NCT03356262

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2005

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2005Dec 2030

Study Start

First participant enrolled

July 25, 2005

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

25.5 years

First QC Date

November 11, 2017

Last Update Submit

November 28, 2024

Conditions

Keywords

Cohort study

Outcome Measures

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

    Through study completion, 13 - 14 years post baseline

Secondary Outcomes (8)

  • Waist circumference

    Through study completion, 13 - 14 years post baseline

  • % body fat mass

    Through study completion, 13 - 14 years post baseline

  • Impaired fasting glucose

    Through study completion, 13 - 14 years post baseline

  • Impaired glucose tolerance

    Through study completion, 13 - 14 years post baseline

  • Type 2 diabetes

    Through study completion, 13 - 14 years post baseline

  • +3 more secondary outcomes

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 21785124BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, blood, serum, urine, stool, saliva

MeSH Terms

Conditions

Pediatric ObesityDiabetes Mellitus, Type 2Precursor Cell Lymphoblastic Leukemia-LymphomaMotor ActivitySedentary BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehaviorBehavior, Animal

Study Officials

  • Melanie Henderson, MD, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

November 11, 2017

First Posted

November 29, 2017

Study Start

July 25, 2005

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share