Joint Diseases, Knee Osteoarthritis
Conditions
Keywords
Physical activity, Osteoarthritis, Knee, Exercise, Arthritis
Brief summary
Physical activity is an essential first-line treatment for patients with knee osteoarthritis (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more per week. The primary goal of this randomized controlled trial is to assess the efficacy of a Fitbit Flex (a wireless physical activity tracking device) paired with a new application, plus a brief education session and telephone counselling by a physiotherapist (PT), to improve physical activity and reduce sedentary time in patients with knee osteoarthritis.
Detailed description
Current practice guidelines emphasize the use of exercise and weight reduction as the first-line management of knee osteoarthritis (OA; affecting 1 in 10 Canadians). However, up to 90% of people with OA are inactive. Several modifiable risk factors are associated with low physical activity participation, including lack of motivation, doubts about the effectiveness of prescribed exercises and lack of health professional advice regarding ways to progress their physical activity. The variety of risk factors highlights the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support to stay active. Our primary objective is to assess the efficacy of a Fitbit/Fitviz intervention, involving the use of a Fitbit Flex paired with a FitViz application (app), a brief education session, and telephone counselling by a physiotherapist, to improve physical activity participation and reduce sedentary time in people with knee OA. Our secondary objective is to assess the effect of the intervention on patients' OA disease status and self-efficacy in disease management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience; 2) To conduct a pilot test for the Fitbit/FitViz intervention; 3) To evaluate the effect of the Fitbit/FitViz intervention in patients with knee OA. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention Group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA) as determined by an objective measure, 2) reduce sedentary time during waking hours, 3) improve in OA disease status, and 4) improve in their self-efficacy of OA management. The investigators will use a mixed-method approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.
Interventions
BEHAVIORALEducation session, Fitbit/FitViz, PT counselling
Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.
BEHAVIORALSame intervention with a 3 month delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.
Sponsors
Simon Fraser University
Arthritis Research Centre of Canada
Fraser Health
Canadian Institutes of Health Research (CIHR)
Vancouver Coastal Health Research Institute
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a physician confirmed diagnosis of knee osteoarthritis OR are both 1) over 50, and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee during the last year (equal to or more than 28 separate or consecutive days). * Have no previous diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), connective tissue diseases, or gout. * Have no history of using disease-modifying anti-rheumatic drugs, such as hydroxychloroquine, sulfasalazine, methotrexate, biologic agents (e.g., Humira, Enbrel), or gout medications. * Have no prior knee arthroplasty, and not on a waiting list for total knee replacement surgery. * Have no history of acute injury to the knee in the past 6 months. * Have not had surgery in the back, hip, knee, or ankle joints in the past 12 months. * Have an email address and use online/mobile applications. * Are able to attend one 1.5-hour education session.
Exclusion criteria
* Have received a hyaluronate injection in a knee in the last 6 months. * Have received a steroid injection in a knee in the last 6 months. * Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Number of Minutes in Moderate/Vigorous Physical Activity | Baseline, 13 weeks, 26 weeks, 39 weeks | Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | Baseline, 13 weeks, 26 weeks, 39 weeks | The Symptom Subscale ranges from 0 - 100, with 0 indicates extreme knee symptoms and 100 indicates no knee symptoms. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | Baseline, 13 weeks, 26 weeks, 39 weeks | The Pain Subscale ranges from 0 - 100, with 0 indicates extreme knee pain and 100 indicates no knee pain. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | Baseline, 13 weeks, 26 weeks, 39 weeks | The Sport and Recreation Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with sport and recreational activities due to knee problems and 100 indicates no difficulties. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | Baseline, 13 weeks, 26 weeks, 39 weeks | The Activity of Daily Living Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with activity of daily living and 100 indicates no difficulties. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | Baseline, 13 weeks, 26 weeks, 39 weeks | The Quality of Life Subscale ranges from 0 - 100, with 0 indicates extreme problems with the knee and 100 indicates no problems. |
| The Patient Health Questionnaire-9 (PHQ-9) | Baseline, 13 weeks, 26 weeks, 39 weeks | The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder. Range 0-27; lower score = less depressive symptoms), |
| Partners in Health Scale | Baseline, Months 3, 6, and 9 | The Partners in Health Scale ranges from 0 to 96, calculated from responses to 12 items on a 9-point Likert scale. A score of 0 represents poor self-management, and a score of 96 represents greater self-management capabilities. |
| Daily Number of Sedentary Minutes | Baseline, 13 weeks, 26 weeks, 39 weeks | Time spent in sedentary behaviour was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of \<=1.5 METs, occurring in bouts of \>= 20 minutes during waking hours. |
| Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | Baseline, 13 weeks, 26 weeks, 39 weeks | The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit. |
| Self-Reported Habit Index (SRHI) - Walking Subscale | Baseline, 13 weeks, 26 weeks, 39 weeks | The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit. |
| Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | Baseline, 13 weeks, 26 weeks, 39 weeks | The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive) |
| Theory of Planned Behavior Questionnaire - Subjective Norm | Baseline, 13 weeks, 26 weeks, 39 weeks | The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive) |
| Theory of Planned Behavior Questionnaire - Perceived Control | Baseline, 13 weeks, 26 weeks, 39 weeks | The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive) |
| Theory of Planned Behavior Questionnaire - Intention | Baseline, 13 weeks, 26 weeks, 39 weeks | The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive) |
| Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | Baseline, 13 weeks, 26 weeks, 39 weeks | The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit. |
Countries
Canada
Participant flow
Recruitment details
Patient participants were recruited between 2017 and 2019 from the Mary Pack Arthritis Program (Vancouver Coastal Health Authority) and the Fraser Health Authority in British Columbia, Canada. We also posted study information on Facebook, Twitter, Kajiji, and Craigslist.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Group Participants received an education session, Fitbit/FitViz, physical therapist (PT) counselling in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered PT, and an orientation to the Fitbit Flex and the FitViz app.
In Weeks 1-8, participants used the Fitbit/FitViz. The PT reviewed the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities.
In Weeks 9-13, participants continued using the Fitbit/FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
In Weeks 14-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit and FitViz. | 26 |
| Delay Group Participants received the same intervention with a 13-week delay. The full intervention was initiated in Week 14 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physical therapist (PT).
In Week 26-38, participants did not have access to a PT but were encouraged to continue using the Fitbit/FitViz. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Week 13 (RCT Period) | Participant refused assessment | 0 | 1 |
| Week 13 (RCT Period) | Withdrawal by Subject | 2 | 0 |
| Week 26 (All Received Intervention) | Withdrawal by Subject | 2 | 0 |
| Week 39 (All Received Intervention) | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Immediate Group | Delay Group | Total |
|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 8 | 64.8 years STANDARD_DEVIATION 9 | 64.9 years STANDARD_DEVIATION 8.5 |
| Daily number of minutes in moderate/vigorous physical activity | 31.0 Minutes per day STANDARD_DEVIATION 37.3 | 71.3 Minutes per day STANDARD_DEVIATION 99.8 | 50.8 Minutes per day STANDARD_DEVIATION 76.7 |
| Daily number of sedentary minutes | 567.5 Minutes per day STANDARD_DEVIATION 183.1 | 551.1 Minutes per day STANDARD_DEVIATION 234.9 | 559.4 Minutes per day STANDARD_DEVIATION 208.1 |
| Daily number of steps | 6294.0 Steps per day STANDARD_DEVIATION 3418 | 7030.1 Steps per day STANDARD_DEVIATION 3921.6 | 6654.8 Steps per day STANDARD_DEVIATION 3655.3 |
| Knee Injury and Osteoarthritis Outcome Score - Activity of Daily Living | 75.5 units on a scale STANDARD_DEVIATION 14.7 | 72.2 units on a scale STANDARD_DEVIATION 15.8 | 73.9 units on a scale STANDARD_DEVIATION 15.2 |
| Knee Injury and Osteoarthritis Outcome Score - Pain | 72.6 units on a scale STANDARD_DEVIATION 13.5 | 65.1 units on a scale STANDARD_DEVIATION 13.7 | 69.0 units on a scale STANDARD_DEVIATION 14 |
| Knee Injury and Osteoarthritis Outcome Score - Quality of Life | 44.0 units on a scale STANDARD_DEVIATION 16 | 47.5 units on a scale STANDARD_DEVIATION 16 | 45.7 units on a scale STANDARD_DEVIATION 17.4 |
| Knee Injury and Osteoarthritis Outcome Score - Sports and Recreation | 47.9 units on a scale STANDARD_DEVIATION 23.7 | 46.8 units on a scale STANDARD_DEVIATION 25.4 | 47.4 units on a scale STANDARD_DEVIATION 24.3 |
| Knee Injury and Osteoarthritis Outcome Score - Symptom | 68.5 units on a scale STANDARD_DEVIATION 10.7 | 65.7 units on a scale STANDARD_DEVIATION 12.3 | 67.2 units on a scale STANDARD_DEVIATION 11.5 |
| Partners in Health Scale | 76.8 units on a scale STANDARD_DEVIATION 11 | 78.0 units on a scale STANDARD_DEVIATION 12 | 77.4 units on a scale STANDARD_DEVIATION 11.4 |
| Patient Health Questionnaire-9 | 5.2 units on a scale STANDARD_DEVIATION 4.6 | 5.4 units on a scale STANDARD_DEVIATION 5.3 | 5.3 units on a scale STANDARD_DEVIATION 4.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 26 participants | 25 participants | 51 participants |
| Self-Reported Habit Index - Sitting at Leisure subscale | 4.8 units on a scale STANDARD_DEVIATION 1.1 | 5.1 units on a scale STANDARD_DEVIATION 1.4 | 5.0 units on a scale STANDARD_DEVIATION 1.2 |
| Self-Reported Habit Index - Sitting at Work subscale | 5.0 units on a scale STANDARD_DEVIATION 1.4 | 4.5 units on a scale STANDARD_DEVIATION 2.1 | 4.7 units on a scale STANDARD_DEVIATION 1.8 |
| Self-Reported Habit Index - Walking subscale | 4.3 units on a scale STANDARD_DEVIATION 1.8 | 4.8 units on a scale STANDARD_DEVIATION 2 | 4.5 units on a scale STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 23 Participants | 19 Participants | 42 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
| Theory of Planned Behavior Questionnaire - Attitude toward Physical Activity | 6.0 units on a scale STANDARD_DEVIATION 0.6 | 6.1 units on a scale STANDARD_DEVIATION 0.6 | 6.0 units on a scale STANDARD_DEVIATION 0.6 |
| Theory of Planned Behavior Questionnaire - Intention | 6.2 units on a scale STANDARD_DEVIATION 0.8 | 6.3 units on a scale STANDARD_DEVIATION 0.8 | 6.3 units on a scale STANDARD_DEVIATION 0.8 |
| Theory of Planned Behavior Questionnaire - Perceived Control | 5.8 units on a scale STANDARD_DEVIATION 1 | 6.1 units on a scale STANDARD_DEVIATION 0.7 | 6.0 units on a scale STANDARD_DEVIATION 0.9 |
| Theory of Planned Behavior Questionnaire - Subjective Norm | 6.2 units on a scale STANDARD_DEVIATION 0.6 | 6.3 units on a scale STANDARD_DEVIATION 0.8 | 6.3 units on a scale STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 7 / 26 | 3 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
Daily Number of Minutes in Moderate/Vigorous Physical Activity
Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 1 refused assessment 24 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown 29 weeks: I Group: 2 withdrew - reason unknown
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | Baseline (T0) | 31.0 Minutes per day | Standard Deviation 37.3 |
| Immediate Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | 13 weeks (T1) | 37.7 Minutes per day | Standard Deviation 30.5 |
| Immediate Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | 26 weeks (T2) | 37.0 Minutes per day | Standard Deviation 32.3 |
| Immediate Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | 39 weeks (T3) | 34.0 Minutes per day | Standard Deviation 25.2 |
| Delayed Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | 39 weeks (T3) | 54.8 Minutes per day | Standard Deviation 66.2 |
| Delayed Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | Baseline (T0) | 71.3 Minutes per day | Standard Deviation 99.8 |
| Delayed Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | 26 weeks (T2) | 74.6 Minutes per day | Standard Deviation 102.1 |
| Delayed Group | Daily Number of Minutes in Moderate/Vigorous Physical Activity | 13 weeks (T1) | 49.4 Minutes per day | Standard Deviation 63.6 |
Comparison: We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 13 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.p-value: 0.0595% CI: [1.6, 24.5]ANCOVA
Secondary
Daily Number of Sedentary Minutes
