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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Diabetes Mellitus, Type II

Treatments: Behavioral: Walk@WorkApp-Diab

Study type: Interventional

Funder types: Other

Identifiers

NCT04092738

PI17/01788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 368 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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368 participants in 2 patient groups

Intervention Group

Experimental group

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.

Treatment:

Behavioral: Walk@WorkApp-Diab

Control Group

No Intervention group

Description:

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