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Monitoring Physical Activity (Fitbit)

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ClinicalTrials.gov Identifier: NCT03248752
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ryan Rhodes, University of Victoria

Tracking Information
First Submitted Date  ICMJE July 26, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE July 4, 2017
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03248752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • 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).
  • 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).
  • 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).
  • Change in cardiovascular fitness from baseline to 3 months. [ Time Frame: Baseline, 3 months ]
    Participants will perform a submaximal walking treadmill test as per the Ebbeling protocol. Standardized procedures will be followed. Cardiovascular fitness will be quantified as an estimate of maximal uptake of oxygen (VO2max) using heart rate data from the Ebbeling test and formulas. Changes in this measure will be examined (3 months to baseline).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monitoring Physical Activity (Fitbit)
Official Title  ICMJE Physical Activity Promotion Through Wearable Monitors: A Test of Self and Partner Monitoring Strategies.
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Physical Activity
  • Health Promotion
Intervention  ICMJE
  • Behavioral: Fitbit use and reports
    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.
  • Behavioral: Partner engagement
    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 Arms  ICMJE
  • 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.
    Intervention: Behavioral: Fitbit use and reports
  • 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.
    Interventions:
    • Behavioral: Fitbit use and reports
    • Behavioral: Partner engagement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
160
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2017)
80
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Emily Medd, MSc 250-472-5288 ermedd@uvic.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248752
Other Study ID Numbers  ICMJE BC17-180
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ryan Rhodes, University of Victoria
Study Sponsor  ICMJE University of Victoria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ryan Rhodes, PhD University of Victoria
Study Chair: Scott Hofer, PhD University of Victoria
PRS Account University of Victoria
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP