ClinicalTrials.gg
Active, not recruitingNCT03356262QUALITYUpdated Dec 2, 2024

The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort

An observational study in Obesity, Childhood, Diabetes Mellitus, Type 2 and Cardiovascular Risk Factor, sponsored by St. Justine's Hospital. Active, not recruiting. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by St. Justine's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
630
Ages
8 Years to 10 Years
Sex
All
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Study summary

The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort study is a unique and comprehensive longitudinal study of 630 Caucasian children and their parents that was designed to investigate the natural history and determinants of childhood obesity and its cardiometabolic consequences.

Read the detailed description

The QUALITY Cohort is funded by the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Canada, as well as the Fonds de la recherche en santé du Québec. The multidisciplinary study team comprises over 20 researchers with a wide variety of relevant expertise as well as research fellows, students and staff (www.etudequalitystudy.ca).

The specific objectives of QUALITY are: 1) To increase understanding of the natural history of excess weight and its associated cardiometabolic consequences (dyslipidemia, hyperinsulinemia, dysglycemia, inflammation, elevated blood pressure, sympathetic overactivity) in youth at risk for the development of obesity; 2) To investigate the relative importance of the genetic, biological, environmental and psychosocial determinants of excess weight and its associated cardiometabolic consequences. Determinants of particular interest include social factors (socio-economic status, family composition, built environment), behavioural factors (eating behaviour, physical activity, smoking, sleep, stress), biological factors (adverse fetal environment, body fat distribution, growth trajectory, aerobic fitness), metabolic factors (insulin sensitivity, adipocytokines), and genetic/familial factors (family history, parental characteristics, gene variations); 3) To examine the relation between obesity, cardiometabolic complications, and subclinical markers of atherosclerosis; and 4) To examine whether obesity and its associated risk factor are related to children's oral health.

The QUALITY Cohort used a school-based sampling strategy to identify potential participants. About 400 000 recruitment flyers were distributed over three consecutive years to parents of children in Grades 2 to 5, in 1040 primary schools (89% of schools approached) including 44 private schools situated within 75 km of Montreal, Quebec City and Sherbrooke in the province of Quebec, Canada. Families interested in participating were invited to contact the research coordinator for additional information, to confirm eligibility, and to set an appointment with the research team; 1320 of 3350 families who contacted the coordinator met the inclusion criteria. Six hundred and thirty families agreed to participate and completed the baseline evaluation.

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Conditions studied

  • Obesity, Childhood
  • Diabetes Mellitus, Type 2
  • Cardiovascular Risk Factor
  • Pediatric ALL
  • Lifestyle
  • Physical Activity
  • Sedentary Lifestyle
  • Diet Habit
  • Metabolic Complication

Keywords

  • Cohort study
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In context

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's enrollment of 630 is above the median of 180 across 235 observational studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

630 Caucasian families with a child aged 8-10 years agreed to participate and completed the baseline evaluation.

564 families completed the second round of data collection 2 years later. 377 families completed the third round of data collection 7 years after the baseline assessment.

A 4th round of data collection is currently being prepared.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 8-10 years at baseline;
  • Caucasian of Western European ancestry;
  • At least one obese biological parent (i.e., (BMI) ≥30 kg/m2 or waist circumference >102 cm in men and >88 cm in women, based on self-reported measurements of height, weight and waist circumference)
  • Both biological parents available to participate in the baseline assessment.

Exclusion criteria

Exclusion Criteria:

  • Children with a previous diagnosis of Type 1 or 2 diabetes;
  • Children with a previous diagnosis of a serious illness, psychological condition, or cognitive disorder which hindered participation in some or all of the study components;
  • Children treated with anti-hypertensive medication or (except if administered topically or through inhalation);
  • Children following a very restricted diet (\< 600 kcal/day);
  • Mother pregnant or breastfeeding at the baseline evaluation;
  • Family with pending plans to move out of the province of Quebec (Canada).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
630 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Body mass index (BMI)

    Weight (kg) and height (m) will be combined to report BMI in kg/m\^2 and transformed to z-scores using WHO standards

    Time frame: Through study completion, 13 - 14 years post baseline

Secondary outcomes

  1. Waist circumference

    Measured in centimeters, midway between the last floating rib and the iliac crest

    Time frame: Through study completion, 13 - 14 years post baseline

  2. % body fat mass

    Measured using dual energy x-ray absorptiometry and combined as total body fat mass in kg / total body mass in kg \* 100

    Time frame: Through study completion, 13 - 14 years post baseline

  3. Impaired fasting glucose

    Measured from a blood sample collected using venipuncture following a 12-hour overnight fast. Plasma glucose concentrations were computed on the Beckman Coulter Synchron LX20 automat using the glucose oxidase method. Analyses were performed in batches at the Centre Hospitalier Universitaire Sainte-Justine Clinical Biochemistry laboratory twice monthly. Considered as impaired fasting blood glucose if greater or equal to 5.6 mmol/L.