Time spent in sedentary behaviour was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of \<=1.5 METs, occurring in bouts of \>= 20 minutes during waking hours.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 1 refused assessment 24 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown 29 weeks: I Group: 2 withdrew - reason unknown
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Daily Number of Sedentary Minutes | Baseline (T0) | 567.5 Minutes per day | Standard Deviation 183.1 |
| Immediate Group | Daily Number of Sedentary Minutes | 13 weeks (T1) | 531.4 Minutes per day | Standard Deviation 173.5 |
| Immediate Group | Daily Number of Sedentary Minutes | 26 weeks (T2) | 492.5 Minutes per day | Standard Deviation 156.6 |
| Immediate Group | Daily Number of Sedentary Minutes | 39 weeks (T3) | 502.8 Minutes per day | Standard Deviation 135.3 |
| Delayed Group | Daily Number of Sedentary Minutes | 39 weeks (T3) | 483.1 Minutes per day | Standard Deviation 225.4 |
| Delayed Group | Daily Number of Sedentary Minutes | Baseline (T0) | 551.1 Minutes per day | Standard Deviation 234.9 |
| Delayed Group | Daily Number of Sedentary Minutes | 26 weeks (T2) | 499.5 Minutes per day | Standard Deviation 248.9 |
| Delayed Group | Daily Number of Sedentary Minutes | 13 weeks (T1) | 558.3 Minutes per day | Standard Deviation 224.9 |
p-value: 0.0595% CI: [-75.8, 16.7]ANCOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living
The Activity of Daily Living Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with activity of daily living and 100 indicates no difficulties.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | Baseline (T0) | 75.5 score on a scale | Standard Deviation 14.7 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | 13 weeks (T1) | 75.0 score on a scale | Standard Deviation 13.1 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | 26 weeks (T2) | 77.7 score on a scale | Standard Deviation 18.9 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | 39 weeks (T3) | 74.8 score on a scale | Standard Deviation 20.7 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | 39 weeks (T3) | 80.0 score on a scale | Standard Deviation 14 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | Baseline (T0) | 72.2 score on a scale | Standard Deviation 15.8 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | 26 weeks (T2) | 80.3 score on a scale | Standard Deviation 13.1 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activity of Daily Living | 13 weeks (T1) | 70.3 score on a scale | Standard Deviation 16.9 |
p-value: 0.0595% CI: [-3.3, 8.8]ANCOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
The Pain Subscale ranges from 0 - 100, with 0 indicates extreme knee pain and 100 indicates no knee pain.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 24 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | Baseline (T0) | 72.6 score on a scale | Standard Deviation 13.5 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | 13 weeks (T1) | 73.1 score on a scale | Standard Deviation 15.3 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | 26 weeks (T2) | 72.5 score on a scale | Standard Deviation 18.3 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | 39 weeks (T3) | 72.1 score on a scale | Standard Deviation 19.8 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | 39 weeks (T3) | 72.8 score on a scale | Standard Deviation 13.2 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | Baseline (T0) | 65.1 score on a scale | Standard Deviation 13.7 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | 26 weeks (T2) | 74.8 score on a scale | Standard Deviation 15.4 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain | 13 weeks (T1) | 65.9 score on a scale | Standard Deviation 15.6 |
p-value: 0.0595% CI: [-4.2, 9.5]ANCOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
The Quality of Life Subscale ranges from 0 - 100, with 0 indicates extreme problems with the knee and 100 indicates no problems.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | Baseline (T0) | 44.0 score on a scale | Standard Deviation 16 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | 13 weeks (T1) | 48.7 score on a scale | Standard Deviation 17.5 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | 39 weeks (T3) | 49.3 score on a scale | Standard Deviation 19.1 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | 26 weeks (T2) | 49.4 score on a scale | Standard Deviation 15.7 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | 39 weeks (T3) | 54.4 score on a scale | Standard Deviation 14.6 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | Baseline (T0) | 47.5 score on a scale | Standard Deviation 16 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | 13 weeks (T1) | 46.9 score on a scale | Standard Deviation 13.6 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life | 26 weeks (T2) | 54.7 score on a scale | Standard Deviation 14.7 |
