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

NCT03987932 | Terminated Results

• 1 other identifier: Pro00085868
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle; Knee Osteoarthritis; Knee Injuries; Knee Pain Chronic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Timed Up & Go at 1 Month

  Baseline to 1 month

• Change in Chair Stands at 1 Month

  Baseline to 1 month

• Change in 6 Minute Walk at 1 Month

  Baseline to 1 month

• Change in Timed Up & Go at 3 Months

  Baseline to 3 months

• Change in Chair Stands at 3 Months

  Baseline to 3 months

Other Outcomes (1)

• Maintenance of Changes in Sedentary Behavior at 6 Months

  Baseline to 6 months

Study Arms (3)

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.

Behavioral: NEAT!2

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.

Behavioral: NEAT!2+Calls

Delayed NEAT!2

OTHER

Participants will receive the NEAT!2 app to use between 3 and 6 months.

Behavioral: Delayed NEAT!2

Interventions

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.

NEAT!2

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.

NEAT!2+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.

Delayed NEAT!2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have any contraindications to activity
• Have a mobility limiting comorbidity
• Have a scheduled surgery within the next 6 months

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Behavior; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Christine Pellegrini
• Organization: University of South Carolina

pellegca@mailbox.sc.edu

803-777-0911

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: June 22, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: July 19, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)