Trial Outcomes & Findings for Applying Mobile Persuasive Technologies to Increase Physical Activity in Women (NCT NCT01280812)
NCT ID: NCT01280812
Last Updated: 2025-04-29
Results Overview
This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
210 participants
Primary outcome timeframe
Baseline, 3, and 9 months
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
PA Intervention and Maintenance Plus
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Pedometer
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
69
|
|
Overall Study
COMPLETED
|
67
|
69
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
PA Intervention and Maintenance Plus
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Pedometer
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
Baseline Characteristics
Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Baseline characteristics by cohort
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Pedometer
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
Total
n=210 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
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
71 participants
n=7 Participants
|
69 participants
n=5 Participants
|
210 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, and 9 monthsPopulation: Intention to treat (ITT) analysis
This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.
Outcome measures
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Control
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps
Mean total daily steps at baseline
|
5837 Steps/Day
Standard Deviation 3235
|
5063 Steps/Day
Standard Deviation 2526
|
5384 Steps/Day
Standard Deviation 2920
|
|
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps
Mean total daily steps at 3 months
|
8709 Steps/Day
Standard Deviation 3910
|
8096 Steps/Day
Standard Deviation 3903
|
6608 Steps/Day
Standard Deviation 3719
|
|
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps
Mean total daily steps at 9 months
|
7807 Steps/Day
Standard Deviation 4093
|
6909 Steps/Day
Standard Deviation 3704
|
6265 Steps/Day
Standard Deviation 3524
|
PRIMARY outcome
Timeframe: Baseline, 3 and 9 monthsPopulation: Intention to treat (ITT) analysis
This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.
Outcome measures
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Control
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)
Mean Daily MVPA at baseline
|
43.5 minutes per day
Standard Deviation 29.6
|
38.0 minutes per day
Standard Deviation 24.4
|
45.7 minutes per day
Standard Deviation 33.4
|
|
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)
Mean Daily MVPA at 9 months
|
60.1 minutes per day
Standard Deviation 33.7
|
56.6 minutes per day
Standard Deviation 36.4
|
50.8 minutes per day
Standard Deviation 34.4
|
|
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)
Mean Daily MVPA at 3 months
|
67.6 minutes per day
Standard Deviation 34.9
|
61.6 minutes per day
Standard Deviation 33.3
|
53.0 minutes per day
Standard Deviation 38.0
|
SECONDARY outcome
Timeframe: Baseline, 3 and 9 monthsPopulation: Intention to treat analysis
An interviewer-administered 7-day physical activity recall (PAR) is used to assess physical activities performed during the week preceding each visit. The PAR is a widely used and well-validated self-report recall instrument that assesses the frequency, duration, and intensity of physical activity. It yields average kcal/kg/day.
Outcome measures
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Control
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)
kcal/kg/day at baseline
|
33.1 kcal/kg/day
Standard Deviation 1.07
|
32.9 kcal/kg/day
Standard Deviation 1.09
|
32.9 kcal/kg/day
Standard Deviation 1.42
|
|
Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)
kcal/kg/day at 3 months
|
34.5 kcal/kg/day
Standard Deviation 1.75
|
34.8 kcal/kg/day
Standard Deviation 2.14
|
33.7 kcal/kg/day
Standard Deviation 1.78
|
|
Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)
kcal/kg/day at 9 months
|
34.3 kcal/kg/day
Standard Deviation 2.22
|
33.8 kcal/kg/day
Standard Deviation 1.90
|
34.1 kcal/kg/day
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: Baseline, 3 and 9 monthsPopulation: Intent to treat analysis
The Self-Efficacy for Physical Activity will be used to measure how confident the participant is to engage in physical activity in a specific situation. A sample item is, "I am confident I can participate in regular physical activity when I am tired." The measure consists of five items on a scale of 1 to 5, "1" being "not at all confident" and "5" being "very confident." The possible range of scores is from 5 to 25 points. Higher scores indicate higher self-efficacy for physical activity. Reported internal consistency ranges from 0.78 to 0.82. This measure has been widely used in adult women and men. Based on our pilot study, we added one additional question to this survey.
Outcome measures
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Control
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Modified Self-Efficacy for Physical Activity Survey
Self-efficacy at baseline
|
19.0 units on a scale
Standard Deviation 4.79
|
19.8 units on a scale
Standard Deviation 5.09
|
18.8 units on a scale
Standard Deviation 3.95
|
|
Modified Self-Efficacy for Physical Activity Survey
Self-efficacy at 3 months
|
18.1 units on a scale
Standard Deviation 4.50
|
18.0 units on a scale
Standard Deviation 5.13
|
19.1 units on a scale
Standard Deviation 5.53
|
|
Modified Self-Efficacy for Physical Activity Survey
Self-efficacy at 9 months
|
18.3 units on a scale
Standard Deviation 4.93
|
17.8 units on a scale
Standard Deviation 5.24
|
19.2 units on a scale
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Baseline, 3 and 9 monthsPopulation: Intention to treat analysis
The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months. The measure comprises two subscales (friend and family support subscales). Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often"). The ratings of all 12 items are summed for a subtotal score (possible ranges from 12 to 60). Internal consistency (Cronbach's alpha) of the measure was 0.83 in previous studies. Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales. Reported internal consistencies ranged between 0.80 to 0.93 for both scales. Higher scores indicate greater support.
