title: Cost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial.
abstract: BACKGROUND
  The high prevalence of women that do not reach the recommended level of physical activity is worrisome. A sedentary lifestyle has negative consequences on health status and increases health care costs. The main objective of this project is to assess the cost-effectiveness of a primary care-based exercise intervention in perimenopausal women.
  
  
  METHODS
  The present study is a Randomized Controlled Trial. A total of 150 eligible women will be recruited and randomly assigned to either a 16-week exercise intervention (3 sessions/week), or to usual care (control) group. The primary outcome measure is the incremental cost-effectiveness ratio. The secondary outcome measures are: i) socio-demographic and clinical information; ii) body composition; iii) dietary patterns; iv) glycaemic and lipid profile; v) physical fitness; vi) physical activity and sedentary behaviour; vii) sleep quality; viii) quality of life, mental health and positive health; ix) menopause symptoms. All outcomes will be assessed at baseline and post intervention. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct a cost effectiveness analysis from a health system perspective.
  
  
  CONCLUSIONS
  The intervention designed is feasible and if it proves to be clinically and cost effective, it can be easily transferred to other similar contexts. Consequently, the findings of this project might help the Health Systems to identify strategies for primary prevention and health promotion as well as to reduce health care requirements and costs.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02358109. Date of registration: 05/02/2015.
authors.affiliation: Department of Physical Education, Faculty of Education Science, University of Cádiz, Cádiz, Spain. ana.carbonell@uca.es.
authors.forename: Ana
authors.initials: A
authors.lastname: Carbonell-Baeza
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. asm@ugr.es.
authors.forename: Alberto
authors.initials: A
authors.lastname: Soriano-Maldonado
authors.affiliation: Zaidín Sur healthcare centre and Department of Medicine, Faculty of Medicine, University of Granada, Granada, Spain. fjgallov@gmail.com.
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Gallo
authors.affiliation: Department of Applied Economics, Faculty of Economics, University of Granada, Granada, Spain. puerto.lopezdelamo@hotmail.es.
authors.forename: María Puerto
authors.initials: MP
authors.lastname: López del Amo
authors.affiliation: Andalusian School of Public Health, Granada, Spain. prcturmo@gmail.com.
authors.forename: Pilar
authors.initials: P
authors.lastname: Ruiz-Cabello
authors.affiliation: Andalusian School of Public Health, Granada, Spain. anikiaf@gmail.com.
authors.forename: Ana
authors.initials: A
authors.lastname: Andrade
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. milkanaa@hotmail.com.
authors.forename: Milkana
authors.initials: M
authors.lastname: Borges-Cosic
authors.affiliation: Andalusian School of Public Health, Granada, Spain. arpr@correo.ugr.es.
authors.forename: Antonio Rubén
authors.initials: AR
authors.lastname: Peces-Rama
authors.affiliation: Department of Applied Economics, Faculty of Economics, University of Granada, Granada, Spain. zuzspa@correo.ugr.es.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Spacírová
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. alvarezg@ugr.es.
authors.forename: Inmaculada C
authors.initials: IC
authors.lastname: Álvarez-Gallardo
authors.affiliation: Andalusian School of Public Health, Granada, Spain. leticia.garcia.easp@juntadeandalucia.es.
authors.forename: Leticia
authors.initials: L
authors.lastname: García-Mochón
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. vsegura@ugr.es.
authors.forename: Víctor
authors.initials: V
authors.lastname: Segura-Jiménez
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. festevez@ugr.es.|Department of Clinical and Health Psychology, Utrecht University, Utrecht, The Netherlands. festevez@ugr.es.
authors.forename: Fernando
authors.initials: F
authors.lastname: Estévez-López
authors.affiliation: Department of Physiology, Faculty of Pharmacy, Faculty of Sport Sciences, and Institute of Nutrition and Food Technology, University of Granada, Granada, Spain. dcamiletti@ugr.es.
authors.forename: Daniel
authors.initials: D
authors.lastname: Camiletti-Moirón
authors.affiliation: Department of Applied Economics, Faculty of Economics, University of Granada, Granada, Spain. jjmartin@ugr.es.
authors.forename: Jose Jesús
authors.initials: JJ
authors.lastname: Martín-Martín
authors.affiliation: Andalusian School of Public Health, Granada, Spain. manueldf@ugr.es.
authors.forename: Pilar
authors.initials: P
authors.lastname: Aranda
authors.affiliation: Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. manueldf@ugr.es.
authors.forename: Manuel
authors.initials: M
authors.lastname: Delgado-Fernández
authors.affiliation: Department of Physiology, Faculty of Pharmacy, Faculty of Sport Sciences, and Institute of Nutrition and Food Technology, University of Granada, Granada, Spain. virginiaparicio@ugr.es.|Department of Public and Occupational Health, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. virginiaparicio@ugr.es.
authors.forename: Virginia A
authors.initials: VA
authors.lastname: Aparicio
mesh_terms: D001521:Behavior Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D003695:Delivery of Health Care / Q000191:economics; D015444:Exercise; D005081:Exercise Therapy / Q000191:economics; D005260:Female; D017048:Health Care Costs; D006293:Health Promotion / Q000191:economics*; D006304:Health Status; D006801:Humans; D008603:Mental Health; D008875:Middle Aged; D047648:Perimenopause; D010809:Physical Fitness; D011320:Primary Health Care / Q000379:methods; D011788:Quality of Life; D012107:Research Design; D057185:Sedentary Behavior; D016896:Treatment Outcome