Reducing Sedentary Behaviour With Technology

NCT ID: NCT02911649

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Prostate Cancer Breast Cancer Sedentary Behaviour Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wearable Technology - Garmin Vivosmart

Intervention Type OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Wearable Technology - FitBit Alta

Intervention Type OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Wearable Technology - Polar Loop 2

Intervention Type OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

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.

Group Type EXPERIMENTAL

Online Educational Group

Intervention Type OTHER

A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour

Wearable Device+Online Edu Workshop

Both the wearable technology intervention and Online Educational Group intervention simultaneously.

Group Type EXPERIMENTAL

Wearable Technology - Garmin Vivosmart

Intervention Type OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Online Educational Group

Intervention Type OTHER

A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour

Wearable Technology - FitBit Alta

Intervention Type OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Wearable Technology - Polar Loop 2

Intervention Type OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Control Group

Participants in this group will receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Online Educational Group

A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shabbir Alibhai, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16-5437

Identifier Type: -

Identifier Source: org_study_id

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