Physical ActivityNCT03983447
School Intervention to Promote Physical Activity and Reduce the Sedentary Time of Low-income Children Aged 6-13 Years
A study testing School-based intervention to promote PA and reduce ST in people with Physical Activity and Sedentary Behavior, run by University of Pau and Pays de l'Adour.
Trial summary
This study is realized in 2 primary schools in the city of Tarbes (France), located in a disadvantaged neighbourhood : 352 children are included in the study. This study has many goals: 1) to propose an intervention to promote PA (Physical Activity) and reduce ST (Sedentary Time) of children aged 6 to 13 years from a… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Behavior, Children
- What is being tested?
- School-based intervention to promote PA and reduce ST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 31 May 2019
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (girls, boys) aged 5-13 years old
Who cannot join
- Physical diseases that prevent PA practice
About this study
This study is realized in 2 primary schools in the city of Tarbes (France), located in a disadvantaged neighbourhood : 352 children are included in the study.
This study has many goals: 1) to propose an intervention to promote PA (Physical Activity) and reduce ST (Sedentary Time) of children aged 6 to 13 years from a primary school located in a disadvantaged neighbourhood and measures the effectiveness of this intervention (1rst grade-5th grade). This intervention was based on the factors of socio-ecological model related to health behaviours. The levels of PA and ST of the experimental school will be compared to a control school with the realization of pre and post intervention measures. 2) To study the relationships between PA, ST, motors skills, attentional abilities and academic achievement. 3)To realise a descriptive analysis of PA and ST of children in 2nd and 5th grade from France and Spain (observational study). For this goal, an other school in Spain was included in the study (city of Huesca, 60 children).
Read the detailed description
Physical activity (PA) has decreased drastically in the 21st century in developed and industrialized societies. In 2009, 23.3% of the world's population did not comply with WHO's recommendations for physical activity, reaching real levels of pandemic. Technological advances have contributed to the emergence of new leisure activities, which may preclude the participation in PA and encourage sedentary behaviours. However, it is now well known that PA has numerous benefits on physical, psychological and social health. Thus, promoting PA becomes a necessity for adults and even more for children since healthy habits that are adopted during childhood will last throughout life and predict adult health. Hence, for this last population, 60 minutes of moderate-to-vigorous physical activity (MVPA) per day are recommended in public health guidelines.
A recent project named "Capas-Cité", created in 2012 in Tarbes (France) and in Zaragoza (Spain) realize PA programs and promotion actions that have a beneficial impact on health. These two similar cities have been selected for their geographical proximity and their similarity. These programs are included in research work carried out by the University of Tarbes and the University of Zaragoza that focus on the promotion of PA. "Capas-Cité" project aims to improve the health of disadvantaged population.
The two primary schools (School A and School B) located in the disadvantaged neighbourhood of Tarbes were contacted to participate in the study. Both schools include children from grade 1 (6 years old) to grade 5 (10 years old). They have never benefited from intervention programs on the field of PA and agreed to participate in the project.
During the academic year 2016/2017, baseline assessments were carried out in the two French schools: measures of PA, ST, motors skills, attentional abilities and academic achievement. These assessments were performed in November/December 2016 (First Time - T1) and May/June 2017 (Second time - T2). The measures of attentional abilities involve only children in 2nd, 3th and 4th grade. Children in both schools had to have parental permission to participate in PA, ST and attentional abilities measurements. Motor skills were assessed for all the children at school and their academic achievement were collected.
During the academic school year 2017/2018, School A benefited of an intervention to increase PA and reduce ST. This intervention program involves all the children from grade 1 to grade 5 without parental permission. Families are not required to contribute financially participation in this project. During this intervention year, the same periods of assessment as those carried at baseline were repeated in November/December 2017 (T3) and May/June 2018 (T4). These repeated assessment time provide a first overview of the efficiency of the intervention. The school B has the intervention program during the school year 2018/2019.
Accelerometers were used to measure PA and ST. Accelerometry is a reliable and valid objective to measure PA and ST. Children should wear the accelerometer on the right side of the hip, adjusted with an elastic belt.
In Spain, only observational measures were realised. . A total of 179 children have worn accelerometers for a week. PA and ST were analysed for week end days on one hand and on the other hand according to different periods of time for weekdays: the time before school, lunch, after school and at night.54.97% of the children complied with the MVPA guidelines all days of the week. MVPA represented 67.70±17.83 min.day-1 and ST was 606.14±37.39 min.day-1 for the total sample.
- Being tested
- School-based intervention to promote PA and reduce ST
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based intervention to promote PA and reduce STBehavioural
This intervention was realized with all the children (1st grade-5th grade) and involved :
- Physical (Environmental) adaptation of playgrounds
- Time adaptation of lunch breaks
- Curriculum-based program for children
- Workshops and newsletters for parents
- Meetings for teachers
| Study group | Role | What they receive |
|---|---|---|
| School-based intervention to promote Physical Activity (PA) | Experimental | This intervention included :
1. Physical (Environmental) adaptation of playground
2. Time adaptation of lunch breaks
3. Curriculum-based program of children
4. Workshops and newsletters for parents
5. Meetings for teachers Receives: Behavioral: School-based intervention to promote PA and reduce ST |
| Control | No intervention | Nothing has changed in the school. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity (PA)
Units : "counts/minute" and "minutes". Children from grade 1 to 5 who had parental permission to participate in the project carried an accelerometer (Actilife, Pensacola, FL, USA) to assess their usual levels of PA. Accelerometry is a reliable and valid objective to measure PA.
Measured: 7 days
Sedentary Time (ST)
Units : "counts/minute" and "minutes". Children from grade 1 to 5 who had parental permission to participate in the project carried an accelerometer (Actilife, Pensacola, FL, USA) to assess their usual levels of ST. Accelerometry is a reliable and valid objective to measure ST.
Measured: 7 days
Secondary outcomes (8)
Anthropometry: Body Mass Index (BMI)
Units : kg/m^2.The weight and height of the children were measured just prior of this test, in each measurement period
Measured: 10 minutes for each child
Subjective information about family and child
Parents participating in the project were asked to complete a questionnaire to obtain some information: age and gender of the child; socioeconomic data measured by the four-item scale "Family Affluence Scale II" (FAS II) (Boyce, Torsheim, Currie et Zambon, 2006). FAS II: 4 item-scale that asks families how many "car/bedrooms/computers" they have and how often they go on holiday. A composite FAS score is calculated for each family summing up the responses to these four items. The sample is then categorised using a three-point ordinal scale where low FAS (score=0,1,2) indicates low affluence, medium FAS (score=3,4,5) indicates medium affluence, and high FAS (score=6,7,8,9) indicates high affluence (Aibar, 2012) ; parental perception of the competence of their children in physical activity practice; sedentary behaviour of the child (time spent playing video games, wa
Measured: 20 minutes
Standing broad jump (Motor Skills)
Units : cm. The test was realized for all children from grade 1 to 5 in a two-hour physical education class. This test of the Eurofit battery measures power and inter-segmental coordination. He stands behind a starting line and jump by throwing his arms forward. Three trials are allowed and only the best performance is analysed.
Measured: 2 hours for each grade
Plate tapping test (Motor Skills)
Units : seconds.The assessment of this test was realized for all children from grade 1 to 5 in a two-hour physical education class. The speed and coordination of the upper limbs is measured. The child is situated in from of a table. Two rubber discs 20 cm in diameter are fixed horizontally on the table, with a gap of 60 cm. A rectangular plate is placed between the two discs. The child puts a hand in the middle of the rectangular plate and touches the discs alternatively as quickly as possible with the other hand, passing over the hand situated in the middle. He performs 25 cycles.
Measured: 2 hours for each grade
6 x 5m Shuttle Run (Motor Skills)
Units: seconds.This test was realized for all children from grade 1 to 5 in a two-hour physical education class.This test was adapted from the 10x5m shuttle test of the Eurofit battery. It measures the speed-coordination of inter-segmental limbs. The specialist evaluates the time needed to cover the distance with a stopwatch.
Measured: 2 hours for each grade
Cardiorespiratory fitness: 20m shuttle run test
Units: seconds.The assessment of motor skills was realized for all children from grade 1 to 5 in a two-hour physical education class.The aerobic capacity of the children was measured with an adapted version of the 20m shuttle run test (Cadenas Sanchez, 2011). The initial speed is reduced at 6.5 km/h and increase according to the laps and the stage numbers.
Measured: 2 hours for each grade
Academic achievement
Units : %. The learning achievement for children from grade 1 to 5 was collected at the beginning of the school year. The percentages of success rate of "reading", "spelling" and "mathematics" were collected.
Measured: 1 hour for each grade
Attention
Units : % and seconds.The computer-based modified Erickson Flanker Task was used (Have et al, 2016). It was designed with the software Superlab 4.5 (AD instruments) by the researcher specialist. This test is a variant version of the classing Flanker-Task (Eriksen et Ericksen, 1974). It permits the measurement of inhibition and cognitive flexibility, which are identified as executive functions and specifically attentional abilities.
Measured: 10 minutes for each child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Nov 2016
- Primary completion20 Dec 2016
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During the academic year 2016/2017, baseline assessments were carried out in two schools (school A, school B): measures of PA, ST, motors skills, attentional capacity and academic achievement. These assessments were performed in November/December 2016 (First Time - T1) and May/June 2017 (Second time - T2). During the academic school year 2017/2018, a school-based intervention to increase PA and reduce ST was realised in School A (measure in November 2017 and May/June 2018). Finally, during the academic school year 2018/2019, a school-based intervention to increase PA and reduce ST was realised in School B (measure only in May/June 2019).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pau and Pays de l'Adour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983447
- Sponsor's protocol ID
- UPPA (University of Pau)
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aibar A, Bois JE, Generelo E, Zaragoza Casterad J, Paillard T. A cross-cultural study of adolescents' physical activity levels in France and Spain. Eur J Sport Sci. 2013;13(5):551-8. doi: 10.1080/17461391.2012.746733. Epub 2012 Nov 23.
PubMed 24050473Kriemler S, Meyer U, Martin E, van Sluijs EM, Andersen LB, Martin BW. Effect of school-based interventions on physical activity and fitness in children and adolescents: a review of reviews and systematic update. Br J Sports Med. 2011 Sep;45(11):923-30. doi: 10.1136/bjsports-2011-090186.
PubMed 21836176Hartmann T, Zahner L, Puhse U, Puder JJ, Kriemler S. Effects of a school-based physical activity program on physical and psychosocial quality of life in elementary school children: a cluster-randomized trial. Pediatr Exerc Sci. 2010 Nov;22(4):511-22. doi: 10.1123/pes.22.4.511.
PubMed 21242601Rhodes RE, Janssen I, Bredin SSD, Warburton DER, Bauman A. Physical activity: Health impact, prevalence, correlates and interventions. Psychol Health. 2017 Aug;32(8):942-975. doi: 10.1080/08870446.2017.1325486. Epub 2017 May 30.
PubMed 28554222Scudder MR, Lambourne K, Drollette ES, Herrmann SD, Washburn RA, Donnelly JE, Hillman CH. Aerobic capacity and cognitive control in elementary school-age children. Med Sci Sports Exerc. 2014;46(5):1025-35. doi: 10.1249/MSS.0000000000000199.
PubMed 24743109Khan NA, Hillman CH. The relation of childhood physical activity and aerobic fitness to brain function and cognition: a review. Pediatr Exerc Sci. 2014 May;26(2):138-46. doi: 10.1123/pes.2013-0125. Epub 2014 Apr 10.
PubMed 24722921Bernal CMM, Lhuisset L, Fabre N, Bois J. School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 23;9(9):e17815. doi: 10.2196/17815.
PubMed 32965238
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Intervention to Promote Physical Activity and Reduce the Sedentary Time of Low-income Children Aged 6-13 Years
- ClinicalTrials.gov ID
- NCT03983447
- Acronym / sponsor ID
- UPPA (University of Pau)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Pau and Pays de l'AdourUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 12 Jun 2019 (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.
This study is realized in 2 primary schools in the city of Tarbes (France), located in a disadvantaged neighbourhood : 352 children are included in the study.
