Overweight and ObesityNCT03482193
Health Literacy and Overweight in Adolescents
An observational study of Overweight and Obesity, run by University of Liege at 1 site in Belgium.
Trial summary
Obesity in children and adolescents has become a major public health problem in recent years. In Belgium, 20% of people aged between 2 and 17 are overweight and 7% suffer from obesity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- How many people
- 254 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2017to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adolescents studying in 2nd or 4th year in one of the participating secondary school. Students in those years receive a medical examination, which facilitate the collect of data and made us chose to limit the participation to these 2 years.
Who may be able to join
- Studying in one of the participating school
- Being in 2nd or 4th year
- Parental consent to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Adolescents' Interactive and Critical Health Literacy With Their Overweight: a Study in a Medium Urban City in Belgium
Obesity in children and adolescents has become a major public health problem in recent years. In Belgium, 20% of people aged between 2 and 17 are overweight and 7% suffer from obesity. While studies often associate this overweight with socio-economic level, other factors, such as health literacy (HL), may also play a role. Among adolescents, some studies have shown an association between the level of HL and the Body Mass Index (BMI). Our study aims to investigate the association between HL of adolescents and their BMI.
This is a cross-sectional survey among 9 high schools in a medium city of Belgium, including 254 high school students aged between 12-17 years. Health literacy was assessed by the Health Literacy Measure for Adolescents (HELMA). Student's age, sex, weight, size and parental socio-economic status are gathered in the medical file during the medical examination organized by the schools after obtaining the informed consent of the students and their parents.
- Conditions
- Overweight and Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Adolescents in 2nd or 4th year in secondary school, from 9 different schools in Liège, Belgium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy
The degree to which individuals can obtain, process and understand basic health information and services needed to make appropriate health decisions. It also includes the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. It is measured by the Health Literacy Measure for Adolescents (HELMA) (Ghanbari et al., 2016), which is composed of 44 items. Health literacy was categorized into 4 categories based on the score to the questionnaire: excellent, sufficient, problematic and inadequate.
Measured: 1 day (At the inclusion in the study)
Body Mass Index
Calculated with the standard formula (weight/height²) and categorized into 4 categories (underweight, normal, overweight, obesity) according to the PNNS and IOTF-25 and -30 curves.
Measured: 1 day (At the inclusion in the study)
Parents' socio-economic status
We collected the profession of the parents' through the adolescent's medical file, and categorized them into 4 categories: worker, employee, independent, unemployed.
Measured: 1 day (At the inclusion in the study)
Secondary outcomes (2)
Language spoken at home
Collected through a socio-demographic questionnaire
Measured: 1 day (At the inclusion in the study)
Education type
General eduction versus other (differentiated, professional, transition, qualification). Collected through a socio-demographic questionnaire
Measured: 1 day (At the inclusion in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Cross-sectional
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Bragard, University of Liege
- Investigators
- Isabelle Bragard, Study director, Université de Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482193
- Sponsor's protocol ID
- HL-ado-obésité
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Adolescents' Interactive and Critical Health Literacy With Their Overweight: a Study in a Medium Urban City in Belgium
- ClinicalTrials.gov ID
- NCT03482193
- Acronym / sponsor ID
- HL-ado-obésité
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Mar 2018 (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.
Obesity in children and adolescents has become a major public health problem in recent years. In Belgium, 20% of people aged between 2 and 17 are overweight and 7% suffer from obesity. While studies often associate this overweight with socio-economic level, other factors, such as health literacy (HL), may also play a role. Among adolescents, some studies have shown an association between the level of HL and the Body Mass Index (BMI). Our study aims to investigate the association between HL of adolescents and their BMI.
This is a cross-sectional survey among 9 high schools in a medium city of Belgium, including 254 high school students aged between 12-17 years. Health literacy was assessed by the Health Literacy Measure for Adolescents (HELMA). Student's age, sex, weight, size and parental socio-economic status are gathered in the medical file during the medical examination organized by the schools after obtaining the informed consent of the students and their parents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –Adolescents in 2nd or 4th year in secondary school, from 9 different schools in Liège, Belgium. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents studying in 2nd or 4th year in one of the participating secondary school. Students in those years receive a medical examination, which facilitate the collect of data and made us chose to limit the participation to these 2 years.
Key inclusion criteria (3 listed)
- Studying in one of the participating school
- Being in 2nd or 4th year
- Parental consent to participate
Key exclusion criteria (1 listed)
- None
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
Health Literacy
Time frame: 1 day (At the inclusion in the study)
The degree to which individuals can obtain, process and understand basic health information and services needed to make appropriate health decisions. It also includes the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. It is measured by the Health Literacy Measure for Adolescents (HELMA) (Ghanbari et al., 2016), which is composed of 44 items. Health literacy was categorized into 4 categories based on the score to the questionnaire: excellent, sufficient, problematic and inadequate.
Body Mass Index
Time frame: 1 day (At the inclusion in the study)
Calculated with the standard formula (weight/height²) and categorized into 4 categories (underweight, normal, overweight, obesity) according to the PNNS and IOTF-25 and -30 curves.
Parents' socio-economic status
Time frame: 1 day (At the inclusion in the study)
We collected the profession of the parents' through the adolescent's medical file, and categorized them into 4 categories: worker, employee, independent, unemployed.
2 secondary outcomes
Language spoken at home
Time frame: 1 day (At the inclusion in the study)
Education type
Time frame: 1 day (At the inclusion in the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Isabelle Bragard study director
Université de Liège
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by University of Liege at 1 site in Belgium.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health Literacy (time frame: 1 day (At the inclusion in the study)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2018.