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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cognitive Behavioral (B)
Prescriptive Diet (A)
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring cognitive-behavioral approach, obesity treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Medica 2A

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral (B)

Prescriptive Diet (A)

Arm Description

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).

Outcomes

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
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
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
cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"
Attrition in the two groups

Full Information

First Posted
May 29, 2012
Last Updated
September 13, 2012
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT01686854
Brief Title
Effectiveness of Cognitive Behavioral Therapy vs. Prescriptive Diet in Short and Medium-term Control of Body Weight
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
cognitive-behavioral approach, obesity treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral (B)
Arm Type
Experimental
Arm Description
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.
Arm Title
Prescriptive Diet (A)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral (B)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Prescriptive Diet (A)
Intervention Description
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 Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
body weight reduction by 5% compared to the initial weight
Description
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
Title
cardiovascular risk
Description
cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"
Time Frame
6, 12, 24 months
Title
Attrition in the two groups
Time Frame
6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiara Muggia, MD
Organizational Affiliation
Clinica Medica 2a
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Medica 2A
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

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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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