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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Step Group | Experimental | This group receives feedback about the daily amount of steps by means of a pedometer. |
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| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenseWear display | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Percent of Participants Losing Fat Percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Lefevre, Prof Dr. | KU Leuven | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholieke Universiteit Leuven - Tervuursevest 101 | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29649997 | Derived | 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. |
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Students and seniors were excluded from the study. Participants with an average Physical Activity Level above 1.71 times their resting metabolic rate were excluded from the trial
August 2010 - May 2010: recruitement of employees. Method: flyering at Pharmacists, word of mouth, information session at companies in and around the region of Antwerp
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | This group receives no kind of feedback during the intervention period |
| FG001 | Step Group | This group receives feedback about the daily amount of steps by means of a pedometer. |
| FG002 | Display Group | Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Posttest 3 Months |
| |||||||||||||
| Posttest 6 Months |
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| Posttest 1 Year |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | This group receives no kind of feedback during the intervention period |
| BG001 | Step Group | This group receives feedback about the daily amount of steps by means of a pedometer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study | Posted | Mean | Standard Deviation | Metabolic Equivalent | One year |
|
Participants were followed for a time period of 1 year.
The risk of an adverse cardiovascular event occurring during or following an acute bout of PA is greatest among new exercisers who are formerly sedentary and/or who display certain disease risk factors. The intervention did not result in any observable occurrences that has unfavorable and/or unintended effects on research subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | This group receives no kind of feedback during the intervention period |
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Malfunction of the SenseWear Armband: 4 out of the 320 baseline measurements
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Van Hoye | Katholieke Universiteit Leuven | 0032498617141 | Karen.Vanhoye@faber.kuleuven.be |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
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| Pedometer | Device | Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary. |
|
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| SenseWear Armband | Device | Participants wear the SenseWear Armband for 4 weeks |
|
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| Personal Coaching | Behavioral | A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life |
|
The amount of body fat is measured by bioelectrical impedance analysis (BIA). |
| 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. | One Year |
| Step Count | Daily number of steps | One Year |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| BG002 | Display Group | Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Step Group | This group receives feedback about the daily amount of steps by means of a pedometer. |
| OG002 | Display Group | Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display |
| OG003 | 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 |
|
|
| Secondary | 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. | Not Posted | One year |
| Secondary | Percent of Participants Losing Fat Percentage | The amount of body fat is measured by bioelectrical impedance analysis (BIA). | Not Posted | One Year |
| Secondary | 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. | Not Posted | One Year |
| Secondary | Step Count | Daily number of steps | Not Posted | One Year |
| 0 |
| 0 |
| 0 |
| 56 |
| EG001 | Step Group | This group receives feedback about the daily amount of steps by means of a pedometer. | 0 | 0 | 0 | 57 |
| EG002 | Display Group | Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display | 0 | 3 | 0 | 57 |
| EG003 | 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 | 0 | 5 | 0 | 57 |
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