Trial Outcomes & Findings for NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries (NCT NCT03987932)
NCT ID: NCT03987932
Last Updated: 2021-07-19
Results Overview
Daily sedentary behavior objectively measured by activpal
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline to 1 month
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
NEAT!2
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
|
Overall Study
1 Month
|
4
|
2
|
3
|
|
Overall Study
3 Months
|
4
|
2
|
3
|
|
Overall Study
6 Months
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
NEAT!2
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Non-study related elective surgery
|
0
|
0
|
1
|
Baseline Characteristics
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Baseline characteristics by cohort
| Measure |
NEAT!2
n=4 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=4 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
Total
n=11 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Timed Up and Go
|
7.2 seconds
STANDARD_DEVIATION 0.3 • n=5 Participants
|
6.5 seconds
STANDARD_DEVIATION 1.1 • n=7 Participants
|
8.3 seconds
STANDARD_DEVIATION 3.7 • n=5 Participants
|
7.4 seconds
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Six Minute Walk
|
1491.2 feet
STANDARD_DEVIATION 226.7 • n=5 Participants
|
1553.1 feet
STANDARD_DEVIATION 223.3 • n=7 Participants
|
1496.8 feet
STANDARD_DEVIATION 476.0 • n=5 Participants
|
1510.1 feet
STANDARD_DEVIATION 306.8 • n=4 Participants
|
|
Chair Stands
|
9.3 chair stands
STANDARD_DEVIATION 2.5 • n=5 Participants
|
12.0 chair stands
STANDARD_DEVIATION 3.6 • n=7 Participants
|
10.0 chair stands
STANDARD_DEVIATION 4.5 • n=5 Participants
|
10.3 chair stands
STANDARD_DEVIATION 3.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 monthDaily sedentary behavior objectively measured by activpal
Outcome measures
| Measure |
NEAT!2
n=4 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=4 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in Sedentary Behavior at 1 Month
|
-33.7 change in minutes
Standard Deviation 119.2
|
-24.5 change in minutes
Standard Deviation 23.0
|
32.0 change in minutes
Standard Deviation 44.2
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsDaily sedentary behavior objectively measured by activpal
Outcome measures
| Measure |
NEAT!2
n=4 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in Sedentary Behavior at 3 Months
|
43.4 change in minutes
Standard Deviation 99.1
|
-44.7 change in minutes
Standard Deviation 39.4
|
12.9 change in minutes
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline to 1 monthPopulation: Data collection for function tests stopped after COVID-19
Physical function assessed by Timed Up \& Go (seconds)
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in Timed Up & Go at 1 Month
|
-.4 change in seconds
Standard Deviation 1.0
|
-.4 change in seconds
Standard Deviation 1.5
|
-.1 change in seconds
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline to 1 monthPopulation: Data collection for function tests stopped after COVID-19
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in Chair Stands at 1 Month
|
.3 change in chair stands
Standard Deviation 1.2
|
2 change in chair stands
Standard Deviation 1.4
|
.3 change in chair stands
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline to 1 monthPopulation: Data collection for function tests stopped after COVID-19
Physical function assessed by 6 minute walk (total feet)
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in 6 Minute Walk at 1 Month
|
76.0 change in feet
Standard Deviation 130.7
|
74 change in feet
Standard Deviation 104.7
|
89.0 change in feet
Standard Deviation 123.1
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: Data collection for function tests stopped after COVID-19
Physical function assessed by Timed Up \& Go (seconds)
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in Timed Up & Go at 3 Months
|
-.3 change in seconds
Standard Deviation 1.4
|
-1.1 change in seconds
Standard Deviation 1.0
|
-.6 change in seconds
Standard Deviation .7
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: Data collection for function tests stopped after COVID-19
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in Chair Stands at 3 Months
|
2.3 change in chair stands
Standard Deviation .6
|
3.0 change in chair stands
Standard Deviation 2.8
|
-.7 change in chair stands
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: Data collection for function tests stopped after COVID-19
Physical function assessed by 6 minute walk (total feet)
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
|
NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
|
Delayed NEAT!2
n=3 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
|
|---|---|---|---|
|
Change in 6 Minute Walk at 3 Months
|
15.5 change in feet
Standard Deviation 11.4
|
678.2 change in feet
Standard Deviation 525.8
|
75.1 change in feet
Standard Deviation 81.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 monthsDaily sedentary behavior objectively measured by activpal
Outcome measures
| Measure |
NEAT!2
n=3 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
NEAT!2: Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
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NEAT!2+Calls
n=2 Participants
Participants will be asked to use the NEAT!2 app for 3 months after randomization. In addition, participants will receive bi-weekly coaching calls over 3 months. App use between 4-6 months is optional.
NEAT!2+Calls: Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
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Delayed NEAT!2
n=2 Participants
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Delayed NEAT!2: Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
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|---|---|---|---|
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Maintenance of Changes in Sedentary Behavior at 6 Months
|
-30.5 change in minutes
Standard Deviation 90.9
|
-84.4 change in minutes
Standard Deviation 138.3
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80.2 change in minutes
Standard Deviation 10.8
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Adverse Events
NEAT!2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NEAT!2+Calls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed NEAT!2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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