Trial Outcomes & Findings for TAME Health: Testing Activity Monitors' Effect on Health (NCT NCT02554435)
NCT ID: NCT02554435
Last Updated: 2020-07-20
Results Overview
Minutes of moderate-vigorous physical activity over a 7 day period
COMPLETED
NA
40 participants
Physical activity minutes at the end of the 12 week intervention
2020-07-20
Participant Flow
Participant milestones
| Measure |
Pedometer
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAME Health: Testing Activity Monitors' Effect on Health
Baseline characteristics by cohort
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
63.2 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
64.0 years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
63.7 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Physical Activity
|
40.0 minutes per day
STANDARD_DEVIATION 33.9 • n=99 Participants
|
22.5 minutes per day
STANDARD_DEVIATION 21.5 • n=107 Participants
|
31.3 minutes per day
STANDARD_DEVIATION 29.4 • n=206 Participants
|
|
Steps
|
4560.18 steps per day
STANDARD_DEVIATION 2285.6 • n=99 Participants
|
3849.4 steps per day
STANDARD_DEVIATION 2107.8 • n=107 Participants
|
4204.8 steps per day
STANDARD_DEVIATION 2199.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Physical activity minutes at the end of the 12 week interventionMinutes of moderate-vigorous physical activity over a 7 day period
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Physical Activity Minutes Measured by a SenseWear Armband
|
40.2 minutes per day
Standard Deviation 3.7
|
33.8 minutes per day
Standard Deviation 27.6
|
PRIMARY outcome
Timeframe: Cardiovascular risk at the end of the 12 week interventionFactors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \>30% risk of a cardiovascular event within the next 10 years.
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
|
21.2 Risk score
Standard Deviation 12.6
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16.6 Risk score
Standard Deviation 13.2
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PRIMARY outcome
Timeframe: Fitness at the end of the 12 week interventiondistance walked in 6 minutes
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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6-minute Walk Test
|
1642.9 feet
Standard Deviation 287.3
|
1561 feet
Standard Deviation 353.6
|
PRIMARY outcome
Timeframe: Steps per day at the end of the 12 week interventionMeasured by a SenseWear Armband. Average steps per day over a 7 day period
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Steps Per Day
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4702 steps
Standard Deviation 2259.7
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4353 steps
Standard Deviation 2021.4
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SECONDARY outcome
Timeframe: Weight at the end of the 12 week interventionOutcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Weight
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86.8 kg
Standard Deviation 13.6
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81.9 kg
Standard Deviation 11.2
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SECONDARY outcome
Timeframe: BMI at the end of the 12 week interventionOutcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Body Mass Index (BMI)
|
30.5 kg/m^2
Standard Deviation 3.1
|
30.0 kg/m^2
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Waist-to-hip ratio at the end of the 12 week interventionWaist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Waist-to-Hip Ratio
|
.84 ratio
Standard Deviation 0.1
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0.80 ratio
Standard Deviation 0.1
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SECONDARY outcome
Timeframe: Blood pressure at the end of the 12 week interventionOutcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Blood Pressure
Systolic blood pressure
|
134.3 mmHg
Standard Deviation 14.6
|
125.0 mmHg
Standard Deviation 14.5
|
|
Blood Pressure
Diastolic blood pressure
|
83.4 mmHg
Standard Deviation 10.0
|
80 mmHg
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Exercise motivation at the end of the 12 week interventionMeasured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of "intrinsic" and "identified" are better. Alternatively, low scores of "introjected", "extrinsic", and "amotivation" are better.
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Exercise Motivation
Introjected
|
1.12 units on a scale
Standard Deviation 1.06
|
1.68 units on a scale
Standard Deviation 0.88
|
|
Exercise Motivation
Amotivation
|
0.61 units on a scale
Standard Deviation 0.78
|
0.15 units on a scale
Standard Deviation 0.38
|
|
Exercise Motivation
Intrinsic
|
1.48 units on a scale
Standard Deviation 1.0
|
2.84 units on a scale
Standard Deviation 0.77
|
|
Exercise Motivation
Identified
|
2.24 units on a scale
Standard Deviation 1.04
|
2.92 units on a scale
Standard Deviation 0.59
|
|
Exercise Motivation
Extrinsic
|
0.49 units on a scale
Standard Deviation 0.69
|
0.51 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Quality of life at the end of the 12 week interventionSub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
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|---|---|---|
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Quality of Life Measured by the SF-36 Questionnaire
Physical functioning
|
62.3 units on a scale
Standard Deviation 29.3
|
73.1 units on a scale
Standard Deviation 19.3
|
|
Quality of Life Measured by the SF-36 Questionnaire
Social functioning
|
75.8 units on a scale
Standard Deviation 25.5
|
71.3 units on a scale
Standard Deviation 31.4
|
|
Quality of Life Measured by the SF-36 Questionnaire
Physical role limitations
|
67.9 units on a scale
Standard Deviation 26.6
|
72.2 units on a scale
Standard Deviation 24.2
|
|
Quality of Life Measured by the SF-36 Questionnaire
Emotional role limitations
|
75.8 units on a scale
Standard Deviation 25.5
|
71.3 units on a scale
Standard Deviation 31.4
|
|
Quality of Life Measured by the SF-36 Questionnaire
Mental health
|
70 units on a scale
Standard Deviation 18.6
|
76.3 units on a scale
Standard Deviation 18.7
|
|
Quality of Life Measured by the SF-36 Questionnaire
Energy/vitality
|
53.1 units on a scale
Standard Deviation 15.1
|
58.1 units on a scale
Standard Deviation 16.7
|
|
Quality of Life Measured by the SF-36 Questionnaire
Pain
|
56.8 units on a scale
Standard Deviation 29.1
|
60.3 units on a scale
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: Physical function at the end of the 12 week interventionPhysical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled "tandem balance."
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
|
|---|---|---|
|
Physical Function Measured by the Short Physical Performance Battery
8 feet up and go
|
5.9 seconds
Standard Deviation 1.4
|
6.4 seconds
Standard Deviation 3.0
|
|
Physical Function Measured by the Short Physical Performance Battery
Chair stand
|
14.2 seconds
Standard Deviation 3.7
|
14.7 seconds
Standard Deviation 5.5
|
|
Physical Function Measured by the Short Physical Performance Battery
Tandem balance
|
9.2 seconds
Standard Deviation 2.2
|
9.1 seconds
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Psychological feelings at the end of the 12 week interventionMeasured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
|
|---|---|---|
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Psychological Feelings
Competence
|
2.49 units on a scale
Standard Deviation 0.94
|
3.43 units on a scale
Standard Deviation 0.95
|
|
Psychological Feelings
Autonomy
|
3.16 units on a scale
Standard Deviation 0.95
|
4.01 units on a scale
Standard Deviation 0.95
|
|
Psychological Feelings
Relatedness
|
2.72 units on a scale
Standard Deviation 1.33
|
3.53 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Resting pulse at the end of the 12 week interventionOutcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
|
|---|---|---|
|
Resting Pulse
|
76.5 bpm
Standard Deviation 11.9
|
69.1 bpm
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Change in self-regulation from baseline and 12-weeksMeasured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.
Outcome measures
| Measure |
Pedometer
n=20 Participants
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 Participants
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
|
|---|---|---|
|
Change From Baseline in Self-regulation
Goal-setting
|
22.1 units on a scale
Standard Deviation 5.3
|
31.3 units on a scale
Standard Deviation 9.8
|
|
Change From Baseline in Self-regulation
Planning
|
24.3 units on a scale
Standard Deviation 4.1
|
26.4 units on a scale
Standard Deviation 7.6
|
Adverse Events
Pedometer
Electronic Activity Monitor
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pedometer
n=20 participants at risk
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX). Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
Pedometer: The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
|
Electronic Activity Monitor
n=20 participants at risk
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device. In addition to monitoring activity, the app allows for social comparison and social interaction. Participants will "friend" other participants to utilize these features.
EAM: The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
5 A's counseling: Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Knee replacement
|
0.00%
0/20 • 12 weeks
|
10.0%
2/20 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Product Issues
Adverse reaction
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Additional Information
Dr. Zakkoyya Lewis
California State Polytechnic University, Pomona
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place