Joint Diseases, Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
Keywords
Physical activity, Exercise, Rheumatoid, Arthritis, Lupus, SLE
Brief summary
Being physically active can reduce pain and fatigue, improve mobility and enhance quality of life in people with arthritis, but adherence to an active lifestyle is poor, with less than half of people with arthritis being active. The primary goal of this randomized controlled trial is to assess the efficacy of a physical activity coaching model to improve physical activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application, a group education session, and telephone counselling by a physiotherapist.
Detailed description
Patient self-management is a fundamental component in arthritis care that is often neglected. Physical activity is an essential part of self-management, however, less than half of people with arthritis are active. There are several factors that are associated with low physical activity participation such as motivation, doubts about the effectiveness of prescribed exercises, and lack of health professional advice on ways to progress 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 physical activity counselling model, involving the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application (app), a group education session, and telephone counselling by a physiotherapist, to improve physical activity participation in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Our secondary objective is to assess the effect of the intervention on reducing patients' sedentary time, and improving fatigue, mood, pain, and self-efficacy in arthritis 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 physical activity coaching model in patients with RA and SLE. 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), 2) reduce sedentary time, 3) improve in fatigue, mood, and pain levels, and 4) improve in their self-efficacy in disease management. The investigators will use a mixed-methods 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, Fitbit/FitViz, physiotherapist 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 9-week delay
The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay.
Sponsors
Simon Fraser University
Arthritis Research Centre of Canada
Vancouver General Hospital
The Arthritis Society, Canada
Fraser Health
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 RA or SLE. * Have an email address and daily access to a computer with internet connection. * Be able to attend a 1.5-hour education session at Mary Pack Arthritis Centre, Arthritis Research Centre, or a Fraser Health site.
Exclusion criteria
* Have previously used any physical activity wearables. * Face a level of risk by exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Time in Moderate/Vigorous Physical Activity | Baseline, 9 weeks, 18 weeks, 27 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 |
|---|---|---|
| Fatigue Severity Scale | Baseline, 9 weeks, 18 weeks, 27 weeks | The Fatigue Severity Scale consists of 9 questions and measures the impact of fatigue. A total score is calculated by averaging the rating from each question. Range 1-7; lower score = less fatigue. |
| McGill Pain Questionnaire Short Form (MPQ-SF) | Baseline, 9 weeks, 18 weeks, 27 weeks | The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain. |
| The Patient Health Questionnaire-9 (PHQ-9) | Baseline, 9 weeks, 18 weeks, 27 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), |
| Time Spent in Sedentary Activity | Baseline, 9 weeks, 18 weeks, 27 weeks | Time spent in sedentary activity 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. |
| The Self-Reported Habit Index (SRHI) - Sitting at Work Index | Baseline, 9 weeks, 18 weeks, 27 weeks | The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at work. 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. |
| The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | Baseline, 9 weeks, 18 weeks, 27 weeks | The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at leisure. 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. |
| The Self-Reported Habit Index (SRHI) - Walking Index | Baseline, 9 weeks, 18 weeks, 27 weeks | The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of walking habit. 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. |
| Partners In Health Scale | Baseline, 9 weeks, 18 weeks, 27 weeks | The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle. Range 0-96; higher score = higher perceived confidence and ability in self-care. |
Countries
Canada
Participant flow
Recruitment details
Recruitment period was 2017-2019. Participants were recruited from the Mary Pack Arthritis Program (Vancouver Coastal Health Authority) and Fraser Health Authority in British Columbia, Canada. Study information was also posted on Facebook, Twitter, Kajiji and Craigslist.
