Obesity, ChildhoodCHAMPS-DKNCT03510494
The Svendborg-project
A study testing Augmented physical education program in people with Obesity, Childhood and Risk Factor, Cardiovascular, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Risk Factor, Cardiovascular, Sports Injury
- What is being tested?
- Augmented physical education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,209 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Jun 2015
- Phase
- Interventional
- 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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Childhood Health, Activity, and Motor Performance School Study Denmark
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.
- Conditions
- Obesity, Childhood, Risk Factor, Cardiovascular, Sports Injury, Physical Activity, Motor Activity
- Being tested
- Augmented physical education program
- Medical subject headings
- Pediatric Obesity, Athletic Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented physical education programBehavioural
Augmented physical education program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Trebling of weekly curricular physical education (270 minutes per week) Receives: Behavioral: Augmented physical education program |
| Control | No intervention | Standard curriculum physical education (90 minutes per week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kilograms)
Standardized assessments performed by trained personal using an electronic scale.
Measured: Change over 2 years
Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
Standardized assessments performed by trained personal.
Measured: Change over 2 years
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Weekly short-message-service tracking of participants to determine severity, frequency and nature (acute/overuse) of injuries.
Measured: Total incidence of musculoskeletal problems across 2.5 years
Height (centimeters)
Standardized assessments performed by trained personal using a stadiometer.
Measured: Change over 2 years
Body-mass index (kg/m^2)
Calculated from measured height and weight
Measured: Change over 2 years
Waist circumference (centimeters)
Standardized assessments performed by trained personal at the level of the umbilical cord
Measured: Change over 2 years
DXA determined body fat (%)
In subcohort only. Standardized assessments performed by trained personal.
Measured: Change over 2 years
Serum fasting insulin (IU/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Serum fasting glucose (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Serum fasting triglycerides (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Serum fasting total cholesterol (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Serum fasting low-density lipoprotein cholesterol (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Serum fasting high-density lipoprotein cholesterol (mmol/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Serum fasting C-reactive protein (mg/l)
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Measured: Change over 2 years
Homeostasis model assessment of insulin resistance (HOMA-IR)
Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
Measured: Change over 2 years
Resting systolic blood pressure (mmHg)
Standardized assessments performed by trained personal
Measured: Change over 2 years
Resting diastolic blood pressure (mmHg)
Standardized assessments performed by trained personal
Measured: Change over 2 years
Composite risk factor score (z-scores)
Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
Measured: Change over 2 years
Cardiorespiratory fitness (meters)
Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal
Measured: Change over 2 years
Handgrip strength (kg)
Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal
Measured: Change over 2.5 years
Agility (seconds)
Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal
Measured: Change over 2.5 years
Backward balance (0-72 points)
From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal
Measured: Change over 2.5 years
Maximal vertical jump performance (centimeters)
Standardized assessments performed by trained personal
Measured: Change over 2.5 years
Precision throw (0-30 points)
From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
Measured: Change over 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startAug 2008
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group receiving 270 minutes of weekly physical education Control group receiving 90 minutes of weekly physical education Intervention group physical education teachers receiving physical education courses (ATK-concept)
- Masking
- None (open label)
- Enrolment
- 1,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University College Lillebælt
- Responsible party
- Sponsor
- Investigators
- Niels Wedderkopp, Prof, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510494
- Sponsor's protocol ID
- S-20080047
- Acronym
- CHAMPS-DK
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon request from the CHAMPS Study Steering Committee due to legal and ethical restrictions. Interested parties may contact Dr Niels Wedderkopp (nwedderkopp@health.sdu.dk), and the following information will be required at the time of application: a description of how the data will be used, securely managed, and permanently deleted.
Publications
Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, Moller NC, Leboeuf-Yde C. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK). BMC Pediatr. 2012 Aug 20;12:128. doi: 10.1186/1471-2431-12-128.
PubMed 22906115Cheron C, Leboeuf-Yde C, Le Scanff C, Jespersen E, Rexen CT, Franz C, Wedderkopp N. Leisure-time sport and overuse injuries of extremities in children age 6-13, a 2.5 years prospective cohort study: the CHAMPS-study DK. BMJ Open. 2017 Jan 13;7(1):e012606. doi: 10.1136/bmjopen-2016-012606.
PubMed 28087543Huang T, Gejl AK, Tarp J, Andersen LB, Peijs L, Bugge A. Cross-sectional associations of objectively measured physical activity with brain-derived neurotrophic factor in adolescents. Physiol Behav. 2017 Mar 15;171:87-91. doi: 10.1016/j.physbeh.2016.12.026. Epub 2016 Dec 24.
PubMed 28027935Hebert JJ, Moller NC, Andersen LB, Wedderkopp N. Organized Sport Participation Is Associated with Higher Levels of Overall Health-Related Physical Activity in Children (CHAMPS Study-DK). PLoS One. 2015 Aug 11;10(8):e0134621. doi: 10.1371/journal.pone.0134621. eCollection 2015.
PubMed 26262678Heidemann M, Holst R, Schou AJ, Klakk H, Husby S, Wedderkopp N, Molgaard C. The influence of anthropometry and body composition on children's bone health: the childhood health, activity and motor performance school (the CHAMPS) study, Denmark. Calcif Tissue Int. 2015 Feb;96(2):97-104. doi: 10.1007/s00223-014-9941-9. Epub 2014 Dec 25.
PubMed 25539855Larsen LR, Kristensen PL, Junge T, Rexen CT, Wedderkopp N. Motor Performance as Predictor of Physical Activity in Children: The CHAMPS Study-DK. Med Sci Sports Exerc. 2015 Sep;47(9):1849-56. doi: 10.1249/MSS.0000000000000604.
PubMed 25539477Klakk H, Grontved A, Moller NC, Heidemann M, Andersen LB, Wedderkopp N. Prospective association of adiposity and cardiorespiratory fitness with cardiovascular risk factors in healthy children. Scand J Med Sci Sports. 2014 Aug;24(4):e275-82. doi: 10.1111/sms.12163. Epub 2014 Jan 8.
PubMed 24397591Moller NC, Tarp J, Kamelarczyk EF, Brond JC, Klakk H, Wedderkopp N. Do extra compulsory physical education lessons mean more physically active children--findings from the childhood health, activity, and motor performance school study Denmark (The CHAMPS-study DK). Int J Behav Nutr Phys Act. 2014 Sep 24;11:121. doi: 10.1186/s12966-014-0121-0.
PubMed 25248973Heidemann M, Jespersen E, Holst R, Schou AJ, Husby S, Molgaard C, Wedderkopp N. The impact on children's bone health of a school-based physical education program and participation in leisure time sports: the Childhood Health, Activity and Motor Performance School (the CHAMPS) study, Denmark. Prev Med. 2013 Aug;57(2):87-91. doi: 10.1016/j.ypmed.2013.04.015. Epub 2013 Apr 30.
PubMed 23643934Klakk H, Chinapaw M, Heidemann M, Andersen LB, Wedderkopp N. Effect of four additional physical education lessons on body composition in children aged 8-13 years--a prospective study during two school years. BMC Pediatr. 2013 Oct 17;13:170. doi: 10.1186/1471-2431-13-170.
PubMed 24131778Klakk H, Andersen LB, Heidemann M, Moller NC, Wedderkopp N. Six physical education lessons a week can reduce cardiovascular risk in school children aged 6-13 years: a longitudinal study. Scand J Public Health. 2014 Mar;42(2):128-36. doi: 10.1177/1403494813505726. Epub 2013 Sep 20.
PubMed 24055828Jespersen E, Rexen CT, Franz C, Moller NC, Froberg K, Wedderkopp N. Musculoskeletal extremity injuries in a cohort of schoolchildren aged 6-12: a 2.5-year prospective study. Scand J Med Sci Sports. 2015 Apr;25(2):251-8. doi: 10.1111/sms.12177. Epub 2014 Jan 29.
PubMed 24472003Wedderkopp N, Wang C, Steele R, Hebert J, Rexen C, Jespersen E, Junge T, Thomsen T, Jensen FM, Shrier I. Incidence of and Risk Factors for Lower Extremity Apophysitis in Children and Adolescents. Sports Med. 2026 Mar;56(3):793-803. doi: 10.1007/s40279-025-02328-w. Epub 2025 Nov 3.
PubMed 41182572Tarp J, Jespersen E, Moller NC, Klakk H, Wessner B, Wedderkopp N, Bugge A. Long-term follow-up on biological risk factors, adiposity, and cardiorespiratory fitness development in a physical education intervention: a natural experiment (CHAMPS-study DK). BMC Public Health. 2018 May 9;18(1):605. doi: 10.1186/s12889-018-5524-4.
PubMed 29739385
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Childhood Health, Activity, and Motor Performance School Study Denmark
- ClinicalTrials.gov ID
- NCT03510494
- Acronym / sponsor ID
- CHAMPS-DK / S-20080047
- Conditions
- Obesity, Childhood, Risk Factor, Cardiovascular, Sports Injury, Physical Activity, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,209 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University College Lillebælt
- Study start
- Aug 2008 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Apr 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group receiving 270 minutes of weekly physical education Control group receiving 90 minutes of weekly physical education Intervention group physical education teachers receiving physical education courses (ATK-concept)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Augmented physical education programTrebling of weekly curricular physical education (270 minutes per week) |
| Control | No intervention | –Standard curriculum physical education (90 minutes per week) |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled at school participating in study
- Grade 0 - 4
- written, informed consent provided by parent or legal guardian
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented physical education programAugmented physical education program | Behavioural | Intervention |
Primary outcome
Body weight (kilograms)
Time frame: Change over 2 years
Standardized assessments performed by trained personal using an electronic scale.
Dual-energy X-ray absorptiometry (DXA) determined bone mineral content (grams)
Time frame: Change over 2 years
Standardized assessments performed by trained personal.
Musculoskeletal problems (injuries, defined as inability to participate in sports)
Time frame: Total incidence of musculoskeletal problems across 2.5 years
Weekly short-message-service tracking of participants to determine severity, frequency and nature (acute/overuse) of injuries.
Height (centimeters)
Time frame: Change over 2 years
Standardized assessments performed by trained personal using a stadiometer.
Body-mass index (kg/m^2)
Time frame: Change over 2 years
Calculated from measured height and weight
Waist circumference (centimeters)
Time frame: Change over 2 years
Standardized assessments performed by trained personal at the level of the umbilical cord
DXA determined body fat (%)
Time frame: Change over 2 years
In subcohort only. Standardized assessments performed by trained personal.
Serum fasting insulin (IU/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting glucose (mmol/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting triglycerides (mmol/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting total cholesterol (mmol/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting low-density lipoprotein cholesterol (mmol/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting high-density lipoprotein cholesterol (mmol/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Serum fasting C-reactive protein (mg/l)
Time frame: Change over 2 years
Standardized assessments performed by trained biomedical laboratory technicians. Fasting status affirmed verbally.
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: Change over 2 years
Calculated as fasting insulin (IU/l) x fasting glucose (mmol/l))/ 22.5
Resting systolic blood pressure (mmHg)
Time frame: Change over 2 years
Standardized assessments performed by trained personal
Resting diastolic blood pressure (mmHg)
Time frame: Change over 2 years
Standardized assessments performed by trained personal
Composite risk factor score (z-scores)
Time frame: Change over 2 years
Standardized (z-scores) values of HOMA-IR, triglycerides, cholesterol-fractions, systolic blood pressure, and cardiorespiratory fitness
Cardiorespiratory fitness (meters)
Time frame: Change over 2 years
Performance on indirect cardiorespiratory fitness test (Andersen-test). Standardized assessments performed by trained personal
Handgrip strength (kg)
Time frame: Change over 2.5 years
Maximal strength measured by a dynamometer. Standardized assessments performed by trained personal
Agility (seconds)
Time frame: Change over 2.5 years
Measured by the 50 meter short-shuttle test. Standardized assessments performed by trained personal
Backward balance (0-72 points)
Time frame: Change over 2.5 years
From the "Korperkoordinations Test fur Kinder". Standardized assessments performed by trained personal
Maximal vertical jump performance (centimeters)
Time frame: Change over 2.5 years
Standardized assessments performed by trained personal
Precision throw (0-30 points)
Time frame: Change over 2.5 years
From ''Der Allgemeiner Sportmotorischer Test fur Kinder von 6-11 Jahren''
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 27 Apr 2018.
- Background: PubMed 22906115Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, Moller NC, Leboeuf-Yde C. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK). BMC Pediatr. 2012 Aug 20;12:128. doi: 10.1186/1471-2431-12-128.
- Background: PubMed 28087543Cheron C, Leboeuf-Yde C, Le Scanff C, Jespersen E, Rexen CT, Franz C, Wedderkopp N. Leisure-time sport and overuse injuries of extremities in children age 6-13, a 2.5 years prospective cohort study: the CHAMPS-study DK. BMJ Open. 2017 Jan 13;7(1):e012606. doi: 10.1136/bmjopen-2016-012606.
- Background: PubMed 28027935Huang T, Gejl AK, Tarp J, Andersen LB, Peijs L, Bugge A. Cross-sectional associations of objectively measured physical activity with brain-derived neurotrophic factor in adolescents. Physiol Behav. 2017 Mar 15;171:87-91. doi: 10.1016/j.physbeh.2016.12.026. Epub 2016 Dec 24.
- Background: PubMed 26262678Hebert JJ, Moller NC, Andersen LB, Wedderkopp N. Organized Sport Participation Is Associated with Higher Levels of Overall Health-Related Physical Activity in Children (CHAMPS Study-DK). PLoS One. 2015 Aug 11;10(8):e0134621. doi: 10.1371/journal.pone.0134621. eCollection 2015.
- Background: PubMed 25539855Heidemann M, Holst R, Schou AJ, Klakk H, Husby S, Wedderkopp N, Molgaard C. The influence of anthropometry and body composition on children's bone health: the childhood health, activity and motor performance school (the CHAMPS) study, Denmark. Calcif Tissue Int. 2015 Feb;96(2):97-104. doi: 10.1007/s00223-014-9941-9. Epub 2014 Dec 25.
- Background: PubMed 25539477Larsen LR, Kristensen PL, Junge T, Rexen CT, Wedderkopp N. Motor Performance as Predictor of Physical Activity in Children: The CHAMPS Study-DK. Med Sci Sports Exerc. 2015 Sep;47(9):1849-56. doi: 10.1249/MSS.0000000000000604.
- Background: PubMed 24397591Klakk H, Grontved A, Moller NC, Heidemann M, Andersen LB, Wedderkopp N. Prospective association of adiposity and cardiorespiratory fitness with cardiovascular risk factors in healthy children. Scand J Med Sci Sports. 2014 Aug;24(4):e275-82. doi: 10.1111/sms.12163. Epub 2014 Jan 8.
- Results publication: PubMed 25248973Moller NC, Tarp J, Kamelarczyk EF, Brond JC, Klakk H, Wedderkopp N. Do extra compulsory physical education lessons mean more physically active children--findings from the childhood health, activity, and motor performance school study Denmark (The CHAMPS-study DK). Int J Behav Nutr Phys Act. 2014 Sep 24;11:121. doi: 10.1186/s12966-014-0121-0.
- Results publication: PubMed 23643934Heidemann M, Jespersen E, Holst R, Schou AJ, Husby S, Molgaard C, Wedderkopp N. The impact on children's bone health of a school-based physical education program and participation in leisure time sports: the Childhood Health, Activity and Motor Performance School (the CHAMPS) study, Denmark. Prev Med. 2013 Aug;57(2):87-91. doi: 10.1016/j.ypmed.2013.04.015. Epub 2013 Apr 30.
- Results publication: PubMed 24131778Klakk H, Chinapaw M, Heidemann M, Andersen LB, Wedderkopp N. Effect of four additional physical education lessons on body composition in children aged 8-13 years--a prospective study during two school years. BMC Pediatr. 2013 Oct 17;13:170. doi: 10.1186/1471-2431-13-170.
- Results publication: PubMed 24055828Klakk H, Andersen LB, Heidemann M, Moller NC, Wedderkopp N. Six physical education lessons a week can reduce cardiovascular risk in school children aged 6-13 years: a longitudinal study. Scand J Public Health. 2014 Mar;42(2):128-36. doi: 10.1177/1403494813505726. Epub 2013 Sep 20.
- Results publication: PubMed 24472003Jespersen E, Rexen CT, Franz C, Moller NC, Froberg K, Wedderkopp N. Musculoskeletal extremity injuries in a cohort of schoolchildren aged 6-12: a 2.5-year prospective study. Scand J Med Sci Sports. 2015 Apr;25(2):251-8. doi: 10.1111/sms.12177. Epub 2014 Jan 29.
- Individual participant dataSharing planned: Yes. Data are available upon request from the CHAMPS Study Steering Committee due to legal and ethical restrictions. Interested parties may contact Dr Niels Wedderkopp (nwedderkopp@health.sdu.dk), and the following information will be required at the time of application: a description of how the data will be used, securely managed, and permanently deleted.
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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.
Niels Wedderkopp, Prof principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented physical education program in people with Obesity, Childhood and Risk Factor, Cardiovascular, run by University of Southern Denmark 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?
The sponsor lists 3 inclusion and 0 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 27 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 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?
Body weight (kilograms) (time frame: Change over 2 years). The study lists 24 primary outcomes in all. 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 NCT03510494, which also lists 14 linked publications.
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 27 Apr 2018.