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

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ClinicalTrials.gov Identifier: NCT01686854
Recruitment Status : Unknown
Verified September 2012 by Chiara Muggia, IRCCS Policlinico S. Matteo.
Recruitment status was:  Active, not recruiting
First Posted : September 18, 2012
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
Chiara Muggia, IRCCS Policlinico S. Matteo

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Cognitive Behavioral (B) Other: Prescriptive Diet (A) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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."
Study Start Date : March 2007
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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: 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).
Other: 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 :
  1. 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 ]

    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 :
  1. body weight reduction by 5% compared to the initial weight [ Time Frame: 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

  2. cardiovascular risk [ Time Frame: 6, 12, 24 months ]
    cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"

  3. Attrition in the two groups [ Time Frame: 6, 12, 24 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686854


Locations
Italy
Clinica Medica 2A
Pavia, PV, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Chiara Muggia, MD Clinica Medica 2a

Responsible Party: Chiara Muggia, dirigente medico 1° livello, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01686854     History of Changes
Other Study ID Numbers: PSMCM01
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Chiara Muggia, IRCCS Policlinico S. Matteo:
cognitive-behavioral approach
obesity treatment