Pre-assignment details
After completing baseline measures at home, participants were randomized to the Immediate or Delay Group in 1:1 allocation ratio.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Group Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | 59 |
| Delay Group Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls. | 59 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Health issue not related to the study | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Immediate Group | Delay Group | Total |
|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 14.7 | 53.1 years STANDARD_DEVIATION 12.6 | 53.3 years STANDARD_DEVIATION 13.6 |
| Daily sedentary time | 491.6 Minutes STANDARD_DEVIATION 192.5 | 523.0 Minutes STANDARD_DEVIATION 194.4 | 507.3 Minutes STANDARD_DEVIATION 193.3 |
| Daily steps | 5900.8 Steps STANDARD_DEVIATION 3214.1 | 5605.7 Steps STANDARD_DEVIATION 2865.1 | 5753.2 Steps STANDARD_DEVIATION 3035.2 |
| Daily time in moderate/vigorous physical activity | 37.8 Minutes STANDARD_DEVIATION 39.6 | 31.6 Minutes STANDARD_DEVIATION 42.7 | 34.7 Minutes STANDARD_DEVIATION 41.1 |
| Fatigue Severity Scale | 4.8 Units on a scale STANDARD_DEVIATION 1.4 | 4.9 Units on a scale STANDARD_DEVIATION 1.3 | 4.8 Units on a scale STANDARD_DEVIATION 1.3 |
| McGill Pain Questionnaire | 13.3 Units on a scale STANDARD_DEVIATION 10.8 | 13.9 Units on a scale STANDARD_DEVIATION 9.5 | 13.6 Units on a scale STANDARD_DEVIATION 10.1 |
| Partners in Health | 72.8 Units on a scale STANDARD_DEVIATION 11.7 | 73.5 Units on a scale STANDARD_DEVIATION 12.2 | 73.1 Units on a scale STANDARD_DEVIATION 11.9 |
| Patient Health Questionnaire (PHQ-9) | 7.6 Units on a scale STANDARD_DEVIATION 5.9 | 8.1 Units on a scale STANDARD_DEVIATION 5.6 | 7.8 Units on a scale STANDARD_DEVIATION 5.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Self-Reported Habit Index Sitting at leisure subscale | 4.7 units on a scale STANDARD_DEVIATION 1.4 | 4.7 units on a scale STANDARD_DEVIATION 1.3 | 4.7 units on a scale STANDARD_DEVIATION 1.3 |
| Self-Reported Habit Index Sitting at work subscale | 4.5 units on a scale STANDARD_DEVIATION 1.7 | 4.6 units on a scale STANDARD_DEVIATION 1.8 | 4.5 units on a scale STANDARD_DEVIATION 1.7 |
| Self-Reported Habit Index Walking subscale | 4.1 units on a scale STANDARD_DEVIATION 1.8 | 3.7 units on a scale STANDARD_DEVIATION 1.6 | 3.9 units on a scale STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 51 Participants | 54 Participants | 105 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
| Time in purposeful activity | 13.0 Minutes STANDARD_DEVIATION 20.4 | 11.2 Minutes STANDARD_DEVIATION 24.5 | 12.1 Minutes STANDARD_DEVIATION 22.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 13 / 59 | 10 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Daily Time 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, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Daily Time in Moderate/Vigorous Physical Activity | Baseline | 37.8 Minutes | Standard Deviation 39.6 |
| Immediate Group | Daily Time in Moderate/Vigorous Physical Activity | 9 weeks | 44.7 Minutes | Standard Deviation 41.2 |
| Immediate Group | Daily Time in Moderate/Vigorous Physical Activity | 18 weeks | 43.2 Minutes | Standard Deviation 48.2 |
| Immediate Group | Daily Time in Moderate/Vigorous Physical Activity | 27 weeks | 37.8 Minutes | Standard Deviation 38.8 |
| Delay Group | Daily Time in Moderate/Vigorous Physical Activity | 27 weeks | 34.0 Minutes | Standard Deviation 36.1 |
| Delay Group | Daily Time in Moderate/Vigorous Physical Activity | Baseline | 31.6 Minutes | Standard Deviation 42.7 |
| Delay Group | Daily Time in Moderate/Vigorous Physical Activity | 18 weeks | 32.8 Minutes | Standard Deviation 36.8 |
| Delay Group | Daily Time in Moderate/Vigorous Physical Activity | 9 weeks | 31.6 Minutes | Standard Deviation 32.4 |
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 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.95% CI: [-0.5, 19.3]
Secondary
Fatigue Severity Scale
The Fatigue Severity Scale consists of 9 questions and measures the impact of fatigue. A total score is calculated by averaging the rating from each question. Range 1-7; lower score = less fatigue.
