Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19 pandemic
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.
Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function. Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors. To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time. Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention. Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group. Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEAT!2 | Experimental | 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+Calls | Experimental | 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. |
|
| Delayed NEAT!2 | Other | Participants will receive the NEAT!2 app to use between 3 and 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEAT!2 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sedentary Behavior at 1 Month | Daily sedentary behavior objectively measured by activpal | Baseline to 1 month |
| Change in Sedentary Behavior at 3 Months | Daily sedentary behavior objectively measured by activpal | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Timed Up & Go at 1 Month | Physical function assessed by Timed Up & Go (seconds) | Baseline to 1 month |
| Change in Chair Stands at 1 Month | Physical function assessed by Chair Stand Test (# stands in 30 seconds) |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Changes in Sedentary Behavior at 6 Months | Daily sedentary behavior objectively measured by activpal | Baseline to 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NEAT!2+Calls | Behavioral | 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 | Behavioral | 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. |
|
| Baseline to 1 month |
| Change in 6 Minute Walk at 1 Month | Physical function assessed by 6 minute walk (total feet) | Baseline to 1 month |
| Change in Timed Up & Go at 3 Months | Physical function assessed by Timed Up & Go (seconds) | Baseline to 3 months |
| Change in Chair Stands at 3 Months | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Baseline to 3 months |
| Change in 6 Minute Walk at 3 Months | Physical function assessed by 6 minute walk (total feet) | Baseline to 3 months |
| FG001 | 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. |
| FG002 | 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. |
|
| 1 Month |
|
| 3 Months |
|
| 6 Months |
|
| COMPLETED | Study stopped due to COVID-19 |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Timed Up and Go | Mean | Standard Deviation | seconds |
| |||||||||||||||
| Six Minute Walk | Mean | Standard Deviation | feet |
| |||||||||||||||
| Chair Stands | Mean | Standard Deviation | chair stands |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sedentary Behavior at 1 Month | Daily sedentary behavior objectively measured by activpal | Posted | Mean | Standard Deviation | change in minutes | Baseline to 1 month |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Change in Sedentary Behavior at 3 Months | Daily sedentary behavior objectively measured by activpal | Posted | Mean | Standard Deviation | change in minutes | Baseline to 3 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Timed Up & Go at 1 Month | Physical function assessed by Timed Up & Go (seconds) | Data collection for function tests stopped after COVID-19 | Posted | Mean | Standard Deviation | change in seconds | Baseline to 1 month |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Chair Stands at 1 Month | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Data collection for function tests stopped after COVID-19 | Posted | Mean | Standard Deviation | change in chair stands | Baseline to 1 month |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in 6 Minute Walk at 1 Month | Physical function assessed by 6 minute walk (total feet) | Data collection for function tests stopped after COVID-19 | Posted | Mean | Standard Deviation | change in feet | Baseline to 1 month |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Timed Up & Go at 3 Months | Physical function assessed by Timed Up & Go (seconds) | Data collection for function tests stopped after COVID-19 | Posted | Mean | Standard Deviation | change in seconds | Baseline to 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Chair Stands at 3 Months | Physical function assessed by Chair Stand Test (# stands in 30 seconds) | Data collection for function tests stopped after COVID-19 | Posted | Mean | Standard Deviation | change in chair stands | Baseline to 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in 6 Minute Walk at 3 Months | Physical function assessed by 6 minute walk (total feet) | Data collection for function tests stopped after COVID-19 | Posted | Mean | Standard Deviation | change in feet | Baseline to 3 months |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Maintenance of Changes in Sedentary Behavior at 6 Months | Daily sedentary behavior objectively measured by activpal | Posted | Mean | Standard Deviation | change in minutes | Baseline to 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Pellegrini | University of South Carolina | 803-777-0911 | pellegca@mailbox.sc.edu |
| May 27, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|