Physical ActivityYSSNCT03244150
Youth and Sport Study
An observational study of Physical Activity and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born between 1964 and 1969. Baseline data originate from two different studies carried out in 1983 and 1985, and the follow-up study was carried out in 2005. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Physical Activity, Obesity, Lifestyle
- How many people
- 3,008 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 1983to 1 Aug 2005
- 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 15 to 19 years
- All sexes
- Child, Adult
Study population: The first baseline study included 1260 students in gymnasium, vocational school, or trade school born in 1964-68. The second baseline study included a representative sample of 2498 teenagers born in 1967 or 1969 (1.5% of the total population).
Danish teenagers born between 1964 and 1969.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Youth and Sport Study - a 20 Year Follow-up Study of Danish Teenagers Born Between 1964 and 1969
The Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born between 1964 and 1969. Baseline data originate from two different studies carried out in 1983 and 1985, and the follow-up study was carried out in 2005.
Read the detailed description
The first baseline study was conducted in 1983 and included 1260 students in high school or trade school. The questionnaire was designed with focus on various aspects of sports and physical activity beside more general questions on family, socioeconomic status, height, weight, alcohol intake, smoking, etc. Furthermore, the participants were subjected to a set of physical tests and measurements.
The second baseline study was conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR) and invited to participate in the study with the aim of validating the results from the first baseline sample. The study consisted of a questionnaire with virtually the same questions as the questionnaire from 1983. A short 28-item food frequency questionnaire (FFQ) was added to the questionnaire, as well as a few questions about dietary habits.
The follow-up study was carried out in 2005, when the subjects had reached an age of around 40 years. A total of 1904 subjects were traced and asked to complete a general questionnaire, a food frequency questionnaire, and deliver a DNA sample, all distributed and returned through mail correspondence. The general questionnaire included questions on education, occupation, height, previous and present weight, weight loss history, physical activity, smoking, civil status, children, other family, stress, diseases, hospital admissions, and medicine use, among other things. The questions about physical activity were adopted from the baseline questionnaire. Other questions were adopted from other validated questionnaires. Moreover, a semi-quantitative, 195-item Food Frequency Questionnaire (FFQ), which previously has been used and validated in the Danish "Diet, Cancer and Health" study was included. The study was approved by the local ethics committee for Copenhagen and Frederiksberg (J.nr. KF 01-260/04).
- Conditions
- Physical Activity, Obesity, Lifestyle
- Keywords
- Physical activity, Obesity, Overweight, Lifestyle, Diet
- Medical subject headings
- Motor Activity, Obesity, Overweight
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 |
|---|---|---|
| School sample | Conducted in 1983 and included 1260 students in high school or trade school. | |
| Nationwide sample | Conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Leisure time physical activity has been assessed by questionnaire, where participants filled in the different types of sports they attended and the time they actively participated in each type of sport per week. Lastly, the type and the amount of time spend on activities outside of school and sports clubs were also assessed. Each sport and activity has been translated into metabolic equivalent (MET) scores [28]. MET scores at the individual time points and changes during follow-up will be used as outcome.
Measured: Collected/measured in 1983 or 1985 and at follow-up in 2005
Secondary outcomes (7)
Body Mass Index (BMI)
BMI will be calculated using self-reported height and weight for both baseline and follow-up surveys. BMI at the individual time points and changes during follow-up will be used as outcome.
Measured: Weight was reported in 1983 or 1985 and at follow-up in 2005
Waist circumference
Waist circumference was self-reported at the follow-up survey.
Measured: Waist circumference was at follow-up in 2005
Alcohol consumption
Alcohol consumption was assessed by the question "How often do you drink different types of alcohol?" with three choices - beer, wine and spirit". Alcohol at the individual time points and changes during follow-up will be used as outcome.
Measured: Alcohol consumption was reported in 1983 or 1985 and at follow-up in 2005
Smoking
Smoking was assessed with the questions on smoking status and amount of tobacco smoked at baseline and follow-up. Information on smoking at the individual time points and changes during follow-up will be used as outcome.
Measured: Information on smoking was reported in 1983 or 1985 and at follow-up in 2005
Education and occupation
At follow-up, participants were asked to report their occupation and highest achieved education.
Measured: Information on education and occupation was reported in 2005
Parental education and occupation
At baseline, participants were asked to report parental occupation and highest education.
Measured: Information on education and occupation was reported in 1983 or 1985
Macronutrient intake
At follow-up, participants completed a 28-item food frequency questionnaire. From this we will calculate the participants' macronutrient intake.