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Fatigue Severity Scale | Baseline | 4.8 score on a scale | Standard Deviation 1.4 |
| Immediate Group | Fatigue Severity Scale | 9 weeks | 4.5 score on a scale | Standard Deviation 1.3 |
| Immediate Group | Fatigue Severity Scale | 18 weeks | 4.8 score on a scale | Standard Deviation 1.3 |
| Immediate Group | Fatigue Severity Scale | 27 weeks | 4.5 score on a scale | Standard Deviation 1.4 |
| Delay Group | Fatigue Severity Scale | 27 weeks | 4.7 score on a scale | Standard Deviation 1.4 |
| Delay Group | Fatigue Severity Scale | Baseline | 4.9 score on a scale | Standard Deviation 1.3 |
| Delay Group | Fatigue Severity Scale | 18 weeks | 4.6 score on a scale | Standard Deviation 1.5 |
| Delay Group | Fatigue Severity Scale | 9 weeks | 4.9 score on a scale | Standard Deviation 1.3 |
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 the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking.95% CI: [-0.63, 0.01]
Secondary
McGill Pain Questionnaire Short Form (MPQ-SF)
The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | McGill Pain Questionnaire Short Form (MPQ-SF) | Baseline | 13.3 score on a scale | Standard Deviation 10.8 |
| Immediate Group | McGill Pain Questionnaire Short Form (MPQ-SF) | 9 weeks | 10.9 score on a scale | Standard Deviation 8.4 |
| Immediate Group | McGill Pain Questionnaire Short Form (MPQ-SF) | 18 weeks | 10.6 score on a scale | Standard Deviation 9.6 |
| Immediate Group | McGill Pain Questionnaire Short Form (MPQ-SF) | 27 weeks | 11.8 score on a scale | Standard Deviation 10 |
| Delay Group | McGill Pain Questionnaire Short Form (MPQ-SF) | 27 weeks | 11.0 score on a scale | Standard Deviation 9.8 |
| Delay Group | McGill Pain Questionnaire Short Form (MPQ-SF) | Baseline | 13.9 score on a scale | Standard Deviation 9.5 |
| Delay Group | McGill Pain Questionnaire Short Form (MPQ-SF) | 18 weeks | 12.6 score on a scale | Standard Deviation 10 |
| Delay Group | McGill Pain Questionnaire Short Form (MPQ-SF) | 9 weeks | 14.6 score on a scale | Standard Deviation 9.7 |
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 pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking.95% CI: [-4.78, -0.13]
Secondary
Partners In Health Scale
The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle. Range 0-96; higher score = higher perceived confidence and ability in self-care.
Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Partners In Health Scale | Baseline | 72.8 score on a scale | Standard Deviation 11.7 |
| Immediate Group | Partners In Health Scale | 9 weeks | 75.5 score on a scale | Standard Deviation 12.5 |
| Immediate Group | Partners In Health Scale | 18 weeks | 77.7 score on a scale | Standard Deviation 11.4 |
| Immediate Group | Partners In Health Scale | 27 weeks | 77.9 score on a scale | Standard Deviation 12.6 |
| Delay Group | Partners In Health Scale | 27 weeks | 77.4 score on a scale | Standard Deviation 10.7 |
| Delay Group | Partners In Health Scale | Baseline | 73.5 score on a scale | Standard Deviation 12.2 |
| Delay Group | Partners In Health Scale | 18 weeks | 78.7 score on a scale | Standard Deviation 10.8 |
| Delay Group | Partners In Health Scale | 9 weeks | 74.6 score on a scale | Standard Deviation 11.2 |
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 the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.95% CI: [-1.02, 4.18]
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, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | Baseline | 7.6 score on a scale | Standard Deviation 5.9 |
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | 9 weeks | 6.8 score on a scale | Standard Deviation 5.6 |
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | 18 weeks | 6.0 score on a scale | Standard Deviation 5 |
| Immediate Group | The Patient Health Questionnaire-9 (PHQ-9) | 27 weeks | 5.2 score on a scale | Standard Deviation 3.8 |
| Delay Group | The Patient Health Questionnaire-9 (PHQ-9) | 27 weeks | 6.7 score on a scale | Standard Deviation 5.9 |
| Delay Group | The Patient Health Questionnaire-9 (PHQ-9) | Baseline | 8.1 score on a scale | Standard Deviation 5.6 |
| Delay Group | The Patient Health Questionnaire-9 (PHQ-9) | 18 weeks | 6.2 score on a scale | Standard Deviation 5.4 |
| Delay Group | The Patient Health Questionnaire-9 (PHQ-9) | 9 weeks | 7.9 score on a scale | Standard Deviation 5.7 |
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 the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.95% CI: [-1.78, 1.35]
Secondary
