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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01537939
Other study ID # ASUKI2009
Secondary ID
Status Completed
Phase Phase 4
First received February 18, 2012
Last updated February 22, 2012
Start date March 2009
Est. completion date December 2009

Study information

Verified date February 2012
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardSweden: Swedish Research Council
Study type Interventional

Clinical 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 the trial period;

2. 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;

3. to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and

4. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2018
Est. completion date December 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
ASUKI Step Worksite Pedometer Intervention
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.

Locations

Country Name City State
United States Arizona State University and Karolinska Institutet Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University Karolinska Institutet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. End of walking intervention at 6 months No
Secondary 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 End of the 6 month walking study No
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