Carbonell-Baeza, AnaSoriano-Maldonado, AlbertoGallo, Francisco JavierLópez Del Amo, María PuertoRuiz-Cabello, PilarAndrade, AnaBorges-Cosic, MilkanaPeces-Rama, Antonio RubénSpacírová, ZuzanaÁlvarez-Gallardo, Inmaculada CGarcía-Mochón, LeticiaSegura-Jiménez, VíctorEstévez-López, FernandoCamiletti-Moirón, DanielMartín-Martín, Jose JesúsAranda, PilarDelgado-Fernández, ManuelAparicio, Virginia A2015-08-112015-08-112015-06-17Carbonell-Baeza A, Soriano-Maldonado A, Gallo FJ, López Del Amo MP, Ruiz-Cabello P, Andrade A, et al. Cost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial. BMC Public Health 2015; 15:555http://hdl.handle.net/10668/1963Journal Article;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/DESIGN 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. DISCUSSION 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. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02358109 . Date of registration: 05/02/2015.enCost-effectivenessHealth statusQuality of lifePhysical activityPhysical fitnessPrimary carePerimenopausiaAnálisis Costo-BeneficioTerapia por EjercicioFemeninoPromoción de la SaludActividad MotoraCalidad de VidaEstilo de Vida SedentarioMedical Subject Headings::Phenomena and Processes::Reproductive and Urinary Physiological Phenomena::Reproductive Physiological Phenomena::Climacteric::Menopause::PerimenopauseMedical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit AnalysisMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Physical Therapy Modalities::Exercise TherapyMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Health Care::Health Care Facilities, Manpower, and Services::Health PromotionMedical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Behavior::Motor ActivityMedical Subject Headings::Disciplines and Occupations::Social Sciences::Quality of LifeMedical Subject Headings::Psychiatry and Psychology::Behavior and Behavior Mechanisms::Psychology, Social::Life Style::Sedentary LifestyleCost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial.research article26081934open access10.1186/s12889-015-1868-11471-2458PMC4470091