TY - JOUR
T1 - Cost-effectiveness of an exercise intervention program in perimenopausal women
T2 - the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial
AU - Carbonell-Baeza, Ana
AU - Soriano-Maldonado, Alberto
AU - Gallo, Francisco Javier
AU - López del Amo, María Puerto
AU - Ruiz-Cabello, Pilar
AU - Andrade, Ana
AU - Borges-Cosic, Milkana
AU - Peces-Rama, Antonio Rubén
AU - Spacírová, Zuzana
AU - Álvarez-Gallardo, Inmaculada C
AU - García-Mochón, Leticia
AU - Segura-Jiménez, Víctor
AU - Estévez-López, Fernando
AU - Camiletti-Moirón, Daniel
AU - Martín-Martín, Jose Jesús
AU - Aranda, Pilar
AU - Delgado-Fernández, Manuel
AU - Aparicio, Virginia A
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
KW - Behavior Therapy
KW - Cost-Benefit Analysis
KW - Counseling
KW - Delivery of Health Care
KW - Exercise
KW - Exercise Therapy
KW - Female
KW - Health Care Costs
KW - Health Promotion
KW - Health Status
KW - Humans
KW - Mental Health
KW - Middle Aged
KW - Perimenopause
KW - Physical Fitness
KW - Primary Health Care
KW - Quality of Life
KW - Research Design
KW - Sedentary Lifestyle
KW - Treatment Outcome
U2 - 10.1186/s12889-015-1868-1
DO - 10.1186/s12889-015-1868-1
M3 - Article
C2 - 26081934
SN - 1471-2458
VL - 15
JO - BMC Public Health
JF - BMC Public Health
IS - 555
ER -
