Sedentary LifestyleNCT01432327
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees
A study testing SenseWear display, Pedometer and SenseWear Armband in people with Sedentary Lifestyle, run by KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- SenseWear display, Pedometer and SenseWear Armband
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee
- Physical Activity Level < 1.71 MET
- Willing to wear the SenseWear Armband for 5-6 weeks
Who cannot join
- Student
- Senior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- SenseWear display, Pedometer, SenseWear Armband, Personal Coaching
- Keywords
- motor activity, randomized controlled trial, feedback
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseWear displayDevice
Also called BodyMedia® Display (Model DD100)
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.
PedometerDevice
Also called Yamax Digi-Walker SW-200
Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary.
SenseWear ArmbandDevice
Also called SenseWear Pro3 Armband, BodyMedia, Inc. Pittsburgh, PA
Participants wear the SenseWear Armband for 4 weeks
Personal CoachingBehavioural
A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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. Receives: Device: SenseWear Armband |
| Step Group | Experimental | This group receives feedback about the daily amount of steps by means of a pedometer. Receives: Device: Pedometer |
| Display Group | Experimental | Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display Receives: Device: SenseWear display |
| Coaching Group | Experimental | 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 Receives: Behavioral: Personal Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
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.
Measured: One year
Secondary outcomes (4)
Daily Energy Expenditure in Physical Activity
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.
Measured: One year
Percent of Participants Losing Fat Percentage
The amount of body fat is measured by bioelectrical impedance analysis (BIA).
Measured: One Year
Stages of Motivational Readiness for Physical Activity
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.
Measured: One Year
Step Count
Daily number of steps
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Van Hoye, KU Leuven
- Investigators
- Johan Lefevre, Prof Dr., Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432327
- Sponsor's protocol ID
- KULEUVEN_RTFDB
- Status last verified
- Feb 2015
- First submitted
- 9 Sep 2011
- Last updated
- 13 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Van Hoye K, Wijtzes AI, Lefevre J, De Baere S, Boen F. Year-round effects of a four-week randomized controlled trial using different types of feedback on employees' physical activity. BMC Public Health. 2018 Apr 12;18(1):492. doi: 10.1186/s12889-018-5402-0.
PubMed 29649997
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees: an Intervention Study
- ClinicalTrials.gov ID
- NCT01432327
- Acronym / sponsor ID
- KULEUVEN_RTFDB
- Conditions
- Sedentary Lifestyle
- Keywords
- motor activity, randomized controlled trial, feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 18 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: SenseWear ArmbandThis 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. |
| Step Group | Experimental | Device: PedometerThis group receives feedback about the daily amount of steps by means of a pedometer. |
| Display Group | Experimental | Device: SenseWear displayParticipants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display |
| Coaching Group | Experimental | Behavioral: Personal CoachingParticipants 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 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employee
- Physical Activity Level < 1.71 MET
- Willing to wear the SenseWear Armband for 5-6 weeks
Key exclusion criteria (2 listed)
- Student
- Senior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SenseWear displayAlso: BodyMedia® Display (Model DD100)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. | Device | Display Group |
| PedometerAlso: Yamax Digi-Walker SW-200Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary. | Device | Step Group |
| SenseWear ArmbandAlso: SenseWear Pro3 Armband, BodyMedia, Inc. Pittsburgh, PAParticipants wear the SenseWear Armband for 4 weeks | Device | Control group |
| Personal CoachingA weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life | Behavioural | Coaching Group |
Primary outcome
Physical Activity Level
Time frame: One year
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.
4 secondary outcomes
Daily Energy Expenditure in Physical Activity
Time frame: One year
Percent of Participants Losing Fat Percentage
Time frame: One Year
Stages of Motivational Readiness for Physical Activity
Time frame: One Year
Step Count
Time frame: One Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29649997Van Hoye K, Wijtzes AI, Lefevre J, De Baere S, Boen F. Year-round effects of a four-week randomized controlled trial using different types of feedback on employees' physical activity. BMC Public Health. 2018 Apr 12;18(1):492. doi: 10.1186/s12889-018-5402-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Lefevre, Prof Dr. study director
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenseWear display, Pedometer and SenseWear Armband in people with Sedentary Lifestyle, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01432327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.