Monitoring Physical Activity (Fitbit)

November 10, 2020 updated by: Ryan Rhodes, University of Victoria

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

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

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Victoria, British Columbia, Canada, V8P 5C2
        • Behavioural Medicine Lab, University of Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Scott Hofer, PhD, University of Victoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2017

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2018

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

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Fitbit use and reports

3
Subscribe