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


CONCLUSIONS
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.
Castelnuovo
Gianluca
G
Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Ospedale San Giuseppe, Verbania, Italy. gianluca.castelnuovo@auxologico.it
Manzoni
Gian Mauro
GM
Cuzziol
Paola
P
Cesa
Gian Luca
GL
Tuzzi
Cristina
C
Villa
Valentina
V
Liuzzi
Antonio
A
Petroni
Maria Letizia
ML
Molinari
Enrico
E
D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000379:methods; D001828:Body Image; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000523:psychology / Q000628:therapy*; D004734:Energy Metabolism; D015438:Health Behavior; D006760:Hospitalization; D006801:Humans; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000523:psychology / Q000628:therapy*; D010348:Patient Care Team; D015397:Program Evaluation; D011788:Quality of Life; D017216:Telemedicine / Q000379:methods*; D015431:Weight Loss; D055815:Young Adult