Physical ActivityNCT03248752
Monitoring Physical Activity (Fitbit)
A study testing Fitbit use and reports and Partner engagement in people with Physical Activity and Health Promotion, run by University of Victoria at 1 site in Canada.
Trial summary
The purpose of this study is to examine the effect of monitoring and sharing physical activity outcomes (using Fitbit technology) with a domestic partner on physical activity participation. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Promotion
- What is being tested?
- Fitbit use and reports and Partner engagement
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2017to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One or both partners currently not meeting the Canadian Physical Activity Guidelines of 150 minutes of moderate to vigorous physical activity per week
- Currently living in Victoria, BC
- Safe to participate in physical activity (physician clearance required if applicable)
Who cannot join
- No smartphone or tablet device (with bluetooth technology)
- No email address
- No partner and/or not living with partner
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioural Medicine Lab, University of Victoria
Victoria, British Columbia, V8P 5C2
About this study
Official title: Physical Activity Promotion Through Wearable Monitors: A Test of Self and Partner Monitoring Strategies.
The purpose of this study is to examine the effect of monitoring and sharing physical activity outcomes (using Fitbit technology) with a domestic partner on physical activity participation.
Primary research question: Does sharing physical activity outcomes from wearable technology with a participant's partner improve overall physical activity over 3 months compared to not sharing outcomes? Physical activity will be measured as minutes of moderate to vigorous physical activity per week.
Hypothesis: Knowledge that physical activity outcomes are visible to a participant's partner will serve as a proxy-supervision intervention. Awareness of partner's progress will serve as further motivation. Both factors will improve physical activity adherence in comparison to participants without shared outcomes.
Read the detailed description
Background: Physical activity is associated with management and/or prevention of over 25 chronic health conditions; however the majority of adults in North America are not active enough to experience these benefits. Behavioral strategies have been shown to be effective for increasing physical activity, and wearable fitness monitors such as Fitbits include components of several behavioral strategies including goal setting and feedback. While this technology provides a platform for implementing self-regulation techniques important for behavior change, direct supervision is still the most effective strategy for behavior change. Supervised exercise programs and personal trainers may not be accessible or affordable for people; this study will examine whether proxy supervision by a partner is effective in changing behavior compared to self-regulation alone.
Target Population: Sedentary adults aged 45-75 years old living in Victoria, British-Columbia, Canada.
Sample Size: 80 participant pairs (160 total participants), 40 pairs per group (80 participants per group).
Intervention: Participants will be randomized to two groups: 1 - Self Monitored, 2 - Partner monitored. Both groups will receive an intervention with Group 1 (Self monitored) serving as the comparison group. Participants from both groups will wear an accelerometer for 1 week and complete an online questionnaire at baseline, 6 weeks, and 3 months. Measures of height, weight, waist circumference, and resting blood pressure and heart rate will be taken at baseline and 3 months. Participants will all receive a Fitbit activity tracker and wear it for 3 months. Group 2 (Partner monitor) participants will also have access to their partner's daily progress, receive eachother's Weekly Fitbit reports, and engage in a weekly discussion related to their Weekly Fitbit Report.
- Conditions
- Physical Activity, Health Promotion
- Being tested
- Fitbit use and reports, Partner engagement
- Keywords
- Behavioural
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit use and reportsBehavioural
Participants will receive a Fitbit device to be used for the duration of the study. Participants will engage with the Fitbit and application and receive Weekly Progress Reports from Fitbit.
Partner engagementBehavioural
Participants will be connected with their partner in the Fitbit app and therefore have the ability to access their partner's progress. Participants' Weekly Progress Reports will be automatically forwarded to their partner. Participants will engage in a weekly discussion on the topic of their Weekly Progress Reports.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Self monitored | Active comparator | Fitbit use and reports details: Participants will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device and receive a Weekly Progress Report from Fitbit. Receives: Behavioral: Fitbit use and reports |
| Group 2 - Partner monitored | Experimental | Fitbit use and reports details: Participant will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device. Participant will also engage with their partner through the Fitbit application. They will have access to their partner's daily progress and be able to communicate through the application. They will also receive their partner's Weekly Fitbit Reports and have a weekly discussion about the Weekly Fitbit Report. Receives: Behavioral: Fitbit use and reports; Behavioral: Partner engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in participants' weekly physical activity participation at 3 months.
Quantified as minutes of moderate to vigorous physical activity measured with accelerometry. Participants will wear an accelerometer for a minimum of 10 hours per day for 7 consecutive days. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, and 3 months
Secondary outcomes (10)
Change in Body Mass Index from baseline to 3 months.
Standardized protocols for measuring weight in kilograms (kg) and height in centimeters (cm) will be performed as per the Canadian Society for Exercise Physiology guidelines. Body Mass Index (BMI) will be calculated as kg/m^2. Body Mass Index is an indicator of body composition which is associated with physical activity. Changes in BMI will be examined (3 months to baseline).
Measured: Baseline and 3 months
Change in waist circumference from baseline to 3 months.
Standardized protocols for measuring waist circumference in centimeters (cm) will be performed as per the Canadian Society for Exercise Physiology guidelines. Waist circumference is an indicator of body composition which is associated with physical activity. Changes in waist circumference will be examined (3 months to baseline).
Measured: Baseline, 3 months
Change in self-reported physical activity from baseline to 3 months.
Measured from questionnaire using Godin's personal self report leisure time measurement tool, also known as the Leisure Score Index (LSI). The Leisure Score Index contains three questions, which assess the frequency of mild, moderate, and strenuous activity performed for at least 15 minutes during free time in a typical week. Changes in these measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months.
Change in quality of life from baseline to 3 months measured using the Short Form 12 questionnaire.
The online questionnaire will asses participants' quality of life using the short form 12 questionnaire. Changes in this measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Change in life satisfaction from baseline to 3 months measured using Diener's satisfaction with life scale in a questionnaire.
The online questionnaire will asses participants' life satisfaction using Diener's satisfaction with life scale. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Change in mood from baseline to 3 months measured using the Hospital Anxiety and Depression Scale in a questionnaire.
The online questionnaire will asses participants' mood using the Hospital Anxiety and Depression scale. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 3 months.
Included in questionnaire - Ajzen's theory of planned behaviour questionnaire will be applied to measure participants' beliefs, attitudes, barriers, and motivation related to physical activity. Changes in these measures will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Change in physical activity behaviour regulation from baseline to 3 months.
Included in questionnaire - 5 items adapted from Umstattd's scale measuring physical activity self-regulation strategies in older adults. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Change in physical activity habits from baseline to 3 months.
Included in questionnaire - 12 Self Report Habit Index items from the measure developed by Verplanken and Orbell and adapted to physical activity by Chatzisarantis and Hagger. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Change in physical activity identity from baseline to 3 months.
Included in questionnaire - Anderson and Cychosz Exercise Identity Scale is used to measure participants' identification as someone who participates in physical activity. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
Measured: Baseline, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start4 Jul 2017
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Rhodes, University of Victoria
- Investigators
- Ryan Rhodes, PhD, Principal investigator, University of VictoriaScott Hofer, PhD, Study chair, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248752
- Sponsor's protocol ID
- BC17-180
- Status last verified
- Nov 2018
- First submitted
- 26 Jul 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Promotion Through Wearable Monitors: A Test of Self and Partner Monitoring Strategies.
- ClinicalTrials.gov ID
- NCT03248752
- Acronym / sponsor ID
- BC17-180
- Conditions
- Physical Activity, Health Promotion
- Keywords
- Behavioural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of monitoring and sharing physical activity outcomes (using Fitbit technology) with a domestic partner on physical activity participation.
Primary research question: Does sharing physical activity outcomes from wearable technology with a participant's partner improve overall physical activity over 3 months compared to not sharing outcomes? Physical activity will be measured as minutes of moderate to vigorous physical activity per week.
Hypothesis: Knowledge that physical activity outcomes are visible to a participant's partner will serve as a proxy-supervision intervention. Awareness of partner's progress will serve as further motivation. Both factors will improve physical activity adherence in comparison to participants without shared outcomes.
Detailed description
Background: Physical activity is associated with management and/or prevention of over 25 chronic health conditions; however the majority of adults in North America are not active enough to experience these benefits. Behavioral strategies have been shown to be effective for increasing physical activity, and wearable fitness monitors such as Fitbits include components of several behavioral strategies including goal setting and feedback. While this technology provides a platform for implementing self-regulation techniques important for behavior change, direct supervision is still the most effective strategy for behavior change. Supervised exercise programs and personal trainers may not be accessible or affordable for people; this study will examine whether proxy supervision by a partner is effective in changing behavior compared to self-regulation alone.
