ABSTRACT
Introduction: Obesity is a growing health problem in
Europe and it causes many diseases. Many weightreducing
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 selfempowerment
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
