Sedentary LifestyleMovingSoundNCT02270138
An Experimental Study on Music and Sedentariness Among Mothers and Children
A study testing Movement-to-music video program in people with Sedentary Lifestyle, run by UKK Institute at 1 site in Finland.
Trial summary
The aims of the study: Main objective of the current study is to decrease sedentary behavior and increase physical activity among mothers and their offspring by using music-to-movement video program. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Movement-to-music video program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2014to Apr 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women who have participated to the previous intervention study
- child age between 4 and 7 years
Who cannot join
- mother and/or child unable to perform physical activity for medical reasons
- mother and/or child unable to use accelerometer as instructed
- no possibility to use DVD player or YouTube-link
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Movement-to-music Video Program in Decreasing Sedentary Time in Mothers and Children: a Randomized Controlled Trial
The aims of the study: Main objective of the current study is to decrease sedentary behavior and increase physical activity among mothers and their offspring by using music-to-movement video program. Primary outcomes of the study are objectively assessed sedentary behavior and physical activity time measured both in minutes and as a proportion of measurement time. Secondary outcomes of the study are quantity and quality of self-reported screen time among mothers and children and motivational quality of music and music-to-movement video. Additional secondary outcomes are mother's weight, workability, mental health and mood. Specific aim is to study effectiveness of intervention with accelerometer use only or with a combination of accelerometer plus music-to-movement video program for mother-child pairs.
Materials and methods: Participants (mother and child -pairs) of the Movement-to-music video program (Moving Sound) -study will be recruited from the cohort of the original Lifestyle, counselling and exercise in maternity care (NELLI) -project from 14 municipalities of Pirkanmaa area. Participants will be randomized in two groups: accelerometer (ACC) vs. accelerometer plus movement-to-music video program (ACC+DVD) groups. Objective measurement of sedentariness and physical activity is based on accelerometer. Information on current health behavior will be based on intervention questionnaires. In the analysis physical activity, sedentary time and body weight of the intervention and control group will be compared. Effects of mother's musical (and PA) background and other mediating factors will be analyzed separately in subgroup analyses.
Read the detailed description
The aims of the study Quite many people use music during exercise for example while jogging or in the gym. Anyhow some mothers might have difficulties to exercise when they have small children and thereby importance of physical activity at home increases. Consequently, there is a need to perform an experimental study which combines the understanding of the benefits of music, objective physical activity measurement in decreasing sedentariness and thereafter transgenerational obesity.
Main objective of the current study is to decrease sedentary behavior and increase physical activity among mothers and their offspring by using music-to-movement video program.
Specific aim is to study effectiveness of intervention with accelerometer use only or with a combination of accelerometer plus music-to-movement video program for mother-child pairs.
Research questions:
- Are there changes in sedentary time and physical activity while using accelerometer and movement-to-music video program? Hypothesis: Movement-to-music video program developed for mother-child pairs decrease sedentary time more than wearing accelerometer only. There are no changes in moderate-to-vigorous physical activity, although amount of light intensity physical activity increases.
II. How does motivational effects of music affect to physical activity? Hypothesis: Movement-to-music video motivates mother-child pairs increase physical activity and decrease sedentary behavior.
III. Is there any relationship between mothers' musical background and physical activity/sedentary behavior? Hypothesis: Mothers' musicality motivates them exercise more with video program than mothers' without musical background.
Research methods Accelerometer measures and pretest. Main aim of the project is to reduce sedentariness among women and their children. Accelerometer measures continuously tri-axial acceleration caused by any movement and permits accurate individual assessment of both physical activity and sedentary behavior. Data on physical activity and sedentary behavior will be collected with tri-axial accelerometer (Hookie AM 20, Traxmeet Ltd, Espoo, Finland). The data will be collected in raw mode and analyzed as the mean signal amplitude deviation (MAD) of acceleration, which permits accurate individual assessment of both physical activity and sedentariness. The algorithms used in the present study are based on pilot studies conducted at the UKK Institute.
Accelerometers were pretested with eleven 2-9 years old children. Children did different kind of free movements, play, and games in test track field during one hour. That was done to find out how scurry-like movements appear in accelerometers. Another test in running track tested different speeds from the slow walking to the maximum rate of running. In addition accelerometers piloted with ten 4-7 years children during one week. On the basis of these tests acceleration signal acted as expected.
