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

NCT ID: NCT03356262

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-25

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melanie Henderson

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melanie Henderson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21785124 (View on PubMed)

Saade MB, Holden S, Kakinami L, McGrath JJ, Mathieu ME, Poirier P, Barnett TA, Beaucage P, Henderson M. Adiposity and cardiac autonomic function in children with a family history of obesity. Clin Auton Res. 2024 Dec;34(6):583-592. doi: 10.1007/s10286-024-01063-y. Epub 2024 Sep 21.

Reference Type DERIVED
PMID: 39304555 (View on PubMed)

Harnois-Leblanc S, Van Hulst A, Lucibello KM, Harbec MJ, Sabiston CM, Maximova K, Sylvestre MP, Henderson M. Associations Between Weight-Loss Attempts, Weight-Related Stress, and Body Image During Childhood and Adolescence in Children With Parental Obesity. Child Obes. 2024 Sep;20(6):434-441. doi: 10.1089/chi.2023.0082. Epub 2024 Jan 19.

Reference Type DERIVED
PMID: 38241489 (View on PubMed)

Sohi DK, Van Hulst A, McNealis V, Simoneau G, Drapeau V, Barnett TA, Mathieu ME, Paradis G, Tremblay A, Benedetti A, Henderson M. Early Lifestyle Determinants of Adiposity Trajectories from Childhood into Late Adolescence. Child Obes. 2024 Jul;20(5):336-345. doi: 10.1089/chi.2023.0062. Epub 2023 Dec 13.

Reference Type DERIVED
PMID: 38100098 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34302856 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30383280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30366774 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30137396 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QUALITY

Identifier Type: -

Identifier Source: org_study_id