Diabetes Mellitus, Type II
Conditions
Keywords
mHealth, Physical Activity, Glucose, Blood, Glycated Hemoglobin A1c, Health-Related Quality Of Life, Quality of Life, Triglycerides, HDL Cholesterol, LDL Cholesterol, Blood Pressure, Arterial, Presenteeism, Sitting time, Sedentary Behaviour, Workplace
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.
Interventions
BEHAVIORALWalk@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
Sponsors
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
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Fasting glucose levels | Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished | Blood tests |
| 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 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 concentration of HbA1c | Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished. | Blood tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Sociodemographic variables (age, gender, socio economic status) | One measurment point: (a) before the intervention. | Questionnaire |
| 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) |
| 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 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 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) |
Countries
Spain
Contacts
Primary ContactAnna Puig-Ribera
Backup ContactFrancesc Alos Colomer
Outcome results
None listed