Trial Outcomes & Findings for The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees (NCT NCT01432327)
NCT ID: NCT01432327
Last Updated: 2015-03-13
Results Overview
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.
COMPLETED
NA
227 participants
One year
2015-03-13
Participant Flow
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
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
Participant milestones
| Measure |
Control Group
This group receives no kind of feedback during the intervention period
|
Step Group
This group receives feedback about the daily amount of steps by means of a pedometer.
|
Display Group
Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
|
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
|
|---|---|---|---|---|
|
Baseline
STARTED
|
56
|
57
|
57
|
57
|
|
Baseline
COMPLETED
|
56
|
57
|
57
|
57
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Posttest 3 Months
STARTED
|
56
|
57
|
57
|
57
|
|
Posttest 3 Months
COMPLETED
|
52
|
55
|
55
|
56
|
|
Posttest 3 Months
NOT COMPLETED
|
4
|
2
|
2
|
1
|
|
Posttest 6 Months
STARTED
|
52
|
55
|
55
|
56
|
|
Posttest 6 Months
COMPLETED
|
52
|
55
|
50
|
54
|
|
Posttest 6 Months
NOT COMPLETED
|
0
|
0
|
5
|
2
|
|
Posttest 1 Year
STARTED
|
52
|
55
|
50
|
54
|
|
Posttest 1 Year
COMPLETED
|
28
|
27
|
30
|
31
|
|
Posttest 1 Year
NOT COMPLETED
|
24
|
28
|
20
|
23
|
Reasons for withdrawal
| Measure |
Control Group
This group receives no kind of feedback during the intervention period
|
Step Group
This group receives feedback about the daily amount of steps by means of a pedometer.
|
Display Group
Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
|
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
|
|---|---|---|---|---|
|
Posttest 3 Months
depression
|
3
|
0
|
0
|
0
|
|
Posttest 3 Months
Lost to Follow-up
|
1
|
0
|
2
|
1
|
|
Posttest 3 Months
Allergic reaction
|
0
|
2
|
0
|
0
|
|
Posttest 6 Months
Lost to Follow-up
|
0
|
0
|
3
|
2
|
|
Posttest 6 Months
Allergic reaction
|
0
|
0
|
1
|
0
|
|
Posttest 6 Months
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Posttest 1 Year
Measurement have to take place in future
|
24
|
28
|
15
|
20
|
|
Posttest 1 Year
Lost to Follow-up
|
0
|
0
|
4
|
2
|
|
Posttest 1 Year
Allergic reaction
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees
Baseline characteristics by cohort
| Measure |
Control Group
n=56 Participants
This group receives no kind of feedback during the intervention period
|
Step Group
n=57 Participants
This group receives feedback about the daily amount of steps by means of a pedometer.
|
Display Group
n=57 Participants
Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
|
Coaching Group
n=57 Participants
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
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
227 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11 • n=5 Participants
|
43 years
STANDARD_DEVIATION 11 • n=7 Participants
|
44 years
STANDARD_DEVIATION 10 • n=5 Participants
|
41 years
STANDARD_DEVIATION 10 • n=4 Participants
|
41 years
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
56 participants
n=5 Participants
|
57 participants
n=7 Participants
|
57 participants
n=5 Participants
|
57 participants
n=4 Participants
|
227 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study
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.
Outcome measures
| Measure |
Control Group
n=55 Participants
This group receives no kind of feedback during the intervention period
|
Step Group
n=56 Participants
This group receives feedback about the daily amount of steps by means of a pedometer.
|
Display Group
n=57 Participants
Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
|
Coaching Group
n=56 Participants
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
|
|---|---|---|---|---|
|
Physical Activity Level
|
1.45 Metabolic Equivalent
Standard Deviation 0.15
|
1.40 Metabolic Equivalent
Standard Deviation 0.16
|
1.46 Metabolic Equivalent
Standard Deviation 0.17
|
1.46 Metabolic Equivalent
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: One yearMinutes 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One YearThe amount of body fat is measured by bioelectrical impedance analysis (BIA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One YearAccording 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One YearDaily number of steps
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Step Group
Display Group
Coaching Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place