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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chiara Muggia, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01686854
First received: May 29, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Obesity
 Behavioral: Cognitive Behavioral (B)
Other: Prescriptive Diet (A)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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."

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • body weight reduction by 5% compared to the initial weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
    cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"

  • Attrition in the two groups [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: March 2007
Estimated Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Chiara Muggia, dirigente medico 1° livello, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01686854     History of Changes
Other Study ID Numbers: PSMCM01
Study First Received: May 29, 2012
Last Updated: September 13, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013