NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries

Study Overview
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Brief Summary
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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
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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.

Official Title
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NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries

Conditions
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Sedentary Lifestyle, Knee Osteoarthritis, Knee Injuries, Knee Pain Chronic

Intervention / Treatment
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* Behavioral: NEAT!2
* Behavioral: NEAT!2+Calls
* Behavioral: Delayed NEAT!2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEAT!2<br>Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional. | Behavioral: NEAT!2<br>* 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.<br>|
| Experimental: NEAT!2+Calls<br>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. | Behavioral: NEAT!2+Calls<br>* 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.<br>|
| Other: Delayed NEAT!2<br>Participants will receive the NEAT!2 app to use between 3 and 6 months. | Behavioral: Delayed NEAT!2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |