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

´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.

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type II
• Intervention / Treatment: Behavioral: Walk@WorkApp-Diab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Puig-Ribera; Phone Number: +34 619352497; Email: annam.puig@uvic.cat
• Study Contact Backup: Name: Francesc Alos Colomer; Phone Number: +34 618429646; Email: cesc.alos@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08007
    • Recruiting
    • IDIAP Jordi Gol
    • Contact: Francesc Alos Colomer; Phone Number: +34 618429645; Email: cesc.alos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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; Other Names: mHealth intervention
No Intervention: Control Group; Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Institut Català de la Salut; Instituto de Salud Carlos III; Puerta de Hierro University Hospital; Consorci Hospitalari de Vic; University of Vic - Central University of Catalonia
• Investigators: Principal Investigator: Anna Puig Ribera, Universitat de Vic; Study Chair: Carlos Martin Cantera, Jordi Gol i Gurina Foundation - IDIAP Jordi Gol; Study Chair: Francesc Alòs Colomer, 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)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Quality of Life; mHealth; Workplace; Health-Related Quality Of Life; Triglycerides; LDL Cholesterol; Sedentary Behaviour; Presenteeism; HDL Cholesterol; Sitting time; Glucose, Blood; Glycated Hemoglobin A1c; Blood Pressure, Arterial
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PI17/01788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No