<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/NCT02188823</url>
  </required_header>
  <id_info>
    <org_study_id>13-11813p</org_study_id>
    <nct_id>NCT02188823</nct_id>
  </id_info>
  <brief_title>Examining the Effects of Diet on Health in Prediabetes With an Online Program</brief_title>
  <official_title>Examining the Effects of Diet on Health in Prediabetes With an Online Program</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 pilot, designed to provide data regarding the feasibility and acceptability of&#xD;
      conducting such a study on a larger scale. The present study is a clinical trial assessing a&#xD;
      programs to help people manage prediabetes and lose weight with a low-carbohydrate diet (LC)&#xD;
      along with information about positive affect, mindful eating strategies, exercise, and sleep.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with prediabetes will be assigned to the treatment group. Classes will occur&#xD;
      online. Participants will be evaluated at 0, 8, and 16 weeks. Our main outcome of interest is&#xD;
      HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes&#xD;
      severity) at 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>baseline to 16 weeks</time_frame>
    <description>We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>baseline to 16 weeks</time_frame>
    <description>We will test whether body weight changes from pre-intervention to 16 weeks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Prediabetes</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, ketogenic diet: carbohydrate intake 20-35 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 exercise, sleep, 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>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion criteria&#xD;
&#xD;
               1. Self-reported clinical diagnosis of prediabetes occurring within the past year.&#xD;
&#xD;
               2. Aged 18 years old and older&#xD;
&#xD;
               3. Per the Centers for Disease Control and Prevention Diabetes Prevention&#xD;
                  Recognition Program have a self-reported body mass index (BMI) of ≥ 24 kg/m2 (≥&#xD;
                  22 kg/m2 if Asian).&#xD;
&#xD;
               4. Willing and able to participate in the intervention such as having sufficient&#xD;
                  control over their food intake. Must have the ability to make choices about the&#xD;
                  food they eat; cannot have a lifestyle in which they eat out most of their&#xD;
                  meals.)&#xD;
&#xD;
          -  Exclusion criteria&#xD;
&#xD;
               1. Unable to provide informed consent.&#xD;
&#xD;
               2. Non English speaker. The intervention groups are conducted in English.&#xD;
&#xD;
               3. No current use of insulin, no immediate plans to start or increase diabetic&#xD;
                  mediations, and no use of diabetes medications besides metformin. Insulin and&#xD;
                  other diabetes medications other than metformin can alter the safety of the&#xD;
                  diets, so to ensure greater safety, we will exclude diabetics using insulin or&#xD;
                  medications besides metformin.&#xD;
&#xD;
               4. A substance abuse, mental health, or medical condition that, in the opinion of&#xD;
                  investigators, will make it difficult for the potential participant to&#xD;
                  participate in the intervention. Such conditions may include: cancer, liver&#xD;
                  failure, unstable coronary artery disease, severe emphysema, binge eating&#xD;
                  disorder or history of binge eating disorder, bulimia or strong history of&#xD;
                  bulimia.&#xD;
&#xD;
               5. Previous use or recent changes in medications that can interfere with the&#xD;
                  measures used in the study: current use of insulin; use of systemic (oral or IV)&#xD;
                  corticosteroids in the 1 month prior to enrollment or severe autoimmune disorders&#xD;
                  or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to&#xD;
                  require these medications; and initiation of new class of psychiatric medications&#xD;
                  in past 2 months. Such medications can alter measures used in our research, such&#xD;
                  as assessments of markers of inflammation, or negatively influence the safety of&#xD;
                  the diets.&#xD;
&#xD;
               6. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less&#xD;
                  than 6 months post-partum. The intervention is not designed for the particular&#xD;
                  diet considerations during pregnancy and breast-feeding.&#xD;
&#xD;
               7. Current use of weight loss medications or supplements such as Alli or&#xD;
                  amphetamine-based drugs that are believed to have some effect on weight. Use of&#xD;
                  weight loss aids by potential participants will be reviewed by a core study team&#xD;
                  to determine whether participant would be eligible if they stop using the&#xD;
                  substance.&#xD;
&#xD;
               8. History of or planned weight loss surgery. The intervention is not designed to&#xD;
                  address either the often substantial food intake limits that often result from&#xD;
                  weight loss surgery or the significantly disordered eating that people who fail&#xD;
                  this extreme intervention may have.&#xD;
&#xD;
               9. Vegan or vegetarian. The intervention diets are more challenging for vegan and&#xD;
                  vegetarian participants.&#xD;
&#xD;
              10. No or very limited internet access at a computer. Must be able to complete the&#xD;
                  online assessments and access the online class materials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://ucbpsych.qualtrics.com/SE/?SID=SV_9LXQ9BJvMR1Qcbb</url>
    <description>eligibility survey</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>June 14, 2017</last_update_submitted>
  <last_update_submitted_qc>June 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prediabetes</keyword>
  <keyword>obesity</keyword>
  <keyword>mindful eating</keyword>
  <keyword>positive affect</keyword>
  <keyword>low carbohydrate</keyword>
  <keyword>ketogenic</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT02188823
org study id: 13-11813p
nct id: NCT02188823
lead sponsor: 
has dmc: No
The study is a pilot, designed to provide data regarding the feasibility and acceptability of
      conducting such a study on a larger scale. The present study is a clinical trial assessing a
      programs to help people manage prediabetes and lose weight with a low-carbohydrate diet (LC)
      along with information about positive affect, mindful eating strategies, exercise, and sleep.
Individuals with prediabetes will be assigned to the treatment group. Classes will occur
      online. Participants will be evaluated at 0, 8, and 16 weeks. Our main outcome of interest is
      HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes
      severity) at 16 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hemoglobin A1c
time frame: baseline to 16 weeks
description: We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.
measure: Body weight
time frame: baseline to 16 weeks
description: We will test whether body weight changes from pre-intervention to 16 weeks.
arm group label: Low Carbohydrate Diet
arm group type: Experimental
description: Participants will be instructed to follow a low carbohydrate, ketogenic diet: carbohydrate intake 20-35 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 exercise, sleep, 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
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
url: http://ucbpsych.qualtrics.com/SE/?SID=SV_9LXQ9BJvMR1Qcbb
description: eligibility survey
responsible party type: Sponsor
mesh term: Prediabetic State
mesh term: Glucose Intolerance