<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/NCT01664026</url>
  </required_header>
  <id_info>
    <org_study_id>PWeb123</org_study_id>
    <nct_id>NCT01664026</nct_id>
  </id_info>
  <brief_title>Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk Factors</brief_title>
  <official_title>A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clínica Bazterrica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clínica Bazterrica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of a 6-month web-based lifestyle modification program with and without&#xD;
      telephone counseling versus usual care in obese patients with cardiovascular risk factors on:&#xD;
&#xD;
        -  Weight Loss&#xD;
&#xD;
        -  Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol,&#xD;
           HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.&#xD;
&#xD;
        -  Physical activity and eating habits&#xD;
&#xD;
        -  Quality of life&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funds&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight from randomization to 6 months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glycemic parameters (glucose and hemoglobin A1c)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in C-reactive protein</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in lifestyle behaviors (physical activity and eating habits)</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Web</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Web+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-based lifestyle modification</intervention_name>
    <description>Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.</description>
    <arm_group_label>Web</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-based lifestyle modification +</intervention_name>
    <description>Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.</description>
    <arm_group_label>Web+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female 25-70 years of age&#xD;
&#xD;
          2. Obese (BMI ≥ 30 kg/m2 and &lt;40 kg/m2)&#xD;
&#xD;
          3. At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i)&#xD;
             Hypertension defined by a history of hypertension, treatment of hypertension or BP&#xD;
             values &gt;140/90 mmHg in two consecutive office visits ii) High cholesterol defined by&#xD;
             an LDL-C ≥130 mg/dL and/or HDL-C &lt;40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2&#xD;
             Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting&#xD;
             glucose ≥126 mg/dL in two consecutive office visits&#xD;
&#xD;
          4. Participant must be willing and able to provide written informed consent&#xD;
&#xD;
          5. Participant must be willing and able to comply with study related procedures&#xD;
&#xD;
          6. Participant must have access to Internet and e-mail&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stage 1 or 2 on Patient Activation Measures tool&#xD;
&#xD;
          2. Weight change of more than 5 kg during the 3 months preceding the screening visit&#xD;
&#xD;
          3. History of bariatric surgery&#xD;
&#xD;
          4. Fasting Plasma Glucose at screening &gt; 250 mg/dL (&gt; 13.9 mmol/L)&#xD;
&#xD;
          5. Hemoglobin A1c at screening &gt;8.5%&#xD;
&#xD;
          6. Treatment of type 2 diabetes with insulin (except for history of intermittent acute&#xD;
             use, no more than 2 weeks usage in previous 6 months)&#xD;
&#xD;
          7. Uncontrolled or inadequately controlled hypertension at the time of screening with&#xD;
             blood pressure &gt;160/100 mmHg&#xD;
&#xD;
          8. Secondary hypertension&#xD;
&#xD;
          9. Changes in lipid, blood pressure or diabetes modifying agents including introduction,&#xD;
             change in dose or cessation in the 3 months prior to Screening Visit&#xD;
&#xD;
         10. Personal history of coronary heart disease, congestive heart failure, serious&#xD;
             arrhythmias and stroke&#xD;
&#xD;
         11. Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or&#xD;
             other major systemic disease making implementation of the protocol or interpretation&#xD;
             of the study results difficult.&#xD;
&#xD;
         12. Presence of any condition (medical, psychological, social, or geographical), actual or&#xD;
             anticipated, that in the opinion of the Investigator would restrict or limit the&#xD;
             patient's successful participation for the duration of the study&#xD;
&#xD;
         13. Presence of history of cancer within the past five years with the exception of&#xD;
             adequately treated localized basal cell skin cancer or in situ uterine cervical cancer&#xD;
&#xD;
         14. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for&#xD;
             one week or more within 3 months prior to the time of screening&#xD;
&#xD;
         15. Use of any investigational agent (drug, biologic, device) within 3 months prior to&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres Digenio, MD</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Bazterrica</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clínica Bazterrica</investigator_affiliation>
    <investigator_full_name>Arnaldo Angelino</investigator_full_name>
    <investigator_title>Jefe de Prevencion y Rehabilitacion</investigator_title>
  </responsible_party>
  <!-- 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/NCT01664026
org study id: PWeb123
nct id: NCT01664026
lead sponsor: 
has dmc: No
To evaluate the effect of a 6-month web-based lifestyle modification program with and without
      telephone counseling versus usual care in obese patients with cardiovascular risk factors on:

        -  Weight Loss

        -  Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol,
           HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.

        -  Physical activity and eating habits

        -  Quality of life
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in body weight from randomization to 6 months
time frame: 6 months
measure: Changes in waist circumference
time frame: 6 months
measure: Changes in blood pressure
time frame: 6 months
measure: Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)
time frame: 6 months
measure: Changes in glycemic parameters (glucose and hemoglobin A1c)
time frame: 6 months
measure: Changes in C-reactive protein
time frame: 6 months
measure: Changes in lifestyle behaviors (physical activity and eating habits)
time frame: 6 months
measure: Changes in quality of life
time frame: 6 months
arm group label: Control
arm group type: No Intervention
description: Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care.
arm group label: Web
arm group type: Experimental
description: Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.
arm group label: Web+
arm group type: Experimental
description: Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.
intervention type: Behavioral
intervention name: Web-based lifestyle modification
description: Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.
arm group label: Web
intervention type: Behavioral
intervention name: Web-based lifestyle modification +
description: Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.
arm group label: Web+
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andres Digenio, MD
role: Study Director
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Clínica Bazterrica
investigator full name: Arnaldo Angelino
investigator title: Jefe de Prevencion y Rehabilitacion