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| Name | Class |
|---|---|
| Azienda per i servizi Sanitari 4 Medio Friuli, Dipartimento di Salute Mentale, Udine | UNKNOWN |
| Associazione Diamo Peso al Benessere | UNKNOWN |
| Università degli Studi di Udine, Facoltà di Medicina e Chirurgia, Clinica Psichiatrica |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overweight, obese adult patients | Patients following a self empowerment group will be included in the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self empowerment | Behavioral | 1. Group meeting, introducing the method and the assessment tools
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decreasing body weight | A persistent reduction of body weight is expected after 6 and 12 months | 6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improved blood pressure control | 6 and 12 months | |
| decreasing glycemic levels | 6 and 12 months | |
| decreasing total cholesterol values |
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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:
Exclusion Criteria:
- minors will be excluded and
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All adult persons with BMI equal or above 25
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| Name | Affiliation | Role |
|---|---|---|
| Pierluigi Struzzo, MD | Regional Centre for the Training in Primary Care | Principal Investigator |
| Mario Novello, MD | Azienda per i Servizi Sanitari Medio Friuli | Study Director |
| Anita Cacitti, dr | Azienda per i Servizi Sanitari Medio Friuli | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Salute Mentale | Udine | 33100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23676799 | Derived | Struzzo P, Fumato R, Tillati S, Cacitti A, Gangi F, Stefani A, Torcutti A, Crapesi L, Tubaro G, Balestrieri M. Individual empowerment in overweight and obese patients: a study protocol. BMJ Open. 2013 May 14;3(5):e002669. doi: 10.1136/bmjopen-2013-002669. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Centro Regionale di Formazione per l'Area delle Cure Primarie | UNKNOWN |
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| 6 and 12 months |
| decreasing triglyceride values | 6 and 12 months |
| improvements in the creatinine levels | 6 and 12 months |
| stabilization and improvement of mood and temper (reduction in benzodiazepines and antidepressants) | 6 and 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |