Reducing Sedentary Behaviour With Technology

April 11, 2021 updated by: University Health Network, Toronto

Reducing Sedentary Behaviour Through Wearable Technology and Education

Cancer-related fatigue (CRF) can be experienced by individuals with Prostate Cancer (PC), which can have profound effects on their well-being. Although physical activity has been shown to improve CRF, the recommended levels are generally not met. Step count and distance traveled information can help individuals to increase their physical activity. Wearable technology (WEAR) provides the user with feedback of their physical activity which can motivate behaviour change. Similarly, education workshops (EDU) on the effects of sedentary behaviour and physical activity may also reduce sedentary behaviour.

The objectives of this study are to evaluate the effects of WEAR and EDU on sedentary behaviour and CRF, and to explore the feasibility of WEAR in this population. Participants in this study will be randomly assigned into WEAR, EDU, WEAR+EDU, or control over a three-month intervention. Assessments at baseline, post-intervention and a 3-month follow up will evaluate CRF, quality of life and level of sedentary behaviour, and use of WEAR devices.

The results from this study will provide evidence-based knowledge on the impact of WEAR and EDU on sedentary behaviour and CRF, and an understanding on the use of technology within the PC population. These results can shape the development of programming for CRF and the use of scale-able technology-based interventions/approaches in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • PC survivors aged 18 years or older
  • Currently sedentary, defined as <90 minutes per week of activity
  • Fluent in English
  • Access to a computer with internet connectivity

Exclusion Criteria:

• Men who are or have received chemotherapy

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable Device Only
Participants will be allowed to choose one of three wearable devices (FitBit, Garmi or Polar), for the wearable technology intervention. Once the participant has chosen their wearable device they will be oriented to their chosen device, platform to obtain information from the device, as well as a guide with ideas for reducing sedentary behaviour. Participants will be asked to wear the devices every day during waking hours.
Other: Wearable Technology - Garmin Vivosmart
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Other: Wearable Technology - FitBit Alta
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Other: Wearable Technology - Polar Loop 2
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Experimental: Online Educational Workshop Only
The Online Educational Group will be asked to participate in 6 online workshops that will occur during the 12-week intervention. Adobe connect software will be used to implement these workshops which allows for interaction between participants and leader. Workshops will focus on specific aspects related to reducing sedentary behaviours and increasing PA time. Each workshop will be developed by study coordinator/author (MO) and constructed using Social Cognitive Theory (SCT), ensuring the themes such as self-efficacy, self-control and reinforcements are within each topic. EDU topics will include motivation, goal setting, and activities and ways to reduce sedentary behaviour.
Other: Online Educational Group
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
Experimental: Wearable Device+Online Edu Workshop
Both the wearable technology intervention and Online Educational Group intervention simultaneously.
Other: Wearable Technology - Garmin Vivosmart
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Other: Wearable Technology - FitBit Alta
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Other: Wearable Technology - Polar Loop 2
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Other: Online Educational Group
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
No Intervention: Control Group
Participants in this group will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline
At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate
Baseline
Retention rate
Time Frame: 3 month assessment (Post-Intervention)
At the end of the intervention and follow-up assessment, we will measure retention rate through number of participants who have withdrawn from the study.
3 month assessment (Post-Intervention)
Adherence
Time Frame: 3 month assessment (Post-Intervention)
Adherence will be measured for participants attendance throughout the intervention.
3 month assessment (Post-Intervention)
WEAR device preference
Time Frame: 3 month assessment (Post-Intervention)
This will be measured through the number of participants that choose each of the three devices.
3 month assessment (Post-Intervention)
Acceptability
Time Frame: 6 months assessment (follow-up)
Acceptability will be measured through the end of study questionnaire at the follow-up assessment
6 months assessment (follow-up)
Outcome measures captured
Time Frame: 6 month assessment (follow-up)
This will be measured through review and analysis of data obatined for completeness
6 month assessment (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-Related Fatigue
Time Frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Sedentary Behaviour
Time Frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Assessed through accelerometry and Sit-Q 7 Day questionnaire
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Quality of Life
Time Frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Assessed with Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Depression
Time Frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Assessed with Patient Health Questionnaire - 9 (PHQ-9)
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Understand attitudes towards using wearable technology
Time Frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Assessed through semi-structured interviews
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Collaborators

University of Toronto

Investigators

  • Principal Investigator: Shabbir Alibhai, MD MSc, University Health Network, Toronto

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)

September 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-5437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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 Breast Cancer

Clinical Trials on Wearable Technology - Garmin Vivosmart

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe