Obesity
Conditions
Keywords
cognitive-behavioral approach, obesity treatment
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral (B)
a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies.
OTHERPrescriptive Diet (A)
prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003).
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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;
Exclusion criteria
patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight reduction by 5% compared to the initial weight | 6 months | subjects will be considered responder to therapy if they reach such a result in 6 months , even if according Italian guidelines this will be considered failure |
| cardiovascular risk | 6, 12, 24 months | cardiovascular risk according definition of Italian Istituto Superiore di Sanità |
| Attrition in the two groups | 6, 12, 24 months | — |
Countries
Italy
Outcome results
None listed