Clinical trial NCT03248752: Monitoring Physical Activity (Fitbit)
Official title: Physical Activity Promotion Through Wearable Monitors: A Test of Self and Partner Monitoring Strategies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Health Promotion
Keywords: Behavioural
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in participants' weekly physical activity participation at 3 months.
timeFrame: Baseline, 6 weeks, and 3 months
Secondary outcomes:
measure: Change in Body Mass Index from baseline to 3 months.
timeFrame: Baseline and 3 months
measure: Change in waist circumference from baseline to 3 months.
timeFrame: Baseline, 3 months
measure: Change in self-reported physical activity from baseline to 3 months.
timeFrame: Baseline, 6 weeks, 3 months.
measure: Change in quality of life from baseline to 3 months measured using the Short Form 12 questionnaire.
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in life satisfaction from baseline to 3 months measured using Diener's satisfaction with life scale in a questionnaire.
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in mood from baseline to 3 months measured using the Hospital Anxiety and Depression Scale in a questionnaire.
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 3 months.
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in physical activity behaviour regulation from baseline to 3 months.
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in physical activity habits from baseline to 3 months.
timeFrame: Baseline, 6 weeks, 3 months
measure: Change in physical activity identity from baseline to 3 months.
timeFrame: Baseline, 6 weeks, 3 months
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Behavioural Medicine Lab, University of Victoria
state: British Columbia
Study officials:
affiliation: University of Victoria
name: Ryan Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Victoria
name: Scott Hofer, PhD
role: STUDY_CHAIR
References: