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The Svendborg-project (NCT03510494) | Clinical Trial Compass

CompletedNot Applicable

The Svendborg-project

Denmark1,209 participantsStarted 2008-08

Plain-language summary

The main aim of this study is to describe differences in development of health and motor performance over time in relation to type of school and other background variables.

Who can participate

Age range5 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Enrolled at school participating in study * Grade 0 - 4 * written, informed consent provided by parent or legal guardian Exclusion Criteria:

What they're measuring

1

Body weight (kilograms)

Timeframe: Change over 2 years

2

Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)

Timeframe: Change over 2 years

3

Musculoskeletal problems (injuries, defined as inability to participate in sports)

Timeframe: Total incidence of musculoskeletal problems across 2.5 years

4

Height (centimeters)

Timeframe: Change over 2 years

5

Body-mass index (kg/m^2)

Timeframe: Change over 2 years

6

Waist circumference (centimeters)

Timeframe: Change over 2 years

7

DXA determined body fat (%)

Timeframe: Change over 2 years

8

Serum fasting insulin (IU/l)

Timeframe: Change over 2 years

9

Trial details

NCT IDNCT03510494

SponsorUniversity of Southern Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Obesity, Childhood trials

Serum fasting glucose (mmol/l)

Timeframe: Change over 2 years

10

Serum fasting triglycerides (mmol/l)

Timeframe: Change over 2 years

11

Serum fasting total cholesterol (mmol/l)

Timeframe: Change over 2 years

12

Serum fasting low-density lipoprotein cholesterol (mmol/l)

Timeframe: Change over 2 years

13

Serum fasting high-density lipoprotein cholesterol (mmol/l)

Timeframe: Change over 2 years

14

Serum fasting C-reactive protein (mg/l)

Timeframe: Change over 2 years

15

Homeostasis model assessment of insulin resistance (HOMA-IR)

Timeframe: Change over 2 years

16

Resting systolic blood pressure (mmHg)

Timeframe: Change over 2 years

17

Resting diastolic blood pressure (mmHg)

Timeframe: Change over 2 years

18

Composite risk factor score (z-scores)

Timeframe: Change over 2 years

19

Cardiorespiratory fitness (meters)

Timeframe: Change over 2 years

20

Handgrip strength (kg)

Timeframe: Change over 2.5 years

21

Agility (seconds)

Timeframe: Change over 2.5 years

22

Backward balance (0-72 points)

Timeframe: Change over 2.5 years

23

Maximal vertical jump performance (centimeters)

Timeframe: Change over 2.5 years

24

Precision throw (0-30 points)

Timeframe: Change over 2.5 years