´Sit Less, Move More' at Work: Impact of a mHealth Intervention on the Glycaemic Control and Anthropometric Profile of Office Employees With Diabetes Type 2. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- Change in height
研究概览
简要总结
The objective of the study is measuring the impact of a ´sit less, move more' mHealth intervention at work on the glycaemic control and anthropometric profile of office employees with diabetes type 2 (DT2) at short, mid and long term.
详细描述
A double-blind randomized controlled trial. Seven Primary Care Centers from Spain (n=5 Catalonia, n=2 Madrid), 2 hospitals (n=1 Catalonia, n=1 Madrid) and 2 companies (occupational health services; n=1 public, n=1 private) will participate in the study. In each center, physicians, nurses, endocrinologists and occupational physicians will recruit patients with DT2 who spend at least 55% of their working hours doing desk-based tasks (OSPAQ) and have a cellphone. Following the CONSORT Statement (2010), volunteers will be randomized into a control (CG) or intervention group (IG) by the research team using a computer program to generate the random sequence. 184 individuals are needed in each group. Main variables: fasting glucose levels, HbA1c, weight, height, BMI, waist circumference. Occupational sitting time and sitting time breaks will be measured using ActivPAL devices. Other variables: physical activity (IPAQ short), quality of life (EuroQool), presenteeism (WLQ), triglycerides, total cholesterol (LDL and HDL), blood pressure and sociodemographic variables.
Intervention: A mHealth program (13 wks) will progressively replace occupational sitting time with light physical activities. Participants from the CG will receive usual care. Multivariate analysis will assess changes over time (post intervention and at 6 months follow up) in the dependent variables; looking at differences between groups. Intention to treat will be applied.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DM2 diagnosed office employees according to international criteria.
- •Doing sedentary tasks during at least a 55% of their daily work schedule (according to the Occupational Sedentary and Physical Activity Questionnaire: OSPAQ >55%).
- •Having a cellphone .
- •Having a minimum work contract of 18.5 hours per week.
- •Being able to get up from the chair or to walk by themselves (without any help).
排除标准
- •Not having a cellphone.
- •Having some pathology/disability/injury which changes their ability and capacity to walk or getting up from the chair.
- •Doing less than a 55% of the daily tasks in a sitting position according to the OSPAQ questionnaire.
研究组 & 干预措施
Intervention Group
In the intervention group, subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2. In addition, participants will be provided with an external movement sensor that will be linked to the Walk@WalkApp-Diab for Android and iOS. This App will monitor the time participants spend sitting, walking and standing during working hours. It will also provide participants with strategies to "sit less and move more" at work throughout 13 weeks. This mHealth intervention aims to change occupational sitting by replacing desk-based activities by active tasks.
干预措施: Walk@WorkApp-Diab (Behavioral)
Control Group
Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2.
结局指标
主要结局
Change in height
时间窗: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Body height in metres (electronic scale-Seca 899/217)
Change in Waist circumference
时间窗: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished
Waist circumference in centimetres using a flexible steel tape (Seca 203)
Change in Fasting glucose levels
时间窗: Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
Blood tests
Change in concentration of HbA1c
时间窗: Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished.
Blood tests
Change in weight
时间窗: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Body weight in kilograms (electronic scale-Seca 899/217)
Change in Body Mass Index
时间窗: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Weight and height will be combined to report Body Mass Index (kg/m2)
次要结局
- Change in objective Occupational sedentary behaviour(Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.)
- Change in objective occupational physical activity(Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.)
- Change in subjective occupational physical activity(Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.)
- Change in subjective domain-specific sedentary behaviour(Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.)