This study has many goals: 1) to propose an intervention to promote PA (Physical Activity) and reduce ST (Sedentary Time) of children aged 6 to 13 years from a primary school located in a disadvantaged neighbourhood and measures the effectiveness of this intervention (1rst grade-5th grade). This intervention was based on the factors of socio-ecological model related to health behaviours. The levels of PA and ST of the experimental school will be compared to a control school with the realization of pre and post intervention measures. 2) To study the relationships between PA, ST, motors skills, attentional abilities and academic achievement. 3)To realise a descriptive analysis of PA and ST of children in 2nd and 5th grade from France and Spain (observational study). For this goal, an other school in Spain was included in the study (city of Huesca, 60 children).
Detailed description
Physical activity (PA) has decreased drastically in the 21st century in developed and industrialized societies. In 2009, 23.3% of the world's population did not comply with WHO's recommendations for physical activity, reaching real levels of pandemic. Technological advances have contributed to the emergence of new leisure activities, which may preclude the participation in PA and encourage sedentary behaviours. However, it is now well known that PA has numerous benefits on physical, psychological and social health. Thus, promoting PA becomes a necessity for adults and even more for children since healthy habits that are adopted during childhood will last throughout life and predict adult health. Hence, for this last population, 60 minutes of moderate-to-vigorous physical activity (MVPA) per day are recommended in public health guidelines.
A recent project named "Capas-Cité", created in 2012 in Tarbes (France) and in Zaragoza (Spain) realize PA programs and promotion actions that have a beneficial impact on health. These two similar cities have been selected for their geographical proximity and their similarity. These programs are included in research work carried out by the University of Tarbes and the University of Zaragoza that focus on the promotion of PA. "Capas-Cité" project aims to improve the health of disadvantaged population.
The two primary schools (School A and School B) located in the disadvantaged neighbourhood of Tarbes were contacted to participate in the study. Both schools include children from grade 1 (6 years old) to grade 5 (10 years old). They have never benefited from intervention programs on the field of PA and agreed to participate in the project.
During the academic year 2016/2017, baseline assessments were carried out in the two French schools: measures of PA, ST, motors skills, attentional abilities and academic achievement. These assessments were performed in November/December 2016 (First Time - T1) and May/June 2017 (Second time - T2). The measures of attentional abilities involve only children in 2nd, 3th and 4th grade. Children in both schools had to have parental permission to participate in PA, ST and attentional abilities measurements. Motor skills were assessed for all the children at school and their academic achievement were collected.
During the academic school year 2017/2018, School A benefited of an intervention to increase PA and reduce ST. This intervention program involves all the children from grade 1 to grade 5 without parental permission. Families are not required to contribute financially participation in this project. During this intervention year, the same periods of assessment as those carried at baseline were repeated in November/December 2017 (T3) and May/June 2018 (T4). These repeated assessment time provide a first overview of the efficiency of the intervention. The school B has the intervention program during the school year 2018/2019.
Accelerometers were used to measure PA and ST. Accelerometry is a reliable and valid objective to measure PA and ST. Children should wear the accelerometer on the right side of the hip, adjusted with an elastic belt.
In Spain, only observational measures were realised. . A total of 179 children have worn accelerometers for a week. PA and ST were analysed for week end days on one hand and on the other hand according to different periods of time for weekdays: the time before school, lunch, after school and at night.54.97% of the children complied with the MVPA guidelines all days of the week. MVPA represented 67.70±17.83 min.day-1 and ST was 606.14±37.39 min.day-1 for the total sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- During the academic year 2016/2017, baseline assessments were carried out in two schools (school A, school B): measures of PA, ST, motors skills, attentional capacity and academic achievement. These assessments were performed in November/December 2016 (First Time - T1) and May/June 2017 (Second time - T2). During the academic school year 2017/2018, a school-based intervention to increase PA and reduce ST was realised in School A (measure in November 2017 and May/June 2018). Finally, during the academic school year 2018/2019, a school-based intervention to increase PA and reduce ST was realised in School B (measure only in May/June 2019).
| Arm | Type | Receives |
|---|---|---|
| School-based intervention to promote Physical Activity (PA) | Experimental | Behavioral: School-based intervention to promote PA and reduce STThis intervention included : 1. Physical (Environmental) adaptation of playground 2. Time adaptation of lunch breaks 3. Curriculum-based program of children 4. Workshops and newsletters for parents 5. Meetings for teachers |
| Control | No intervention | –Nothing has changed in the school. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (girls, boys) aged 5-13 years old
Key exclusion criteria (1 listed)
- Physical diseases that prevent PA practice
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 |
|---|---|---|
| School-based intervention to promote PA and reduce STThis intervention was realized with all the children (1st grade-5th grade) and involved : 1. Physical (Environmental) adaptation of playgrounds 2. Time adaptation of lunch breaks 3. Curriculum-based program for children 4. Workshops and newsletters for parents 5. Meetings for teachers | Behavioural | School-based intervention to promote Physical Activity (PA) |
Primary outcome
Physical Activity (PA)
Time frame: 7 days
Units : "counts/minute" and "minutes". Children from grade 1 to 5 who had parental permission to participate in the project carried an accelerometer (Actilife, Pensacola, FL, USA) to assess their usual levels of PA. Accelerometry is a reliable and valid objective to measure PA.
Sedentary Time (ST)
Time frame: 7 days
Units : "counts/minute" and "minutes". Children from grade 1 to 5 who had parental permission to participate in the project carried an accelerometer (Actilife, Pensacola, FL, USA) to assess their usual levels of ST. Accelerometry is a reliable and valid objective to measure ST.
8 secondary outcomes
Anthropometry: Body Mass Index (BMI)
Time frame: 10 minutes for each child
Subjective information about family and child
Time frame: 20 minutes
Standing broad jump (Motor Skills)
Time frame: 2 hours for each grade
Plate tapping test (Motor Skills)
Time frame: 2 hours for each grade
6 x 5m Shuttle Run (Motor Skills)
Time frame: 2 hours for each grade
Cardiorespiratory fitness: 20m shuttle run test
Time frame: 2 hours for each grade
Academic achievement
Time frame: 1 hour for each grade
Attention
Time frame: 10 minutes for each child
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 12 Jun 2019.
- Background: PubMed 24050473Aibar A, Bois JE, Generelo E, Zaragoza Casterad J, Paillard T. A cross-cultural study of adolescents' physical activity levels in France and Spain. Eur J Sport Sci. 2013;13(5):551-8. doi: 10.1080/17461391.2012.746733. Epub 2012 Nov 23.
- Background: PubMed 21836176Kriemler S, Meyer U, Martin E, van Sluijs EM, Andersen LB, Martin BW. Effect of school-based interventions on physical activity and fitness in children and adolescents: a review of reviews and systematic update. Br J Sports Med. 2011 Sep;45(11):923-30. doi: 10.1136/bjsports-2011-090186.
- Background: PubMed 21242601Hartmann T, Zahner L, Puhse U, Puder JJ, Kriemler S. Effects of a school-based physical activity program on physical and psychosocial quality of life in elementary school children: a cluster-randomized trial. Pediatr Exerc Sci. 2010 Nov;22(4):511-22. doi: 10.1123/pes.22.4.511.
- Background: PubMed 28554222Rhodes RE, Janssen I, Bredin SSD, Warburton DER, Bauman A. Physical activity: Health impact, prevalence, correlates and interventions. Psychol Health. 2017 Aug;32(8):942-975. doi: 10.1080/08870446.2017.1325486. Epub 2017 May 30.
- Background: PubMed 24743109Scudder MR, Lambourne K, Drollette ES, Herrmann SD, Washburn RA, Donnelly JE, Hillman CH. Aerobic capacity and cognitive control in elementary school-age children. Med Sci Sports Exerc. 2014;46(5):1025-35. doi: 10.1249/MSS.0000000000000199.
- Background: PubMed 24722921Khan NA, Hillman CH. The relation of childhood physical activity and aerobic fitness to brain function and cognition: a review. Pediatr Exerc Sci. 2014 May;26(2):138-46. doi: 10.1123/pes.2013-0125. Epub 2014 Apr 10.
- Derived from this study: PubMed 32965238Bernal CMM, Lhuisset L, Fabre N, Bois J. School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 23;9(9):e17815. doi: 10.2196/17815.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing School-based intervention to promote PA and reduce ST in people with Physical Activity and Sedentary Behavior, run by University of Pau and Pays de l'Adour.
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 1 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: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 (PA) (time frame: 7 days). The study lists 2 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 NCT03983447, which also lists 7 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 12 Jun 2019.