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Completed

NCT Number: NCT03248752

Monitoring Physical Activity (Fitbit)

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioural Medicine Lab, University of Victoria

Victoria, British Columbia, V8P 5C2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit use and reports

Behavioral

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 engagement

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

Sponsors and collaborators

Lead sponsor

University of Victoria

Other

Registry information

Official study title

Physical Activity Promotion Through Wearable Monitors: A Test of Self and Partner Monitoring Strategies.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2017
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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