- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537939
ASUKI Step Pedometer Worksite Intervention (ASUKI-Step)
February 22, 2012 updated by: Barbara E. Ainsworth, Arizona State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
2018
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85142
- Arizona State University and Karolinska Institutet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to walk
- Not employed or a graduate student at ASU or the KI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Walking
Quasi-experimental design with one-group, post-test only
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
End of walking intervention at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.
Time Frame: End of the 6 month walking study
|
Compare the measures between the first week and the last week of the 6-month intervention study
|
End of the 6 month walking study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara E. Ainsworth, Ph.D., Arizona State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 18, 2012
First Submitted That Met QC Criteria
February 22, 2012
First Posted (Estimate)
February 23, 2012
Study Record Updates
Last Update Posted (Estimate)
February 23, 2012
Last Update Submitted That Met QC Criteria
February 22, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- ASUKI2009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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