    Time frame: Through study completion, 13 - 14 years post baseline

  4. Impaired glucose tolerance

    Participants underwent a 2-hour oral glucose tolerance test (OGTT) after a 12-hour overnight fast. Blood samples were collected at 30-, 60-, 90-, and 120-minute intervals after an oral glucose dose of 1.75 g/kg of body weight (maximum 75 g). Plasma glucose concentrations were computed on the Beckman Coulter Synchron LX20 automat using the glucose oxidase method. Analyses were performed in batches at the Centre Hospitalier Universitaire Sainte-Justine Clinical Biochemistry laboratory twice monthly. Considered as impaired glucose tolerence blood glucose at 2hrs of the OGTT greater or equal to 7.8 mmol/L.

    Time frame: Through study completion, 13 - 14 years post baseline

  5. Type 2 diabetes

    Type 2 diabetes was diagnosed according to recognized criteria from the Canadian Diabetes Association (Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes 2013;37(suppl 1):S1-S212.)

    Time frame: Through study completion, 13 - 14 years post baseline

  6. Hypertension (systolic)

    Systolic and diastolic blood pressures (SBP and DBP, respectively) were measured using an appropriately sized arm cuff and an automated oscillometric blood pressure monitor doing 5 repeat measures at 1 min intervals (Dinamap model CR9340). Participants were seated and had to rest for 5 minutes prior to the measurement. The average of the last three measures of SBP and DBP was used in the analyses. These were then transformed to age-, sex-, and height-specific Z-scores according to The Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Considered hypertensive if SBP \> 95th percentile for age, sex, and height.

    Time frame: Through study completion, 13 - 14 years post baseline

  7. Hypertension (diastolic)

    Systolic and diastolic blood pressures (SBP and DBP, respectively) were measured using an appropriately sized arm cuff and an automated oscillometric blood pressure monitor doing 5 repeat measures at 1 min intervals (Dinamap model CR9340). Participants were seated and had to rest for 5 minutes prior to the measurement. The average of the last three measures of SBP and DBP was used in the analyses. These were then transformed to age-, sex-, and height-specific Z-scores according to The Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Considered hypertensive if DBP \> 95th percentile for age, sex, and height.

    Time frame: Through study completion, 13 - 14 years post baseline

  8. Dyslipidemia

    Blood samples were obtained by venipuncture after a 12 hour overnight fast. Lipids (high density lipoprotein (HDL) cholesterol and triglycerides) were measured on a Synchron LX®20 analyzer, with Beckman Instruments reagents, by the Department of Clinical Biochemistry at CHU Sainte-Justine, according to the recommendations of the International Federation of Clinical Chemistry. Low density lipoprotein (LDL) cholesterol was calculated based on the Friedewald equation. Dyslipedimia was defided according to published guidelines (Pediatrics. 2011 Dec; 128(Suppl 5): S213-S256.)

    Time frame: Through study completion, 13 - 14 years post baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Lambert M, Van Hulst A, O'Loughlin J, Tremblay A, Barnett TA, Charron H, Drapeau V, Dubois J, Gray-Donald K, Henderson M, Lagace G, Low NC, Mark S, Mathieu ME, Maximova K, McGrath JJ, Nicolau B, Pelletier C, Poirier P, Sabiston C, Paradis G. Cohort profile: the Quebec adipose and lifestyle investigation in youth cohort. Int J Epidemiol. 2012 Dec;41(6):1533-44. doi: 10.1093/ije/dyr111. Epub 2011 Jul 23. No abstract available. PubMed 21785124 ↗
  • Roberge JB, Harnois-Leblanc S, McNealis V, van Hulst A, Barnett TA, Kakinami L, Paradis G, Henderson M. Body Mass Index Z Score vs Weight-for-Length Z Score in Infancy and Cardiometabolic Outcomes at Age 8-10 Years. J Pediatr. 2021 Nov;238:208-214.e2. doi: 10.1016/j.jpeds.2021.07.046. Epub 2021 Jul 21. PubMed 34302856 ↗
  • Van Hulst A, Paradis G, Harnois-Leblanc S, Benedetti A, Drapeau V, Henderson M. Lowering Saturated Fat and Increasing Vegetable and Fruit Intake May Increase Insulin Sensitivity 2 Years Later in Children with a Family History of Obesity. J Nutr. 2018 Nov 1;148(11):1838-1844. doi: 10.1093/jn/nxy189. PubMed 30383280 ↗
  • Roberge JB, Van Hulst A, Barnett TA, Drapeau V, Benedetti A, Tremblay A, Henderson M. Lifestyle Habits, Dietary Factors, and the Metabolically Unhealthy Obese Phenotype in Youth. J Pediatr. 2019 Jan;204:46-52.e1. doi: 10.1016/j.jpeds.2018.08.063. Epub 2018 Oct 23. PubMed 30366774 ↗
  • Van Hulst A, Paradis G, Benedetti A, Barnett TA, Henderson M. Pathways Linking Birth Weight and Insulin Sensitivity in Early Adolescence: A Double Mediation Analysis. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4524-4532. doi: 10.1210/jc.2018-00525. PubMed 30137396 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03356262
Responsible party
Melanie Henderson (Clinical assistant professor, St. Justine's Hospital) — Principal investigator
First posted
Nov 29, 2017
Start date
Jul 25, 2005
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 2, 2024

Study contacts

Melanie Henderson, MD, PhD
principal investigator · Université de Montréal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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