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

NCT01071811 | Completed Phase 3

• 1 other identifier: 1975
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Physical Inactivity

Keywords

Randomized controlled trial; Pedometer; Physical activity; Health measurement; Self-rated health; Stress; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Physical activity (walking time, sitting time, physical activity level in leisure time)

  12 weeks

Secondary Outcomes (1)

• Health measurements (blood pressure, weight, fat percentage, and aerobic fitness), self-rated health, stress, and sleep quality

  12 weeks

Study Arms (2)

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.

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.

Behavioral: Pedometer-based intervention

Interventions

Pedometer-based intervention BEHAVIORAL

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.

Also known as: Randomized controlled trial, Pedometer, Pedometer program, Health, Self-rated health, Stress, Sleep

Control group; Pedometer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participated in other interventions initiated in relation with the KRAM Study
• Were pregnant

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (3)

The municipiality of Frederiksberg

Frederiksberg, Denmark

Location

The municipiality of Silkeborg

Silkeborg, Denmark

Location

The municipiality of Varde

Varde, Denmark

Location

Related Publications (1)

• 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.

  PMID: 22200586 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Sleep Initiation and Maintenance Disorders

Interventions

Randomized Controlled Trials as Topic; Health; Sleep

Condition Hierarchy (Ancestors)

Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Controlled Clinical Trials as Topic; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Population Characteristics; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Morten Grønbæk, professor

  National Institut of Public Health, University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 22, 2010

Record last verified: 2010-02

Locations

DK (3)