´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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´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.

Conditions
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Behavioral: Walk@WorkApp-Diab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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<br>* Other names: mHealth intervention;|
| No Intervention: Control Group<br>Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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