V, Parkin PC, Wahi G, Birken CS, Maguire JL, Macarthur C, Borkhoff CM; Members of the TARGet Kids! Collaboration. Maternal ethnicity and iron status in early childhood in Toronto, Canada: a cross-sectional study. BMJ Paediatr Open. 2020 Apr 6;4(1):e000635. doi: 10.1136/bmjpo-2020-000635. eCollection 2020.
PubMed 32509978Birken CS, Omand JA, Nurse KM, Borkhoff CM, Koroshegyi C, Lebovic G, Maguire JL, Mamdani M, Parkin PC, Randall Simpson J, Tremblay MS, Duku E, Reid-Westoby C, Janus M; TARGet Kids! Collaboration. Fit for School Study protocol: early child growth, health behaviours, nutrition, cardiometabolic risk and developmental determinants of a child's school readiness, a prospective cohort. BMJ Open. 2019 Nov 19;9(11):e030709. doi: 10.1136/bmjopen-2019-030709.
PubMed 31748293Parkin PC, Koroshegyi C, Mamak E, Borkhoff CM, Birken CS, Maguire JL, Thorpe KE; TARGet Kids! Collaboration. Association between Serum Ferritin and Cognitive Function in Early Childhood. J Pediatr. 2020 Feb;217:189-191.e2. doi: 10.1016/j.jpeds.2019.09.051. Epub 2019 Nov 2.
PubMed 31685227Wong VCH, Maguire JL, Omand JA, Dai DWH, Lebovic G, Parkin PC, O'Connor DL, Birken CS; TARGet Kids! Collaboration. A Positive Association Between Dietary Intake of Higher Cow's Milk-Fat Percentage and Non-High-Density Lipoprotein Cholesterol in Young Children. J Pediatr. 2019 Aug;211:105-111.e2. doi: 10.1016/j.jpeds.2019.03.047. Epub 2019 May 17.
PubMed 31104850
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGet Kids!: Measuring Nutrition in Young Preschool Children in the Primary Care Practice Setting
- ClinicalTrials.gov ID
- NCT01869530
- Acronym / sponsor ID
- TARGetKids! / 2063
- Conditions
- Nutritional Disorders, Obesity, Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- 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.
TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life exposures to health problems including obesity, micronutrient deficiencies, and developmental problems.
TARGet Kids! represents an innovative collaboration between child health researchers and children's primary care doctors (pediatricians and family physicians) to promote research that really matters and create solutions to some of the today's biggest health concerns. The results of this collaborative research study are not only improving the quality of children's healthcare but also the health of children across the country. Coordinated by Sick Kids and St. Michael's Hospital with data management services by the Applied Health Research Centre (AHRC), TARGet Kids! is the only primary care research network for children in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | – |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children are recruited from 12 pediatric and family medicine primary care practices in Toronto, Ontario, and Montreal, Quebec, Canada.
Key inclusion criteria (3 listed)
- Birth to less than 6 years of age
- Parental consent
- Attending a TARGet Kids! research network practice
Key exclusion criteria (1 listed)
- Chronic illness with the exception of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Mass Index (BMI)
Time frame: 10 years (yearly measurements)
Change in BMI over a 10 year follow-up period
8 secondary outcomes
Nutrition
Time frame: Yearly measurements
Development
Time frame: Yearly measurements
Mental Health
Time frame: Yearly measurements
Lifestyle Factors
Time frame: Yearly measurements
Child Behavior
Time frame: Yearly measurements
Social Determinants
Time frame: Yearly measurements
Education
Time frame: Yearly measurements
Parenting
Time frame: Yearly measurements
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 17 Nov 2021.
- Derived from this study: PubMed 42321251Yoshida-Montezuma Y, Keown-Stoneman CDG, Jamnik J, Smith BT, Pabayo R, Kinlin LM, Vanderloo LM, Omand J, Maguire JL, Birken CS, Anderson LN. Changes in obesity and waist circumference in children and parents during the COVID-19 pandemic. Sci Rep. 2026 Jun 20. doi: 10.1038/s41598-026-57151-8. Online ahead of print.
- Derived from this study: PubMed 41049705Borkhoff CM, Imsirovic H, Bayoumi I, Macarthur C, Nurse KM, To T, Feldman M, Lau E, Knight B, Birken CS, Maguire JL, Parkin PC. Developmental screening at 18 months using the Nipissing District Developmental Screen. Paediatr Child Health. 2025 May 11;30(6):477-485. doi: 10.1093/pch/pxaf023. eCollection 2025 Sep.
