Clinical trial NCT03356262: The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort
Official title: The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity, Childhood
Diabetes Mellitus, Type 2
Cardiovascular Risk Factor
Pediatric ALL
Lifestyle
Physical Activity
Sedentary Lifestyle
Diet Habit
Metabolic Complication
Keywords: Cohort study
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 630
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Children aged 8-10 years at baseline;
* Caucasian of Western European ancestry;
* At least one obese biological parent (i.e., body mass index (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:

* 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 steroids (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).

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: Through study completion, 13 - 14 years post baseline
Secondary outcomes:
measure: Waist circumference
timeFrame: Through study completion, 13 - 14 years post baseline
measure: % body fat mass
timeFrame: Through study completion, 13 - 14 years post baseline
measure: Impaired fasting glucose
timeFrame: Through study completion, 13 - 14 years post baseline
measure: Impaired glucose tolerance
timeFrame: Through study completion, 13 - 14 years post baseline
measure: Type 2 diabetes
timeFrame: Through study completion, 13 - 14 years post baseline
measure: Hypertension (systolic)
timeFrame: Through study completion, 13 - 14 years post baseline
measure: Hypertension (diastolic)
timeFrame: Through study completion, 13 - 14 years post baseline
measure: Dyslipidemia
timeFrame: Through study completion, 13 - 14 years post baseline
Other outcomes:
Locations:
Study officials:
affiliation: Université de Montréal
name: Melanie Henderson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.