Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study

BMC Medical Ethics

Research Article

Anna-Maija Pietilä¹  Helena Länsimies-Antikainen²  Vesa Kiviniemi³  Rainer Rauramaa⁴  Tomi Laitinen⁵ 

[1] Department of Nursing Science, University of Eastern Finland, Yliopistonranta 1, 70211, Kuopio, Finland;Department of Nursing Science, University of Eastern Finland, Yliopistonranta 1, 70211, Kuopio, Finland;Unit of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, Puijonlaaksontie 2, 70210, Kuopio, Finland;Information Technology Centre, University of Eastern Finland, Yliopistonranta 1, 70211, Kuopio, Finland;Kuopio Research Institute of Exercise Medicine, Haapaniementie 16, 70100, Kuopio, Finland;Unit of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, Puijonlaaksontie 2, 70210, Kuopio, Finland;Institute of Clinical Medicine, Unit of Clinical Physiology and Nuclear Medicine, University of Eastern Finland, Yliopistonranta 1, 70211, Kuopio, Finland;

关键词: Resistance Exercise;    Aerobic Exercise;    Diet Group;    Smart Card;    Inform Consent Process;   

DOI  :  10.1186/1472-6939-11-9

 received in 2009-06-07, accepted in 2010-06-08,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundThere is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic.MethodsThe subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage.ResultsAbout half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04).ConclusionThe main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent.Trial Registration(ISRCTN 45977199)

【 授权许可】

CC BY   
© Länsimies-Antikainen et al; licensee BioMed Central Ltd. 2010