Sedentary Lifestyle
Conditions
Keywords
motor activity, randomized controlled trial, feedback
Brief 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.
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.
Interventions
DEVICESenseWear display
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.
DEVICEPedometer
Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary.
DEVICESenseWear Armband
Participants wear the SenseWear Armband for 4 weeks
BEHAVIORALPersonal Coaching
A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
Yes
Inclusion criteria
* Employee * Physical Activity Level \< 1.71 MET * Willing to wear the SenseWear Armband for 5-6 weeks
Exclusion criteria
* Student * Senior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Level | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Energy Expenditure in Physical Activity | One year | 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. |
| Percent of Participants Losing Fat Percentage | One Year | The amount of body fat is measured by bioelectrical impedance analysis (BIA). |
| Stages of Motivational Readiness for Physical Activity | One Year | 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. |
| Step Count | One Year | Daily number of steps |
Countries
Belgium
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Control Group This group receives no kind of feedback during the intervention period | 56 |
| Step Group This group receives feedback about the daily amount of steps by means of a pedometer. | 57 |
| Display Group Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display | 57 |
| 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 | 57 |
| Total | 227 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Posttest 1 Year | Allergic reaction | 0 | 0 | 1 | 1 |
| Posttest 1 Year | Lost to Follow-up | 0 | 0 | 4 | 2 |
| Posttest 1 Year | Measurement have to take place in future | 24 | 28 | 15 | 20 |
| Posttest 3 Months | Allergic reaction | 0 | 2 | 0 | 0 |
| Posttest 3 Months | depression | 3 | 0 | 0 | 0 |
| Posttest 3 Months | Lost to Follow-up | 1 | 0 | 2 | 1 |
| Posttest 6 Months | Allergic reaction | 0 | 0 | 1 | 0 |
| Posttest 6 Months | Lost to Follow-up | 0 | 0 | 3 | 2 |
| Posttest 6 Months | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Step Group | Display Group | Control Group | Coaching Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 57 Participants | 56 Participants | 57 Participants | 227 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 11 | 44 years STANDARD_DEVIATION 10 | 40 years STANDARD_DEVIATION 11 | 41 years STANDARD_DEVIATION 10 | 41 years STANDARD_DEVIATION 11 |
| Region of Enrollment Belgium | 57 participants | 57 participants | 56 participants | 57 participants | 227 participants |
| Sex: Female, Male Female | 31 Participants | 31 Participants | 31 Participants | 31 Participants | 124 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants | 25 Participants | 26 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 57 | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 3 | 0 / 5 |
Outcome results
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.
Time frame: One year
Population: Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Physical Activity Level | 1.45 Metabolic Equivalent | Standard Deviation 0.15 |
| Step Group | Physical Activity Level | 1.40 Metabolic Equivalent | Standard Deviation 0.16 |
| Display Group | Physical Activity Level | 1.46 Metabolic Equivalent | Standard Deviation 0.17 |
| Coaching Group | Physical Activity Level | 1.46 Metabolic Equivalent | Standard Deviation 0.18 |
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.
Time frame: One year
Secondary
Percent of Participants Losing Fat Percentage
The amount of body fat is measured by bioelectrical impedance analysis (BIA).
Time frame: 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.
Time frame: One Year
Secondary
Step Count
Daily number of steps
Time frame: One Year