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

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

Research output: Contribution to journalArticle

Abstract

Background: Obesity 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 care-costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Information and communication technologies (ICT) can help clinicians to deliver treatment in a cost-effective and time-saving manner to a large number of obese individuals with co-morbidities. Objective: To examine ad interim effectiveness of a 12-month multidisciplinary telecare intervention for weight loss provided to obese patients with type 2 diabetes. Design, Setting, and Participants: A single-center randomized controlled trial (TECNOB study) started in December 2008. At present, 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the TECNOB program (n=37) or to a control condition (n=39). However, only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis. 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program. Study is still on-going. Intervention: All participants attended 1-month inpatient intensive program that involved individualized medical care, diet therapy, physical training and brief psychological counseling. At discharge, participants allocated to the TECNOB program were instructed to use a weight-loss web-site, a web-based videoconference tool, a dietary software installed into their cellular phones and an electronic armband measuring daily steps and energy expenditure. Main Outcome Measures: Weight and disordered eating-related behaviors and cognitions (EDI-2) at entry to hospital, at discharge from hospital, at 3,6 and 12 months. Results: Ad interim analysis of data from 34 participants showed no statistically significant difference between groups in weight change at any time-point. However, within-group analysis revealed significant reductions of initial weight at discharge from hospital, at 3 months, at 6 months but not at 12 months. Control group had higher scores in Interpersonal distrust at 12 months. Conclusion: This ad interim findings revealed that the effect of the inpatient treatment was high and probably overwhelmed the effect of the TECNOB intervention. Much statistical power and long-term follow-up may enhance the probability to detect the TECNOB effect over and above the great one exerted by the inpatient program.

Original languageEnglish
Pages (from-to)44-50
Number of pages7
JournalClinical Practice and Epidemiology in Mental Health
Volume7
DOIs
Publication statusPublished - 2011

Keywords

  • Obesity
  • RCT
  • Telecare
  • Telemedicine
  • Type-2 diabetes
  • Weight loss
  • Weight loss maintenance

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Epidemiology

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