Walk@Work: ´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Walk@WorkApp-Diab
The intervention (Walk@WorkApp-Diab), based on an mHealth program, consists on replacing sedentary job tasks for active ones, during 13 weeks. The intervention group will download the mHealth program into their personal cellphones
Other Names:
|
| No Intervention: Control Group Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2. |
Outcome Measures
Primary Outcome Measures
- 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 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 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)
- 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)
Secondary Outcome Measures
- 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 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)
- 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)
Other Outcome Measures
- Change in health-related quality of life [Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.]
EQ-5d-3L. Scores range from 0 to 100 (0 describes the worse health you can imagine while 100 describes the best health you can imagine)
- Change in Presenteeism levels [Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.]
Work Limitations Questionnaire. Scores range from 0 to 100 (0 describes that your health dones not limit you at all in doing thw work tasks, while 100 describes your health limits you a lot your work tasks)
- Change in concentration of Triglycerides [Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.]
Blood tests (mg/dL)
- Change in total cholesterol levels [Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.]
Blood tests (mg/dL)
- Change in blood pressure [Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.]
Digital automatic blood pressure monitor-Omron M7 (mmHg)
- Sociodemographic variables (age, gender, socio economic status) [One measurment point: (a) before the intervention.]
Questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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DM2 diagnosed office employees according to international criteria.
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Doing sedentary tasks during at least a 55% of their daily work schedule (according to the Occupational Sedentary and Physical Activity Questionnaire: OSPAQ >55%).
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Having a cellphone .
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Having a minimum work contract of 18.5 hours per week.
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Being able to get up from the chair or to walk by themselves (without any help).
Exclusion Criteria:
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Not having a cellphone.
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Having some pathology/disability/injury which changes their ability and capacity to walk or getting up from the chair.
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Doing less than a 55% of the daily tasks in a sitting position according to the OSPAQ questionnaire.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IDIAP Jordi Gol | Barcelona | Spain | 08007 |
Sponsors and Collaborators
- Jordi Gol i Gurina Foundation
- Instituto de Salud Carlos III
- Consorci Hospitalari de Vic
- Institut Català de la Salut
- University of Vic - Central University of Catalonia
- Puerta de Hierro University Hospital
Investigators
- Principal Investigator: Anna Puig Ribera, Universitat de Vic
- Study Chair: Carlos Martin Cantera, Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
- Study Chair: Francesc Alòs Colomer, Catalan Institute of Health
- Study Chair: Mercè Solà Gonfaus, Catalan Institute of Health
- Study Chair: Ana Urpí Fernández, Catalan Institute of Health
- Study Chair: Josep Maria Molina Aragonés, Catalan Institute of Health
- Study Chair: Blanca Funollet Santos, Catalan Institute of Health
- Study Chair: Laura Illamola Martin, EAP Dreta de l'Eixample S.L.P
- Study Chair: Ignasi Saigí Ullastre, Consorci Hospitalari de Vic (CHV)
- Study Chair: Emi Chirveches-Pérez, Consorci Hospitalari de Vic (CHV)
- Study Chair: Montserrat Martín-Horcajo, Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC)
- Study Chair: Montserrat Munuera Grau, Catalan Institute of Health
- Study Chair: Miguel Brito, Madrid Health Service
- Study Chair: David Pérez Manchon, Madrid Health Service
- Study Chair: María Lorena López Catañon, Madrid Health Service
- Study Chair: Montserrat Solís Muñoz, Madrid Health Service
- Study Chair: Judit Bort-Roig, University of Vic - Central University of Catalonia
- Study Chair: Mireia Félez-Nóbrega, Parc Sanitari Sant Joan de Déu (Sant Boi de Llobregat)
- Study Chair: Francesc Garcia Cuyàs, Hospital Sant Joan de Déu (Barcelona)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI17/01788