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

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ClinicalTrials.gov Identifier: NCT03987932
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Christine A Pellegrini, PhD, University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Knee Osteoarthritis Knee Injuries Knee Pain Chronic Behavioral: NEAT!2 Behavioral: NEAT!2+Calls Behavioral: Delayed NEAT!2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Actual Study Start Date : June 22, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Change in Sedentary Behavior at 1 month [ Time Frame: Baseline to 1 month ]
    Daily sedentary behavior objectively measured by activpal

  2. Change in Sedentary Behavior at 3 months [ Time Frame: Baseline to 3 months ]
    Daily sedentary behavior objectively measured by activpal


Secondary Outcome Measures :
  1. Change in Timed Up & Go at 1 month [ Time Frame: Baseline to 1 month ]
    Physical function assessed by Timed Up & Go (seconds)

  2. Change in Chair Stands at 1 month [ Time Frame: Baseline to 1 month ]
    Physical function assessed by Chair Stand Test (# stands in 30 seconds)

  3. Change in 6 minute walk at 1 month [ Time Frame: Baseline to 1 month ]
    Physical function assessed by 6 minute walk (total feet)

  4. Change in Timed Up & Go at 3 months [ Time Frame: Baseline to 3 months ]
    Physical function assessed by Timed Up & Go (seconds)

  5. Change in Chair Stands at 3 months [ Time Frame: Baseline to 3 months ]
    Physical function assessed by Chair Stand Test (# stands in 30 seconds)

  6. Change in 6 minute walk at 3 months [ Time Frame: Baseline to 3 months ]
    Physical function assessed by 6 minute walk (total feet)


Other Outcome Measures:
  1. Maintenance of Changes in Sedentary Behavior at 6 months [ Time Frame: Baseline to 6 months ]
    Daily sedentary behavior objectively measured by activpal



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987932


Contacts
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Contact: Christine Pellegrini, PhD 803-777-0911 cpellegrini@sc.edu

Locations
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United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Christine Pellegrini    803-777-0911    cpellegrini@sc.edu   
Sponsors and Collaborators
University of South Carolina

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Responsible Party: Christine A Pellegrini, PhD, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT03987932     History of Changes
Other Study ID Numbers: Pro00085868
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Knee Injuries
Wounds and Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries