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

Diabetes Mellitus, Type II Clinical Trial

— Walk@Work  

Official title:

´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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092738
• Other study ID #: PI17/01788
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: September 2021

Study information

• Verified date: September 2019
• Source: Jordi Gol i Gurina Foundation
• Contact: Anna Puig-Ribera
• Phone: +34 619352497
• Email: annam.puig[@]uvic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: September 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

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

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Consorci Hospitalari de Vic, Institut Català de la Salut, Instituto de Salud Carlos III, Puerta de Hierro University Hospital, University of Vic - Central University of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	Sociodemographic variables (age, gender, socio economic status)	Questionnaire	One measurment point: (a) before the intervention.
Primary	Change in Fasting glucose levels	Blood tests	Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
Primary	Change in concentration of HbA1c	Blood tests	Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.