Overview

This trial is active, not recruiting.

Condition obesity
Treatments cognitive behavioral (b), prescriptive diet (a)
Sponsor IRCCS Policlinico S. Matteo
Start date March 2007
End date January 2012
Trial size 163 participants
Trial identifier NCT01686854, PSMCM01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
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.
(Active Comparator)
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).
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 Outcomes

Measure
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
time frame: 12 months

Secondary Outcomes

Measure
body weight reduction by 5% compared to the initial weight
time frame: 6 months
cardiovascular risk
time frame: 6, 12, 24 months
Attrition in the two groups
time frame: 6, 12, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title "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."
Principal investigator Chiara Muggia, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by IRCCS Policlinico S. Matteo.