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

Abstract

BackgroundThere 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/DesignThe 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.DiscussionIf 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 registrationA service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov NCT01729936

Promoción de la salud y prescripción de ejercicio físico desde centros de atención primaria. Justificació y diseño del Programa CAMINEM

“…This study would be, to our knowledge, the first pragmatic study assessing the feasibility of an exercise prescription intervention in primary health-care settings based on matching exercise training principles and public health promotion. In similar previous studies, interventions in primary health-care settings focused primarily in its effectiveness or efficacy both in Spain (Garcia-Ortiz et al, 2010;Grandes et al, 2011;Martin-Borras et al, 2014;Pardo et al, 2014) and elsewhere (Aittasalo, 2008a;Aittasalo et al, 2006;Isaacs et al, 2007;Kallings et al, 2008;Leijon, 2009;Patrick et al, 1994;Smith, Bauman, Bull, Booth, & Harris, 2000;J. Sørensen, Sørensen, Skovgaard, Bredahl, & Puggaard, 2010;J.…”

“…Posiblemente este estudio sea el primero en evaluar la aplicabilidad de una intervención de prescripción de ejercicio físico llevada a cabo en varios CAP que se base en los principios de entrenamiento deportivo (individualización y progresión de las cargas, entre otros) y en los de la promoción de la salud. En otros estudios previos, las intervenciones realizadas en algún CAP se centraban principalmente en la efectividad o eficacia de intervenciones centradas en la promoción de AF (centradas en reducir sedentarismo más que en la dosis de ejercicio físico), tanto como en el estado español (Garcia-Ortiz et al, 2010;Grandes et al, 2011;Martin-Borras et al, 2014;Pardo et al, 2014), como en otros contextos (Aittasalo, 2008a;Aittasalo et al, 2006;Isaacs et al, 2007;Kallings et al, 2008;Leijon, 2009;Patrick et al, 1994;Smith, Bauman, Bull, Booth, & Harris, 2000;J. Sørensen, Sørensen, Skovgaard, Bredahl, & Puggaard, 2010;J.…”

“…40-57. ISSN-1577-4015 ACTIVIDAD FÍSICA Y SALUD | PHYSICAL ACTIVITY AND HEALTH Los resultados de esta investigación permitirán reflejar el impacto sobre la salud pública de este tipo de intervención, realizar el seguimiento objetivo de una prescripción de ejercicio físico individualizada más allá del simple consejo centrado en el hábito de AF, y también servirá para comparar los resultados con otras intervenciones de AF (Aittasalo et al, 2006;Elley, Kerse, Arroll, & Robinson, 2003;Giné-Garriga et al, 2013;Grandes et al, 2011;Isaacs et al, 2007;Leijon et al, 2008;Martin-Borras et al, 2014;Pardo et al, 2014;Smith et al, 2000;J. Sørensen et al, 2010;Van Sluijs et al, 2005).…”

“…El marco de evaluación RE-AIM (representatividad y alcance, eficacia o efectividad, adopción, implementación y mantenimiento) (Estabrooks & Gyurcsik, 2003;Glasgow, Vogt, & Bolas, 1999) surgió para estimar el impacto que tienen las intervenciones en salud pública, y se considera válido para evaluar la aplicabilidad de intervenciones de AF en el ámbito comunitario, como pueden ser los CAP (Estabrooks & Gyurcsik, 2003;Fortier et al, 2007;Gaglio, Shoup, & Glasgow, 2013;Paez et al, 2014). Últimamente se pueden encontrar intervenciones clínicas desarrolladas en algún CAP del estado español (Garcia-Ortiz et al, 2010;Giné-Garriga et al, 2013;Grandes, Sanchez, Montoya, Ortega Sanchez-Pinilla, & Torcal, 2011;Gusi, Reyes, Gonzalez-Guerrero, Herrera, & Garcia, 2008;Martin-Borras et al, 2014;Pardo et al, 2014;Serra-Paya et al, 2013), pero ninguno de ellos evalúa su aplicabilidad (validez externa), entendida como el punto en que una intervención se podría implementar en un contexto concreto más allá del diseño experimental (Wang, Moss, & Hiller, 2006).…”

“…The RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance) framework (Estabrooks & Gyurcsik, 2003;Glasgow, Vogt, & Boles, 1999) was first designed to estimate the public health impact of an intervention and it has been accepted to target the feasibility of HEPA interventions in community settings, such as PHC centers (Estabrooks & Gyurcsik, 2003;Fortier et al, 2007;Gaglio, Shoup, & Glasgow, 2013;Paez et al, 2014). Recently, pragmatic trials are being conducted in Spanish PHC settings (Garcia-Ortiz et al, 2010;Giné-Garriga et al, 2013;Grandes, Sanchez, Montoya, Ortega Sanchez-Pinilla, & Torcal, 2011;Gusi, Reyes, Gonzalez-Guerrero, Herrera, & Garcia, 2008;Martin-Borras et al, 2014;Pardo et al, 2014;Serra-Paya et al, 2013) but none targets its feasibility (i.e., external validity), understood as the extent to which the intervention process could be implemented in the local setting (Wang, Moss, & Hiller, 2006).…”