NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Primary Purpose
Sedentary Lifestyle, Knee Osteoarthritis, Knee Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEAT!2
NEAT!2+Calls
Delayed NEAT!2
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary Lifestyle
Eligibility Criteria
Inclusion Criteria:
- Be at least 40 years of age
- Own an Android or Apple smartphone
- Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for >50% of their waking day
- Be willing to download the study application and be compatible on their smartphone
- Spend at least 7 hours/day sitting
- Have at least 4 days of valid accelerometer data at baseline
- Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years
- Read, speak, and understand English
Exclusion Criteria:
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
Sites / Locations
- University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
NEAT!2
NEAT!2+Calls
Delayed NEAT!2
Arm Description
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
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.
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Outcomes
Primary Outcome Measures
Change in Sedentary Behavior at 1 Month
Daily sedentary behavior objectively measured by activpal
Change in Sedentary Behavior at 3 Months
Daily sedentary behavior objectively measured by activpal
Secondary Outcome Measures
Change in Timed Up & Go at 1 Month
Physical function assessed by Timed Up & Go (seconds)
Change in Chair Stands at 1 Month
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Change in 6 Minute Walk at 1 Month
Physical function assessed by 6 minute walk (total feet)
Change in Timed Up & Go at 3 Months
Physical function assessed by Timed Up & Go (seconds)
Change in Chair Stands at 3 Months
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Change in 6 Minute Walk at 3 Months
Physical function assessed by 6 minute walk (total feet)
Full Information
NCT ID
NCT03987932
First Posted
June 12, 2019
Last Updated
June 28, 2021
Sponsor
University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03987932
Brief Title
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Official Title
NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
June 22, 2019 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Knee Osteoarthritis, Knee Injuries, Knee Pain Chronic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NEAT!2
Arm Type
Experimental
Arm Description
Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional.
Arm Title
NEAT!2+Calls
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed NEAT!2
Arm Type
Other
Arm Description
Participants will receive the NEAT!2 app to use between 3 and 6 months.
Intervention Type
Behavioral
Intervention Name(s)
NEAT!2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NEAT!2+Calls
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed NEAT!2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sedentary Behavior at 1 Month
Description
Daily sedentary behavior objectively measured by activpal
Time Frame
Baseline to 1 month
Title
Change in Sedentary Behavior at 3 Months
Description
Daily sedentary behavior objectively measured by activpal
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Change in Timed Up & Go at 1 Month
Description
Physical function assessed by Timed Up & Go (seconds)
Time Frame
Baseline to 1 month
Title
Change in Chair Stands at 1 Month
Description
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Time Frame
Baseline to 1 month
Title
Change in 6 Minute Walk at 1 Month
Description
Physical function assessed by 6 minute walk (total feet)
Time Frame
Baseline to 1 month
Title
Change in Timed Up & Go at 3 Months
Description
Physical function assessed by Timed Up & Go (seconds)
Time Frame
Baseline to 3 months
Title
Change in Chair Stands at 3 Months
Description
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Time Frame
Baseline to 3 months
Title
Change in 6 Minute Walk at 3 Months
Description
Physical function assessed by 6 minute walk (total feet)
Time Frame
Baseline to 3 months
Other Pre-specified Outcome Measures:
Title
Maintenance of Changes in Sedentary Behavior at 6 Months
Description
Daily sedentary behavior objectively measured by activpal
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be at least 40 years of age
Own an Android or Apple smartphone
Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for >50% of their waking day
Be willing to download the study application and be compatible on their smartphone
Spend at least 7 hours/day sitting
Have at least 4 days of valid accelerometer data at baseline
Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years
Read, speak, and understand English
Exclusion Criteria:
Have any contraindications to activity
Have a mobility limiting comorbidity
Have a scheduled surgery within the next 6 months
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
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