Effectiveness of Cognitive Behavioral Therapy vs. Prescriptive Diet in Short and Medium-term Control of Body Weight

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: Cognitive Behavioral (B); Other: Prescriptive Diet (A)

• Registration Number: NCT01686854
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2012-01
• Study First Submitted: 2012-05-29
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-13
• Last Update Submitted: 2012-09-13
• Study First Posted: 2012-09-18
• Last Update Posted: 2012-09-18
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 163

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral (B)	Cognitive 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.
Prescriptive Diet (A)	Prescriptive 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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
cardiovascular risk	6, 12, 24 months	cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"
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
Attrition in the two groups	6, 12, 24 months

Trial Locations

Locations (1)

Clinica Medica 2A; 🇮🇹 Pavia, PV, Italy