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Open Access Study protocol

Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design

Carme Martín-Borràs12*, Maria Giné-Garriga23, Elena Martínez4, Carlos Martín-Cantera156, Elisa Puigdoménech1, Mercè Solà7, Eva Castillo8, Angela Mª Beltrán1, Anna Puig-Ribera9, José Manuel Trujillo10, Olga Pueyo11, Javier Pueyo11, Beatriz Rodríguez12, Noemí Serra-Paya13 and SEDESTACTIV Study Group14

Author Affiliations

1 Research Unit of Barcelona, Primary Healthcare Research Institution IDIAP Jordi Gol, Barcelona, Spain

2 Department of Physical Activity and Sport Sciences, FPCEE Blanquerna, Universitat Ramon Llull, Barcelona, Spain

3 Department of Physical Therapy, FCS Blanquerna, Universitat Ramon Llull, Barcelona, Spain

4 Primary heatlhcare centre Vilanova, Institut Català de la Salut, Barcelona, Spain

5 Primary healthcare centre Passeig Sant Joan, Institut Català de la Salut, Barcelona, Spain

6 Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain

7 Primary healthcare centre Les Planes, Institut Català de la Salut, Barcelona, Spain

8 Primary healthcare centre Sant Ildefons Cornellà, Institut Català de la Salut, Cerdanyola-Ripollet, Spain

9 Department of Physical Activity Sciences, Universitat de Vic, Vic, Spain

10 Primary healthcare centre Cuevas del Almanzora, Servicio Andaluz de Salud, Almería, Spain

11 Primary healthcare centre Cariñena, Servicio Aragonés de Salud, Zaragoza, Spain

12 Fremap, Zaragoza, Spain

13 National Institute for Physical Education of Catalonia (INEFC) of Lleida, Universitat de Lleida, Lleida, Spain

14 SEDESTACTIV Study Group, redIAPP: Red de Investigación en Actividades Preventivas y Promoción de la Salud, Barcelona, Spain

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BMC Public Health 2014, 14:228  doi:10.1186/1471-2458-14-228

Published: 5 March 2014

Abstract

Background

There is growing evidence suggesting that prolonged sitting has negative effects on people’s weight, chronic diseases and mortality. Interventions to reduce sedentary time can be an effective strategy to increase daily energy expenditure. The purpose of this study is to evaluate the effectiveness of a six-month primary care intervention to reduce daily of sitting time in overweight and mild obese sedentary patients.

Method/Design

The study is a randomized controlled trial (RCT). Professionals from thirteen primary health care centers (PHC) will randomly invite to participate mild obese or overweight patients of both gender, aged between 25 and 65 years old, who spend 6 hours at least daily sitting. A total of 232 subjects will be randomly allocated to an intervention (IG) and control group (CG) (116 individuals each group). In addition, 50 subjects with fibromyalgia will be included.

Primary outcome is: (1) sitting time using the activPAL device and the Marshall questionnaire. The following parameters will be also assessed: (2) sitting time in work place (Occupational Sitting and Physical Activity Questionnaire), (3) health-related quality of life (EQ-5D), (4) evolution of stage of change (Prochaska and DiClemente's Stages of Change Model), (5) physical inactivity (catalan version of Brief Physical Activity Assessment Tool), (6) number of steps walked (pedometer and activPAL), (7) control based on analysis (triglycerides, total cholesterol, HDL, LDL, glycemia and, glycated haemoglobin in diabetic patients) and (8) blood pressure and anthropometric variables. All parameters will be assessed pre and post intervention and there will be a follow up three, six and twelve months after the intervention. A descriptive analysis of all variables and a multivariate analysis to assess differences among groups will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle.

Discussion

If the SEDESTACTIV intervention shows its effectiveness in reducing sitting time, health professionals would have a low-cost intervention tool for sedentary overweight and obese patients management.

Trial registration

A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov NCT01729936

Keywords:
Sedentary behaviour; Sitting time; Primary care; Overweight; Obese patients