RT Journal Article SR Electronic T1 Individual empowerment in overweight and obese patients: a study protocol JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e002669 DO 10.1136/bmjopen-2013-002669 VO 3 IS 5 A1 Pierluigi Struzzo A1 Raffaella Fumato A1 Silvia Tillati A1 Anita Cacitti A1 Fabrizio Gangi A1 Alessia Stefani A1 Alessia Torcutti A1 Lucia Crapesi A1 Gianni Tubaro A1 Matteo Balestrieri YR 2013 UL http://bmjopen.bmj.com/content/3/5/e002669.abstract 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.