Target Population: Sedentary adults aged 45-75 years old living in Victoria, British-Columbia, Canada.
Sample Size: 80 participant pairs (160 total participants), 40 pairs per group (80 participants per group).
Intervention: Participants will be randomized to two groups: 1 - Self Monitored, 2 - Partner monitored. Both groups will receive an intervention with Group 1 (Self monitored) serving as the comparison group. Participants from both groups will wear an accelerometer for 1 week and complete an online questionnaire at baseline, 6 weeks, and 3 months. Measures of height, weight, waist circumference, and resting blood pressure and heart rate will be taken at baseline and 3 months. Participants will all receive a Fitbit activity tracker and wear it for 3 months. Group 2 (Partner monitor) participants will also have access to their partner's daily progress, receive eachother's Weekly Fitbit reports, and engage in a weekly discussion related to their Weekly Fitbit Report.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Self monitored | Active comparator | Behavioral: Fitbit use and reportsFitbit use and reports details: Participants will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device and receive a Weekly Progress Report from Fitbit. |
| Group 2 - Partner monitored | Experimental | Behavioral: Fitbit use and reports, Behavioral: Partner engagementFitbit use and reports details: Participant will receive a Fitbit device to wear for 3 months. They will engage with the Fitbit application on their smartphone or tablet device. Participant will also engage with their partner through the Fitbit application. They will have access to their partner's daily progress and be able to communicate through the application. They will also receive their partner's Weekly Fitbit Reports and have a weekly discussion about the Weekly Fitbit Report. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- One or both partners currently not meeting the Canadian Physical Activity Guidelines of 150 minutes of moderate to vigorous physical activity per week
- Currently living in Victoria, BC
- Safe to participate in physical activity (physician clearance required if applicable)
Key exclusion criteria (3 listed)
- No smartphone or tablet device (with bluetooth technology)
- No email address
- No partner and/or not living with partner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit use and reportsParticipants will receive a Fitbit device to be used for the duration of the study. Participants will engage with the Fitbit and application and receive Weekly Progress Reports from Fitbit. | Behavioural | Group 1 - Self monitored, Group 2 - Partner monitored |
| Partner engagementParticipants will be connected with their partner in the Fitbit app and therefore have the ability to access their partner's progress. Participants' Weekly Progress Reports will be automatically forwarded to their partner. Participants will engage in a weekly discussion on the topic of their Weekly Progress Reports. | Behavioural | Group 2 - Partner monitored |
Primary outcome
Change from baseline in participants' weekly physical activity participation at 3 months.
Time frame: Baseline, 6 weeks, and 3 months
Quantified as minutes of moderate to vigorous physical activity measured with accelerometry. Participants will wear an accelerometer for a minimum of 10 hours per day for 7 consecutive days. Changes in this measure will be examined (3 months to baseline, 3 months to 6 weeks, 6 weeks to baseline).
10 secondary outcomes
Change in Body Mass Index from baseline to 3 months.
Time frame: Baseline and 3 months
Change in waist circumference from baseline to 3 months.
Time frame: Baseline, 3 months
Change in self-reported physical activity from baseline to 3 months.
Time frame: Baseline, 6 weeks, 3 months.
Change in quality of life from baseline to 3 months measured using the Short Form 12 questionnaire.
Time frame: Baseline, 6 weeks, 3 months
Change in life satisfaction from baseline to 3 months measured using Diener's satisfaction with life scale in a questionnaire.
Time frame: Baseline, 6 weeks, 3 months
Change in mood from baseline to 3 months measured using the Hospital Anxiety and Depression Scale in a questionnaire.
Time frame: Baseline, 6 weeks, 3 months
Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 3 months.
Time frame: Baseline, 6 weeks, 3 months
Change in physical activity behaviour regulation from baseline to 3 months.
Time frame: Baseline, 6 weeks, 3 months
Change in physical activity habits from baseline to 3 months.
Time frame: Baseline, 6 weeks, 3 months
Change in physical activity identity from baseline to 3 months.
Time frame: Baseline, 6 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Rhodes, PhD principal investigator
University of Victoria
Scott Hofer, PhD study chair
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit use and reports and Partner engagement in people with Physical Activity and Health Promotion, run by University of Victoria at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in participants' weekly physical activity participation at 3 months. (time frame: Baseline, 6 weeks, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020; AzTrials last refreshed its copy on 4 Nov 2026.