<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/NCT03837405</url>
  </required_header>
  <id_info>
    <org_study_id>4R33AT009333</org_study_id>
    <secondary_id>4R33AT009333</secondary_id>
    <nct_id>NCT03837405</nct_id>
  </id_info>
  <brief_title>(R33 Phase) Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger</brief_title>
  <acronym>Delish R33</acronym>
  <official_title>Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM)&#xD;
      will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate&#xD;
      restricted diet for T2DM, or this same education content with added mindful&#xD;
      eating/Mindfulness-Based Intervention components (Ed+MBI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will randomize 120 persons with T2DM in a 1:1 ratio to a nutrition&#xD;
      education alone arm (Ed n=60) vs. a nutrition education with mindfulness-based intervention&#xD;
      components (Ed+MBI n=60) arm and follow them for 12 months. The interventions will be&#xD;
      provided in a weekly group setting, with about 10 to 12 persons per group. Some educational&#xD;
      intervention components will be delivered using a smartphone app. After the 12-week initial&#xD;
      intervention, the investigators will re-randomize participants using an adaptive intervention&#xD;
      design to receive low, medium, or high intensity maintenance training, depending on level of&#xD;
      adherence achieved during the initial intervention period. Follow-up assessments will be&#xD;
      performed at 3, 6, 9, and 12 months. The investigators will address the following specific&#xD;
      aims:&#xD;
&#xD;
        1. Test the hypothesis that the Ed+MBI arm will have better dietary adherence than the Ed&#xD;
           arm.&#xD;
&#xD;
        2. Test whether our proposed behavioral mechanisms (e.g. decreased eating in response to&#xD;
           cravings or difficult emotions) predict dietary adherence.&#xD;
&#xD;
        3. Compare randomized arms in the adaptive maintenance intervention design to optimize&#xD;
           maintenance phase dosing in future trials.&#xD;
&#xD;
        4. Obtain preliminary assessment of intervention effects on clinical outcomes&#xD;
&#xD;
      This is the second phase of a two-phase study. Pilot testing has been completed in the first&#xD;
      phase (R61). The second phase (R33) will include employing an adaptive intervention design in&#xD;
      the post-treatment phase to test optimization of the maintenance intervention (i.e. assigning&#xD;
      maintenance intensity/dose based on how a participant is doing). The investigators will use&#xD;
      fingerstick blood ketone measures, which provide an objective measure of whether the target&#xD;
      levels of carbohydrate restriction have been attained, as our primary adherence outcome&#xD;
      measure. This will be supplemented by 24-hour diet recall measures of carbohydrate&#xD;
      consumption. Important secondary outcome measures will include clinical measures such as&#xD;
      glycosylated hemoglobin and behavioral measures such as frequency of eating in response to&#xD;
      food cravings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">June 17, 2021</completion_date>
  <primary_completion_date type="Actual">June 17, 2021</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>Single (Outcomes Assessor)</masking>
    <masking_description>Blood tests at LabCorp and 24-hour dietary recall interviews are done by research assistants blinded to treatment assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>diet adherence between intervention arms as measured by ketones</measure>
    <time_frame>measures from ketone measure initiation (week 5) to 12 months</time_frame>
    <description>proportion of ketone measures dichotomized as &gt; or = 0.3 mmol/L versus &lt; 0.3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diet adherence between intervention arms as measured by 24- hour diet recall--dichotomous</measure>
    <time_frame>from 3 to 12 months</time_frame>
    <description>proportion of participants consuming &lt; 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>executive functioning /decreased impulsivity-Delayed Discounting</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>change in Delayed Discounting task score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>emotion-related eating</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control--a1c</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>hemoglobin a1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of eating in response to cravings</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>frequency of eating in response to cravings using ecological momentary assessment (EMA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diet adherence between intervention arms as measured by 24- hour diet recall--total carbs, continuous</measure>
    <time_frame>from 3 to 12 months</time_frame>
    <description>mean grams of non-fiber carbohydrate consumed per day (from 24-hour diet recall)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>executive functioning /decreased impulsivity--Relative Reinforcing Value of Food (RRVF)</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>change in RRVF score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salzburg Stress Eating Scale</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>change in stress-related eating as measured by Salzburg Stress Eating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dietary resilience (resumption of dietary adherence) after dietary non-adherence occurs</measure>
    <time_frame>12 months</time_frame>
