Cost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial Carbonell-Baeza, Ana Soriano‑Maldonado, Alberto Gallo, Francisco Javier López Del Amo González, María Del Puerto Ruiz-Cabello, Pilar Andrade, Ana Borges-Cosic, Milkana Peces-Rama, Antonio Rubén Spacírova, Zuzana Álvarez-Gallardo, Inmaculada C. García-Monchón, Leticia Segura Jiménez, Víctor Estévez-López, Fernando Camiletti-Moirón, Daniel Martín Martín, José Jesús Aranda Ramírez, Pilar Delgado Fernández, Manuel Aparicio García-Molina, Virginia Cost-effectiveness Health status Quality of life Physical activity Physical fitness Primary care [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. 2015-09-04T08:41:30Z 2015-09-04T08:41:30Z 2015 info:eu-repo/semantics/article Carbonell-Baeza, 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, 15: 555 (2015). [http://hdl.handle.net/10481/37249] 1471-2458 http://hdl.handle.net/10481/37249 10.1186/s12889-015-1868-1 eng info:eu-repo/grantAgreement/EC/FP7/291780 info:eu-repo/semantics/openAccess Biomed Central