Movement-to-music DVD production and pretest. There will be three separate movement-to-music video programs prepared by the Sibelius-Academy music education students in the specific course for children's music programs during spring 2014. Directors, Soili Perkiö and Eeva-Leena Pokela are children's music professionals. The student group is called Mutaveijarit (The Mud Mates). Video programs were produced for this study. First and second videos last about 10 minutes including two songs and their movement preparation. There are three songs altogether, because the title song Mutaveijarit is in both tracks. The third video includes all songs together without their movement preparation.
To rate the motivational qualities of these three songs, a panel of 8 physiotherapists (all female) assessed each song by using Brunel Music Rating Inventory-2 (BMRI-2; BMRI-3). Another reason for pretest was to find out the influence of visual stimuli on the responses to the music. BMRI-2 was translated in Finnish by investigators of this study.
Each song was rated by indicating one number between 1 (strongly disagree) and 7 (strongly agree) for six statements about how much the song would motivate a person during exercise. The possible range of scores is 6-42, wherein scores below 24 mean low/oudeterous, middle range 24-35 moderately and scores over 36 mean highly motivating ratings.
Video group (n=4, mean age 41 years, SD 16,2 years) was first watching DVD and assessed all three songs separately using BMRI-2. Then they listened music only (without illustration) and rated the motivational qualities of each song. Music group (n=4, mean age 42,8 years, SD 15,8 years) assessed first only the motivational qualities of the songs. After that music group was watching DVD and appraised the music and illustration together. In addition both groups moved to DVD and rated the motivational qualities of music during movement. All songs were rated moderately motivating (ratings between 31,4 and 34,6).
The rhythm, style, melody, tempo and beat motivated movement more in video group than in music group. Music group assessed sound motivated them more than sound did in video group. During movement rhythm, style, and beat motivated video group more while melody, tempo, and sound motivated music group. As expected in both groups music and picture together motivated movement more than music alone.
Data collection. Objective measurements of sedentary behavior and physical activity of the mothers and their children will be collected at first, second and eighth weeks of the intervention by using accelerometer. Body weight of the mothers will be measured at baseline. Information on current physical activity, screen time, diet, and self-reported weight, as well as information on quality of life will be collected at the baseline by using same questionnaires as in the NELLI 5-years follow-up study (based on one-year follow-up questionnaires of the NELLI cohort). At 2 and 8 weeks after baseline information on physical activity, screen time, self-reported weight and motivation to exercise by using movement-to-music video program will be collected by questionnaires. Information of the children's physical activity and screen time will be collected at baseline, 2nd and 8th weeks after baseline by questionnaires.
Statistical methods. Effect of the intervention will be analyzed following the intention-to-treat principle by comparing the changes in the main outcomes between intervention and control group participants. Multivariate methods corresponding to analysis of covariance and logistic regression will be used. Non-paramet¬ric methods will also be utilized if needed. In the analysis physical activity, sedentary time and body weight of the intervention and control group will be compared. Subgroup analysis in intervention group will be conducted for mother's motivation to exercise with movement-to-music video program and effects of musical background.
Research materials Participants of the Moving Sound -study will be recruited from the cohort of the original NELLI-RTC. Mother and child -pairs (n=837) will be invited to NELLI 5-years follow-up study and to Moving Sound -study from 14 municipalities of Pirkanmaa area. We expect to get involved 30-40 % of the original cohort, which will be 251-335 mother and child -pairs, altogether.
Randomization will be done for 2:2 ratios, which means two mother-child pairs to intervention group per two pairs of control participants. For allocation of the participants an appointment order list for NELLI 5-years follow-up study will be used. Mothers will be randomized to intervention or control group by using sealed envelopes in contact of sampling for NELLI-study.
Power calculations for the study show that approximately 91 mother and child -pairs are needed, if there are 80 % sedentary women at baseline and the anticipated difference in sedentariness is 25 % between the ACC (accelerometer) and ACC + DVD (accelerometer plus movement-to-music video program) groups after intervention. If the anticipated difference between groups is smaller (than 25 %), the number of pairs needed is 135 per group. In this study sedentary women are defined as being sitting or in reclining posture more than 76 % of waking hours.
- Conditions
- Sedentary Lifestyle
- Being tested
- Movement-to-music video program
- Keywords
- physical activity, music, sedentary lifestyle
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-to-music video programBehavioural
Three separate movement-to-music video programs will be utilized. Genres of the songs are Children's rock, latin and folk. Range of the tempo is 64-124 beats per minute. The use of movement-to-music video program will be instructed 10-30 minutes every other day.
| Study group | Role | What they receive |
|---|---|---|
| Movement-to-music | Experimental | Three movement-to-music video programs will be used by the participants. First and second videos last about 10 minutes including two songs and their movement preparation. The use of movement-to-music video program will be instructed 10-30 minutes every other day. Receives: Behavioral: Movement-to-music video program |
| No movement-to-music | No intervention | Another group will not receive movement-to-music video during intervention. However, their physical activity will be objectively measured as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary lifestyle
Objective measurement of sedentary lifestyle with accelerometer; change from baseline in sedentary lifestyle at 8th week
Measured: Baseline, 8th week
Secondary outcomes (3)
Screen-time
self-reported quantity and quality of screen time
Measured: baseline, 8th week
Motivational quality of music-to-movement video
Self-reports on questionnaire related to music-to-movement video
Measured: baseline, 8th week
Workability
Mother's workability, including mental health and mood will be based on self-reported responses to questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sibelius Academy, Finnish Institute of Occupational Health, University of Jyvaskyla, Academy of Finland
- Responsible party
- Principal investigator, Riitta Luoto, UKK Institute
- Investigators
- Riitta M Luoto, MD, PhD, Principal investigator, Research director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270138
- Sponsor's protocol ID
- 05062014
- Acronym
- MovingSound
- Status last verified
- Apr 2016
- First submitted
- 2 Oct 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Karageorghis C, Jones L, Stuart DP. Psychological effects of music tempi during exercise. Int J Sports Med. 2008 Jul;29(7):613-9. doi: 10.1055/s-2007-989266. Epub 2007 Nov 30.
PubMed 18050063Karageorghis CI, Priest DL, Terry PC, Chatzisarantis NL, Lane AM. Redesign and initial validation of an instrument to assess the motivational qualities of music in exercise: the Brunel Music Rating Inventory-2. J Sports Sci. 2006 Aug;24(8):899-909. doi: 10.1080/02640410500298107.
PubMed 16815785Tuominen PP, Husu P, Raitanen J, Luoto RM. Rationale and methods for a randomized controlled trial of a movement-to-music video program for decreasing sedentary time among mother-child pairs. BMC Public Health. 2015 Oct 5;15:1016. doi: 10.1186/s12889-015-2347-4.
PubMed 26438056
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement-to-music Video Program in Decreasing Sedentary Time in Mothers and Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02270138
- Acronym / sponsor ID
- MovingSound / 05062014
- Conditions
- Sedentary Lifestyle
- Keywords
- physical activity, music, sedentary lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Sibelius Academy, Finnish Institute of Occupational Health, University of Jyvaskyla, Academy of Finland
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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 aims of the study: Main objective of the current study is to decrease sedentary behavior and increase physical activity among mothers and their offspring by using music-to-movement video program. Primary outcomes of the study are objectively assessed sedentary behavior and physical activity time measured both in minutes and as a proportion of measurement time. Secondary outcomes of the study are quantity and quality of self-reported screen time among mothers and children and motivational quality of music and music-to-movement video. Additional secondary outcomes are mother's weight, workability, mental health and mood. Specific aim is to study effectiveness of intervention with accelerometer use only or with a combination of accelerometer plus music-to-movement video program for mother-child pairs.
Materials and methods: Participants (mother and child -pairs) of the Movement-to-music video program (Moving Sound) -study will be recruited from the cohort of the original Lifestyle, counselling and exercise in maternity care (NELLI) -project from 14 municipalities of Pirkanmaa area. Participants will be randomized in two groups: accelerometer (ACC) vs. accelerometer plus movement-to-music video program (ACC+DVD) groups. Objective measurement of sedentariness and physical activity is based on accelerometer. Information on current health behavior will be based on intervention questionnaires. In the analysis physical activity, sedentary time and body weight of the intervention and control group will be compared. Effects of mother's musical (and PA) background and other mediating factors will be analyzed separately in subgroup analyses.
Detailed description
The aims of the study Quite many people use music during exercise for example while jogging or in the gym. Anyhow some mothers might have difficulties to exercise when they have small children and thereby importance of physical activity at home increases. Consequently, there is a need to perform an experimental study which combines the understanding of the benefits of music, objective physical activity measurement in decreasing sedentariness and thereafter transgenerational obesity.
Main objective of the current study is to decrease sedentary behavior and increase physical activity among mothers and their offspring by using music-to-movement video program.
Specific aim is to study effectiveness of intervention with accelerometer use only or with a combination of accelerometer plus music-to-movement video program for mother-child pairs.
Research questions:
- Are there changes in sedentary time and physical activity while using accelerometer and movement-to-music video program? Hypothesis: Movement-to-music video program developed for mother-child pairs decrease sedentary time more than wearing accelerometer only. There are no changes in moderate-to-vigorous physical activity, although amount of light intensity physical activity increases.
II. How does motivational effects of music affect to physical activity? Hypothesis: Movement-to-music video motivates mother-child pairs increase physical activity and decrease sedentary behavior.
III. Is there any relationship between mothers' musical background and physical activity/sedentary behavior? Hypothesis: Mothers' musicality motivates them exercise more with video program than mothers' without musical background.
Research methods Accelerometer measures and pretest. Main aim of the project is to reduce sedentariness among women and their children. Accelerometer measures continuously tri-axial acceleration caused by any movement and permits accurate individual assessment of both physical activity and sedentary behavior. Data on physical activity and sedentary behavior will be collected with tri-axial accelerometer (Hookie AM 20, Traxmeet Ltd, Espoo, Finland). The data will be collected in raw mode and analyzed as the mean signal amplitude deviation (MAD) of acceleration, which permits accurate individual assessment of both physical activity and sedentariness. The algorithms used in the present study are based on pilot studies conducted at the UKK Institute.
Accelerometers were pretested with eleven 2-9 years old children. Children did different kind of free movements, play, and games in test track field during one hour. That was done to find out how scurry-like movements appear in accelerometers. Another test in running track tested different speeds from the slow walking to the maximum rate of running. In addition accelerometers piloted with ten 4-7 years children during one week. On the basis of these tests acceleration signal acted as expected.
Movement-to-music DVD production and pretest. There will be three separate movement-to-music video programs prepared by the Sibelius-Academy music education students in the specific course for children's music programs during spring 2014. Directors, Soili Perkiö and Eeva-Leena Pokela are children's music professionals. The student group is called Mutaveijarit (The Mud Mates). Video programs were produced for this study. First and second videos last about 10 minutes including two songs and their movement preparation. There are three songs altogether, because the title song Mutaveijarit is in both tracks. The third video includes all songs together without their movement preparation.
To rate the motivational qualities of these three songs, a panel of 8 physiotherapists (all female) assessed each song by using Brunel Music Rating Inventory-2 (BMRI-2; BMRI-3). Another reason for pretest was to find out the influence of visual stimuli on the responses to the music. BMRI-2 was translated in Finnish by investigators of this study.
Each song was rated by indicating one number between 1 (strongly disagree) and 7 (strongly agree) for six statements about how much the song would motivate a person during exercise. The possible range of scores is 6-42, wherein scores below 24 mean low/oudeterous, middle range 24-35 moderately and scores over 36 mean highly motivating ratings.
Video group (n=4, mean age 41 years, SD 16,2 years) was first watching DVD and assessed all three songs separately using BMRI-2. Then they listened music only (without illustration) and rated the motivational qualities of each song. Music group (n=4, mean age 42,8 years, SD 15,8 years) assessed first only the motivational qualities of the songs. After that music group was watching DVD and appraised the music and illustration together. In addition both groups moved to DVD and rated the motivational qualities of music during movement. All songs were rated moderately motivating (ratings between 31,4 and 34,6).
The rhythm, style, melody, tempo and beat motivated movement more in video group than in music group. Music group assessed sound motivated them more than sound did in video group. During movement rhythm, style, and beat motivated video group more while melody, tempo, and sound motivated music group. As expected in both groups music and picture together motivated movement more than music alone.
Data collection. Objective measurements of sedentary behavior and physical activity of the mothers and their children will be collected at first, second and eighth weeks of the intervention by using accelerometer. Body weight of the mothers will be measured at baseline. Information on current physical activity, screen time, diet, and self-reported weight, as well as information on quality of life will be collected at the baseline by using same questionnaires as in the NELLI 5-years follow-up study (based on one-year follow-up questionnaires of the NELLI cohort). At 2 and 8 weeks after baseline information on physical activity, screen time, self-reported weight and motivation to exercise by using movement-to-music video program will be collected by questionnaires. Information of the children's physical activity and screen time will be collected at baseline, 2nd and 8th weeks after baseline by questionnaires.
