PT - JOURNAL ARTICLE AU - Pierluigi Struzzo AU - Raffaella Fumato AU - Silvia Tillati AU - Anita Cacitti AU - Fabrizio Gangi AU - Alessia Stefani AU - Alessia Torcutti AU - Lucia Crapesi AU - Gianni Tubaro AU - Matteo Balestrieri TI - Individual empowerment in overweight and obese patients: a study protocol AID - 10.1136/bmjopen-2013-002669 DP - 2013 Jan 01 TA - BMJ Open PG - e002669 VI - 3 IP - 5 4099 - http://bmjopen.bmj.com/content/3/5/e002669.short 4100 - http://bmjopen.bmj.com/content/3/5/e002669.full SO - BMJ Open2013 Jan 01; 3 AB - Introduction Obesity is a growing health problem in Europe and it causes many diseases. Many weight-reducing methods are reported in medical literature, but none of them proved to be effective in maintaining the results achieved over time. Self-empowerment can be an important innovative method, but an effectiveness study is necessary. In order to standardise the procedures for a randomised controlled study, a pilot study will be run to observe, measure and evaluate the effects of a period of self-empowerment group treatment on overweight/obese patients. Methods and analysis Non-controlled, experimental, pilot study. A selected group of patients with body mass index >25, with no severe psychiatric disorders, with no aesthetic or therapeutic motivation will be included in the study. A set of quantitative and qualitative measures will be utilised to evaluate the effects of a self-empowerment course in a 12 month time. Group therapy and medical examinations will also complete this observational phase. At the end of this pilot study, a set of appropriate measures and procedures to determine the effectiveness of individual empowerment will be identified and agreed among the different professional figures. Results will be recorded and analysed to start a randomised controlled trial to evaluate the effectiveness of the proposed methodology. Ethics and dissemination This protocol was approved by the local Ethics Committee of Udine in March 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. Trial Registration http://www.clinicalstrials.gov identifier NCT01644708.