NCT04092738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

July 16, 2018

Last Update Submit

September 16, 2019

Conditions

Diabetes Mellitus, Type II

Keywords

mHealthPhysical ActivityGlucose, BloodGlycated Hemoglobin A1cHealth-Related Quality Of LifeQuality of LifeTriglyceridesHDL CholesterolLDL CholesterolBlood Pressure, ArterialPresenteeismSitting timeSedentary BehaviourWorkplace

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • 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.

Other Outcomes (6)

  • Change in health-related quality of life

    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

    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

    Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.

  • +3 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Walk@WorkApp-DiabBEHAVIORAL

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

Also known as: mHealth intervention
Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, 08007, Spain

RECRUITING

Related Publications (3)

  • Alos F, Colomer MA, Bort-Roig J, Martin-Cantera C, Minaya A, Saigi I, Sitjar-Suner M, Puig-Ribera A. Impact of a primary care-based mobile health intervention to 'sit less and move more' on HbA1c, blood pressure, and other clinical outcomes in office employees with type 2 diabetes: A randomized controlled trial. Prim Care Diabetes. 2025 Oct;19(5):434-445. doi: 10.1016/j.pcd.2025.05.010. Epub 2025 Jun 9.

    PMID: 40494751DERIVED

  • 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.

    PMID: 35768818DERIVED

  • 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.

    PMID: 32459625DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Anna Puig Ribera

    Universitat de Vic

    PRINCIPAL INVESTIGATOR

  • 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)

    STUDY CHAIR

Central Study Contacts

Anna Puig-Ribera

CONTACT

+34 619352497annam.puig@uvic.cat

Francesc Alos Colomer

CONTACT

+34 618429646cesc.alos@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

September 17, 2019

Study Start

March 4, 2019

Primary Completion

January 1, 2020

Study Completion

September 1, 2021

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)