Physical InactivityPhase 3NCT01071811
The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity and Health
A Phase 3 study testing Pedometer-based intervention in people with Physical Inactivity, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
Physical activity is associated with a reduced risk of several chronic diseases in addition to all-cause mortality. Hence for public health purposes, knowledge of effective interventions to increase the physical activity level in the population is important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Pedometer-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 3 sitesDenmark
- Study dates
- Aug 2008to Jan 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low aerobic fitness (defined for men and women in different age groups)
- Reported being sedentary or light physically active in leisure time
Who cannot join
- Participated in other interventions initiated in relation with the KRAM Study
- Were pregnant
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
The municipiality of Frederiksberg
Frederiksberg
The municipiality of Silkeborg
Silkeborg
The municipiality of Varde
Varde
About this study
Official title: The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity, Health Measurements, Self-rated Health, Stress, and Sleep Quality: a Randomized Controlled Trial
Physical activity is associated with a reduced risk of several chronic diseases in addition to all-cause mortality. Hence for public health purposes, knowledge of effective interventions to increase the physical activity level in the population is important.
The objective of this randomized controlled trial was to examine the effect 12 weeks after having received a pedometer and a pedometer program on physical activity, health measurements, self-rated health, stress, and sleep quality.
A total of 223 men and 445 women were randomly assigned to either a pedometer group (n = 333) in which participants received a pedometer and pedometer program or a control group (n = 335). Of the participants included in the study 198 and 178 completed the health examination, and 192 and 187 completed the questionnaire at follow up in the pedometer group and in the control group, respectively.
Read the detailed description
The results from the KRAM Study are used as baseline for this intervention. In the KRAM study all adult citizens (18+ years) in 13 Danish municipalities were invited by letter to take part in an internet based questionnaire concerning socio-demography, life style, and other health aspects. Furthermore, a random sample of the citizens was invited to participate in a health examination. A total of 76.484 of the invited 538.497 citizens filled in the entire or partially the questionnaire and 18.065 of the invited 180.103 citizens completed the health examination. The examination included the following measurements: Blood pressure, height, weight, fat percentage, blood samples, pulmonary function, bone mineral density, muscle strength, balance test, and aerobic fitness.
Intervention The intervention was carried out in three of the 13 municipalities (Silkeborg, Frederiksberg, and Varde). Participants with a low aerobic fitness (defined for men and women in different age groups) or those who reported being sedentary or light physically active in leisure time were - after they had accomplished the health examination - invited to participate in the intervention. Participants were not included if they participated in other interventions initiated in relation with the KRAM Study or if they were pregnant. All participants gave informed consent. The protocol was approved by the Scientific Ethical Committee B for the Capital Region of Denmark (H-B-2008-097).
The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program, a handout with a summary of the pedometer program, and a calendar for registration of daily steps. The aim of the program is to guide people to use a pedometer and increase their steps with 20 % each week until they reach their goal. During the trial period, they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening, they should take the pedometer off and register the total number of steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program. Participants assigned to the control group received a leaflet from the National Board of Health in Denmark recommending all adults to be physical active for 30 minutes each day of moderate intensity.
Follow up After 12 weeks, participants were invited by letter to answer a short questionnaire. Furthermore, they were invited to participate in a health examination including the measurements of blood pressure, weight, fat percentage, and aerobic fitness. The researchers who performed the examinations were blinded to group assignment.
- Conditions
- Physical Inactivity
- Being tested
- Pedometer-based intervention
- Keywords
- Randomized controlled trial, Pedometer, Physical activity, Health measurement, Self-rated health, Stress, Sleep quality
- Medical subject headings
- Sedentary Behavior, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer-based interventionBehavioural
Also called Randomized controlled trial, Pedometer, Pedometer program, Health
The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program(18), a handout with a summary of the pedometer program, and a calendar for registration of daily steps. During the trial period they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening they should take the pedometer off and register the accumulated steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants assigned to the control group received a leaflet from the National Board of Health in Denmark recommending all adults to be physical active for 30 minutes each day of moderate intensity. Receives: Behavioral: Pedometer-based intervention |
| Pedometer group | Experimental | Received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program, a handout with a summary of the pedometer program, and a calendar for registration of daily steps. Receives: Behavioral: Pedometer-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (walking time, sitting time, physical activity level in leisure time)
Measured: 12 weeks
Secondary outcomes (1)
Health measurements (blood pressure, weight, fat percentage, and aerobic fitness), self-rated health, stress, and sleep quality
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Morten Grønbæk, professor, Study director, National Institut of Public Health, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071811
- Sponsor's protocol ID
- 1975
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2010
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen CB, Severin M, Hansen AW, Curtis T, Gronbaek M, Tolstrup JS. A population-based randomized controlled trial of the effect of combining a pedometer with an intervention toolkit on physical activity among individuals with low levels of physical activity or fitness. Prev Med. 2012 Feb;54(2):125-30. doi: 10.1016/j.ypmed.2011.12.012. Epub 2011 Dec 19.
PubMed 22200586
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity, Health Measurements, Self-rated Health, Stress, and Sleep Quality: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01071811
- Acronym / sponsor ID
- 1975
- Conditions
- Physical Inactivity
- Keywords
- Randomized controlled trial, Pedometer, Physical activity, Health measurement, Self-rated health, Stress, Sleep quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Feb 2010 (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.
Physical activity is associated with a reduced risk of several chronic diseases in addition to all-cause mortality. Hence for public health purposes, knowledge of effective interventions to increase the physical activity level in the population is important.
The objective of this randomized controlled trial was to examine the effect 12 weeks after having received a pedometer and a pedometer program on physical activity, health measurements, self-rated health, stress, and sleep quality.
A total of 223 men and 445 women were randomly assigned to either a pedometer group (n = 333) in which participants received a pedometer and pedometer program or a control group (n = 335). Of the participants included in the study 198 and 178 completed the health examination, and 192 and 187 completed the questionnaire at follow up in the pedometer group and in the control group, respectively.
Detailed description
The results from the KRAM Study are used as baseline for this intervention. In the KRAM study all adult citizens (18+ years) in 13 Danish municipalities were invited by letter to take part in an internet based questionnaire concerning socio-demography, life style, and other health aspects. Furthermore, a random sample of the citizens was invited to participate in a health examination. A total of 76.484 of the invited 538.497 citizens filled in the entire or partially the questionnaire and 18.065 of the invited 180.103 citizens completed the health examination. The examination included the following measurements: Blood pressure, height, weight, fat percentage, blood samples, pulmonary function, bone mineral density, muscle strength, balance test, and aerobic fitness.
Intervention The intervention was carried out in three of the 13 municipalities (Silkeborg, Frederiksberg, and Varde). Participants with a low aerobic fitness (defined for men and women in different age groups) or those who reported being sedentary or light physically active in leisure time were - after they had accomplished the health examination - invited to participate in the intervention. Participants were not included if they participated in other interventions initiated in relation with the KRAM Study or if they were pregnant. All participants gave informed consent. The protocol was approved by the Scientific Ethical Committee B for the Capital Region of Denmark (H-B-2008-097).
The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program, a handout with a summary of the pedometer program, and a calendar for registration of daily steps. The aim of the program is to guide people to use a pedometer and increase their steps with 20 % each week until they reach their goal. During the trial period, they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening, they should take the pedometer off and register the total number of steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program. Participants assigned to the control group received a leaflet from the National Board of Health in Denmark recommending all adults to be physical active for 30 minutes each day of moderate intensity.
Follow up After 12 weeks, participants were invited by letter to answer a short questionnaire. Furthermore, they were invited to participate in a health examination including the measurements of blood pressure, weight, fat percentage, and aerobic fitness. The researchers who performed the examinations were blinded to group assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | Behavioral: Pedometer-based interventionParticipants assigned to the control group received a leaflet from the National Board of Health in Denmark recommending all adults to be physical active for 30 minutes each day of moderate intensity. |
| Pedometer group | Experimental | Behavioral: Pedometer-based interventionReceived a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program, a handout with a summary of the pedometer program, and a calendar for registration of daily steps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low aerobic fitness (defined for men and women in different age groups)
- Reported being sedentary or light physically active in leisure time
Key exclusion criteria (2 listed)
- Participated in other interventions initiated in relation with the KRAM Study
- Were pregnant
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 |
|---|---|---|
| Pedometer-based interventionAlso: Randomized controlled trial, Pedometer, Pedometer program, HealthThe participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program(18), a handout with a summary of the pedometer program, and a calendar for registration of daily steps. During the trial period they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening they should take the pedometer off and register the accumulated steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program. | Behavioural | Control group, Pedometer group |
Primary outcome
Physical activity (walking time, sitting time, physical activity level in leisure time)
Time frame: 12 weeks
1 secondary outcome
Health measurements (blood pressure, weight, fat percentage, and aerobic fitness), self-rated health, stress, and sleep quality
Time frame: 12 weeks
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 22 Feb 2010.
- Derived from this study: PubMed 22200586Petersen CB, Severin M, Hansen AW, Curtis T, Gronbaek M, Tolstrup JS. A population-based randomized controlled trial of the effect of combining a pedometer with an intervention toolkit on physical activity among individuals with low levels of physical activity or fitness. Prev Med. 2012 Feb;54(2):125-30. doi: 10.1016/j.ypmed.2011.12.012. Epub 2011 Dec 19.
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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.
Morten Grønbæk, professor study director
National Institut of Public Health, University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pedometer-based intervention in people with Physical Inactivity, run by University of Southern Denmark at 3 sites 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 2 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 22 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (walking time, sitting time, physical activity level in leisure time) (time frame: 12 weeks). 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 NCT01071811, which also lists 1 linked publication.
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 22 Feb 2010.