Sedentary LifestyleNCT03987932
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
A study testing NEAT!2, NEAT!2+Calls and Delayed NEAT!2 in people with Sedentary Lifestyle and Knee Osteoarthritis, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Knee Osteoarthritis, Knee Injuries
- What is being tested?
- NEAT!2, NEAT!2+Calls and Delayed NEAT!2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2019to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Being tested
- NEAT!2, NEAT!2+Calls, Delayed NEAT!2
- Medical subject headings
- Sedentary Behavior, Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAT!2Behavioural
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+CallsBehavioural
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!2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: NEAT!2+Calls |
| Delayed NEAT!2 | Other | Participants will receive the NEAT!2 app to use between 3 and 6 months. Receives: Behavioral: Delayed NEAT!2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sedentary Behavior at 1 Month
Daily sedentary behavior objectively measured by activpal
Measured: Baseline to 1 month
Change in Sedentary Behavior at 3 Months
Daily sedentary behavior objectively measured by activpal
Measured: Baseline to 3 months
Secondary outcomes (6)
Change in Timed Up & Go at 1 Month
Physical function assessed by Timed Up \& Go (seconds)
Measured: Baseline to 1 month
Change in Chair Stands at 1 Month
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Measured: Baseline to 1 month
Change in 6 Minute Walk at 1 Month
Physical function assessed by 6 minute walk (total feet)
Measured: Baseline to 1 month
Change in Timed Up & Go at 3 Months
Physical function assessed by Timed Up \& Go (seconds)
Measured: Baseline to 3 months
Change in Chair Stands at 3 Months
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Measured: Baseline to 3 months
Change in 6 Minute Walk at 3 Months
Physical function assessed by 6 minute walk (total feet)
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start22 Jun 2019
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine A Pellegrini, PhD, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987932
- Sponsor's protocol ID
- Pro00085868
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2019
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
- ClinicalTrials.gov ID
- NCT03987932
- Acronym / sponsor ID
- Pro00085868
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 22 Jun 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEAT!2 | Experimental | Behavioral: NEAT!2Participants will be asked to use the NEAT!2 app for 3 months after randomization. App use between 4-6 months is optional. |
| NEAT!2+Calls | Experimental | Behavioral: NEAT!2+CallsParticipants 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. |
| Delayed NEAT!2 | Other | Behavioral: Delayed NEAT!2Participants will receive the NEAT!2 app to use between 3 and 6 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEAT!2Participants 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. | Behavioural | NEAT!2 |
| NEAT!2+CallsParticipants 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. | Behavioural | NEAT!2+Calls |
| Delayed NEAT!2Participants 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. | Behavioural | Delayed NEAT!2 |
Primary outcome
Change in Sedentary Behavior at 1 Month
Time frame: Baseline to 1 month
Daily sedentary behavior objectively measured by activpal
Change in Sedentary Behavior at 3 Months
Time frame: Baseline to 3 months
Daily sedentary behavior objectively measured by activpal
6 secondary outcomes
Change in Timed Up & Go at 1 Month
Time frame: Baseline to 1 month
Change in Chair Stands at 1 Month
Time frame: Baseline to 1 month
Change in 6 Minute Walk at 1 Month
Time frame: Baseline to 1 month
Change in Timed Up & Go at 3 Months
Time frame: Baseline to 3 months
Change in Chair Stands at 3 Months
Time frame: Baseline to 3 months
Change in 6 Minute Walk at 3 Months
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAT!2, NEAT!2+Calls and Delayed NEAT!2 in people with Sedentary Lifestyle and Knee Osteoarthritis, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sedentary Behavior at 1 Month (time frame: Baseline to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.