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

Primary Purpose

Diabetes Mellitus, Type II

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Walk@WorkApp-Diab
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type II focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IDIAP Jordi GolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm 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 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.

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

Outcomes

Primary Outcome Measures

Change in Fasting glucose levels
Blood tests
Change in concentration of HbA1c
Blood tests
Change in weight
Body weight in kilograms (electronic scale-Seca 899/217)
Change in height
Body height in metres (electronic scale-Seca 899/217)
Change in Body Mass Index
Weight and height will be combined to report Body Mass Index (kg/m2)
Change in Waist circumference
Waist circumference in centimetres using a flexible steel tape (Seca 203)

Secondary Outcome Measures

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)
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)
Change in objective occupational physical activity
Minutes/day spent doing light and moderate-to-vigorous physical activity (ActivPal device)
Change in subjective occupational physical activity
Minutes/day walking, doing moderate and vigorous physical activity (International Physical Activity Questionnaire, IPAQ)

Full Information

First Posted
July 16, 2018
Last Updated
September 16, 2019
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04092738
Brief Title
´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial.
Masking
Participant
Allocation
Randomized
Enrollment
368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2.
Intervention Type
Behavioral
Intervention Name(s)
Walk@WorkApp-Diab
Other Intervention Name(s)
mHealth intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Fasting glucose levels
Description
Blood tests
Time Frame
Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
Title
Change in concentration of HbA1c
Description
Blood tests
Time Frame
Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished.
Title
Change in weight
Description
Body weight in kilograms (electronic scale-Seca 899/217)
Time Frame
Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Title
Change in height
Description
Body height in metres (electronic scale-Seca 899/217)
Time Frame
Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Title
Change in Body Mass Index
Description
Weight and height will be combined to report Body Mass Index (kg/m2)
Time Frame
Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Title
Change in Waist circumference
Description
Waist circumference in centimetres using a flexible steel tape (Seca 203)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished
Secondary Outcome Measure Information:
Title
Change in objective Occupational sedentary behaviour
Description
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)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Title
Change in subjective domain-specific sedentary behaviour
Description
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)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Title
Change in objective occupational physical activity
Description
Minutes/day spent doing light and moderate-to-vigorous physical activity (ActivPal device)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Title
Change in subjective occupational physical activity
Description
Minutes/day walking, doing moderate and vigorous physical activity (International Physical Activity Questionnaire, IPAQ)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Other Pre-specified Outcome Measures:
Title
Change in health-related quality of life
Description
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)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Title
Change in Presenteeism levels
Description
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)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Title
Change in concentration of Triglycerides
Description
Blood tests (mg/dL)
Time Frame
Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.
Title
Change in total cholesterol levels
Description
Blood tests (mg/dL)
Time Frame
Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.
Title
Change in blood pressure
Description
Digital automatic blood pressure monitor-Omron M7 (mmHg)
Time Frame
Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Title
Sociodemographic variables (age, gender, socio economic status)
Description
Questionnaire
Time Frame
One measurment point: (a) before the intervention.

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Puig-Ribera
Phone
+34 619352497
Email
annam.puig@uvic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Francesc Alos Colomer
Phone
+34 618429646
Email
cesc.alos@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Puig Ribera
Organizational Affiliation
Universitat de Vic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Martin Cantera
Organizational Affiliation
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesc Alòs Colomer
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mercè Solà Gonfaus
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ana Urpí Fernández
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Josep Maria Molina Aragonés
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Blanca Funollet Santos
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laura Illamola Martin
Organizational Affiliation
EAP Dreta de l'Eixample S.L.P
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ignasi Saigí Ullastre
Organizational Affiliation
Consorci Hospitalari de Vic (CHV)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emi Chirveches-Pérez
Organizational Affiliation
Consorci Hospitalari de Vic (CHV)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Montserrat Martín-Horcajo
Organizational Affiliation
Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Montserrat Munuera Grau
Organizational Affiliation
Catalan Institute of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Miguel Brito
Organizational Affiliation
Madrid Health Service
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Pérez Manchon
Organizational Affiliation
Madrid Health Service
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María Lorena López Catañon
Organizational Affiliation
Madrid Health Service
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Montserrat Solís Muñoz
Organizational Affiliation
Madrid Health Service
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Judit Bort-Roig
Organizational Affiliation
University of Vic - Central University of Catalonia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mireia Félez-Nóbrega
Organizational Affiliation
Parc Sanitari Sant Joan de Déu (Sant Boi de Llobregat)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesc Garcia Cuyàs
Organizational Affiliation
Hospital Sant Joan de Déu (Barcelona)
Official's Role
Study Chair
Facility Information:
Facility Name
IDIAP Jordi Gol
City
Barcelona
ZIP/Postal Code
08007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesc Alos Colomer
Phone
+34 618429645
Email
cesc.alos@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35768818
Citation
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.
Results Reference
derived
PubMed Identifier
32459625
Citation
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.
Results Reference
derived

Learn more about this trial

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

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