SuPRA: Using Wearable Activity Trackers With a New Applic... | NCT02585323

Status Module

Name	Class
Simon Fraser University	OTHER
Arthritis Research Centre of Canada	OTHER
Fraser Health	OTHER
Canadian Institutes of Health Research (CIHR)

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate Intervention Group	Active Comparator	Education session, Fitbit/FitViz, PT counselling: Participants receive this intervention in Months 1-3. The session will include a presentation on physical activity, an individual goal-setting session with a registered physiotherapist, and an orientation to the Fitbit Flex and the FitViz app. In Months 1 and 2, participants will use the Fitbit/FitViz. The PT will review the progress with participants via 20-minute bi-weekly phone calls, and progressively modify their activities. In Month 3, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. In Months 4-9, participants may continue using the Fitbit/FitViz without access to a PT.	Behavioral: Education session, Fitbit/FitViz, PT counselling
Delayed Intervention Group	Placebo Comparator	Same intervention with a 3 month delay: The full intervention will be initiated in Month 4 and with a brief education session, use of a Fitbit Flex paired with the FitViz app, and counseling by a physiotherapist. In Months 6-9, participants will continue using Fitbit/FitViz without the PT phone calls.	Behavioral: Same intervention with a 3 month delay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education session, Fitbit/FitViz, PT counselling	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, 13 weeks, 26 weeks, 39 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline, 13 weeks, 26 weeks, 39 weeks

Eligibility Module

Name	Affiliation	Role
Linda Li, PhD	Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arthritis Research Canada		Vancouver	British Columbia	V5Y 3P2	Canada
Arthritis Research Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32618578	Result	Li LC, Feehan LM, Xie H, Lu N, Shaw CD, Gromala D, Zhu S, Avina-Zubieta JA, Hoens AM, Koehn C, Tam J, Therrien S, Townsend AF, Noonan G, Backman CL. Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 3;8(7):e19116. doi: 10.2196/19116.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Immediate Intervention 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 9, 2017

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (T0)

- ParticipantsOG00026
- ParticipantsOG00125

Title	Measurements
	OG00031.0± 37.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	ANCOVA		0.05		Adjusted difference in mean change	13.1			2-Sided	95	1.6	24.5					Superiority

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.

Posted

Mean

Standard Deviation

Minutes per day

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	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.

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.

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

Posted

Mean

Standard Deviation

units on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delayed 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.

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	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.

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),

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

Secondary

Partners in Health Scale

Posted

Mean

Standard Deviation

score on a scale

Baseline, Months 3, 6, and 9

ID	Title	Description
OG000	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.
OG001	Delay Group

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.

Secondary

Self-Reported Habit Index (SRHI) - Sitting at Leisure Subscale

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.

Secondary

Self-Reported Habit Index (SRHI) - Walking Subscale

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.

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)

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

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)

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

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)

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

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)

Posted

Mean

Standard Deviation

score on a scale

Baseline, 13 weeks, 26 weeks, 39 weeks

ID	Title	Description
OG000	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.
OG001	Delay Group

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Immediate Group	Education session, Fitbit/FitViz, PT counselling: Participants received this intervention in Weeks 1-13. The session included a presentation on physical activity, an individual goal-setting session with a registered physiotherapist, 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/FitViz.	0	26	0	26	7	26
EG001	Delay Group	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 physiotherapist. In Week 26-38, participants did not have access to a PT, but were encouraged to continue using the Fitbit/FitViz.	0	25	0	25	3	25

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Fall during physical activity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected26 at risk EG0011 events1 affected25 at risk
Muscle pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events5 affected26 at risk EG0012 events2 affected25 at risk
Ligament sprain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk

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.

ID	Term
D007592	Joint Diseases
D020370	Osteoarthritis, Knee
D009043	Motor Activity
D010003	Osteoarthritis
D001168	Arthritis

ID	Term
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D001519	Behavior