"Terapia Dell'obesità: Studio Randomizzato Per la Valutazione Dell'Efficacia Della Terapia Cognitivo-comportamentale Versus Dietoterapia Prescrittiva Nel Controllo a Breve e Medio Termine Del Peso Corporeo e Del Rischio Cardiovascolare."
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight
研究概览
简要总结
Comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial.
According to the Italian guidelines on obesity, the target to reach is the weight loss of 10% compared to the initial weight, obtained in six months and maintained for the next 5 years.
The guideline considers six months as the time required to lose weight, but many patients are not able to achieve this result. Since in clinical practice many patients fail to achieve this weight loss in six months, it was decided to extend to 12 months the time to reach the target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5% on respect of the basal weight in six months.
详细描述
The hypotheses to be tested is that the addition of a short CBT, as it can be applied in a public outpatients, is able to improve the percentage of responders and to raise the proportion of subjects able to maintain the result over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with severe overweight (BMI 27-29.9) or obesity of first step (BMI 30-34.9kg/h2 and obesity of second step (BMI 35-39.9 9kg/h2). Patients with dyslipidemia, hypertension, slight organ damage were eligible in the study;
排除标准
- •patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.
结局指标
主要结局
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight
时间窗: 12 months
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight in 12 months. It will be considered responder to therapy who reach such a result in 12 months
次要结局
- cardiovascular risk(6, 12, 24 months)
- body weight reduction by 5% compared to the initial weight(6 months)
- Attrition in the two groups(6, 12, 24 months)
研究者
Chiara Muggia
dirigente medico 1° livello
Fondazione IRCCS Policlinico San Matteo di Pavia