p-value: 0.0595% CI: [-5, 7.9]ANCOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation
The Sport and Recreation Subscale ranges from 0 - 100, with 0 indicates extreme difficulties with sport and recreational activities due to knee problems and 100 indicates no difficulties.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | Baseline (T0) | 47.9 units on a scale | Standard Deviation 23.7 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | 13 weeks (T1) | 47.1 units on a scale | Standard Deviation 22.4 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | 26 weeks (T2) | 50.5 units on a scale | Standard Deviation 30.1 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | 39 weeks (T3) | 51.6 units on a scale | Standard Deviation 30.4 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | 39 weeks (T3) | 55.8 units on a scale | Standard Deviation 26.3 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | Baseline (T0) | 46.8 units on a scale | Standard Deviation 25.4 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | 26 weeks (T2) | 62.5 units on a scale | Standard Deviation 22.5 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport and Recreation | 13 weeks (T1) | 52.5 units on a scale | Standard Deviation 22.7 |
p-value: 0.0595% CI: [-14.9, 7.2]ANCOVA
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom
The Symptom Subscale ranges from 0 - 100, with 0 indicates extreme knee symptoms and 100 indicates no knee symptoms.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | Baseline (T0) | 68.5 units on a scale | Standard Deviation 10.7 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | 13 weeks (T1) | 69.3 units on a scale | Standard Deviation 12.7 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | 26 weeks (T2) | 65.4 units on a scale | Standard Deviation 45.8 |
| Immediate Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | 39 weeks (T3) | 68.4 units on a scale | Standard Deviation 16.3 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | 39 weeks (T3) | 72.5 units on a scale | Standard Deviation 13.3 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | Baseline (T0) | 65.7 units on a scale | Standard Deviation 12.3 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | 26 weeks (T2) | 72.2 units on a scale | Standard Deviation 16.8 |
| Delayed Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptom | 13 weeks (T1) | 66.9 units on a scale | Standard Deviation 14.9 |
p-value: 0.0595% CI: [-7.8, 4.9]ANCOVA
Secondary
Partners in Health Scale
The Partners in Health Scale ranges from 0 to 96, calculated from responses to 12 items on a 9-point Likert scale. A score of 0 represents poor self-management, and a score of 96 represents greater self-management capabilities.
Time frame: Baseline, Months 3, 6, and 9
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Partners in Health Scale | Baseline (T0) | 76.8 score on a scale | Standard Deviation 11 |
| Immediate Group | Partners in Health Scale | 26 weeks (T2) | 78.9 score on a scale | Standard Deviation 9 |
| Immediate Group | Partners in Health Scale | 13 weeks (T1) | 76.7 score on a scale | Standard Deviation 11.5 |
| Immediate Group | Partners in Health Scale | 29 weeks (T3) | 81.0 score on a scale | Standard Deviation 7 |
| Delayed Group | Partners in Health Scale | 29 weeks (T3) | 82.6 score on a scale | Standard Deviation 10 |
| Delayed Group | Partners in Health Scale | Baseline (T0) | 78.0 score on a scale | Standard Deviation 12 |
| Delayed Group | Partners in Health Scale | 13 weeks (T1) | 81.6 score on a scale | Standard Deviation 9.6 |
| Delayed Group | Partners in Health Scale | 26 weeks (T2) | 82.6 score on a scale | Standard Deviation 9.3 |
p-value: 0.0595% CI: [-6.6, 1.9]ANCOVA
Secondary
Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | Baseline (T0) | 4.8 score on a scale | Standard Deviation 1.1 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | 13 weeks (T1) | 5.1 score on a scale | Standard Deviation 1.1 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | 26 weeks (T2) | 5.0 score on a scale | Standard Deviation 1.1 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | 39 weeks (T3) | 5.5 score on a scale | Standard Deviation 1.1 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | 39 weeks (T3) | 4.7 score on a scale | Standard Deviation 1.7 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | Baseline (T0) | 5.1 score on a scale | Standard Deviation 1.4 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | 26 weeks (T2) | 4.4 score on a scale | Standard Deviation 1.9 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale | 13 weeks (T1) | 4.7 score on a scale | Standard Deviation 1.6 |
p-value: 0.0595% CI: [0.2, 1.1]ANCOVA
Secondary
Self-Reported Habit Index (SRHI) - Sitting at Work Subscale
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | Baseline (T0) | 5.0 score on a scale | Standard Deviation 1.4 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | 13 weeks (T1) | 5.2 score on a scale | Standard Deviation 1.6 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | 26 weeks (T2) | 4.7 score on a scale | Standard Deviation 2.1 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | 39 weeks (T3) | 5.0 score on a scale | Standard Deviation 1.9 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | 39 weeks (T3) | 4.1 score on a scale | Standard Deviation 2.1 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | Baseline (T0) | 4.5 score on a scale | Standard Deviation 2.1 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | 26 weeks (T2) | 4.3 score on a scale | Standard Deviation 2.1 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Sitting at Work Subscale | 13 weeks (T1) | 4.4 score on a scale | Standard Deviation 2 |
p-value: 0.0595% CI: [0.2, 1.2]ANCOVA
Secondary
Self-Reported Habit Index (SRHI) - Walking Subscale
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. In the Habit index, participants rated their strength of habit for three specific activity-related behaviors: sitting during leisure time at home, sitting during usual occupational activities, and walking outside for 10 minutes. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Self-Reported Habit Index (SRHI) - Walking Subscale | Baseline (T0) | 4.3 score on a scale | Standard Deviation 1.8 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Walking Subscale | 13 weeks (T1) | 4.4 score on a scale | Standard Deviation 1.6 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Walking Subscale | 26 weeks (T2) | 4.6 score on a scale | Standard Deviation 1.8 |
| Immediate Group | Self-Reported Habit Index (SRHI) - Walking Subscale | 39 weeks (T3) | 4.7 score on a scale | Standard Deviation 1.8 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Walking Subscale | 39 weeks (T3) | 4.6 score on a scale | Standard Deviation 1.8 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Walking Subscale | Baseline (T0) | 4.8 score on a scale | Standard Deviation 2 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Walking Subscale | 26 weeks (T2) | 4.8 score on a scale | Standard Deviation 1.6 |
| Delayed Group | Self-Reported Habit Index (SRHI) - Walking Subscale | 13 weeks (T1) | 4.6 score on a scale | Standard Deviation 2 |
p-value: 0.0595% CI: [-0.3, 0.9]ANCOVA
Secondary
Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | Baseline (T0) | 6.0 score on a scale | Standard Deviation 0.6 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | 13 weeks (T1) | 5.9 score on a scale | Standard Deviation 0.7 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | 26 weeks (T2) | 6.0 score on a scale | Standard Deviation 0.5 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | 39 weeks (T3) | 6.0 score on a scale | Standard Deviation 0.5 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | 39 weeks (T3) | 6.1 score on a scale | Standard Deviation 0.7 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | Baseline (T0) | 6.1 score on a scale | Standard Deviation 0.6 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | 26 weeks (T2) | 6.2 score on a scale | Standard Deviation 0.6 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Attitude Toward Physical Activity | 13 weeks (T1) | 6.1 score on a scale | Standard Deviation 0.7 |
p-value: 0.0595% CI: [-0.4, 0.2]ANCOVA
Secondary
Theory of Planned Behavior Questionnaire - Intention
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Theory of Planned Behavior Questionnaire - Intention | 13 weeks (T1) | 5.9 score on a scale | Standard Deviation 1 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Intention | Baseline (T0) | 6.2 score on a scale | Standard Deviation 0.8 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Intention | 26 weeks (T2) | 5.7 score on a scale | Standard Deviation 1.1 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Intention | 39 weeks (T3) | 5.8 score on a scale | Standard Deviation 0.8 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Intention | 39 weeks (T3) | 6.3 score on a scale | Standard Deviation 0.9 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Intention | 26 weeks (T2) | 6.3 score on a scale | Standard Deviation 0.6 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Intention | Baseline (T0) | 6.3 score on a scale | Standard Deviation 0.8 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Intention | 13 weeks (T1) | 6.4 score on a scale | Standard Deviation 0.6 |
