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

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

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.

Study Overview

• Status: Terminated
• Conditions: Sedentary Lifestyle; Knee Osteoarthritis; Knee Injuries; Knee Pain Chronic
• Intervention / Treatment: Behavioral: NEAT!2; Behavioral: NEAT!2+Calls; Behavioral: Delayed NEAT!2

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Other: Delayed NEAT!2; Participants will receive the NEAT!2 app to use between 3 and 6 months.	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Changes in Sedentary Behavior at 6 Months	Daily sedentary behavior objectively measured by activpal	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2019
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Wounds and Injuries; Knee Injuries
• Other Study ID Numbers: Pro00085868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No