Health BehaviorNCT03716297
A Study of Some Aspects of Health in Special Youth Care
An observational study of Health Behavior, run by Vrije Universiteit Brussel.
Trial summary
The aim of this study is to examine some aspects of health in the special youth care. In this case it concerns the mental, social and physical and sporting health of the young people in the community institution De Kempen, Campus de Hutten. Read more about this study
- Who is it for?
- Ages 13 to 18 years, men only
- Conditions the study is for
- Health Behavior
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jun 2019
- 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 13 to 18 years
- Men only
- Child, Adult
Study population: Male participants with the age of 13 t.e.m. 18 years who live in the (closed) Community institution De Kempen, Campus de Hutten.
Who may be able to join
- For this research, data will only be collected from male participants with the age of 13 t.e.m. 18 years. These boys are in the (closed) Community institution De Kempen, Campus de Hutten.
Who cannot join
- For this research, no data will be collected from the young people on the other campus of the community institution. Campus de Markt is the open part of the community institution and the young people who live here are not the target group of the research.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of Some Aspects of Health in Special Youth Care: a Pilot Study
The aim of this study is to examine some aspects of health in the special youth care. In this case it concerns the mental, social and physical and sporting health of the young people in the community institution De Kempen, Campus de Hutten. To examine these aspects of health, questionnaires will be used and participants will be asked to wear a SenseWear bracelet during their PE lessons. It is a pilot study that explores and tests the way in which certain things are best investigated in this setting. It examines how the practical side of such research should be carried out. It will also be investigated which obstacles, weaknesses and errors can be encountered when conducting such an investigation.
Read the detailed description
This research is a quantitative cross-sectional study. Questionnaires will be taken from participants to measure mental, social and physical health. In addition, Sensewear bracelets will be used during the PE lessons of the participants to collect data (MET's and number of steps).
Three short questionnaires will be taken from the boys which measure the mental, social and physical health. Completing these questionnaires will take no longer than 10 minutes in total. The questionnaires will be filled in once by each participating individual at the start of the PE lesson.
During the PE class, the participants will receive a Sensewear bracelet in which the number of METs and the number of steps during the effort are measured. A distinction will also be made between the various sports during the PE lesson. Each participant will have to wear the Sensewear bracelet once during a single PE lesson.
It is an open research in which the participants are fully informed. The participants can voluntarily choose whether or not to participate in the study. The quantitative data collected from the questionnaires and Sensewear bracelets will then be used for de-finitive interpretation and decision making.
- Conditions
- Health Behavior
- Medical subject headings
- Health Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of physical health in special youth care by using a questionnaire: The Physical Activity Questionnaire for Adolescents
Use of a questionnaire (The Physical Activity Questionnaire for Adolescents) to assess physical health: there are 9 items in this questionnaire but only the first 8 items are used to calculate the total score. For the score of the first item you take the average of all the activities. On the other items the scores are between 1 and 5. To calculate the total score for this questionnaire, you have to calculate the average for all the 8 items. The final score is between 1 and 5 with 1 indicates low physical activity and 5 indicates high physical activity.
Measured: 1 hour
The level of mental health in special youth care by using a questionnaire: the Mental Health Inventory 5
Use of a questionnaire (Mental Health Inventory 5) to assess mental health: this questionnaire uses 5 questions to assess mental health. The score on each question is between 0 and 5. To calculate the total score of this questionnaire you have to add the scores of all the 5 questions and multiply by 4. The minimum sum score of a person is equal to 0 and the maximum score is equal to 100. The lower the score, the worse the psychological health of the person
Measured: 1 hour
The level of social health in special youth care by using a questionnaire: the Social Functioning Questionnaire
Use of a questionnaire (the Social Functioning Questionnaire) to assess social health: The questionnaire consists of 8 items with 4 answer options each. The score of each item is between 0 and 3. The final score of the SFQ is calculated by adding the score of all items. The total score is then between 0 and 24, with a higher score indicating poorer social functioning.
Measured: 1 hour
Secondary outcomes (1)
The level of physical activity during PE lessons in special youth care
use of a sensewear bracelet
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study startJan 2019 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Leenders, Vrije Universiteit Brussel
- Investigators
- Evert Zinzen, Professor, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716297
- Sponsor's protocol ID
- VrijeUB ALeenders
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Some Aspects of Health in Special Youth Care: a Pilot Study
- ClinicalTrials.gov ID
- NCT03716297
- Acronym / sponsor ID
- VrijeUB ALeenders
- Conditions
- Health Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Oct 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.
The aim of this study is to examine some aspects of health in the special youth care. In this case it concerns the mental, social and physical and sporting health of the young people in the community institution De Kempen, Campus de Hutten. To examine these aspects of health, questionnaires will be used and participants will be asked to wear a SenseWear bracelet during their PE lessons. It is a pilot study that explores and tests the way in which certain things are best investigated in this setting. It examines how the practical side of such research should be carried out. It will also be investigated which obstacles, weaknesses and errors can be encountered when conducting such an investigation.
Detailed description
This research is a quantitative cross-sectional study. Questionnaires will be taken from participants to measure mental, social and physical health. In addition, Sensewear bracelets will be used during the PE lessons of the participants to collect data (MET's and number of steps).
Three short questionnaires will be taken from the boys which measure the mental, social and physical health. Completing these questionnaires will take no longer than 10 minutes in total. The questionnaires will be filled in once by each participating individual at the start of the PE lesson.
During the PE class, the participants will receive a Sensewear bracelet in which the number of METs and the number of steps during the effort are measured. A distinction will also be made between the various sports during the PE lesson. Each participant will have to wear the Sensewear bracelet once during a single PE lesson.
It is an open research in which the participants are fully informed. The participants can voluntarily choose whether or not to participate in the study. The quantitative data collected from the questionnaires and Sensewear bracelets will then be used for de-finitive interpretation and decision making.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- Male participants with the age of 13 t.e.m. 18 years who live in the (closed) Community institution De Kempen, Campus de Hutten.
Key inclusion criteria (1 listed)
- For this research, data will only be collected from male participants with the age of 13 t.e.m. 18 years. These boys are in the (closed) Community institution De Kempen, Campus de Hutten.
Key exclusion criteria (1 listed)
- For this research, no data will be collected from the young people on the other campus of the community institution. Campus de Markt is the open part of the community institution and the young people who live here are not the target group of the research.
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
The level of physical health in special youth care by using a questionnaire: The Physical Activity Questionnaire for Adolescents
Time frame: 1 hour
Use of a questionnaire (The Physical Activity Questionnaire for Adolescents) to assess physical health: there are 9 items in this questionnaire but only the first 8 items are used to calculate the total score. For the score of the first item you take the average of all the activities. On the other items the scores are between 1 and 5. To calculate the total score for this questionnaire, you have to calculate the average for all the 8 items. The final score is between 1 and 5 with 1 indicates low physical activity and 5 indicates high physical activity.
The level of mental health in special youth care by using a questionnaire: the Mental Health Inventory 5
Time frame: 1 hour
Use of a questionnaire (Mental Health Inventory 5) to assess mental health: this questionnaire uses 5 questions to assess mental health. The score on each question is between 0 and 5. To calculate the total score of this questionnaire you have to add the scores of all the 5 questions and multiply by 4. The minimum sum score of a person is equal to 0 and the maximum score is equal to 100. The lower the score, the worse the psychological health of the person
The level of social health in special youth care by using a questionnaire: the Social Functioning Questionnaire
Time frame: 1 hour
Use of a questionnaire (the Social Functioning Questionnaire) to assess social health: The questionnaire consists of 8 items with 4 answer options each. The score of each item is between 0 and 3. The final score of the SFQ is calculated by adding the score of all items. The total score is then between 0 and 24, with a higher score indicating poorer social functioning.
1 secondary outcome
The level of physical activity during PE lessons in special youth care
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Evert Zinzen, Professor principal investigator
Vrije Universiteit Brussel
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by Vrije Universiteit Brussel.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid Leenders (32479742491, Astrid.Leenders@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of physical health in special youth care by using a questionnaire: The Physical Activity Questionnaire for Adolescents (time frame: 1 hour). 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 20 Nov 2018.