Ontology highlight
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/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.
SUBMITTER: Carbonell-Baeza A
PROVIDER: S-EPMC4470091 | biostudies-literature | 2015 Jun
REPOSITORIES: biostudies-literature
Carbonell-Baeza Ana A Soriano-Maldonado Alberto A Gallo Francisco Javier FJ López del Amo María Puerto MP Ruiz-Cabello Pilar P Andrade Ana A Borges-Cosic Milkana M Peces-Rama Antonio Rubén AR Spacírová Zuzana Z Álvarez-Gallardo Inmaculada C IC García-Mochón Leticia L Segura-Jiménez Víctor V Estévez-López Fernando F Camiletti-Moirón Daniel D Martín-Martín Jose Jesús JJ Aranda Pilar P Delgado-Fernández Manuel M Aparicio Virginia A VA
BMC public health 20150617
<h4>Background</h4>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.<h4>Methods/design</h4>The present study is a Randomized Controlled Trial. A total of 150 eligible women will be recruited and randomly as ...[more]