´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.
- Conditions
- Diabetes Mellitus, Type II
- Interventions
- Behavioral: Walk@WorkApp-Diab
- Registration Number
- NCT04092738
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 368
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Walk@WorkApp-Diab 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.
- Primary Outcome Measures
Name Time Method Change in height 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 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 Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished Blood tests
Change in concentration of HbA1c Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished. Blood tests
Change in weight 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 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)
- Secondary Outcome Measures
Name Time Method 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. Total sitting time (minutes/day), sedendary bouts (daily time spent sitting on less than 20 minutes periods, between 20-60 minutes periods, more than 60 minutes period (ActivPal device)
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. Minutes/day spent doing light and moderate-to-vigorous physical activity (ActivPal device)
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. Minutes/day walking, doing moderate and vigorous physical activity (International Physical Activity Questionnaire, IPAQ)
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. Workforce Sitting Questionnaire (daily time spent sitting watching TV, working, at home, as transport and for leisure during working days and nonworking days (minutes/day)
Trial Locations
- Locations (1)
IDIAP Jordi Gol
🇪🇸Barcelona, Spain