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at leisure. 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, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | Baseline | 4.7 score on a scale | Standard Deviation 1.4 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 9 weeks | 4.7 score on a scale | Standard Deviation 1.3 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 18 weeks | 4.6 score on a scale | Standard Deviation 1.3 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 27 weeks | 4.6 score on a scale | Standard Deviation 1.3 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 27 weeks | 4.7 score on a scale | Standard Deviation 1.4 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | Baseline | 4.7 score on a scale | Standard Deviation 1.3 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 18 weeks | 4.8 score on a scale | Standard Deviation 1.2 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index | 9 weeks | 4.8 score on a scale | Standard Deviation 1.4 |
Comparison: We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.95% CI: [-0.37, 0.37]
Secondary
The Self-Reported Habit Index (SRHI) - Sitting at Work Index
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at work. 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, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | Baseline | 4.5 score on a scale | Standard Deviation 1.7 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 9 weeks | 4.3 score on a scale | Standard Deviation 1.8 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 18 weeks | 4.6 score on a scale | Standard Deviation 1.7 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 27 weeks | 4.4 score on a scale | Standard Deviation 1.4 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 27 weeks | 4.6 score on a scale | Standard Deviation 1.7 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | Baseline | 4.6 score on a scale | Standard Deviation 1.8 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 18 weeks | 4.6 score on a scale | Standard Deviation 1.8 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Sitting at Work Index | 9 weeks | 4.7 score on a scale | Standard Deviation 1.7 |
Comparison: We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.95% CI: [-0.05, 0.16]
Secondary
The Self-Reported Habit Index (SRHI) - Walking Index
The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of walking habit. 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, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | The Self-Reported Habit Index (SRHI) - Walking Index | Baseline | 4.1 score on a scale | Standard Deviation 1.8 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Walking Index | 9 weeks | 4.4 score on a scale | Standard Deviation 1.7 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Walking Index | 18 weeks | 4.3 score on a scale | Standard Deviation 1.6 |
| Immediate Group | The Self-Reported Habit Index (SRHI) - Walking Index | 27 weeks | 4.7 score on a scale | Standard Deviation 1.5 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Walking Index | 27 weeks | 4.0 score on a scale | Standard Deviation 1.7 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Walking Index | Baseline | 3.7 score on a scale | Standard Deviation 1.6 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Walking Index | 18 weeks | 4.0 score on a scale | Standard Deviation 1.6 |
| Delay Group | The Self-Reported Habit Index (SRHI) - Walking Index | 9 weeks | 3.6 score on a scale | Standard Deviation 1.7 |
Comparison: We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.95% CI: [0.08, 0.99]
Secondary
Time Spent in Sedentary Activity
Time spent in sedentary activity 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, 9 weeks, 18 weeks, 27 weeks
Population: 59 participants were randomized into each group. Week 9: Immediate Group - 3 withdrew;1 with missing data. Delay Group - 2 withdrew Week 18: Immediate Group - 3 additional participants withdrew; 2 with missing data. Delay Group - 1 additional participant withdrew.~Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | Time Spent in Sedentary Activity | Baseline | 491.6 Minutes | Standard Deviation 192.5 |
| Immediate Group | Time Spent in Sedentary Activity | 9 weeks | 508.4 Minutes | Standard Deviation 203.5 |
| Immediate Group | Time Spent in Sedentary Activity | 18 weeks | 507.8 Minutes | Standard Deviation 195.8 |
| Immediate Group | Time Spent in Sedentary Activity | 27 weeks | 506.8 Minutes | Standard Deviation 179.7 |
| Delay Group | Time Spent in Sedentary Activity | 27 weeks | 498.0 Minutes | Standard Deviation 155.6 |
| Delay Group | Time Spent in Sedentary Activity | Baseline | 523.0 Minutes | Standard Deviation 194.4 |
| Delay Group | Time Spent in Sedentary Activity | 18 weeks | 531.4 Minutes | Standard Deviation 165.4 |
| Delay Group | Time Spent in Sedentary Activity | 9 weeks | 530.0 Minutes | Standard Deviation 180.2 |
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 sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking.95% CI: [-53.4, 32.6]