Empowerment and Overweight - a Prospective Observational Study — ADPB-EMPW  

Obesity Clinical Trial

Official title: Th Efficacy of Individual Empowerment on Overweight and Obese Patients - a Prospective Observational Study.

Status Completed

Clinical Trial Summary

Overweight and obesity put an heavy burden over people's health. Many methods are reported in medical literature but none of them proved to be effective in maintaining the results achieved over time. Motivational change remains a fundamental step towards the maintenance of a new lifestyle. Strengthening personal capabilities and self-esteem seem to be key strategies in motivating persons for change and facilitating a capacity of coping.

The aim of this study is to observe the effects of an individual empowerment program on the health of a group of overweight/obese persons.

Clinical Trial Description

With this observational, uncontrolled prospective study we aim to observe any clinical modifications (concerning weight and other health indicators) achieved by a group of overweight and obese persons who underwent a therapy treatment by means of "self-empowerment".

The study will include all adults, with a Body Mass Index (BMI) above 25, entering the new "therapy groups" of the project, named "Diamo Peso al Benessere" ("Let's Give Weight to Well-Being") an NGO located within the Local Health Unit 4 Medio Friuli, Mental Health Department.

The added value of the strategy proposed by this association is relevant because it is mainly directed to the the improvement of the capacity building of each obese participant instead of focusing only to the food intake. General practice trainees will be dedicated to the evaluation and monitoring of the health status of a group of obese patients included into self-empowerment groups will be assessed for the following year. Major health indicators will be assessed: Body weight, height, waist circumference, brachial blood pressure (two measurements), non-invasive oxymetry.

Some questionnaires will be utilized: Antonovsky's sense of coherence scale, 10-point Likert scale about empowerment, Likert scale about perceived health, Berlin test, Hamilton rating scale for depression.

Blood tests will also be observed. Statistical Analysis A descriptive analysis of all the parameters collected, both the baseline data and those from the 6 and 12- month follow-ups.

For continuous variables (age, weight, BMI…) indicators will be calculated such as the mean, standard deviation, minimum, median and maximum values. The categorical data will be presented by means of frequency tables (n, %).

The changes in the parameters and in the distribution of categorical variables pertaining to the main and secondary outcomes will be assessed by comparing the baseline data collected and those from the 6 and 12-month follow-ups. McNemar's test will be used on the categorical variables, with a level of significance for the p-value fixed at < 0.05. This will allow to record any differences in the distributions of the main factors of interest. T-tests will be used for paired data for assessing changes in the categorical variables. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Overweight
• Power, Personal

• NCT number: NCT01644708
• Study type: Observational
• Source: Azienda Per I Servizi Sanitari N. 2 Isontina
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Completion date: March 2013