Trial Outcomes & Findings for IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial (NCT NCT01869348)
NCT ID: NCT01869348
Last Updated: 2017-10-04
Results Overview
Minutes of physical activity measured over a seven day period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-10-04
Participant Flow
Participant milestones
| Measure |
Wait List Control
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
|
Monitor Intervention
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Wait List Control
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
|
Monitor Intervention
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
Baseline characteristics by cohort
| Measure |
Wait List Control
n=20 Participants
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
|
Monitor Intervention
n=20 Participants
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.70 years
STANDARD_DEVIATION 6.26 • n=93 Participants
|
61.25 years
STANDARD_DEVIATION 5.00 • n=4 Participants
|
61.48 years
STANDARD_DEVIATION 5.60 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksMinutes of physical activity measured over a seven day period
Outcome measures
| Measure |
Wait List Control
n=20 Participants
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
|
Monitor Intervention
n=20 Participants
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
|
|---|---|---|
|
Change in Physical Activity From Baseline to 12 Weeks
|
-2.25 minutes
Standard Deviation 33.91
|
50.93 minutes
Standard Deviation 128.34
|
SECONDARY outcome
Timeframe: 12 weeksMinutes of total sedentary time measured over a seven day period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksWe will measure feelings of autonomous and controlled motivation/regulation for physical activity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksWe will use the six minute walk test to measure physical fitness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksWe will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksFunctional measurements will be made using the Senior Fitness Test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksWe will measure weight (and height at baseline) using a calibrated scale
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksWe will use many different measures of feasibility, including adherence to study protocol, attrition, barriers to adherence, exposure/dose of intervention received, and any adverse events that occur
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksAcceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability
Outcome measures
Outcome data not reported
Adverse Events
Wait List Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Monitor Intervention
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Wait List Control
n=40 participants at risk
This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.
|
Monitor Intervention
n=40 participants at risk
This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls
Monitor intervention: Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Stitches to hand
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Nerve damage during blood draw
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Weakness
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Bone spur
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Eye disorders
Retinal detachment
|
2.5%
1/40 • Number of events 2
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place