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Published in: BMC Public Health 1/2010

Open Access 01-12-2010 | Study protocol

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

Authors: Gianluca Castelnuovo, Gian Mauro Manzoni, Paola Cuzziol, Gian Luca Cesa, Cristina Tuzzi, Valentina Villa, Antonio Liuzzi, Maria Letizia Petroni, Enrico Molinari

Published in: BMC Public Health | Issue 1/2010

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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
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Metadata
Title
TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes
Authors
Gianluca Castelnuovo
Gian Mauro Manzoni
Paola Cuzziol
Gian Luca Cesa
Cristina Tuzzi
Valentina Villa
Antonio Liuzzi
Maria Letizia Petroni
Enrico Molinari
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2010
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-10-204

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