The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity and Health

This study has been completed.
Sponsor:
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01071811
First received: February 18, 2010
Last updated: February 19, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Physical Inactivity
Behavioral: Pedometer-based intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Physical activity (walking time, sitting time, physical activity level in leisure time) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health measurements (blood pressure, weight, fat percentage, and aerobic fitness), self-rated health, stress, and sleep quality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 668
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
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.
Behavioral: Pedometer-based intervention
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.
Other Names:
  • Randomized controlled trial
  • Pedometer
  • Pedometer program
  • Health
  • Self-rated health
  • Stress
  • Sleep
Experimental: 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.
Behavioral: Pedometer-based intervention
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.
Other Names:
  • Randomized controlled trial
  • Pedometer
  • Pedometer program
  • Health
  • Self-rated health
  • Stress
  • Sleep

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low aerobic fitness (defined for men and women in different age groups)
  • Reported being sedentary or light physically active in leisure time

Exclusion Criteria:

  • Participated in other interventions initiated in relation with the KRAM Study
  • Were pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071811

Locations
Denmark
The municipiality of Frederiksberg
Frederiksberg, Denmark
The municipiality of Silkeborg
Silkeborg, Denmark
The municipiality of Varde
Varde, Denmark
Sponsors and Collaborators
University of Southern Denmark
Investigators
Study Director: Morten Grønbæk, professor National Institut of Public Health, University of Southern Denmark
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Morten Grønbæk, National Institut of Public Health, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01071811     History of Changes
Other Study ID Numbers: 1975
Study First Received: February 18, 2010
Last Updated: February 19, 2010
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Randomized controlled trial
Pedometer
Physical activity
Health measurement
Self-rated health
Stress
Sleep quality

ClinicalTrials.gov processed this record on September 18, 2014