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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Consorci Hospitalari de Vic | OTHER |
| Institut Català de la Salut | OTHER |
| University of Vic - Central University of Catalonia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Control Group | No Intervention | Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk@WorkApp-Diab | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting glucose levels | Blood tests | Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished |
| Change in concentration of HbA1c | Blood tests | Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished. |
| Change in weight | Body weight in kilograms (electronic scale-Seca 899/217) | Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished. |
| Change in height | Body height in metres (electronic scale-Seca 899/217) | Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished. |
| Change in Body Mass Index | Weight and height will be combined to report Body Mass Index (kg/m2) | Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished. |
| Change in Waist circumference | Waist circumference in centimetres using a flexible steel tape (Seca 203) | Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished |
| Measure | Description | Time Frame |
|---|---|---|
| Change in objective Occupational sedentary behaviour | 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) | Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life | 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) | Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Puig-Ribera | Contact | +34 619352497 | annam.puig@uvic.cat | |
| Francesc Alos Colomer | Contact | +34 618429646 | cesc.alos@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna Puig Ribera | Universitat de Vic | Principal Investigator |
| Carlos Martin Cantera | Jordi Gol i Gurina Foundation - IDIAP Jordi Gol | Study Chair |
| Francesc Alòs Colomer |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDIAP Jordi Gol | Recruiting | Barcelona | 08007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40494751 | Derived | Alos F, Colomer MA, Bort-Roig J, Martin-Cantera C, Minaya A, Saigi I, Sitjar-Suner M, Puig-Ribera A. Impact of a primary care-based mobile health intervention to 'sit less and move more' on HbA1c, blood pressure, and other clinical outcomes in office employees with type 2 diabetes: A randomized controlled trial. Prim Care Diabetes. 2025 Oct;19(5):434-445. doi: 10.1016/j.pcd.2025.05.010. Epub 2025 Jun 9. | |
| 35768818 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Puerta de Hierro University Hospital | OTHER |
Randomized controlled trial.
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|
| Change in subjective domain-specific sedentary behaviour | 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) | 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 | Minutes/day spent doing light and moderate-to-vigorous physical activity (ActivPal device) | 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 | Minutes/day walking, doing moderate and vigorous physical activity (International Physical Activity Questionnaire, IPAQ) | Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished. |
| Change in Presenteeism levels |
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) |
| Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished. |
| Change in concentration of Triglycerides | Blood tests (mg/dL) | Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished. |
| Change in total cholesterol levels | Blood tests (mg/dL) | Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished. |
| Change in blood pressure | Digital automatic blood pressure monitor-Omron M7 (mmHg) | Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished. |
| Sociodemographic variables (age, gender, socio economic status) | Questionnaire | One measurment point: (a) before the intervention. |
| 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 Chair |
| Derived |
| Alos F, Colomer MA, Martin-Cantera C, Solis-Munoz M, Bort-Roig J, Saigi I, Chirveches-Perez E, Sola-Gonfaus M, Molina-Aragones JM, Puig-Ribera A. Effectiveness of a healthcare-based mobile intervention on sedentary patterns, physical activity, mental well-being and clinical and productivity outcomes in office employees with type 2 diabetes: study protocol for a randomized controlled trial. BMC Public Health. 2022 Jun 29;22(1):1269. doi: 10.1186/s12889-022-13676-x. |
| 32459625 | Derived | Bort-Roig J, Chirveches-Perez E, Garcia-Cuyas F, Dowd KP, Puig-Ribera A. Monitoring Occupational Sitting, Standing, and Stepping in Office Employees With the W@W-App and the MetaWearC Sensor: Validation Study. JMIR Mhealth Uhealth. 2020 Aug 4;8(8):e15338. doi: 10.2196/15338. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |