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

NCT ID: NCT04092738

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Walk@WorkApp-Diab

Intervention Type BEHAVIORAL

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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mHealth intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Consorci Hospitalari de Vic

OTHER

Sponsor Role collaborator

Institut Català de la Salut

OTHER

Sponsor Role collaborator

University of Vic - Central University of Catalonia

OTHER

Sponsor Role collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Puig Ribera

Role: PRINCIPAL_INVESTIGATOR

Universitat de Vic

Carlos Martin Cantera

Role: STUDY_CHAIR

Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

Francesc Alòs Colomer

Role: STUDY_CHAIR

Catalan Institute of Health

Mercè Solà Gonfaus

Role: STUDY_CHAIR

Catalan Institute of Health

Ana Urpí Fernández

Role: STUDY_CHAIR

Catalan Institute of Health

Josep Maria Molina Aragonés

Role: STUDY_CHAIR

Catalan Institute of Health

Blanca Funollet Santos

Role: STUDY_CHAIR

Catalan Institute of Health

Laura Illamola Martin

Role: STUDY_CHAIR

EAP Dreta de l'Eixample S.L.P

Ignasi Saigí Ullastre

Role: STUDY_CHAIR

Consorci Hospitalari de Vic (CHV)

Emi Chirveches-Pérez

Role: STUDY_CHAIR

Consorci Hospitalari de Vic (CHV)

Montserrat Martín-Horcajo

Role: STUDY_CHAIR

Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC)

Montserrat Munuera Grau

Role: STUDY_CHAIR

Catalan Institute of Health

Miguel Brito

Role: STUDY_CHAIR

Madrid Health Service

David Pérez Manchon

Role: STUDY_CHAIR

Madrid Health Service

María Lorena López Catañon

Role: STUDY_CHAIR

Madrid Health Service

Montserrat Solís Muñoz

Role: STUDY_CHAIR

Madrid Health Service

Judit Bort-Roig

Role: STUDY_CHAIR

University of Vic - Central University of Catalonia

Mireia Félez-Nóbrega

Role: STUDY_CHAIR

Parc Sanitari Sant Joan de Déu (Sant Boi de Llobregat)

Francesc Garcia Cuyàs

Role: STUDY_CHAIR

Hospital Sant Joan de Déu (Barcelona)

Locations

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IDIAP Jordi Gol

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Anna Puig-Ribera

Role: CONTACT

+34 619352497

Francesc Alos Colomer

Role: CONTACT

+34 618429646

Facility Contacts

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Francesc Alos Colomer

Role: primary

+34 618429645

References

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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.

Reference Type DERIVED
PMID: 40494751 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35768818 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32459625 (View on PubMed)

Other Identifiers

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PI17/01788

Identifier Type: -

Identifier Source: org_study_id

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