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临床试验/NCT04219800
NCT04219800已完成不适用

Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)

Umeå University6 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年12月8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
46
试验地点
6
主要终点
Sitting time

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) patients are suboptimal treated due to low uptake of physical activity. Recent research shows promising beneficial health effects from reducing sitting time by regular short bouts of light-intensity physical activity. These findings open up for a new focus in T2DM treatment but conclusive evidence is missing as studies have been short-term trials, mainly conducted in laboratory environments. Recent research suggest that reduced sitting and increased physical activity can be supported at a low cost by mHealth (mobile health) technology such as activity tracker armbands that warns of prolonged sitting and SMS text messages that reminds of activity breaks.

The overarching purpose of the project is to evaluate the effects of an intervention aimed to reduce occupational sitting in T2DM using mHealth (mobile health). It is hypothesized that the intervention will lead to (1) Activity changes - reduced sitting time and/or increased number of steps (primary outcome measures) and (2) Health effects - lower fatigue, improved health-related quality of life, reduced cardiometabolic risk, less sick leave, less medication, less musculoskeletal problems (secondary outcome measures)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 Diabetes Melltitus
  • 40-64 years
  • HbA1c 48-100 mmol/mol
  • BMI ≥ 25 kg/m2
  • Working at least 75% of full-time in a mainly seated job.

排除标准

  • Pregnancy
  • Regular vigorous intensity exercise
  • Severe disease or for other reason unable to follow the study protocol

研究组 & 干预措施

mHealth

Experimental
  1. Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps.
  2. SMS text messages; reminds of activity breaks.
  3. Mobile video instruction for standing pause gymnastics.

干预措施: Patient-centered counselling and written material (Behavioral)

mHealth

Experimental
  1. Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps.
  2. SMS text messages; reminds of activity breaks.
  3. Mobile video instruction for standing pause gymnastics.

干预措施: mHealth (Behavioral)

Control

Other

Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.

干预措施: Patient-centered counselling and written material (Behavioral)

结局指标

主要结局

Sitting time

时间窗: 12 months

Assessed by activPAL3 thigh-worn accelerometer

次要结局

  • Fatigue(12 months)
  • Health-related quality of life(12 months)
  • Steps(12 months)
  • Medications(12 months)
  • Cardiometabolic composite score (CCMR)(12 months)
  • Sick leave(12 months)
  • Musculoskeletal problems(12 months)

研究者

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

Patrik Wennberg

Professor

Umeå University

研究点 (6)

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