<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/NCT03037528</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00115537</org_study_id>
    <nct_id>NCT03037528</nct_id>
  </id_info>
  <brief_title>Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes</brief_title>
  <official_title>Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</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 goal of the research is to optimize an online and mobile multicomponent 12-month diet and&#xD;
      lifestyle intervention for improving the blood glucose control of individuals with type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The core of the program, administered to all participants, includes recommendations to follow&#xD;
      a very low carbohydrate, ketogenic diet. The researchers will test whether adding the&#xD;
      following experimental components will enhance the intervention's ability to improve health&#xD;
      outcomes: (1) active vs. periodic self-monitoring of dietary intake using an &quot;app&quot;; (2)&#xD;
      training vs. no training in positive affect; and (3) training vs. no training in mindfulness&#xD;
      and mindful eating.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">June 4, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Control</measure>
    <time_frame>12 months</time_frame>
    <description>Measured with HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>12 months</time_frame>
    <description>Measured with percent body weight lost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>12 months</time_frame>
    <description>Measured with Patient Health Questionnaire-8</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Positive Affect, Mindfulness, Tracking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness, Tracking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Affect, Tracking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tracking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to actively track what they eat in addition to receiving the core program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Affect, Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive information about positive affect and mindfulness in addition to the core program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Affect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive information about positive affect in addition to the core program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive information about mindfulness in addition to the core program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Extras</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the core program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>diet and lifestyle program</intervention_name>
    <description>Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.</description>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_label>Mindfulness, Tracking</arm_group_label>
    <arm_group_label>No Extras</arm_group_label>
    <arm_group_label>Positive Affect</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness, Tracking</arm_group_label>
    <arm_group_label>Positive Affect, Tracking</arm_group_label>
    <arm_group_label>Tracking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>positive affect informational materials</intervention_name>
    <description>Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.</description>
    <arm_group_label>Positive Affect</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness, Tracking</arm_group_label>
    <arm_group_label>Positive Affect, Tracking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mindfulness informational materials</intervention_name>
    <description>Participants will be taught about mindfulness and mindful eating techniques.</description>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_label>Mindfulness, Tracking</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness, Tracking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>dietary tracking</intervention_name>
    <description>Participants will be asked to track their diet consistently.</description>
    <arm_group_label>Mindfulness, Tracking</arm_group_label>
    <arm_group_label>Positive Affect, Mindfulness, Tracking</arm_group_label>
    <arm_group_label>Positive Affect, Tracking</arm_group_label>
    <arm_group_label>Tracking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weight: Body Mass Index of 25-45 kg/m2 or greater.&#xD;
&#xD;
          -  Current HbA1c of 6.5% or higher&#xD;
&#xD;
          -  Regular access to the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking glucose lowering medications other than metformin&#xD;
&#xD;
          -  Being pregnant or breastfeeding&#xD;
&#xD;
          -  Currently undergoing cancer treatments&#xD;
&#xD;
          -  Active use of a weight loss program or medications&#xD;
&#xD;
          -  Self-reported impaired renal or hepatic function&#xD;
&#xD;
          -  Self-reported untreated thyroid condition&#xD;
&#xD;
          -  Vegetarian or vegan&#xD;
&#xD;
          -  Weight loss surgery within the past year&#xD;
&#xD;
          -  Medical concerns that prevent participants from following the assigned protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</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>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Laura Saslow</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>
  <pending_results>
    <submitted>June 1, 2022</submitted>
    <returned>March 14, 2023</returned>
    <submitted>March 14, 2023</submitted>
    <returned>April 7, 2023</returned>
    <submitted>April 14, 2023</submitted>
    <returned>May 8, 2023</returned>
  </pending_results>
  <!-- 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/NCT03037528
org study id: HUM00115537
nct id: NCT03037528
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the research is to optimize an online and mobile multicomponent 12-month diet and
      lifestyle intervention for improving the blood glucose control of individuals with type 2
      diabetes.
The core of the program, administered to all participants, includes recommendations to follow
      a very low carbohydrate, ketogenic diet. The researchers will test whether adding the
      following experimental components will enhance the intervention's ability to improve health
      outcomes: (1) active vs. periodic self-monitoring of dietary intake using an "app"; (2)
      training vs. no training in positive affect; and (3) training vs. no training in mindfulness
      and mindful eating.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Glycemic Control
time frame: 12 months
description: Measured with HbA1c
measure: Weight Loss
time frame: 12 months
description: Measured with percent body weight lost
measure: Depressive symptoms
time frame: 12 months
description: Measured with Patient Health Questionnaire-8
arm group label: Positive Affect, Mindfulness, Tracking
arm group type: Experimental
description: Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program
arm group label: Mindfulness, Tracking
arm group type: Experimental
description: Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
arm group label: Positive Affect, Tracking
arm group type: Experimental
description: Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
arm group label: Tracking
arm group type: Experimental
description: Participants will be asked to actively track what they eat in addition to receiving the core program.
arm group label: Positive Affect, Mindfulness
arm group type: Experimental
description: Participants will receive information about positive affect and mindfulness in addition to the core program.
arm group label: Positive Affect
arm group type: Experimental
description: Participants will receive information about positive affect in addition to the core program.
arm group label: Mindfulness
arm group type: Experimental
description: Participants will receive information about mindfulness in addition to the core program.
arm group label: No Extras
arm group type: Experimental
description: Participants will receive the core program.
intervention type: Behavioral
intervention name: diet and lifestyle program
description: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.
arm group label: Mindfulness
arm group label: Mindfulness, Tracking
arm group label: No Extras
arm group label: Positive Affect
arm group label: Positive Affect, Mindfulness
arm group label: Positive Affect, Mindfulness, Tracking
arm group label: Positive Affect, Tracking
arm group label: Tracking
intervention type: Behavioral
intervention name: positive affect informational materials
description: Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
arm group label: Positive Affect
arm group label: Positive Affect, Mindfulness
arm group label: Positive Affect, Mindfulness, Tracking
arm group label: Positive Affect, Tracking
intervention type: Behavioral
intervention name: mindfulness informational materials
description: Participants will be taught about mindfulness and mindful eating techniques.
arm group label: Mindfulness
arm group label: Mindfulness, Tracking
arm group label: Positive Affect, Mindfulness
arm group label: Positive Affect, Mindfulness, Tracking
intervention type: Behavioral
intervention name: dietary tracking
description: Participants will be asked to track their diet consistently.
arm group label: Mindfulness, Tracking
arm group label: Positive Affect, Mindfulness, Tracking
arm group label: Positive Affect, Tracking
arm group label: Tracking
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Laura Saslow
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
submitted: June 1, 2022
returned: March 14, 2023
submitted: March 14, 2023
returned: April 7, 2023
submitted: April 14, 2023
returned: May 8, 2023