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

Overview

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 Title of Study: “´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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2020

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.

Interventions

  • Behavioral: 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

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: Control Group
    • Subjects will receive brief advice on occupational physical activity, sedentary behaviour and Diabetes Type 2.

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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.
    • 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)
  • 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.
    • 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)
  • 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.
    • Minutes/day spent doing light and moderate-to-vigorous physical activity (ActivPal device)
  • 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.
    • Minutes/day walking, doing moderate and vigorous physical activity (International Physical Activity Questionnaire, IPAQ)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundacio d’Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Collaborator
    • Instituto de Salud Carlos III
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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
    • Mercè Solà Gonfaus, Study Chair, Catalan Institute of Health
    • Ana Urpí Fernández, Study Chair, Catalan Institute of Health
    • Josep Maria Molina Aragonés, Study Chair, Catalan Institute of Health
    • Blanca Funollet Santos, Study Chair, Catalan Institute of Health
    • Laura Illamola Martin, Study Chair, EAP Dreta de l’Eixample S.L.P
    • Ignasi Saigí Ullastre, Study Chair, Consorci Hospitalari de Vic (CHV)
    • Emi Chirveches-Pérez, Study Chair, Consorci Hospitalari de Vic (CHV)
    • Montserrat Martín-Horcajo, Study Chair, Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC)
    • Montserrat Munuera Grau, Study Chair, Catalan Institute of Health
    • Miguel Brito, Study Chair, Madrid Health Service
    • David Pérez Manchon, Study Chair, Madrid Health Service
    • María Lorena López Catañon, Study Chair, Madrid Health Service
    • Montserrat Solís Muñoz, Study Chair, Madrid Health Service
    • Judit Bort-Roig, Study Chair, University of Vic – Central University of Catalonia
    • Mireia Félez-Nóbrega, Study Chair, Parc Sanitari Sant Joan de Déu (Sant Boi de Llobregat)
    • Francesc Garcia Cuyàs, Study Chair, Hospital Sant Joan de Déu (Barcelona)
  • Overall Contact(s)
    • Anna Puig-Ribera, +34 619352497, annam.puig@uvic.cat

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