    <description>time from a ketone measure of &lt; 0.3 mmol/L to higher levels of &gt;/= 0.3 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight change</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>pounds</description>
  </secondary_outcome>
  <other_outcome>
    <measure>stress-related eating</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>change in stress-related eating as measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>change in Perceived Stress Scale total score</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin resistance</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>Homeostatic model assessment (HOMA) index of insulin resistance (computed from insulin and fasting glucose measures)</description>
  </other_outcome>
  <other_outcome>
    <measure>Glycemic control--fasting glucose</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>fasting blood glucose</description>
  </other_outcome>
  <other_outcome>
    <measure>Mindfulness</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>Five-factor mindfulness scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Diet Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet Education + Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Carbohydrate-restricted diet</intervention_name>
    <description>Education for carbohydrate-restricted diet</description>
    <arm_group_label>Diet Education</arm_group_label>
    <arm_group_label>Diet Education + Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfuless</intervention_name>
    <description>Mindful eating app use plus group sessions to learn mindfulness</description>
    <arm_group_label>Diet Education + Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of T2DM mellitus.&#xD;
&#xD;
          2. HbA1c ≥ 6.5% and &lt; 12.0% at screening.&#xD;
&#xD;
          3. Experience food-related cravings most days of the week and eat in response to these&#xD;
             cravings regularly.&#xD;
&#xD;
          4. Aged 18 years old and older.&#xD;
&#xD;
          5. Able to engage in light physical activity.&#xD;
&#xD;
          6. Willing and able to participate in the interventions including appropriate&#xD;
             participation in the group setting.&#xD;
&#xD;
          7. Have smartphone and are willing to use it on a regular basis for data collection.&#xD;
&#xD;
          8. Ability to speak English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to provide informed consent.&#xD;
&#xD;
          2. A substance abuse, mental health, or medical condition that, in the opinion of&#xD;
             investigators, will make it difficult for the potential participant to participate in&#xD;
             the intervention, that may need immediate changes in medical management that will&#xD;
             affect study outcome measures, or that may require important adaptations in the study&#xD;
             diet.&#xD;
&#xD;
          3. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than&#xD;
             6 months post-partum.&#xD;
&#xD;
          4. Current use of weight loss medications, such as Alli or amphetamine-based drugs that&#xD;
             may affect weight.&#xD;
&#xD;
          5. Planned or history of weight-loss (bariatric) surgery, or other intestinal surgeries&#xD;
             that cause malabsorption. These are likely to change study outcome measures, making it&#xD;
             difficult to distinguish the effects of the intervention program, or require extensive&#xD;
             tailoring of the diet intervention.&#xD;
&#xD;
          6. Currently enrolled in a weight loss program, such as Weight Watchers or a self-help&#xD;
             group such as Overeaters Anonymous, or have unalterable plans to enroll in one of&#xD;
             these programs in the next year; using a ketogenic low carbohydrate diet in the past 6&#xD;
             months with advice from a health care professional; or use of a mindful eating program&#xD;
             with guidance from a professional in the past 6 months or have ever used the study&#xD;
             mindful-eating app.&#xD;
&#xD;
          7. Vegan or vegetarian.&#xD;
&#xD;
          8. Unwilling to do regular blood testing at home for glucose or ketone 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>Rick Hecht, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elissa Epel, PhD</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>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03837405/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03837405
org study id: 4R33AT009333
secondary id: 4R33AT009333
nct id: NCT03837405
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM)
      will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate
      restricted diet for T2DM, or this same education content with added mindful
      eating/Mindfulness-Based Intervention components (Ed+MBI).
The investigators will randomize 120 persons with T2DM in a 1:1 ratio to a nutrition
      education alone arm (Ed n=60) vs. a nutrition education with mindfulness-based intervention
      components (Ed+MBI n=60) arm and follow them for 12 months. The interventions will be
      provided in a weekly group setting, with about 10 to 12 persons per group. Some educational
      intervention components will be delivered using a smartphone app. After the 12-week initial
      intervention, the investigators will re-randomize participants using an adaptive intervention
      design to receive low, medium, or high intensity maintenance training, depending on level of
      adherence achieved during the initial intervention period. Follow-up assessments will be
      performed at 3, 6, 9, and 12 months. The investigators will address the following specific
      aims:

