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

November 28, 2024 updated by: Melanie Henderson, St. Justine's Hospital
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (Child)

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: Through study completion, 13 - 14 years post baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: Through study completion, 13 - 14 years post baseline
Measured in centimeters, midway between the last floating rib and the iliac crest
Through study completion, 13 - 14 years post baseline
% body fat mass
Time Frame: Through study completion, 13 - 14 years post baseline
Measured using dual energy x-ray absorptiometry and combined as total body fat mass in kg / total body mass in kg * 100
Through study completion, 13 - 14 years post baseline
Impaired fasting glucose
Time Frame: Through study completion, 13 - 14 years post baseline
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.
Through study completion, 13 - 14 years post baseline
Impaired glucose tolerance
Time Frame: Through study completion, 13 - 14 years post baseline
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.
Through study completion, 13 - 14 years post baseline
Type 2 diabetes
Time Frame: Through study completion, 13 - 14 years post baseline
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.)
Through study completion, 13 - 14 years post baseline
Hypertension (systolic)
Time Frame: Through study completion, 13 - 14 years post baseline
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.
Through study completion, 13 - 14 years post baseline
Hypertension (diastolic)
Time Frame: Through study completion, 13 - 14 years post baseline
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.
Through study completion, 13 - 14 years post baseline
Dyslipidemia
Time Frame: Through study completion, 13 - 14 years post baseline
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.)
Through study completion, 13 - 14 years post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Melanie Henderson, MD, PhD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2005

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 11, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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