<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/NCT01713764</url>
  </required_header>
  <id_info>
    <org_study_id>12-09549</org_study_id>
    <nct_id>NCT01713764</nct_id>
  </id_info>
  <brief_title>A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics</brief_title>
  <acronym>SUCCEED</acronym>
  <official_title>A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a small pilot, designed to provide data regarding the feasibility and&#xD;
      acceptability of conducting such a study on a larger scale. The present study is a randomized&#xD;
      controlled clinical trial comparing two mindfulness-based lifestyle modification programs to&#xD;
      help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and&#xD;
      the other using a moderate-carbohydrate diet promoted by the American Diabetes Association&#xD;
      (ADA). Intervention content will include information about nutrition (carbohydrate&#xD;
      restriction or American Diabetes Association recommended diet) and emotion regulation and&#xD;
      mindful eating strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1&#xD;
      ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately&#xD;
      biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants&#xD;
      will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c&#xD;
      (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes&#xD;
      severity).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2</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>Hemoglobin A1c</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>We test whether Hemoglobin A1c changes from pre-intervention to 6 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Diabetes Type II</condition>
  <arm_group>
    <arm_group_label>Low Carbohydrate Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be instructed to follow a low carbohydrate diet: carbohydrate intake 10-50 grams a day not including fiber. Foods permitted include: meats, poultry, fish, eggs, cheese, cream, some nuts and seeds, green leafy vegetables, and most other non-starchy vegetables. Because most individuals self-limit caloric intake, no calorie restriction will be recommended.&#xD;
Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>American Diabetes Association Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the American Diabetes Association (ADA) diet group will receive standard ADA advice. The diet includes high-fiber foods (such as vegetables, fruits, whole grains, and legumes), low-fat dairy products, fresh fish, and foods low in saturated fat.&#xD;
Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low Carbohydrate Diet</intervention_name>
    <arm_group_label>Low Carbohydrate Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>American Diabetes Association Diet</intervention_name>
    <arm_group_label>American Diabetes Association Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness and Positive Affect Skills</intervention_name>
    <arm_group_label>American Diabetes Association Diet</arm_group_label>
    <arm_group_label>Low Carbohydrate Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus, Type 2.&#xD;
&#xD;
          -  HgbA1c &gt; 6.0% at screening. This is to confirm the diabetes diagnosis.&#xD;
&#xD;
          -  Aged 18 years old and older&#xD;
&#xD;
          -  BMI 25 and above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Condition that will make it difficult for participation. Such as:&#xD;
&#xD;
               -  cancer&#xD;
&#xD;
               -  liver failure&#xD;
&#xD;
               -  unstable coronary artery disease&#xD;
&#xD;
               -  severe emphysema&#xD;
&#xD;
               -  bulimia or strong history of bulimia&#xD;
&#xD;
               -  vegan&#xD;
&#xD;
          -  Laboratory evidence of organ dysfunction&#xD;
&#xD;
               -  Abnormal kidney function (serum creatinine)&#xD;
&#xD;
               -  thyroid stimulating hormone out of normal range&#xD;
&#xD;
          -  Previous use or new changes in medications that can interfere with the measures used&#xD;
             in the study:&#xD;
&#xD;
               -  current use of insulin and no immediate plans to start or increase diabetic&#xD;
                  mediations.&#xD;
&#xD;
               -  more than 3 oral hypoglycemic medications.&#xD;
&#xD;
               -  use of systemic (oral or IV) corticosteroids in the 6 months prior&#xD;
&#xD;
               -  severe autoimmune disorders&#xD;
&#xD;
               -  initiation of psychiatric medications in past 2 months.&#xD;
&#xD;
          -  Weight loss confounds&#xD;
&#xD;
               -  Current use of weight loss medications or supplements.&#xD;
&#xD;
               -  History of or planned weight loss surgery.&#xD;
&#xD;
          -  Other&#xD;
&#xD;
               -  Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6&#xD;
                  months post-partum.&#xD;
&#xD;
               -  Unable or unwilling to do home glucose monitoring.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick M Hecht, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Osher Center for Integrative Medicine</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>December 24, 2013</last_update_submitted>
  <last_update_submitted_qc>December 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>obesity</keyword>
  <keyword>mindful eating</keyword>
  <keyword>positive affect</keyword>
  <keyword>low carbohydrate</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01713764
org study id: 12-09549
nct id: NCT01713764
lead sponsor: 
has dmc: No
The study is a small pilot, designed to provide data regarding the feasibility and
      acceptability of conducting such a study on a larger scale. The present study is a randomized
      controlled clinical trial comparing two mindfulness-based lifestyle modification programs to
      help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and
      the other using a moderate-carbohydrate diet promoted by the American Diabetes Association
      (ADA). Intervention content will include information about nutrition (carbohydrate
      restriction or American Diabetes Association recommended diet) and emotion regulation and
      mindful eating strategies.
Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1
      ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately
      biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants
      will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c
      (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes
      severity).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemoglobin A1c
time frame: Change from baseline to 3 months
description: We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months.
measure: Hemoglobin A1c
time frame: Change from baseline to 6 months
description: We test whether Hemoglobin A1c changes from pre-intervention to 6 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 6 months.
arm group label: Low Carbohydrate Diet
arm group type: Experimental
description: Participants will be instructed to follow a low carbohydrate diet: carbohydrate intake 10-50 grams a day not including fiber. Foods permitted include: meats, poultry, fish, eggs, cheese, cream, some nuts and seeds, green leafy vegetables, and most other non-starchy vegetables. Because most individuals self-limit caloric intake, no calorie restriction will be recommended.
Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.
arm group label: American Diabetes Association Diet
arm group type: Active Comparator
description: Participants in the American Diabetes Association (ADA) diet group will receive standard ADA advice. The diet includes high-fiber foods (such as vegetables, fruits, whole grains, and legumes), low-fat dairy products, fresh fish, and foods low in saturated fat.
Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.
intervention type: Behavioral
intervention name: Low Carbohydrate Diet
arm group label: Low Carbohydrate Diet
intervention type: Behavioral
intervention name: American Diabetes Association Diet
arm group label: American Diabetes Association Diet
intervention type: Behavioral
intervention name: Mindfulness and Positive Affect Skills
arm group label: American Diabetes Association Diet
arm group label: Low Carbohydrate Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederick M Hecht, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2