Statistical methods. Effect of the intervention will be analyzed following the intention-to-treat principle by comparing the changes in the main outcomes between intervention and control group participants. Multivariate methods corresponding to analysis of covariance and logistic regression will be used. Non-paramet¬ric methods will also be utilized if needed. In the analysis physical activity, sedentary time and body weight of the intervention and control group will be compared. Subgroup analysis in intervention group will be conducted for mother's motivation to exercise with movement-to-music video program and effects of musical background.
Research materials Participants of the Moving Sound -study will be recruited from the cohort of the original NELLI-RTC. Mother and child -pairs (n=837) will be invited to NELLI 5-years follow-up study and to Moving Sound -study from 14 municipalities of Pirkanmaa area. We expect to get involved 30-40 % of the original cohort, which will be 251-335 mother and child -pairs, altogether.
Randomization will be done for 2:2 ratios, which means two mother-child pairs to intervention group per two pairs of control participants. For allocation of the participants an appointment order list for NELLI 5-years follow-up study will be used. Mothers will be randomized to intervention or control group by using sealed envelopes in contact of sampling for NELLI-study.
Power calculations for the study show that approximately 91 mother and child -pairs are needed, if there are 80 % sedentary women at baseline and the anticipated difference in sedentariness is 25 % between the ACC (accelerometer) and ACC + DVD (accelerometer plus movement-to-music video program) groups after intervention. If the anticipated difference between groups is smaller (than 25 %), the number of pairs needed is 135 per group. In this study sedentary women are defined as being sitting or in reclining posture more than 76 % of waking hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movement-to-music | Experimental | Behavioral: Movement-to-music video programThree movement-to-music video programs will be used by the participants. First and second videos last about 10 minutes including two songs and their movement preparation. The use of movement-to-music video program will be instructed 10-30 minutes every other day. |
| No movement-to-music | No intervention | –Another group will not receive movement-to-music video during intervention. However, their physical activity will be objectively measured as well. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- women who have participated to the previous intervention study
- child age between 4 and 7 years
Key exclusion criteria (3 listed)
- mother and/or child unable to perform physical activity for medical reasons
- mother and/or child unable to use accelerometer as instructed
- no possibility to use DVD player or YouTube-link
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 |
|---|---|---|
| Movement-to-music video programThree separate movement-to-music video programs will be utilized. Genres of the songs are Children's rock, latin and folk. Range of the tempo is 64-124 beats per minute. The use of movement-to-music video program will be instructed 10-30 minutes every other day. | Behavioural | Movement-to-music |
Primary outcome
Sedentary lifestyle
Time frame: Baseline, 8th week
Objective measurement of sedentary lifestyle with accelerometer; change from baseline in sedentary lifestyle at 8th week
3 secondary outcomes
Screen-time
Time frame: baseline, 8th week
Motivational quality of music-to-movement video
Time frame: baseline, 8th week
Workability
Time frame: baseline
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 2016.
- Background: PubMed 18050063Karageorghis C, Jones L, Stuart DP. Psychological effects of music tempi during exercise. Int J Sports Med. 2008 Jul;29(7):613-9. doi: 10.1055/s-2007-989266. Epub 2007 Nov 30.
- Results publication: PubMed 16815785Karageorghis CI, Priest DL, Terry PC, Chatzisarantis NL, Lane AM. Redesign and initial validation of an instrument to assess the motivational qualities of music in exercise: the Brunel Music Rating Inventory-2. J Sports Sci. 2006 Aug;24(8):899-909. doi: 10.1080/02640410500298107.
- Derived from this study: PubMed 26438056Tuominen PP, Husu P, Raitanen J, Luoto RM. Rationale and methods for a randomized controlled trial of a movement-to-music video program for decreasing sedentary time among mother-child pairs. BMC Public Health. 2015 Oct 5;15:1016. doi: 10.1186/s12889-015-2347-4.
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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.
Riitta M Luoto, MD, PhD principal investigator
Research director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement-to-music video program in people with Sedentary Lifestyle, run by UKK Institute at 1 site in Finland.
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 3 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 2016. 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 Finland. 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?
Sedentary lifestyle (time frame: Baseline, 8th week). 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 NCT02270138, which also lists 3 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 2016.