Trial Outcomes & Findings for OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis (NCT NCT02554474)

NCT ID: NCT02554474

Last Updated: 2024-01-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 118 participants
• Primary outcome timeframe: Baseline, 9 weeks, 18 weeks, 27 weeks
• Results posted on: 2024-01-30

Participant Flow

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.

After completing baseline measures at home, participants were randomized to the Immediate or Delay Group in 1:1 allocation ratio.

Participant milestones

Measure	Immediate Group Education, Fitbit/FitViz, physiotherapist counselling. These 3 components will be delivered to the participants in Months 1 and 2. The session will include 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 will use the Fitbit/FitViz. The PT will review the progress with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. Education, 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.	Delay Group Same intervention with a 2 month delay: The full intervention will be initiated in Month 3 and 4 with a brief education session, use of a Fitbit paired with the FitViz app, and counseling by a PT. In Month 5-6, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed. Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.
Overall Study STARTED	59	59
Overall Study COMPLETED	56	57
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Immediate Group Education, Fitbit/FitViz, physiotherapist counselling. These 3 components will be delivered to the participants in Months 1 and 2. The session will include 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 will use the Fitbit/FitViz. The PT will review the progress with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. Education, 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.	Delay Group Same intervention with a 2 month delay: The full intervention will be initiated in Month 3 and 4 with a brief education session, use of a Fitbit paired with the FitViz app, and counseling by a PT. In Month 5-6, participants will continue the intervention without the PT phone calls, but will have email access to PT, if needed. Same intervention with a 2 month delay: The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.
Overall Study Protocol Violation	1	1
Overall Study Health issue not related to the study	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.	Total n=118 Participants Total of all reporting groups
Self-Reported Habit Index Sitting at work subscale	4.5 units on a scale STANDARD_DEVIATION 1.7 • n=59 Participants	4.6 units on a scale STANDARD_DEVIATION 1.8 • n=59 Participants	4.5 units on a scale STANDARD_DEVIATION 1.7 • n=118 Participants
Age, Continuous	53.5 years STANDARD_DEVIATION 14.7 • n=59 Participants	53.1 years STANDARD_DEVIATION 12.6 • n=59 Participants	53.3 years STANDARD_DEVIATION 13.6 • n=118 Participants
Sex: Female, Male Female	51 Participants n=59 Participants	54 Participants n=59 Participants	105 Participants n=118 Participants
Sex: Female, Male Male	8 Participants n=59 Participants	5 Participants n=59 Participants	13 Participants n=118 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Daily time in moderate/vigorous physical activity	37.8 Minutes STANDARD_DEVIATION 39.6 • n=59 Participants	31.6 Minutes STANDARD_DEVIATION 42.7 • n=59 Participants	34.7 Minutes STANDARD_DEVIATION 41.1 • n=118 Participants
Time in purposeful activity	13.0 Minutes STANDARD_DEVIATION 20.4 • n=59 Participants	11.2 Minutes STANDARD_DEVIATION 24.5 • n=59 Participants	12.1 Minutes STANDARD_DEVIATION 22.5 • n=118 Participants
Daily steps	5900.8 Steps STANDARD_DEVIATION 3214.1 • n=59 Participants	5605.7 Steps STANDARD_DEVIATION 2865.1 • n=59 Participants	5753.2 Steps STANDARD_DEVIATION 3035.2 • n=118 Participants
Daily sedentary time	491.6 Minutes STANDARD_DEVIATION 192.5 • n=59 Participants	523.0 Minutes STANDARD_DEVIATION 194.4 • n=59 Participants	507.3 Minutes STANDARD_DEVIATION 193.3 • n=118 Participants
McGill Pain Questionnaire	13.3 Units on a scale STANDARD_DEVIATION 10.8 • n=59 Participants	13.9 Units on a scale STANDARD_DEVIATION 9.5 • n=59 Participants	13.6 Units on a scale STANDARD_DEVIATION 10.1 • n=118 Participants
Fatigue Severity Scale	4.8 Units on a scale STANDARD_DEVIATION 1.4 • n=59 Participants	4.9 Units on a scale STANDARD_DEVIATION 1.3 • n=59 Participants	4.8 Units on a scale STANDARD_DEVIATION 1.3 • n=118 Participants
Partners in Health	72.8 Units on a scale STANDARD_DEVIATION 11.7 • n=59 Participants	73.5 Units on a scale STANDARD_DEVIATION 12.2 • n=59 Participants	73.1 Units on a scale STANDARD_DEVIATION 11.9 • n=118 Participants
Patient Health Questionnaire (PHQ-9)	7.6 Units on a scale STANDARD_DEVIATION 5.9 • n=59 Participants	8.1 Units on a scale STANDARD_DEVIATION 5.6 • n=59 Participants	7.8 Units on a scale STANDARD_DEVIATION 5.7 • n=118 Participants
Self-Reported Habit Index Sitting at leisure subscale	4.7 units on a scale STANDARD_DEVIATION 1.4 • n=59 Participants	4.7 units on a scale STANDARD_DEVIATION 1.3 • n=59 Participants	4.7 units on a scale STANDARD_DEVIATION 1.3 • n=118 Participants
Self-Reported Habit Index Walking subscale	4.1 units on a scale STANDARD_DEVIATION 1.8 • n=59 Participants	3.7 units on a scale STANDARD_DEVIATION 1.6 • n=59 Participants	3.9 units on a scale STANDARD_DEVIATION 1.7 • n=118 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
Daily Time in Moderate/Vigorous Physical Activity Baseline	37.8 Minutes Standard Deviation 39.6	31.6 Minutes Standard Deviation 42.7
Daily Time in Moderate/Vigorous Physical Activity 9 weeks	44.7 Minutes Standard Deviation 41.2	31.6 Minutes Standard Deviation 32.4
Daily Time in Moderate/Vigorous Physical Activity 18 weeks	43.2 Minutes Standard Deviation 48.2	32.8 Minutes Standard Deviation 36.8
Daily Time in Moderate/Vigorous Physical Activity 27 weeks	37.8 Minutes Standard Deviation 38.8	34.0 Minutes Standard Deviation 36.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
Time Spent in Sedentary Activity Baseline	491.6 Minutes Standard Deviation 192.5	523.0 Minutes Standard Deviation 194.4
Time Spent in Sedentary Activity 9 weeks	508.4 Minutes Standard Deviation 203.5	530.0 Minutes Standard Deviation 180.2
Time Spent in Sedentary Activity 18 weeks	507.8 Minutes Standard Deviation 195.8	531.4 Minutes Standard Deviation 165.4
Time Spent in Sedentary Activity 27 weeks	506.8 Minutes Standard Deviation 179.7	498.0 Minutes Standard Deviation 155.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
Fatigue Severity Scale Baseline	4.8 score on a scale Standard Deviation 1.4	4.9 score on a scale Standard Deviation 1.3
Fatigue Severity Scale 9 weeks	4.5 score on a scale Standard Deviation 1.3	4.9 score on a scale Standard Deviation 1.3
Fatigue Severity Scale 18 weeks	4.8 score on a scale Standard Deviation 1.3	4.6 score on a scale Standard Deviation 1.5
Fatigue Severity Scale 27 weeks	4.5 score on a scale Standard Deviation 1.4	4.7 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
McGill Pain Questionnaire Short Form (MPQ-SF) Baseline	13.3 score on a scale Standard Deviation 10.8	13.9 score on a scale Standard Deviation 9.5
McGill Pain Questionnaire Short Form (MPQ-SF) 9 weeks	10.9 score on a scale Standard Deviation 8.4	14.6 score on a scale Standard Deviation 9.7
McGill Pain Questionnaire Short Form (MPQ-SF) 18 weeks	10.6 score on a scale Standard Deviation 9.6	12.6 score on a scale Standard Deviation 10.0
McGill Pain Questionnaire Short Form (MPQ-SF) 27 weeks	11.8 score on a scale Standard Deviation 10.0	11.0 score on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: 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.

