title: Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT).
abstract: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training - concomitant with lifestyle counselling - as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus).
  
  
  
  Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group.
  
  
  
  The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle.
  
  
  
  Clinical trials.gov. NTC02832453 . Registered 6 July 2016 (retrospectively registered).
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain. aensenat@inefc.udl.cat.
authors.forename: Assumpta
authors.identifier: 0000-0002-1149-8858
authors.initials: A
authors.lastname: Ensenyat
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Gemma
authors.initials: G
authors.lastname: Espigares-Tribo
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Machado
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Francisco José
authors.initials: FJ
authors.lastname: Verdejo
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Rodriguez-Arregui
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Serrano
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Miret
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Gisela
authors.initials: G
authors.lastname: Galindo
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Blanco
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Josep-Ramon
authors.initials: JR
authors.lastname: Marsal
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Susana
authors.initials: S
authors.lastname: Sarriegui
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Xenia
authors.initials: X
authors.lastname: Sinfreu-Bergues
authors.affiliation: Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
authors.forename: Noemi
authors.initials: N
authors.lastname: Serra-Paya
mesh_terms: D000328:Adult; D001521:Behavior Therapy; D003362:Cost-Benefit Analysis; D003376:Counseling; D015444:Exercise; D005247:Feeding Behavior; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D024821:Metabolic Syndrome / Q000209:etiology / Q000517:prevention & control*; D008875:Middle Aged; D011320:Primary Health Care; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors