Diabetes Mellitus, Type IIWalk@WorkNCT04092738
´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.
A study testing Walk@WorkApp-Diab in people with Diabetes Mellitus, Type II, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Walk@WorkApp-Diab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IDIAP Jordi Gol
Barcelona, 08007
Francesc Alos Colomer, +34 618429645, cesc.alos@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Walk@WorkApp-Diab
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk@WorkApp-DiabBehavioural
Also called mHealth intervention
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Walk@WorkApp-Diab |
| Control Group | No intervention | Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting glucose levels
Blood tests
Measured: Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
Change in concentration of HbA1c
Blood tests
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start4 Mar 2019
- Primary completionJan 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Anna Puig Ribera, Principal investigator, Universitat de VicCarlos Martin Cantera, Study chair, Jordi Gol i Gurina Foundation - IDIAP Jordi GolFrancesc Alòs Colomer, Study chair, Catalan Institute of HealthMercè Solà Gonfaus, Study chair, Catalan Institute of HealthAna Urpí Fernández, Study chair, Catalan Institute of HealthJosep Maria Molina Aragonés, Study chair, Catalan Institute of HealthBlanca Funollet Santos, Study chair, Catalan Institute of HealthLaura Illamola Martin, Study chair, EAP Dreta de l'Eixample S.L.P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092738
- Sponsor's protocol ID
- PI17/01788
- Acronym
- Walk@Work
- Status last verified
- Sep 2019
- First submitted
- 16 Jul 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40494751Alos 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.
PubMed 35768818Bort-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.
PubMed 32459625
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04092738
- Acronym / sponsor ID
- Walk@Work / PI17/01788
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- mHealth, Physical Activity, Glucose, Blood, Glycated Hemoglobin A1c, Health-Related Quality Of Life, Quality of Life, Triglycerides, HDL Cholesterol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- 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
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Walk@WorkApp-DiabIn 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. |
| Control Group | No intervention | –Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk@WorkApp-DiabAlso: mHealth interventionThe 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 | Behavioural | Intervention Group |
Primary outcome
Change in Fasting glucose levels
Time frame: Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
Blood tests
Change in concentration of HbA1c
Time frame: Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished.
Blood tests
Change in weight
Time frame: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Body weight in kilograms (electronic scale-Seca 899/217)
Change in height
Time frame: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Body height in metres (electronic scale-Seca 899/217)
Change in Body Mass Index
Time frame: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
Weight and height will be combined to report Body Mass Index (kg/m2)
Change in Waist circumference
Time frame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished
Waist circumference in centimetres using a flexible steel tape (Seca 203)
4 secondary outcomes
Change in objective Occupational sedentary behaviour
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 40494751Alos 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.
- Derived from this study: PubMed 35768818Alos 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.
- Derived from this study: PubMed 32459625Bort-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Puig Ribera principal investigator
Universitat de Vic
Carlos Martin Cantera study chair
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Francesc Alòs Colomer study chair
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk@WorkApp-Diab in people with Diabetes Mellitus, Type II, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Puig-Ribera (+34 619352497, annam.puig@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fasting glucose levels (time frame: Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092738, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.