p-value: 0.0595% CI: [-0.1, 0.3]ANCOVA
Secondary
Theory of Planned Behavior Questionnaire - Perceived Control
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Theory of Planned Behavior Questionnaire - Perceived Control | Baseline (T0) | 5.8 score on a scale | Standard Deviation 1 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Perceived Control | 13 weeks (T1) | 5.6 score on a scale | Standard Deviation 1.4 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Perceived Control | 26 weeks (T2) | 5.6 score on a scale | Standard Deviation 1.5 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Perceived Control | 39 weeks (T3) | 5.7 score on a scale | Standard Deviation 1.4 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Perceived Control | 39 weeks (T3) | 6.2 score on a scale | Standard Deviation 0.9 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Perceived Control | Baseline (T0) | 6.1 score on a scale | Standard Deviation 0.7 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Perceived Control | 26 weeks (T2) | 6.2 score on a scale | Standard Deviation 1 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Perceived Control | 13 weeks (T1) | 5.8 score on a scale | Standard Deviation 1.2 |
p-value: 0.0595% CI: [-0.6, 0.8]ANCOVA
Secondary
Theory of Planned Behavior Questionnaire - Subjective Norm
The Theory of Planned Behavior Questionnaire consists of 16 items measuring all components of theory. It was used to measure motivation for physical activity. Range: 1-7; higher = more positive)
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Theory of Planned Behavior Questionnaire - Subjective Norm | Baseline (T0) | 6.2 score on a scale | Standard Deviation 0.6 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Subjective Norm | 13 weeks (T1) | 6.2 score on a scale | Standard Deviation 0.8 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Subjective Norm | 26 weeks (T2) | 6.1 score on a scale | Standard Deviation 0.8 |
| Immediate Group | Theory of Planned Behavior Questionnaire - Subjective Norm | 39 weeks (T3) | 6.2 score on a scale | Standard Deviation 1.1 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Subjective Norm | 39 weeks (T3) | 6.3 score on a scale | Standard Deviation 0.7 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Subjective Norm | Baseline (T0) | 6.3 score on a scale | Standard Deviation 0.8 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Subjective Norm | 26 weeks (T2) | 6.3 score on a scale | Standard Deviation 0.8 |
| Delayed Group | Theory of Planned Behavior Questionnaire - Subjective Norm | 13 weeks (T1) | 6.2 score on a scale | Standard Deviation 0.7 |
p-value: 0.0595% CI: [-0.1, 0.5]ANCOVA
Secondary
The Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder. Range 0-27; lower score = less depressive symptoms),
Time frame: Baseline, 13 weeks, 26 weeks, 39 weeks
Population: 13 weeks: Immediate (I) Group: 1 withdrew due to Fitbit wear issues; 1 withdrew, reason unknown. Delayed (D) Group: 3 refused assessment 26 weeks: I Group: 1 withdrew due to family issues, 1 reason unknown. Delayed (D) Group: 1 refused assessment 39 weeks: I Group: 2 withdrew - reason unknown; 1 refused assessment. Delayed (D) Group: 1 refused assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | Baseline (T0) | 5.2 score on a scale | Standard Deviation 4.6 |
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | 13 weeks (T1) | 4.0 score on a scale | Standard Deviation 3 |
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | 26 weeks (T2) | 3.6 score on a scale | Standard Deviation 3.3 |
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | 39 weeks (T3) | 4.2 score on a scale | Standard Deviation 4.1 |
| Delayed Group | The Patient Health Questionnaire-9 (PHQ-9) | 39 weeks (T3) | 4.5 score on a scale | Standard Deviation 5.3 |
| Delayed Group | The Patient Health Questionnaire-9 (PHQ-9) | Baseline (T0) | 5.4 score on a scale | Standard Deviation 5.3 |
| Delayed Group | The Patient Health Questionnaire-9 (PHQ-9) | 26 weeks (T2) | 4.5 score on a scale | Standard Deviation 5.2 |
| Delayed Group | The Patient Health Questionnaire-9 (PHQ-9) | 13 weeks (T1) | 4.7 score on a scale | Standard Deviation 4.9 |
p-value: 0.0595% CI: [-1.7, 0.8]ANCOVA