´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.

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

Sponsors

Lead sponsor: Jordi Gol i Gurina Foundation

Collaborator: 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

Source Jordi Gol i Gurina Foundation
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.

Overall Status Recruiting
Start Date March 4, 2019
Completion Date September 2021
Primary Completion Date January 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Fasting glucose levels Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
Change in concentration of HbA1c Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished.
Change in weight Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Change in height 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 Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
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
Secondary Outcome
Measure Time Frame
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.
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.
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.
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.
Enrollment 368
Condition
Intervention

Intervention type: Behavioral

Intervention name: [email protected]

Description: The intervention ([email protected]), 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

Arm group label: Intervention Group

Other name: mHealth intervention

Eligibility

Criteria:

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.

Gender: All

Gender based: Yes

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Anna Puig-Ribera

Phone: +34 619352497

Email: [email protected]

Location
facility status contact IDIAP Jordi Gol Francesc Alos Colomer +34 618429645 [email protected]
Location Countries

Spain

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intervention Group

Arm group type: Experimental

Description: 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 [email protected] 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.

Arm group label: Control Group

Arm group type: No Intervention

Description: Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2.

Acronym [email protected]
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled trial.

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov