<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01686854</url>
  </required_header>
  <id_info>
    <org_study_id>PSMCM01</org_study_id>
    <nct_id>NCT01686854</nct_id>
  </id_info>
  <brief_title>Effectiveness of Cognitive Behavioral Therapy vs. Prescriptive Diet in Short and Medium-term Control of Body Weight</brief_title>
  <official_title>&quot;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.&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Matteo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Matteo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between different treatments of obesity in the short and medium term: prescriptive&#xD;
      diet therapy compared to to cognitive-behavioral approach in the treatment of obesity&#xD;
      according to the method of clinical trial.&#xD;
&#xD;
      According to the Italian guidelines on obesity, the target to reach is the weight loss of 10%&#xD;
      compared to the initial weight, obtained in six months and maintained for the next 5 years.&#xD;
&#xD;
      The guideline considers six months as the time required to lose weight, but many patients are&#xD;
      not able to achieve this result. Since in clinical practice many patients fail to achieve&#xD;
      this weight loss in six months, it was decided to extend to 12 months the time to reach the&#xD;
      target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5%&#xD;
      on respect of the basal weight in six months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypotheses to be tested is that the addition of a short CBT, as it can be applied in a&#xD;
      public outpatients, is able to improve the percentage of responders and to raise the&#xD;
      proportion of subjects able to maintain the result over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2007</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <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</measure>
    <time_frame>12 months</time_frame>
    <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.&#xD;
It will be considered responder to therapy who reach such a result in 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body weight reduction by 5% compared to the initial weight</measure>
    <time_frame>6 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiovascular risk</measure>
    <time_frame>6, 12, 24 months</time_frame>
    <description>cardiovascular risk according definition of Italian &quot;Istituto Superiore di Sanità&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition in the two groups</measure>
    <time_frame>6, 12, 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prescriptive Diet (A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral (B)</intervention_name>
    <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.</description>
    <arm_group_label>Cognitive Behavioral (B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prescriptive Diet (A)</intervention_name>
    <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).</description>
    <arm_group_label>Prescriptive Diet (A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects with severe overweight (BMI 27-29.9) or obesity of first step (BMI 30-34.9kg/h2&#xD;
        and obesity of second step (BMI 35-39.9 9kg/h2). Patients with dyslipidemia, hypertension,&#xD;
        slight organ damage were eligible in the study; Exclusion Criteria:&#xD;
&#xD;
        patients treated with anorectic, estrogen or progestin and patients with diabetes or eating&#xD;
        disordes were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chiara Muggia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Medica 2a</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Medica 2A</name>
      <address>
        <city>Pavia</city>
        <state>PV</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>May 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Matteo</investigator_affiliation>
    <investigator_full_name>Chiara Muggia</investigator_full_name>
    <investigator_title>dirigente medico 1° livello</investigator_title>
  </responsible_party>
  <keyword>cognitive-behavioral approach</keyword>
  <keyword>obesity treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 21, 2014</submitted>
    <returned>April 23, 2014</returned>
    <submitted>July 13, 2016</submitted>
    <returned>August 23, 2016</returned>
    <submitted>August 29, 2016</submitted>
    <returned>October 25, 2016</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01686854
org study id: PSMCM01
nct id: NCT01686854
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
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
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
measure: body weight reduction by 5% compared to the initial weight
time frame: 6 months
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
measure: cardiovascular risk
time frame: 6, 12, 24 months
description: cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"
measure: Attrition in the two groups
time frame: 6, 12, 24 months
arm group label: Cognitive Behavioral (B)
arm group type: Experimental
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 group label: Prescriptive Diet (A)
arm group type: Active Comparator
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: Cognitive Behavioral (B)
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 group label: Cognitive Behavioral (B)
intervention type: Other
intervention name: Prescriptive Diet (A)
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).
arm group label: Prescriptive Diet (A)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chiara Muggia, MD
role: Principal Investigator
affiliation: Clinica Medica 2a
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Matteo
investigator full name: Chiara Muggia
investigator title: dirigente medico 1° livello
mesh term: Obesity
submitted: March 21, 2014
returned: April 23, 2014
submitted: July 13, 2016
returned: August 23, 2016
submitted: August 29, 2016
returned: October 25, 2016