<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/NCT01685957</url>
  </required_header>
  <id_info>
    <org_study_id>ASC-01-2012</org_study_id>
    <nct_id>NCT01685957</nct_id>
  </id_info>
  <brief_title>Optimal Dietary Treatment of Obese Adults</brief_title>
  <acronym>OPDIOS</acronym>
  <official_title>Optimal Dietary Treatment of Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospitalsenheden Vest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospitalsenheden Vest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent decades have shown an alarming increase in obesity. Obesity is associated with high&#xD;
      costs for both the individual and for society. It is therefore important to prevent and treat&#xD;
      obesity. The investigators believe that if you add a self-help weightloss book and teach&#xD;
      cooking skills to a standard dietary treatment, then it will result in greater weight loss&#xD;
      than with dietary treatment alone. However, this has not yet been studied. Since it will&#xD;
      require more resources, it is important to investigate whether it also works better before&#xD;
      changing the current treatment.&#xD;
&#xD;
      Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and&#xD;
      cooking classes are more effective than dietary treatment alone in changes in body weight and&#xD;
      body composition in obese persons over a period of 12 months. There is no difference if the&#xD;
      intervention are based on the national dietary guidelines or a relative low-gi and&#xD;
      high-protein diet.&#xD;
&#xD;
      Secondary to investigate the impact the interventions have; on diet quality and quantity, on&#xD;
      markers of metabolic syndrome and on how many subjects complete the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>From week 0 to week 52</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>From week 0 to week 52</time_frame>
    <description>Both systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dexa-scan (body composition)</measure>
    <time_frame>From week 0 to week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>From week 0 to week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers in blood samples</measure>
    <time_frame>From week 0 to week 52</time_frame>
    <description>Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>From week 0 to week 52</time_frame>
    <description>EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>From week 0 to week 52</time_frame>
    <description>Diet records</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Standard dietary treatment (STD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary treatment - 6 individual sessions with a registered dietitian</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Ned i vaegt&quot; (NIV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Verdens bedste kur&quot; (VBK)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard dietary treatment (STD)</intervention_name>
    <description>This group will receive 6 one-on-one sessions with a registered dietitian. Total time spent is 6½ hour. Dietary treatment is based national guidelines and counseling is individualized and tailored to the patient's needs and goals.</description>
    <arm_group_label>Standard dietary treatment (STD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;Ned i vaegt&quot; (NIV)</intervention_name>
    <description>This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on the national dietary guidelines. Focus is to learn to make &quot;normal&quot; danish dishes in a more healthy way both ingredients, cooking, composition and quantity. They also learn about changing habits, making realistic goals and using their motivation.</description>
    <arm_group_label>&quot;Ned i vaegt&quot; (NIV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;Verdens bedste kur&quot; (VBK)</intervention_name>
    <description>This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on &quot;new nordic diet&quot; and are a relative low-GI and high-protein diet. Focus is to learn to make new healthy dishes both ingredients, cooking and composition. They also learn about making realistic goals.</description>
    <arm_group_label>&quot;Verdens bedste kur&quot; (VBK)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 25&#xD;
&#xD;
          -  Waist: female ≥ 88 cm; male ≥ 102 cm)&#xD;
&#xD;
          -  Stable weight for the past three month (+- 5 kilogram)&#xD;
&#xD;
          -  Motivated to make changes in their dietary habits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Waist &gt; 150 cm&#xD;
&#xD;
          -  Significant cardiovascular, renal or endocrine disease&#xD;
&#xD;
          -  Psychiatric history&#xD;
&#xD;
          -  Treatment with steroids&#xD;
&#xD;
          -  Alcohol- or drug-addiction&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Obesity surgery&#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>Allan S Christensen, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition, Regional Hospital West Jutland, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lone Viggers, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition, Regional Hospital West Jutland, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Regional Hospital West Jutland, Denmark</name>
      <address>
        <city>Holstebro</city>
        <zip>7500</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>May 18, 2018</last_update_submitted>
  <last_update_submitted_qc>May 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospitalsenheden Vest</investigator_affiliation>
    <investigator_full_name>Allan Stubbe Christensen</investigator_full_name>
    <investigator_title>MHSc, RD</investigator_title>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <keyword>Dietary intervention</keyword>
  <keyword>Self-help book</keyword>
  <keyword>Cooking</keyword>
  <keyword>Dietitian</keyword>
  <keyword>Dietary therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT01685957
org study id: ASC-01-2012
nct id: NCT01685957
lead sponsor: 
has dmc: No
Recent decades have shown an alarming increase in obesity. Obesity is associated with high
      costs for both the individual and for society. It is therefore important to prevent and treat
      obesity. The investigators believe that if you add a self-help weightloss book and teach
      cooking skills to a standard dietary treatment, then it will result in greater weight loss
      than with dietary treatment alone. However, this has not yet been studied. Since it will
      require more resources, it is important to investigate whether it also works better before
      changing the current treatment.

      Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and
      cooking classes are more effective than dietary treatment alone in changes in body weight and
      body composition in obese persons over a period of 12 months. There is no difference if the
      intervention are based on the national dietary guidelines or a relative low-gi and
      high-protein diet.

      Secondary to investigate the impact the interventions have; on diet quality and quantity, on
      markers of metabolic syndrome and on how many subjects complete the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body weight
time frame: From week 0 to week 52
measure: Blood pressure
time frame: From week 0 to week 52
description: Both systolic and diastolic blood pressure
measure: Dexa-scan (body composition)
time frame: From week 0 to week 52
measure: Waist circumference
time frame: From week 0 to week 52
measure: Biomarkers in blood samples
time frame: From week 0 to week 52
description: Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c
measure: Quality of life
time frame: From week 0 to week 52
description: EQ-5D-5L
measure: Dietary intake
time frame: From week 0 to week 52
description: Diet records
arm group label: Standard dietary treatment (STD)
arm group type: Active Comparator
description: Dietary treatment - 6 individual sessions with a registered dietitian
arm group label: "Ned i vaegt" (NIV)
arm group type: Experimental
description: Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
arm group label: "Verdens bedste kur" (VBK)
arm group type: Experimental
description: Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.
intervention type: Behavioral
intervention name: Standard dietary treatment (STD)
description: This group will receive 6 one-on-one sessions with a registered dietitian. Total time spent is 6½ hour. Dietary treatment is based national guidelines and counseling is individualized and tailored to the patient's needs and goals.
arm group label: Standard dietary treatment (STD)
intervention type: Behavioral
intervention name: "Ned i vaegt" (NIV)
description: This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on the national dietary guidelines. Focus is to learn to make "normal" danish dishes in a more healthy way both ingredients, cooking, composition and quantity. They also learn about changing habits, making realistic goals and using their motivation.
arm group label: "Ned i vaegt" (NIV)
intervention type: Behavioral
intervention name: "Verdens bedste kur" (VBK)
description: This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on "new nordic diet" and are a relative low-GI and high-protein diet. Focus is to learn to make new healthy dishes both ingredients, cooking and composition. They also learn about making realistic goals.
arm group label: "Verdens bedste kur" (VBK)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Allan S Christensen, MHSc
role: Principal Investigator
affiliation: Department of Nutrition, Regional Hospital West Jutland, Denmark
last name: Lone Viggers, MSc
role: Principal Investigator
affiliation: Department of Nutrition, Regional Hospital West Jutland, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hospitalsenheden Vest
investigator full name: Allan Stubbe Christensen
investigator title: MHSc, RD
mesh term: Overweight