Th Efficacy of Individual Empowerment on Overweight and Obese Patients - a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Decreasing body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Decreasing body weight
时间窗: 6,12 months
A persistent reduction of body weight is expected after 6 and 12 months
次要结局
- decreasing total cholesterol values(6 and 12 months)
- decreasing glycemic levels(6 and 12 months)
- decreasing triglyceride values(6 and 12 months)
- Improved blood pressure control(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)
研究者
Pierluigi Struzzo, MD
Research Area Responsible
Azienda Per I Servizi Sanitari N. 2 Isontina