Empowerment and Overweight - a Prospective Observational Study

Obesity Clinical Trial

— ADPB-EMPW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644708
• Other study ID #: CeformedDSM1
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: June 6, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: Azienda Per I Servizi Sanitari N. 2 Isontina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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"), (Local Health Unit 4 Medio Friuli, Mental Health Department). Before being included in the therapy groups, persons will undergo three individual in-depth interviews with an empowerment consultant, with:

• Verification of the motivation (Importance of the problem + Self-esteem, Likert scales 0 -10)

• Request to underwrite the "therapy contract"

• Final meeting for inclusion in the group and acquisition of informed consent.

Exclusion Criteria:

• minors will be excluded and

• those who must shed weight in a short time because of planned surgery,

• those who suffer from severe health problems (severe stroke outcomes, heart or kidney failure, neoplasia)

• those who want to lose weight only for esthetic reasons,

• those who cannot guarantee regular weekly attendance for the treatment,

• those who also use other means for losing weight (weight-loss surgery, psychoanalysis, or other nutritional regimens).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Overweight
• Power, Personal

Intervention

Behavioral:
• Self empowerment
1. Group meeting, introducing the method and the assessment tools Self-empowerment, Handing over the "journal", Questionnaire about emotional states and motivations for losing weight and for change. The group meetings, lasting one hour and a half, will take place every week, always on the same day and at the same time, for one year. During each meeting the participant "weighs himself" and he notes his weight down in his journal.

Locations

Country	Name	City	State
Italy	Dipartimento di Salute Mentale	Udine

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Per I Servizi Sanitari N. 2 Isontina	Associazione Diamo Peso al Benessere, Azienda per i servizi Sanitari 4 Medio Friuli, Dipartimento di Salute Mentale, Udine, Centro Regionale di Formazione per l'Area delle Cure Primarie, Università degli Studi di Udine, Facoltà di Medicina e Chirurgia, Clinica Psichiatrica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreasing body weight	A persistent reduction of body weight is expected after 6 and 12 months	6,12 months	No
Secondary	Improved blood pressure control		6 and 12 months	No
Secondary	decreasing glycemic levels		6 and 12 months	No
Secondary	decreasing total cholesterol values		6 and 12 months	No
Secondary	decreasing triglyceride values		6 and 12 months	No
Secondary	improvements in the creatinine levels		6 and 12 months	No
Secondary	stabilization and improvement of mood and temper (reduction in benzodiazepines and antidepressants)		6 and 12 months	No