Outcome measures
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Control
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Social Support for Physical Activity (Family)
Physical activity social support from family at baseline
|
32.8 units on a scale
Standard Deviation 9.16
|
31.5 units on a scale
Standard Deviation 10.9
|
32.0 units on a scale
Standard Deviation 9.18
|
|
Social Support for Physical Activity (Family)
Physical activity social support from family at 3 months
|
34.8 units on a scale
Standard Deviation 10.7
|
35.6 units on a scale
Standard Deviation 11.2
|
31.6 units on a scale
Standard Deviation 9.94
|
|
Social Support for Physical Activity (Family)
Physical activity social support from family at 9 months
|
34.3 units on a scale
Standard Deviation 11.1
|
34.5 units on a scale
Standard Deviation 9.86
|
33.4 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Baseline, 3 and 9 monthsPopulation: Intention to treat analysis
The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months. The measure comprises two subscales (friend and family support subscales). Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often"). The ratings of all 12 items are summed for a subtotal score (possible ranges from 12 to 60). Internal consistency (Cronbach's alpha) of the measure was 0.83 in previous studies. Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales. Reported internal consistencies ranged between 0.80 to 0.93 for both scales.
Outcome measures
| Measure |
PA Intervention and Maintenance Plus
n=70 Participants
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 Participants
3-month physical activity intervention and 6-month maintenance - Regular program
Mobile phone based physical activity intervention with maintenance regular: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Control
n=69 Participants
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Social Support for Physical Activity (Friends)
PA social support from friend at baseline
|
31.8 units on a scale
Standard Deviation 8.11
|
31.5 units on a scale
Standard Deviation 8.21
|
31.1 units on a scale
Standard Deviation 8.91
|
|
Social Support for Physical Activity (Friends)
PA social support from friend at 3 months
|
34.7 units on a scale
Standard Deviation 8.36
|
35.1 units on a scale
Standard Deviation 8.48
|
31.1 units on a scale
Standard Deviation 8.35
|
|
Social Support for Physical Activity (Friends)
PA social support from friend at 9 months
|
35.4 units on a scale
Standard Deviation 9.17
|
33.9 units on a scale
Standard Deviation 9.17
|
31.8 units on a scale
Standard Deviation 8.74
|
Adverse Events
PA Intervention and Maintenance Plus
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
PA Intervention and Maintenance Regular
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Control
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PA Intervention and Maintenance Plus
n=70 participants at risk
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 participants at risk
3-month physical activity intervention and 6-month maintenance intervention regular program
Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to stop using the app (activity diary).
|
Control
n=69 participants at risk
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
2.9%
2/69 • Number of events 2 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Infections and infestations
Hospitalization
|
1.4%
1/70 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Reproductive system and breast disorders
Hospitalization
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/69 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/71 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/69 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
Other adverse events
| Measure |
PA Intervention and Maintenance Plus
n=70 participants at risk
3-month physical activity intervention and 6-month maintenance intervention-Plus program
Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
|
PA Intervention and Maintenance Regular
n=71 participants at risk
3-month physical activity intervention and 6-month maintenance intervention regular program
Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to stop using the app (activity diary).
|
Control
n=69 participants at risk
Non-intervention group
Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Emergency Department or Urgent Care Facility Visit
|
1.4%
1/70 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/71 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Infections and infestations
Emergency Department or Urgent Care Facility Visit
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/71 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Gastrointestinal disorders
Emergency Department or Urgent Care Facility Visit
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/71 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
4.3%
3/69 • Number of events 3 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Injury, poisoning and procedural complications
Emergency Department or Urgent Care Facility Visit
|
4.3%
3/70 • Number of events 4 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
4.2%
3/71 • Number of events 3 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Cardiac disorders
Emergency Department or Urgent Care Facility Visit
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/69 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Vascular disorders
Emergency Department or Urgent Care Facility Visit
|
0.00%
0/70 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/71 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Eye disorders
Emergency Department or Urgent Care Facility Visits
|
1.4%
1/70 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Emergency Department or Urgent Care Facility Visit
|
7.1%
5/70 • Number of events 5 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
2.8%
2/71 • Number of events 2 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/69 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Emergency Department or Urgent Care Facility Visit
|
1.4%
1/70 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/71 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
1.4%
1/69 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
|
Investigations
Emergency Department or Urgent Care Facility Visit
|
1.4%
1/70 • Number of events 1 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/71 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
0.00%
0/69 • 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place