Open Access Study protocol

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

Gianluca Castelnuovo123*, Gian Mauro Manzoni12, Paola Cuzziol12, Gian Luca Cesa1, Cristina Tuzzi4, Valentina Villa1, Antonio Liuzzi5, Maria Letizia Petroni4 and Enrico Molinari123

Author Affiliations

1 Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy

2 Department of Psychology, University of Bergamo, Bergamo, Italy

3 Department of Psychology, Catholic University of Milan, Milan, Italy

4 Istituto Auxologico Italiano IRCCS, Laboratory of Nutrition Research, Ospedale San Giuseppe, Verbania, Italy

5 Istituto Auxologico Italiano IRCCS, Diabetes Research Laboratory, Ospedale San Giuseppe, Verbania, Italy

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BMC Public Health 2010, 10:204  doi:10.1186/1471-2458-10-204

Published: 23 April 2010

Abstract

Background

Obesity 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/Design

TECNOB (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.

Discussion

The 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 registration

Current Controlled Trials ISRCTN07265661