Physical ActivityPhase 4ASUKI-StepNCT01537939
ASUKI Step Pedometer Worksite Intervention
A Phase 4 study testing ASUKI Step Worksite Pedometer Intervention in people with Physical Activity, run by Arizona State University at 1 site in United States.
Trial summary
ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive. Study aims were: 1. to have a minimum of 400 employee participants from each university site reach a level of 10, 000 steps per day on at least 100 days (3.5 months) during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- ASUKI Step Worksite Pedometer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,018 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2009
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed at Arizona State University (ASU)or the Karolinska Institute (KI)
- The ability to read, speak and understand English (ASU only)
- Not currently pregnant or lactating
- Free of physical problems that affect the ability to walk, and e) ages 18 and older
Who cannot join
- Inability to walk
- Not employed or a graduate student at ASU or the KI
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona State University and Karolinska Institutet
Phoenix, Arizona, 85142
About this study
ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive.
Study aims were:
- to have a minimum of 400 employee participants from each university site reach a level of 10, 000 steps per day on at least 100 days (3.5 months) during the trial period;
- to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day;
- to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and
- to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.
Read the detailed description
ASUKI Step is a 9-month pedometer-based worksite intervention conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona. ASUKI Step used a quasi-experimental design based on the theory of social support. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps.
- Conditions
- Physical Activity
- Being tested
- ASUKI Step Worksite Pedometer Intervention
- Keywords
- Physical Activity, Walking, Pedometer, Body Composition, Aerobic Fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASUKI Step Worksite Pedometer InterventionBehavioural
Also called Pedometer-monitored daily walking
The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week.
| Study group | Role | What they receive |
|---|---|---|
| Walking | Other | Quasi-experimental design with one-group, post-test only Receives: Behavioral: ASUKI Step Worksite Pedometer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of sample walking 10,000 steps per day on at least 100 days (3.5 months) during the trial period.
Tally of the participants recording 10,000 steps on their pedometer log for 100 days of the 6 month walking intervention.
Measured: End of walking intervention at 6 months
Secondary outcomes (1)
Changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.
Compare the measures between the first week and the last week of the 6-month intervention study
Measured: End of the 6 month walking study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionDec 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 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Barbara E. Ainsworth, Arizona State University
- Investigators
- Barbara E. Ainsworth, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537939
- Sponsor's protocol ID
- ASUKI2009
- Acronym
- ASUKI-Step
- Status last verified
- Feb 2012
- First submitted
- 18 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ainsworth BE, Der Ananian C, Soroush A, Walker J, Swan P, Poortvliet E, Yngve A. "ASUKI Step" pedometer intervention in university staff: rationale and design. BMC Public Health. 2012 Aug 15;12:657. doi: 10.1186/1471-2458-12-657.
PubMed 22894138
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASUKI Step Pedometer Worksite Intervention
- ClinicalTrials.gov ID
- NCT01537939
- Acronym / sponsor ID
- ASUKI-Step / ASUKI2009
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Walking, Pedometer, Body Composition, Aerobic Fitness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,018 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Feb 2012 (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.
ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive.
Study aims were:
- to have a minimum of 400 employee participants from each university site reach a level of 10, 000 steps per day on at least 100 days (3.5 months) during the trial period;
- to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day;
- to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and
- to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.
Detailed description
ASUKI Step is a 9-month pedometer-based worksite intervention conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona. ASUKI Step used a quasi-experimental design based on the theory of social support. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking | Other | Behavioral: ASUKI Step Worksite Pedometer InterventionQuasi-experimental design with one-group, post-test only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Employed at Arizona State University (ASU)or the Karolinska Institute (KI)
- The ability to read, speak and understand English (ASU only)
- Not currently pregnant or lactating
- Free of physical problems that affect the ability to walk, and e) ages 18 and older
Key exclusion criteria (2 listed)
- Inability to walk
- Not employed or a graduate student at ASU or the KI
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 |
|---|---|---|
| ASUKI Step Worksite Pedometer InterventionAlso: Pedometer-monitored daily walkingThe intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. | Behavioural | Walking |
Primary outcome
Percent of sample walking 10,000 steps per day on at least 100 days (3.5 months) during the trial period.
Time frame: End of walking intervention at 6 months
Tally of the participants recording 10,000 steps on their pedometer log for 100 days of the 6 month walking intervention.
1 secondary outcome
Changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.
Time frame: End of the 6 month walking study
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 23 Feb 2012.
- Derived from this study: PubMed 22894138Ainsworth BE, Der Ananian C, Soroush A, Walker J, Swan P, Poortvliet E, Yngve A. "ASUKI Step" pedometer intervention in university staff: rationale and design. BMC Public Health. 2012 Aug 15;12:657. doi: 10.1186/1471-2458-12-657.
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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.
Barbara E. Ainsworth, Ph.D. principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ASUKI Step Worksite Pedometer Intervention in people with Physical Activity, run by Arizona State University at 1 site in United States.
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 4 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 23 Feb 2012. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percent of sample walking 10,000 steps per day on at least 100 days (3.5 months) during the trial period. (time frame: End of walking intervention at 6 months). 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 NCT01537939, 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 23 Feb 2012.