An interventional study of Cognitive Behavioral (B) and Prescriptive Diet (A) in Obesity, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-09-18.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Supportive care
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 163 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Behavioral: Cognitive Behavioral (B)
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).
Other: Prescriptive Diet (A)
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.
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).
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
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
Time frame: 12 months
body weight reduction by 5% compared to the initial weight
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
Time frame: 6 months
cardiovascular risk
cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"
Time frame: 6, 12, 24 months
Attrition in the two groups
Time frame: 6, 12, 24 months
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia