Obesity, ChildhoodQUALITYNCT03356262
The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort
An observational study of Obesity, Childhood and Diabetes Mellitus, Type 2, run by St. Justine's Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Diabetes Mellitus, Type 2, Cardiovascular Risk Factor
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2005to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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.
- Conditions
- Obesity, Childhood, Diabetes Mellitus, Type 2, Cardiovascular Risk Factor, Pediatric ALL, Lifestyle, Physical Activity
- Keywords
- Cohort study
- Medical subject headings
- Pediatric Obesity, Diabetes Mellitus, Type 2, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity, Sedentary Behavior, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, 13 - 14 years post baseline
Secondary outcomes (8)
Waist circumference
Measured in centimeters, midway between the last floating rib and the iliac crest
Measured: Through study completion, 13 - 14 years post baseline
% 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
Measured: Through study completion, 13 - 14 years post baseline
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.
Measured: Through study completion, 13 - 14 years post baseline
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.
Measured: Through study completion, 13 - 14 years post baseline
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.)
Measured: Through study completion, 13 - 14 years post baseline
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.
Measured: Through study completion, 13 - 14 years post baseline
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.
Measured: Through study completion, 13 - 14 years post baseline
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.)
Measured: Through study completion, 13 - 14 years post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start25 Jul 2005
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Henderson, St. Justine's Hospital
- Investigators
- Melanie Henderson, MD, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356262
- Sponsor's protocol ID
- QUALITY
- Acronym
- QUALITY
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2017
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21785124Saade 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.
PubMed 39304555Harnois-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.
PubMed 38241489Sohi 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.
PubMed 38100098Roberge 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 34302856Van 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 30383280Roberge 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 30366774Van 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort
- ClinicalTrials.gov ID
- NCT03356262
- Acronym / sponsor ID
- QUALITY / QUALITY
- Conditions
- Obesity, Childhood, Diabetes Mellitus, Type 2, Cardiovascular Risk Factor, Pediatric ALL, Lifestyle, Physical Activity
- Keywords
- Cohort study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 630 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 25 Jul 2005 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Waist circumference
Time frame: Through study completion, 13 - 14 years post baseline
% body fat mass
Time frame: Through study completion, 13 - 14 years post baseline
Impaired fasting glucose
Time frame: Through study completion, 13 - 14 years post baseline
Impaired glucose tolerance
Time frame: Through study completion, 13 - 14 years post baseline
Type 2 diabetes
Time frame: Through study completion, 13 - 14 years post baseline
Hypertension (systolic)
Time frame: Through study completion, 13 - 14 years post baseline
Hypertension (diastolic)
Time frame: Through study completion, 13 - 14 years post baseline
Dyslipidemia
Time frame: Through study completion, 13 - 14 years post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 21785124Lambert 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.
- Derived from this study: PubMed 39304555Saade 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.
- Derived from this study: PubMed 38241489Harnois-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.
- Derived from this study: PubMed 38100098Sohi 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.
- Derived from this study: PubMed 34302856Roberge 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.
- Derived from this study: PubMed 30383280Van 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.
- Derived from this study: PubMed 30366774Roberge 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.
- Derived from this study: PubMed 30137396Van 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.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Henderson, MD, PhD principal investigator
Université de Montréal
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Diabetes Mellitus, Type 2, run by St. Justine's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) (time frame: Through study completion, 13 - 14 years post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356262, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.