Measured: Information on macronutrient intake was reported in 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Aug 1983
- Primary completion1 Aug 2005
- Study completion1 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- 3,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- the Danish Medical Research Council (grant number 09-060078/FSS), The Danish Ministry of Health (2003-0200-13), Aase and Ejnar Danielsens Foundation, Region Capital Denmark
- Responsible party
- Principal investigator, Berit Lilienthal Heitmann, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244150
- Sponsor's protocol ID
- 09-060078/FSS
- Other IDs
- 2003-0200-13
- Acronym
- YSS
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poudel P, Ismailova K, Andersen LB, Larsen SC, Heitmann BL. Adolescent wine consumption is inversely associated with long-term weight gain: results from follow-up of 20 or 22 years. Nutr J. 2019 Sep 10;18(1):56. doi: 10.1186/s12937-019-0478-7.
PubMed 31506084
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth and Sport Study - a 20 Year Follow-up Study of Danish Teenagers Born Between 1964 and 1969
- ClinicalTrials.gov ID
- NCT03244150
- Acronym / sponsor ID
- YSS / 09-060078/FSS
- Conditions
- Physical Activity, Obesity, Lifestyle
- Keywords
- Physical activity, Obesity, Overweight, Lifestyle, Diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,008 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- the Danish Medical Research Council (grant number 09-060078/FSS), The Danish Ministry of Health (2003-0200-13), Aase and Ejnar Danielsens Foundation, Region Capital Denmark
- Study start
- 1 Aug 1983 (actual)
- Primary completion
- 1 Aug 2005 (actual)
- Study completion
- 1 Aug 2005 (actual)
- First posted
- 9 Aug 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 Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born between 1964 and 1969. Baseline data originate from two different studies carried out in 1983 and 1985, and the follow-up study was carried out in 2005.
Detailed description
The first baseline study was conducted in 1983 and included 1260 students in high school or trade school. The questionnaire was designed with focus on various aspects of sports and physical activity beside more general questions on family, socioeconomic status, height, weight, alcohol intake, smoking, etc. Furthermore, the participants were subjected to a set of physical tests and measurements.
The second baseline study was conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR) and invited to participate in the study with the aim of validating the results from the first baseline sample. The study consisted of a questionnaire with virtually the same questions as the questionnaire from 1983. A short 28-item food frequency questionnaire (FFQ) was added to the questionnaire, as well as a few questions about dietary habits.
The follow-up study was carried out in 2005, when the subjects had reached an age of around 40 years. A total of 1904 subjects were traced and asked to complete a general questionnaire, a food frequency questionnaire, and deliver a DNA sample, all distributed and returned through mail correspondence. The general questionnaire included questions on education, occupation, height, previous and present weight, weight loss history, physical activity, smoking, civil status, children, other family, stress, diseases, hospital admissions, and medicine use, among other things. The questions about physical activity were adopted from the baseline questionnaire. Other questions were adopted from other validated questionnaires. Moreover, a semi-quantitative, 195-item Food Frequency Questionnaire (FFQ), which previously has been used and validated in the Danish "Diet, Cancer and Health" study was included. The study was approved by the local ethics committee for Copenhagen and Frederiksberg (J.nr. KF 01-260/04).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School sample | – | –Conducted in 1983 and included 1260 students in high school or trade school. |
| Nationwide sample | – | –Conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR) |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The first baseline study included 1260 students in gymnasium, vocational school, or trade school born in 1964-68. The second baseline study included a representative sample of 2498 teenagers born in 1967 or 1969 (1.5% of the total population).
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
Physical activity
Time frame: Collected/measured in 1983 or 1985 and at follow-up in 2005
Leisure time physical activity has been assessed by questionnaire, where participants filled in the different types of sports they attended and the time they actively participated in each type of sport per week. Lastly, the type and the amount of time spend on activities outside of school and sports clubs were also assessed. Each sport and activity has been translated into metabolic equivalent (MET) scores [28]. MET scores at the individual time points and changes during follow-up will be used as outcome.
7 secondary outcomes
Body Mass Index (BMI)
Time frame: Weight was reported in 1983 or 1985 and at follow-up in 2005
Waist circumference
Time frame: Waist circumference was at follow-up in 2005
Alcohol consumption
Time frame: Alcohol consumption was reported in 1983 or 1985 and at follow-up in 2005
Smoking
Time frame: Information on smoking was reported in 1983 or 1985 and at follow-up in 2005
Education and occupation
Time frame: Information on education and occupation was reported in 2005
Parental education and occupation
Time frame: Information on education and occupation was reported in 1983 or 1985
Macronutrient intake
Time frame: Information on macronutrient intake was reported in 2005
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 9 Aug 2017.
- Derived from this study: PubMed 31506084Poudel P, Ismailova K, Andersen LB, Larsen SC, Heitmann BL. Adolescent wine consumption is inversely associated with long-term weight gain: results from follow-up of 20 or 22 years. Nutr J. 2019 Sep 10;18(1):56. doi: 10.1186/s12937-019-0478-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Physical Activity and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Aug 2017. 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 Denmark. 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?
Physical activity (time frame: Collected/measured in 1983 or 1985 and at follow-up in 2005). 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 NCT03244150, which also lists 1 linked publication.
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 9 Aug 2017.