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临床试验/NCT02911649
NCT02911649已完成不适用

Reducing Sedentary Behaviour Through Wearable Technology and Education

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Retention rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Men who are or have received chemotherapy

研究组 & 干预措施

Wearable Device Only

Experimental

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.

干预措施: Wearable Technology - Garmin Vivosmart (Other)

Wearable Device Only

Experimental

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.

干预措施: Wearable Technology - FitBit Alta (Other)

Wearable Device Only

Experimental

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.

干预措施: Wearable Technology - Polar Loop 2 (Other)

Online Educational Workshop Only

Experimental

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.

干预措施: Online Educational Group (Other)

Wearable Device+Online Edu Workshop

Experimental

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

干预措施: Wearable Technology - Garmin Vivosmart (Other)

Wearable Device+Online Edu Workshop

Experimental

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

干预措施: Online Educational Group (Other)

Wearable Device+Online Edu Workshop

Experimental

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

干预措施: Wearable Technology - FitBit Alta (Other)

Wearable Device+Online Edu Workshop

Experimental

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

干预措施: Wearable Technology - Polar Loop 2 (Other)

Control Group

No Intervention

Participants in this group will receive usual care

结局指标

主要结局

Retention rate

时间窗: 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.

Outcome measures captured

时间窗: 6 month assessment (follow-up)

This will be measured through review and analysis of data obatined for completeness

Recruitment rate

时间窗: Baseline

At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate

Adherence

时间窗: 3 month assessment (Post-Intervention)

Adherence will be measured for participants attendance throughout the intervention.

WEAR device preference

时间窗: 3 month assessment (Post-Intervention)

This will be measured through the number of participants that choose each of the three devices.

Acceptability

时间窗: 6 months assessment (follow-up)

Acceptability will be measured through the end of study questionnaire at the follow-up assessment

次要结局

  • Cancer-Related Fatigue(Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up))
  • Understand attitudes towards using wearable technology(Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up))
  • Sedentary Behaviour(Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up))
  • Quality of Life(Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up))
  • Depression(Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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