Healthy ChildrenActChildNCT06791278
Improvements in Daily Activity and Exercise in School Children: the ActChild Study
A study testing Exercise in people with Healthy Children and Children, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to assess the health-related effects of an exercise intervention in children aged 5-8 years. Main research questions: Does a municipality-driven exercise intervention improve physical activity levels in children? Does a municipality-driven exercise intervention improve sleep… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children, Children, Children in School
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Feb 2025to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schoolchildren, 0.-1. Grade, 5-8 years of age,
- Resident in Aarhus Municipality
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jens M Bruun, Professor contact
Denmark1 site
Aarhus Municipality
Aarhus
Marie Madsen, +4529209704, madmari@aarhus.dk
About this study
The goal of this clinical trial is to assess the health-related effects of an exercise intervention in children aged 5-8 years.
Main research questions:
Read more
- Does a municipality-driven exercise intervention improve physical activity levels in children?
- Does a municipality-driven exercise intervention improve sleep parameters in children?
- Does a municipality-driven exercise intervention improve eating behaviors in children?
- Does a municipality-driven exercise intervention improve quality of life in children?
Study Design:
Participants will be assigned to either:
- Intervention group: Attend 1-2 weekly sessions of 45-60 minutes of child-friendly exercise for 1 year.
- Control group: Receive no intervention.
Data Collection:
Participants will:
- Complete questionnaires at baseline, and at 1-year, 3-year, and 5-year follow-ups.
- Wear accelerometers for 7 consecutive days at baseline, and at 1-year, 3-year, and 5-year follow-ups.
Read the detailed description
Introduction:
Being physically inactive is associated with increased risk of developing non-communicable, lifestyle diseases such as Type 2 Diabetes (T2D), overweight/obesity, coronary heart disease (CHD) and premature death. In Denmark it is estimated that physical inactivity is responsible for more than 6000 deaths and related costs of 5.3 billion Danish Kroner each year. Although not fully elucidated, an increase in physical inactivity among children has over the last 20-30 years been observed in parallel with an increase in childhood overweight and obesity.
Aim:
The overall aim of this study is to promote (increase and sustain) healthy physical activity behaviors in children aged 5-8 years. The investigators wish to investigate the effects of an exercise intervention on physical activity, sleep (e.g. quality and duration), eating behavior, quality of life and anthropometrics.
Design The project is a collaborative clinical trial investigating the implementation of supervised physical activity in school children in Aarhus Municipality.
Intervention Children aged 5-8 years from Aarhus municipality will be included in the study. Initially first-year students from selected schools will be recruited as a control group. After one year an intervention group will be formed out of first-year students from the same schools. The intervention group will be invited to participate in a supervised training intervention during after-school daycare time.
The supervised physical activity will be conducted by after-school childcare educators in the municipalities, who have years of experience in handling children. The childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions.
Parents/legal guardians and participants will be able to withdraw from the study at any time.
Feasibility Feasibility and sustainability form the foundation of this exercise intervention. The project is developed, evaluated, and implemented in close collaboration with Aarhus Municipality. The intervention is designed to be easily maintained and scalable for implementation beyond the research setting.
- Conditions
- Healthy Children, Children, Children in School, Child Health, Child Behavior, Physical Activity
- Being tested
- Exercise
- Keywords
- Exercise Intervention, Children, School Children, CEBQ, Eating Behavior, Sleep, Physical Activity, Quality of Life
- Medical subject headings
- Child Behavior, Motor Activity, Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called physical activity
After-school childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions. The children will receive 1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year. Receives: Behavioral: Exercise |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group change in time spent in moderate to vigorous physical activity (MVPA)
Time spent in moderate to vigorous physical activity (MVPA). Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of MVPA per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in total movement time
Total daily time the children spent moving in different body positions and engaging in different physical activities (standing, walking, running and biking). Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in time spent in light physical activity (LPA)
Time spent in light physical activity. Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in time spent being sedentary
Sedentary time is defined as any waking activity characterized as being in a sitting, reclining or lying posture with minimal stationary movement. Sedentary time will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sedentary time between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in total sleep time (TST)
Total sleep time will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in sleep efficiency (SE)
Sleep efficiency will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in sleep onset latency (SOL)
Sleep onset latency will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group change in wake after sleep onset (WASO)
Wake after sleep onset will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Secondary outcomes (4)
Between group change in eating behavior
Eating behavior traits assessed by Children's Eating Behavior Questionnaire (the CEBQ). The CEBQ is a 35-item parent-report questionnaire assessing eating behavior in children. Eating behavior is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), emotional undereating (4 items), and food fussiness (7 items). CEBQ responses will be scored from 1 to 5 and means for each subscale will be calculated. Changes in eating behavior will be compared between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: The CEBQ will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group changes in self-reported quality of life
Quality of life will be assessed by the Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a 23-item questionnaire with four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items on the PedsQL Generic Core Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life. Two Summary Scores will be computed (the Psychosocial Health Summary Score and the Physical Health Summary Score), as well as a Total Scale Score. The Psychosocial Health Summary Score is the mean score on the Emotional, Social and School Functioning Scales. The Physical Health Summary Score is the mean score on the Physical Functioning Scale. The Total Scale Score is the mean of all items.
A subsample analysis will be conducted on children who do not meet the WHO recommendations of 60 minutes of MVPA per day.
Measured: Questionnaires will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups.
Between group change in BMI-SDS
Anthropometry data (i.e. heigth in cm, weight in kg and BMI in kg/m^2) measured from routine visits with the school health nurse will be transferred from Aarhus Municipality. Anthropometry data will be converted to standard deviation scores (BMI-SDS).
Changes in BMI-SDS will be compared between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Measured: From enrollment to the end of 5-year follow-up.
Baseline characteristics and data from school questionnaires
Baseline characteristics is collected at enrollment. Aarhus Municipality will provide additional descriptive data from municipality-driven questionnaires (www.boernungeliv.dk).
Measured: From enrollment to the end of the 5-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start4 Feb 2025 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a quasi-experimental study and participants will be assigned to intervention or control based on the time of inclusion. Each participating school will include controls at baseline. After one year, new participants will be included to the intervention group.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus Municipality, Denmark
- Responsible party
- Sponsor
- Investigators
- Jens M Bruun, Professor, Principal investigator, Aarhus University and Steno Diabetes Center Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791278
- Sponsor's protocol ID
- ActChild
- Acronym
- ActChild
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have decided not to share individual participant data (IPD) due to ethical and privacy considerations, particularly given the sensitive nature of the data and the young age of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvements in Daily Activity and Exercise in School Children: the ActChild Study
- ClinicalTrials.gov ID
- NCT06791278
- Acronym / sponsor ID
- ActChild / ActChild
- Conditions
- Healthy Children, Children, Children in School, Child Health, Child Behavior, Physical Activity
- Keywords
- Exercise Intervention, Children, School Children, CEBQ, Eating Behavior, Sleep, Physical Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus Municipality, Denmark
- Study start
- 4 Feb 2025 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 24 Jan 2025 (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 goal of this clinical trial is to assess the health-related effects of an exercise intervention in children aged 5-8 years.
Main research questions:
- Does a municipality-driven exercise intervention improve physical activity levels in children?
- Does a municipality-driven exercise intervention improve sleep parameters in children?
- Does a municipality-driven exercise intervention improve eating behaviors in children?
- Does a municipality-driven exercise intervention improve quality of life in children?
Study Design:
Participants will be assigned to either:
- Intervention group: Attend 1-2 weekly sessions of 45-60 minutes of child-friendly exercise for 1 year.
- Control group: Receive no intervention.
Data Collection:
Participants will:
- Complete questionnaires at baseline, and at 1-year, 3-year, and 5-year follow-ups.
- Wear accelerometers for 7 consecutive days at baseline, and at 1-year, 3-year, and 5-year follow-ups.
Detailed description
Introduction:
Being physically inactive is associated with increased risk of developing non-communicable, lifestyle diseases such as Type 2 Diabetes (T2D), overweight/obesity, coronary heart disease (CHD) and premature death. In Denmark it is estimated that physical inactivity is responsible for more than 6000 deaths and related costs of 5.3 billion Danish Kroner each year. Although not fully elucidated, an increase in physical inactivity among children has over the last 20-30 years been observed in parallel with an increase in childhood overweight and obesity.
Aim:
The overall aim of this study is to promote (increase and sustain) healthy physical activity behaviors in children aged 5-8 years. The investigators wish to investigate the effects of an exercise intervention on physical activity, sleep (e.g. quality and duration), eating behavior, quality of life and anthropometrics.
Design The project is a collaborative clinical trial investigating the implementation of supervised physical activity in school children in Aarhus Municipality.
Intervention Children aged 5-8 years from Aarhus municipality will be included in the study. Initially first-year students from selected schools will be recruited as a control group. After one year an intervention group will be formed out of first-year students from the same schools. The intervention group will be invited to participate in a supervised training intervention during after-school daycare time.
The supervised physical activity will be conducted by after-school childcare educators in the municipalities, who have years of experience in handling children. The childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions.
Parents/legal guardians and participants will be able to withdraw from the study at any time.
Feasibility Feasibility and sustainability form the foundation of this exercise intervention. The project is developed, evaluated, and implemented in close collaboration with Aarhus Municipality. The intervention is designed to be easily maintained and scalable for implementation beyond the research setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental study and participants will be assigned to intervention or control based on the time of inclusion. Each participating school will include controls at baseline. After one year, new participants will be included to the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Exercise1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Schoolchildren, 0.-1. Grade, 5-8 years of age,
- Resident in Aarhus Municipality
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ExerciseAlso: physical activityAfter-school childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions. The children will receive 1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year. | Behavioural | Intervention group |
Primary outcome
Between group change in time spent in moderate to vigorous physical activity (MVPA)
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Time spent in moderate to vigorous physical activity (MVPA). Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of MVPA per day.
Between group change in total movement time
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Total daily time the children spent moving in different body positions and engaging in different physical activities (standing, walking, running and biking). Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Between group change in time spent in light physical activity (LPA)
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Time spent in light physical activity. Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Between group change in time spent being sedentary
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Sedentary time is defined as any waking activity characterized as being in a sitting, reclining or lying posture with minimal stationary movement. Sedentary time will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sedentary time between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Between group change in total sleep time (TST)
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Total sleep time will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Between group change in sleep efficiency (SE)
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Sleep efficiency will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Between group change in sleep onset latency (SOL)
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Sleep onset latency will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Between group change in wake after sleep onset (WASO)
Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Wake after sleep onset will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
4 secondary outcomes
Between group change in eating behavior
Time frame: The CEBQ will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Between group changes in self-reported quality of life
Time frame: Questionnaires will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups.
Between group change in BMI-SDS
Time frame: From enrollment to the end of 5-year follow-up.
Baseline characteristics and data from school questionnaires
Time frame: From enrollment to the end of the 5-year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. The investigators have decided not to share individual participant data (IPD) due to ethical and privacy considerations, particularly given the sensitive nature of the data and the young age of the participants.
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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.
Jens M Bruun, Professor contact
Jens M Bruun, Professor principal investigator
Aarhus University and Steno Diabetes Center Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy Children and Children, run by University of Aarhus 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 2 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: opening soon, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bjarke Westergaard, phd student (+4527134351, bjarkeb@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group change in time spent in moderate to vigorous physical activity (MVPA) (time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups). The study lists 8 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 24 Jan 2025.