TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes

BMC Public Health

Study Protocol

Antonio Liuzzi¹  Maria Letizia Petroni²  Cristina Tuzzi²  Valentina Villa³  Gian Luca Cesa³  Paola Cuzziol⁴  Gian Mauro Manzoni⁴  Enrico Molinari⁵  Gianluca Castelnuovo⁵ 

[1] Istituto Auxologico Italiano IRCCS, Diabetes Research Laboratory, Ospedale San Giuseppe, Verbania, Italy;Istituto Auxologico Italiano IRCCS, Laboratory of Nutrition Research, Ospedale San Giuseppe, Verbania, Italy;Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy;Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy;Department of Psychology, University of Bergamo, Bergamo, Italy;Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy;Department of Psychology, University of Bergamo, Bergamo, Italy;Department of Psychology, Catholic University of Milan, Milan, Italy;

关键词: Eating Disorder;    Binge Eating;    Italian Version;    Body Satisfaction;    Weight Loss Maintenance;   

DOI  :  10.1186/1471-2458-10-204

 received in 2009-12-10, accepted in 2010-04-23,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundObesity is one of the most important medical and public health problems of our time: it increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated.Methods/DesignTECNOB (TEChnology for OBesity) is a comprehensive two-phase stepped down program enhanced by telemedicine for the long-term treatment of obese people with type 2 diabetes seeking intervention for weight loss. Its core features are the hospital-based intensive treatment (1-month), that consists of diet therapy, physical training and psychological counseling, and the continuity of care at home using new information and communication technologies (ICT) such as internet and mobile phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only) will be evaluated in a randomized controlled trial (RCT) with a 12-month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. Furthermore, the study will explore what behavioral and psychological variables are predictive of treatment success among those we have considered.DiscussionThe TECNOB study aims to inform the evidence-based knowledge of how telemedicine may enhance the effectiveness of clinical interventions for weight loss and related type-2 diabetes, and which type of obese patients may benefit the most from such interventions. Broadly, the study aims also to have a effect on the theoretical model behind the traditional health care service, in favor of a change towards a new "health care everywhere" approach.Trial registrationCurrent Controlled Trials ISRCTN07265661

【 授权许可】

CC BY   
© Castelnuovo et al; licensee BioMed Central Ltd. 2010