- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432327
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees
February 23, 2015 updated by: Karen Van Hoye, KU Leuven
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees: an Intervention Study
The aim of the study is to assess an increase of daily physical activity from electronic self-monitoring, to compare these values to the 10.000 step program, and to compare with real-time feedback with and without guidance from a Personal Coach.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this intervention study is to determine the effectiveness of continuous self-monitoring and real-time feedback from the SenseWear Armband (BodyMedia) alone and in combination with Personal Coaching to enhance physical activity and influence consciousness about its own physical activity patterns over a 12-month period in sedentary Flemish employees.
The investigators hypothesize that the use of the feedback will increase awareness and subsequent physical activity levels of inactive office workers.
Another hypothesizes is that the weekly meeting with a Personal Coach will add a controlling element and therefore employees of the 'coaching group' will have a higher physical activity level at the end of the intervention period compared to the other groups.
Study Type
Interventional
Enrollment (Actual)
227
Phase
- Not Applicable
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
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Leuven, Belgium, 3000
- Katholieke Universiteit Leuven - Tervuursevest 101
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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 to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Employee
- Physical Activity Level < 1.71 MET
- Willing to wear the SenseWear Armband for 5-6 weeks
Exclusion Criteria:
- Student
- Senior
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
This group receives no kind of feedback during the intervention period.
The participants wear the SenseWear Armband for 4 weeks and results of the intervention are discussed after the 4 week intervention period.
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Participants wear the SenseWear Armband for 4 weeks
Other Names:
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Experimental: Step Group
This group receives feedback about the daily amount of steps by means of a pedometer.
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Participants receive a pedometer to determine their daily amount of steps.
Every day they write down their amount of steps in a step diary.
Other Names:
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Experimental: Display Group
Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
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Participants use the self-monitoring device (display) to aid behavior change via real-time lifestyle feedback targeting physical activity. The display has a versatile design that allows it to be clipped to a shirt, bag or belt loop. The Display can help participants stay in sync with their daily goals.
Other Names:
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Experimental: Coaching Group
Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
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A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Level
Time Frame: One year
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To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate).
A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity.
This corresponds to PAL values of 1.75 and higher.
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Energy Expenditure in Physical Activity
Time Frame: One year
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Minutes of physical activity.
Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.
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One year
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Percent of Participants Losing Fat Percentage
Time Frame: One Year
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The amount of body fat is measured by bioelectrical impedance analysis (BIA).
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One Year
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Stages of Motivational Readiness for Physical Activity
Time Frame: One Year
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According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983).
Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.
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One Year
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Step Count
Time Frame: One Year
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Daily number of steps
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One Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Johan Lefevre, Prof Dr., KU Leuven
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
August 1, 2010
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
September 9, 2011
First Submitted That Met QC Criteria
September 9, 2011
First Posted (Estimate)
September 12, 2011
Study Record Updates
Last Update Posted (Estimate)
March 13, 2015
Last Update Submitted That Met QC Criteria
February 23, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- KULEUVEN_RTFDB
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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