- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03248752
Monitoring Physical Activity (Fitbit)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8P 5C2
- Behavioural Medicine Lab, University of Victoria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- No smartphone or tablet device (with bluetooth technology)
- No email address
- No partner and/or not living with partner
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 - Self monitored
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.
|
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.
|
Experimental: Group 2 - Partner monitored
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, 6 weeks, and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Mass Index from baseline to 3 months.
Time Frame: Baseline and 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).
|
Baseline and 3 months
|
Change in waist circumference from baseline to 3 months.
Time Frame: Baseline, 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).
|
Baseline, 3 months
|
Change in self-reported physical activity from baseline to 3 months.
Time Frame: Baseline, 6 weeks, 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).
|
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
|
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).
|
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
|
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).
|
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
|
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).
|
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
|
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).
|
Baseline, 6 weeks, 3 months
|
Change in physical activity behaviour regulation from baseline to 3 months.
Time Frame: Baseline, 6 weeks, 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).
|
Baseline, 6 weeks, 3 months
|
Change in physical activity habits from baseline to 3 months.
Time Frame: Baseline, 6 weeks, 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).
|
Baseline, 6 weeks, 3 months
|
Change in physical activity identity from baseline to 3 months.
Time Frame: Baseline, 6 weeks, 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).
|
Baseline, 6 weeks, 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Scott Hofer, PhD, University of Victoria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BC17-180
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
Universitaet InnsbruckRecruiting
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
Clinical Trials on Fitbit use and reports
-
Duke UniversityNorthern Piedmont Carolina Community Care Partners; North Carolina Division...CompletedCoronary Artery Disease | Hypertension | Diabetes | Asthma | Congestive Heart FailureUnited States
-
University of AlbertaAlberta Innovates Health SolutionsRecruitingAcute Renal InjuryCanada
-
Ohio State UniversityNational Institute of Nursing Research (NINR); National Institutes of Health...CompletedCardiovascular Diseases | Physical Activity | Kidney Transplant; Complications | Cardiorenal; ChangeUnited States
-
Avera McKennan Hospital & University Health CenterCellworks Group Inc.Recruiting
-
Savvysherpa, Inc.CompletedType2 DiabetesUnited States
-
Savvysherpa, Inc.CompletedType2 DiabetesUnited States
-
Seattle Children's HospitalCompleted
-
Butler HospitalMichigan State UniversityActive, not recruitingSuicide and Self-harmUnited States
-
Duke UniversityCompletedHealth Behavior | Opioid Use, Unspecified | Benzodiazepine Abuse | Prescription Drug Abuse (Not Dependent) | Benzodiazepine Dependent | Prescription Drug Abuse and DependencyUnited States
-
Institute of Liver and Biliary Sciences, IndiaCompletedLiver Transplant; Complications | Perioperative/Postoperative Complications | Electrolyte DisturbanceIndia