Clinical trial NCT04092738: ´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.
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
Overall status: UNKNOWN
Phase: NA
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
LDL Cholesterol
Blood Pressure, Arterial
Presenteeism
Sitting time
Sedentary Behaviour
Workplace
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Consorci Hospitalari de Vic
name: Institut Català de la Salut
name: University of Vic - Central University of Catalonia
name: Puerta de Hierro University Hospital
First posted: 2019-09-17
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Fasting glucose levels
timeFrame: Two measurement points: (a) Before the intervention starts, (b) at 6 months after intervention has finished
measure: Change in concentration of HbA1c
timeFrame: Two measurement points: (a) before the intervention starts, (b) at 6 months after intervention has finished.
measure: Change in weight
timeFrame: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
measure: Change in height
timeFrame: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
measure: Change in Body Mass Index
timeFrame: Three measurement points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after intervention has finished.
measure: Change in Waist circumference
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished
Secondary outcomes:
measure: Change in objective Occupational sedentary behaviour
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
measure: Change in subjective domain-specific sedentary behaviour
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
measure: Change in objective occupational physical activity
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
measure: Change in subjective occupational physical activity
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
Other outcomes:
measure: Change in health-related quality of life
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
measure: Change in Presenteeism levels
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
measure: Change in concentration of Triglycerides
timeFrame: Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.
measure: Change in total cholesterol levels
timeFrame: Two measurement points: (a) Before the intervention starts, (b) at 6 months after the intervention has finished.
measure: Change in blood pressure
timeFrame: Three measurment points: (a) before the intervention, (b) immediately after the intervention, (c) at 6 months after the intervention has finished.
measure: Sociodemographic variables (age, gender, socio economic status)
timeFrame: One measurment point: (a) before the intervention.
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: Universitat de Vic
name: Anna Puig Ribera
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
name: Carlos Martin Cantera
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Francesc Alòs Colomer
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Mercè Solà Gonfaus
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Ana Urpí Fernández
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Josep Maria Molina Aragonés
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Blanca Funollet Santos
role: STUDY_CHAIR
affiliation: EAP Dreta de l'Eixample S.L.P
name: Laura Illamola Martin
role: STUDY_CHAIR
affiliation: Consorci Hospitalari de Vic (CHV)
name: Ignasi Saigí Ullastre
role: STUDY_CHAIR
affiliation: Consorci Hospitalari de Vic (CHV)
name: Emi Chirveches-Pérez
role: STUDY_CHAIR
affiliation: Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC)
name: Montserrat Martín-Horcajo
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Montserrat Munuera Grau
role: STUDY_CHAIR
affiliation: Madrid Health Service
name: Miguel Brito
role: STUDY_CHAIR
affiliation: Madrid Health Service
name: David Pérez Manchon
role: STUDY_CHAIR
affiliation: Madrid Health Service
name: María Lorena López Catañon
role: STUDY_CHAIR
affiliation: Madrid Health Service
name: Montserrat Solís Muñoz
role: STUDY_CHAIR
affiliation: University of Vic - Central University of Catalonia
name: Judit Bort-Roig
role: STUDY_CHAIR
affiliation: Parc Sanitari Sant Joan de Déu (Sant Boi de Llobregat)
name: Mireia Félez-Nóbrega
role: STUDY_CHAIR
affiliation: Hospital Sant Joan de Déu (Barcelona)
name: Francesc Garcia Cuyàs
role: STUDY_CHAIR
References:
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.
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.