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),

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
The Patient Health Questionnaire-9 (PHQ-9) 27 weeks	5.2 score on a scale Standard Deviation 3.8	6.7 score on a scale Standard Deviation 5.9
The Patient Health Questionnaire-9 (PHQ-9) Baseline	7.6 score on a scale Standard Deviation 5.9	8.1 score on a scale Standard Deviation 5.6
The Patient Health Questionnaire-9 (PHQ-9) 9 weeks	6.8 score on a scale Standard Deviation 5.6	7.9 score on a scale Standard Deviation 5.7
The Patient Health Questionnaire-9 (PHQ-9) 18 weeks	6.0 score on a scale Standard Deviation 5.0	6.2 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
Partners In Health Scale Baseline	72.8 score on a scale Standard Deviation 11.7	73.5 score on a scale Standard Deviation 12.2
Partners In Health Scale 9 weeks	75.5 score on a scale Standard Deviation 12.5	74.6 score on a scale Standard Deviation 11.2
Partners In Health Scale 18 weeks	77.7 score on a scale Standard Deviation 11.4	78.7 score on a scale Standard Deviation 10.8
Partners In Health Scale 27 weeks	77.9 score on a scale Standard Deviation 12.6	77.4 score on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
The Self-Reported Habit Index (SRHI) - Sitting at Work Index Baseline	4.5 score on a scale Standard Deviation 1.7	4.6 score on a scale Standard Deviation 1.8
The Self-Reported Habit Index (SRHI) - Sitting at Work Index 9 weeks	4.3 score on a scale Standard Deviation 1.8	4.7 score on a scale Standard Deviation 1.7
The Self-Reported Habit Index (SRHI) - Sitting at Work Index 18 weeks	4.6 score on a scale Standard Deviation 1.7	4.6 score on a scale Standard Deviation 1.8
The Self-Reported Habit Index (SRHI) - Sitting at Work Index 27 weeks	4.4 score on a scale Standard Deviation 1.4	4.6 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index Baseline	4.7 score on a scale Standard Deviation 1.4	4.7 score on a scale Standard Deviation 1.3
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index 9 weeks	4.7 score on a scale Standard Deviation 1.3	4.8 score on a scale Standard Deviation 1.4
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index 18 weeks	4.6 score on a scale Standard Deviation 1.3	4.8 score on a scale Standard Deviation 1.2
The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index 27 weeks	4.6 score on a scale Standard Deviation 1.3	4.7 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Immediate Group n=59 Participants 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.	Delay Group n=59 Participants 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.
The Self-Reported Habit Index (SRHI) - Walking Index Baseline	4.1 score on a scale Standard Deviation 1.8	3.7 score on a scale Standard Deviation 1.6
The Self-Reported Habit Index (SRHI) - Walking Index 9 weeks	4.4 score on a scale Standard Deviation 1.7	3.6 score on a scale Standard Deviation 1.7
The Self-Reported Habit Index (SRHI) - Walking Index 18 weeks	4.3 score on a scale Standard Deviation 1.6	4.0 score on a scale Standard Deviation 1.6
The Self-Reported Habit Index (SRHI) - Walking Index 27 weeks	4.7 score on a scale Standard Deviation 1.5	4.0 score on a scale Standard Deviation 1.7

Adverse Events

Immediate Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Delay Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Immediate Group n=59 participants at risk 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.	Delay Group n=59 participants at risk 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.
Musculoskeletal and connective tissue disorders Muscle pain	16.9% 10/59 • 26 weeks Self-reported adverse events were collected, including muscle pain, ligament sprain, or falls while being physically active, were collected.	15.3% 9/59 • 26 weeks Self-reported adverse events were collected, including muscle pain, ligament sprain, or falls while being physically active, were collected.
Musculoskeletal and connective tissue disorders Ligament sprain	5.1% 3/59 • 26 weeks Self-reported adverse events were collected, including muscle pain, ligament sprain, or falls while being physically active, were collected.	1.7% 1/59 • 26 weeks Self-reported adverse events were collected, including muscle pain, ligament sprain, or falls while being physically active, were collected.

Additional Information

Dr. Linda Li

University of British Columbia

Phone: 604-207-4020

Email: lli@arthritisresearch.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place