Cost-effectiveness of an exercise intervention program in perimenopausal women: the Fitness League Against MENopause COst (FLAMENCO) randomized controlled trial

BMC Public Health

Study Protocol

Leticia García-Mochón¹  Antonio Rubén Peces-Rama¹  Pilar Ruiz-Cabello¹  Ana Andrade¹  Pilar Aranda¹  María Puerto López del Amo²  Zuzana Spacírová²  Jose Jesús Martín-Martín²  Alberto Soriano-Maldonado³  Inmaculada C. Álvarez-Gallardo³  Víctor Segura-Jiménez³  Milkana Borges-Cosic³  Manuel Delgado-Fernández³  Fernando Estévez-López⁴  Ana Carbonell-Baeza⁵  Daniel Camiletti-Moirón⁶  Virginia A. Aparicio⁷  Francisco Javier Gallo⁸ 

[1] Andalusian School of Public Health, Granada, Spain;Department of Applied Economics, Faculty of Economics, University of Granada, Granada, Spain;Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain;Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain;Department of Clinical and Health Psychology, Utrecht University, Utrecht, The Netherlands;Department of Physical Education, Faculty of Education Science, University of Cádiz, Cádiz, Spain;Department of Physiology, Faculty of Pharmacy, Faculty of Sport Sciences, and Institute of Nutrition and Food Technology, University of Granada, Granada, Spain;Department of Physiology, Faculty of Pharmacy, Faculty of Sport Sciences, and Institute of Nutrition and Food Technology, University of Granada, Granada, Spain;Department of Public and Occupational Health, EMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands;Zaidín Sur healthcare centre and Department of Medicine, Faculty of Medicine, University of Granada, Granada, Spain;

关键词: Cost-effectiveness;    Health status;    Quality of life;    Physical activity;    Physical fitness;    Primary care;   

DOI  :  10.1186/s12889-015-1868-1

 received in 2015-05-11, accepted in 2015-05-26,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThe 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/DesignThe 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.DiscussionThe 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 registrationClinicalTrials.gov Identifier: NCT02358109. Date of registration: 05/02/2015

【 授权许可】

Unknown   
© Carbonell-Baeza et al. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.