- Derived from this study: PubMed 41022151Kucab MD, Keown-Stoneman CD, Birken CS, Perlman M, Parsons J, D'Annunzio D, Thadani S, Allen CA, Maguire JL; TARGet Kids! Collaboration. Center-Based Childcare in Early Childhood and Nutritional Risk in Later Childhood: A Prospective Cohort Study. J Nutr. 2025 Dec;155(12):4530-4539. doi: 10.1016/j.tjnut.2025.09.028. Epub 2025 Sep 27.
- Derived from this study: PubMed 37821023Nurse KM, Parkin PC, Keown-Stoneman CDG, Bayoumi I, Birken CS, Maguire JL, Macarthur C, Borkhoff CM. Association Between Family Income and Positive Developmental Screening Using the Infant Toddler Checklist at the 18-Month Health Supervision Visit. J Pediatr. 2024 Jan;264:113769. doi: 10.1016/j.jpeds.2023.113769. Epub 2023 Nov 1.
- Derived from this study: PubMed 37757868Palumbo AM, Kirkwood D, Borkhoff CM, Keown-Stoneman CDG, Muraca GM, Fuller A, Birken CS, Maguire JL, Brown HK, Anderson LN; TARGet Kids! Collaboration. Validation of Parent-reported Gestational Age Categories for Children Less Than 6 Years of Age. Epidemiology. 2023 Nov 1;34(6):767-773. doi: 10.1097/EDE.0000000000001645. Epub 2023 Sep 26.
- Derived from this study: PubMed 37356500Braddon KE, Keown-Stoneman CD, Dennis CL, Li X, Maguire JL, O'Connor DL, Omand JA, Simpson JR, Birken CS. Maternal Preconception Body Mass Index and Early Childhood Nutritional Risk. J Nutr. 2023 Aug;153(8):2421-2431. doi: 10.1016/j.tjnut.2023.06.022. Epub 2023 Jun 24.
- Derived from this study: PubMed 37106078Kucab MD, Keown-Stoneman CDG, Birken CS, Perlman M, Maguire JL; TARGet Kids! Collaboration. Centre-based childcare in early childhood and growth in later childhood: a prospective cohort study. Int J Obes (Lond). 2023 Aug;47(8):724-731. doi: 10.1038/s41366-023-01316-2. Epub 2023 Apr 27.
- Derived from this study: PubMed 35834646Omand JA, Li X, Keown-Stoneman CDG, Borkhoff CM, Duku E, Lebovic G, Maguire JL, Mamdani MM, Parkin PC, Reid-Westoby C, Randall Simpson J, Tremblay MS, Janus M, Birken CS; TARGet Kids! Study Group. Body Weight at Age Four Years and Readiness to Start School: A Prospective Cohort Study. Child Obes. 2023 Jun;19(4):267-281. doi: 10.1089/chi.2022.0018. Epub 2022 Jul 13.
- Derived from this study: PubMed 34587245Omand JA, Janus M, Maguire JL, Parkin PC, Aglipay M, Randall Simpson J, Keown-Stoneman CDG, Duku E, Reid-Westoby C, Birken CS. Nutritional Risk in Early Childhood and School Readiness. J Nutr. 2021 Dec 3;151(12):3811-3819. doi: 10.1093/jn/nxab307.
- Derived from this study: PubMed 34011305Hamid JS, Atenafu EG, Borkhoff CM, Birken CS, Maguire JL, Bohn MK, Adeli K, Abdelhaleem M, Parkin PC. Reference intervals for hemoglobin and mean corpuscular volume in an ethnically diverse community sample of Canadian children 2 to 36 months. BMC Pediatr. 2021 May 19;21(1):241. doi: 10.1186/s12887-021-02709-w.
- Derived from this study: PubMed 33892660Bayoumi I, Birken CS, Nurse KM, Parkin PC, Maguire JL, Macarthur C, Randall Simpson JA, Borkhoff CM. Screening for marginal food security in young children in primary care. BMC Pediatr. 2021 Apr 23;21(1):196. doi: 10.1186/s12887-021-02674-4.
- Derived from this study: PubMed 32509978Gunaseelan V, Parkin PC, Wahi G, Birken CS, Maguire JL, Macarthur C, Borkhoff CM; Members of the TARGet Kids! Collaboration. Maternal ethnicity and iron status in early childhood in Toronto, Canada: a cross-sectional study. BMJ Paediatr Open. 2020 Apr 6;4(1):e000635. doi: 10.1136/bmjpo-2020-000635. eCollection 2020.
- TARGet Kids! websiteLink provided by the sponsor.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Disorders and Obesity, run by The Hospital for Sick Children at 3 sites in Canada.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Catherine Birken, MD, M.Sc., FRCPC (416-813-7654 ext. 302129, catherine.birken@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: 10 years (yearly measurements)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869530, which also lists 21 linked publications.
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 17 Nov 2021.