        1. Test the hypothesis that the Ed+MBI arm will have better dietary adherence than the Ed
           arm.

        2. Test whether our proposed behavioral mechanisms (e.g. decreased eating in response to
           cravings or difficult emotions) predict dietary adherence.

        3. Compare randomized arms in the adaptive maintenance intervention design to optimize
           maintenance phase dosing in future trials.

        4. Obtain preliminary assessment of intervention effects on clinical outcomes

      This is the second phase of a two-phase study. Pilot testing has been completed in the first
      phase (R61). The second phase (R33) will include employing an adaptive intervention design in
      the post-treatment phase to test optimization of the maintenance intervention (i.e. assigning
      maintenance intensity/dose based on how a participant is doing). The investigators will use
      fingerstick blood ketone measures, which provide an objective measure of whether the target
      levels of carbohydrate restriction have been attained, as our primary adherence outcome
      measure. This will be supplemented by 24-hour diet recall measures of carbohydrate
      consumption. Important secondary outcome measures will include clinical measures such as
      glycosylated hemoglobin and behavioral measures such as frequency of eating in response to
      food cravings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blood tests at LabCorp and 24-hour dietary recall interviews are done by research assistants blinded to treatment assignment.
measure: diet adherence between intervention arms as measured by ketones
time frame: measures from ketone measure initiation (week 5) to 12 months
description: proportion of ketone measures dichotomized as > or = 0.3 mmol/L versus < 0.3
measure: diet adherence between intervention arms as measured by 24- hour diet recall--dichotomous
time frame: from 3 to 12 months
description: proportion of participants consuming < 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall)
measure: executive functioning /decreased impulsivity-Delayed Discounting
time frame: change from baseline to 12 months
description: change in Delayed Discounting task score
measure: emotion-related eating
time frame: change from baseline to 12 months
description: change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS).
measure: Glycemic control--a1c
time frame: change from baseline to 12 months
description: hemoglobin a1c
measure: frequency of eating in response to cravings
time frame: change from baseline to 12 months
description: frequency of eating in response to cravings using ecological momentary assessment (EMA)
measure: diet adherence between intervention arms as measured by 24- hour diet recall--total carbs, continuous
time frame: from 3 to 12 months
description: mean grams of non-fiber carbohydrate consumed per day (from 24-hour diet recall)
measure: executive functioning /decreased impulsivity--Relative Reinforcing Value of Food (RRVF)
time frame: change from baseline to 12 months
description: change in RRVF score
measure: Salzburg Stress Eating Scale
time frame: change from baseline to 12 months
description: change in stress-related eating as measured by Salzburg Stress Eating Scale
measure: dietary resilience (resumption of dietary adherence) after dietary non-adherence occurs
time frame: 12 months
description: time from a ketone measure of < 0.3 mmol/L to higher levels of >/= 0.3 mmol/L
measure: Weight change
time frame: change from baseline to 12 months
description: pounds
measure: stress-related eating
time frame: change from baseline to 12 months
description: change in stress-related eating as measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question
measure: Perceived Stress
time frame: change from baseline to 12 months
description: change in Perceived Stress Scale total score
measure: Insulin resistance
time frame: change from baseline to 12 months
description: Homeostatic model assessment (HOMA) index of insulin resistance (computed from insulin and fasting glucose measures)
measure: Glycemic control--fasting glucose
time frame: change from baseline to 12 months
description: fasting blood glucose
measure: Mindfulness
time frame: change from baseline to 12 months
description: Five-factor mindfulness scale
arm group label: Diet Education
arm group type: Active Comparator
description: All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
arm group label: Diet Education + Mindfulness
arm group type: Experimental
description: In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
intervention type: Behavioral
intervention name: Carbohydrate-restricted diet
description: Education for carbohydrate-restricted diet
arm group label: Diet Education
arm group label: Diet Education + Mindfulness
intervention type: Behavioral
intervention name: Mindfuless
description: Mindful eating app use plus group sessions to learn mindfulness
arm group label: Diet Education + Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rick Hecht, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Elissa Epel, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 