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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03987932

Enrollment

Registered

2019-06-17

Start date

2019-06-22

Completion date

2020-09-09

Last updated

2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

BEHAVIORALNEAT!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.

BEHAVIORALNEAT!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.

BEHAVIORALDelayed 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Sedentary Behavior at 3 Months	Baseline to 3 months	Daily sedentary behavior objectively measured by activpal
Change in Sedentary Behavior at 1 Month	Baseline to 1 month	Daily sedentary behavior objectively measured by activpal

Secondary

Measure	Time frame	Description
Change in Chair Stands at 1 Month	Baseline to 1 month	Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Change in 6 Minute Walk at 1 Month	Baseline to 1 month	Physical function assessed by 6 minute walk (total feet)
Change in Chair Stands at 3 Months	Baseline to 3 months	Physical function assessed by Chair Stand Test (# stands in 30 seconds)
Change in 6 Minute Walk at 3 Months	Baseline to 3 months	Physical function assessed by 6 minute walk (total feet)
Change in Timed Up & Go at 3 Months	Baseline to 3 months	Physical function assessed by Timed Up & Go (seconds)
Change in Timed Up & Go at 1 Month	Baseline to 1 month	Physical function assessed by Timed Up & Go (seconds)

Other

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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.	4
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. 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.	3
Delayed NEAT!2 Participants will receive the NEAT!2 app to use between 3 and 6 months. 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.	4
Total	11

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	2	1	1
Overall Study	Non-study related elective surgery	0	0	1

Baseline characteristics

Characteristic	NEAT!2	NEAT!2+Calls	Delayed NEAT!2	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants	2 Participants
Age, Categorical Between 18 and 65 years	4 Participants	2 Participants	3 Participants	9 Participants
Age, Continuous	58.7 years STANDARD_DEVIATION 10.2	60.2 years STANDARD_DEVIATION 6.9	48.8 years STANDARD_DEVIATION 9	55.5 years STANDARD_DEVIATION 9.7
Chair Stands	9.3 chair stands STANDARD_DEVIATION 2.5	12.0 chair stands STANDARD_DEVIATION 3.6	10.0 chair stands STANDARD_DEVIATION 4.5	10.3 chair stands STANDARD_DEVIATION 3.5
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants	3 Participants	4 Participants	11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	3 Participants	4 Participants	11 Participants
Region of Enrollment United States	4 participants	3 participants	4 participants	11 participants
Sex: Female, Male Female	2 Participants	2 Participants	3 Participants	7 Participants
Sex: Female, Male Male	2 Participants	1 Participants	1 Participants	4 Participants
Six Minute Walk	1491.2 feet STANDARD_DEVIATION 226.7	1553.1 feet STANDARD_DEVIATION 223.3	1496.8 feet STANDARD_DEVIATION 476	1510.1 feet STANDARD_DEVIATION 306.8
Timed Up and Go	7.2 seconds STANDARD_DEVIATION 0.3	6.5 seconds STANDARD_DEVIATION 1.1	8.3 seconds STANDARD_DEVIATION 3.7	7.4 seconds STANDARD_DEVIATION 2.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 3	0 / 4
other Total, other adverse events	0 / 4	0 / 3	0 / 4
serious Total, serious adverse events	0 / 4	0 / 3	0 / 4

Outcome results

Primary

Change in Sedentary Behavior at 1 Month

Daily sedentary behavior objectively measured by activpal

Time frame: Baseline to 1 month

Arm	Measure	Value (MEAN)	Dispersion
NEAT!2	Change in Sedentary Behavior at 1 Month	-33.7 change in minutes	Standard Deviation 119.2
NEAT!2+Calls	Change in Sedentary Behavior at 1 Month	-24.5 change in minutes	Standard Deviation 23
Delayed NEAT!2	Change in Sedentary Behavior at 1 Month	32.0 change in minutes	Standard Deviation 44.2

Primary

Change in Sedentary Behavior at 3 Months

Daily sedentary behavior objectively measured by activpal

Time frame: Baseline to 3 months

Arm	Measure	Value (MEAN)	Dispersion
NEAT!2	Change in Sedentary Behavior at 3 Months	43.4 change in minutes	Standard Deviation 99.1
NEAT!2+Calls	Change in Sedentary Behavior at 3 Months	-44.7 change in minutes	Standard Deviation 39.4
Delayed NEAT!2	Change in Sedentary Behavior at 3 Months	12.9 change in minutes	Standard Deviation 14.3

Secondary