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临床试验/NCT05505864
NCT05505864招募中不适用

A Combined Health Action Process Approach and mHealth Intervention to Assess Sedentary Behaviour in Adults With Type 2 Diabetes - A Randomized Controlled Trial

Western University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Self-reported total sedentary behaviour

研究概览

简要总结

The purpose of this health behaviour change research study is to assist adults with T2D in achieving the Canadian 24-hour sedentary behaviour movement guidelines.

详细描述

Adults with type 2 diabetes (T2D) are less active and accumulate more sedentary behaviour (SB) than those without. Among adults with T2D, increased SB is associated with increased mortality after adjusting for physical activity. Canadian 24-hour SB movement guidelines recommend limiting SB to ≤8 hours, no more than 3 hours of recreational screen time, and breaking up long periods of SB as often as possible. Therefore, the purpose of this research study is for adults with T2D to achieve these SB Canadian 24-hour SB movement guidelines. To address this purpose, we will be conducting a six-week two-arm repeated measures randomized control trial. The intervention group will receive a theory-based behaviour change counselling session through zoom at week 0, mobile phone application at weeks 2 and 4 that encourage participants to create their own personal and specific action plans and coping strategies, and daily text messages that motivate participants to reduce and break up their SB. The control group will receive no intervention. The primary objective of the study is to reduce SB, while the secondary objectives are to break up SB, reduce screen time, improve quality of life, determine the perceptions towards the intervention, and validate the SB questionnaires. SB will be collected in the form of total daily SB, frequency of SB breaks, and duration of SB breaks. These variables will be measured through a SB and quality of life questionnaires that will be delivered through a downloadable mobile phone application. Outcome measures will be compared within and between groups to detect differences.

研究设计

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

入排标准

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

入选标准

  • 18 years or older
  • diagnosed with type 2 diabetes
  • access to a smart phone with internet connection
  • be able to read, write, and speak in english

排除标准

  • any medical or physical limitation that would prevent standing, stretching, and/or light physical activity

结局指标

主要结局

Self-reported total sedentary behaviour

时间窗: Measured at week 12.

Measured by the modified sedentary behaviour questionnaire (SBQ). Where total daily sedentary behaviour ranges from 0 to 24 hours. Higher number of hours is worse.

Objectively measured total sedentary behaviour

时间窗: Measured at week 12.

Measured by the ACTIVPAL4

次要结局

  • Objective sedentary behaviour break duration(Measured at week 12.)
  • Objective sedentary behaviour break frequency(Measured at week 12.)
  • Overall experience of the intervention(Measured at week 6.)
  • Self-reported sedentary behaviour break frequency(Measured at week 12.)
  • Self-reported sedentary behaviour break duration(Measured at week 12.)
  • Self-reported screen time(Measured at week 12.)
  • Validate the modified SIT-Q (no unabbreviated name) questionnaire(Measured at week 12.)
  • Self-reported quality of life(Measured at week 12.)
  • Validate the modified sedentary behaviour questionnaire (SBQ)(Measured at week 12.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siobhan Smith

Dr Harry Prapavessis, Principal Investigator

Western University

研究点 (1)

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