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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03244150
Other study ID # 09-060078/FSS
Secondary ID 2003-0200-13
Status Completed
Phase N/A
First received July 31, 2017
Last updated August 8, 2017
Start date August 1, 1983
Est. completion date August 1, 2005

Study information

Verified date August 2017
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 3008
Est. completion date August 1, 2005
Est. primary completion date August 1, 2005
Accepts healthy volunteers
Gender All
Age group 15 Years to 19 Years
Eligibility Danish teenagers born between 1964 and 1969.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Parker Institute Frederiksberg

Sponsors (5)

Lead Sponsor Collaborator
Bispebjerg Hospital Aase and Ejnar Danielsens Foundation, The Copenhagen Hospital Corporation (now Copenhagen Capital Region), the Danish Medical Research Council (grant number 09-060078/FSS), The Danish Ministry of Health (2003-0200-13)

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Collected/measured in 1983 or 1985 and at follow-up in 2005
Secondary 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. Weight was reported in 1983 or 1985 and at follow-up in 2005
Secondary Waist circumference Waist circumference was self-reported at the follow-up survey. Waist circumference was at follow-up in 2005
Secondary 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. Alcohol consumption was reported in 1983 or 1985 and at follow-up in 2005
Secondary 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. Information on smoking was reported in 1983 or 1985 and at follow-up in 2005
Secondary Education and occupation At follow-up, participants were asked to report their occupation and highest achieved education. Information on education and occupation was reported in 2005
Secondary Parental education and occupation At baseline, participants were asked to report parental occupation and highest education. Information on education and occupation was reported in 1983 or 1985
Secondary Macronutrient intake At follow-up, participants completed a 28-item food frequency questionnaire. From this we will calculate the participants' macronutrient intake. Information on macronutrient intake was reported in 2005
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