<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/NCT03025607</url>
  </required_header>
  <id_info>
    <org_study_id>2420.PIRAP</org_study_id>
    <nct_id>NCT03025607</nct_id>
  </id_info>
  <brief_title>A Mobile Phone-based Program for Adults With Prediabetes</brief_title>
  <official_title>A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Cross Blue Shield of Michigan Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical&#xD;
      activity, yet its prevalence continues to rise. This trend may be due in part to low rates of&#xD;
      participation in evidence-based lifestyle change programs such as the Diabetes Prevention&#xD;
      Program (DPP). New strategies are needed to promote healthy behaviors among individuals at&#xD;
      risk for T2DM, and mobile health technologies may be an effective and scalable approach to&#xD;
      achieve this. One promising tool is JOOL Health, a mobile phone-based application that&#xD;
      leverages principles from Self-Determination Theory to help individuals understand how&#xD;
      certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue&#xD;
      their core values and purpose in life. Through personalized messaging and feedback, JOOL&#xD;
      Health aims to increase autonomous motivation, a form of motivation closely associated with&#xD;
      the initiation and maintenance of healthy behaviors.&#xD;
&#xD;
      In this mixed methods pilot randomized controlled trial, the investigators will test whether&#xD;
      the JOOL Health mobile phone-based application -- used alone and in conjunction with other&#xD;
      mobile health technologies to track weight and physical activity -- can increase autonomous&#xD;
      motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who&#xD;
      previously declined participation in a Diabetes Prevention Program (DPP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This 12-week pilot randomized controlled trial aims to recruit 156 individuals with&#xD;
      prediabetes who declined participation in a formal DPP despite invitation to participate at&#xD;
      no out-of-pocket cost by their health plan. Participants will be randomized to 1 of 3 study&#xD;
      arms: (1) a group that receives information on prediabetes, evidence-based strategies to&#xD;
      decrease progression to diabetes, and a list of resources for mHealth tools for monitoring&#xD;
      diet, physical activity, and weight (control group); (2) a group that receives the JOOL&#xD;
      Health mobile phone application; and (3) a group that receives the JOOL Health mobile phone&#xD;
      application and other mHealth tools (e.g. Fitbit activity tracker and wireless-enabled scale)&#xD;
      whose results can be uploaded into JOOL.&#xD;
&#xD;
      The investigators will use a mixed methods approach with a sequential explanatory design,&#xD;
      which is to say that quantitative data and qualitative data will be collected in 2&#xD;
      consecutive phases within the study. Specifically, in the first phase, investigators will&#xD;
      collect and analyze qualitative data (e.g. focus groups) from a purposive sample of&#xD;
      participants with differing levels of engagement and success. The rationale for this approach&#xD;
      is that the quantitative data will provide a general overview of the intervention's efficacy&#xD;
      and limitations, and the qualitative data will help to explain these findings by exploring&#xD;
      participants' experiences and perspectives in more depth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Autonomous Motivation to Prevent T2DM</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Change from baseline mean score on a scale of 1 - 7 as assessed by the Treatment Self Regulation Questionnaire- Autonomous Section survey instrument where 1 means little autonomous motivation and 7 means high autonomous motivation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported weight</measure>
    <time_frame>Baseline to 12-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>Baseline to 12-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psychosocial measures</measure>
    <time_frame>Baseline to 12-week follow-up</time_frame>
    <description>Overall motivation to prevent T2DM; purpose in life; perceived competence to prevent T2DM; social support; eating behavior; self-reported physical activity; patient activation; willingness to participate in a Diabetes Prevention Program</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Prediabetic State</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes as well as a list of resources for mHealth tools for monitoring diet, physical activity, and weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JOOL-Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, and will receive the JOOL Health mobile phone application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JOOL-Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, the JOOL Health mobile phone application, a digital scale, and a Fitbit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>JOOL Health Mobile Phone Application</intervention_name>
    <description>JOOL Health is a mobile phone-based application that aims to increase autonomous motivation to prevent T2DM by helping individuals make connections between certain health behaviors and the energy and willpower needed to achieve personal goals. On a daily basis, JOOL Health users chart the following health behaviors: Sleep, Presence, Activity, Creativity, and Eating. On a weekly basis, JOOL Health users are asked to record how well they lived according to their purpose and values. Through the integration of user-entered information with contextual data, JOOL Health provides tailored messaging and daily predictions of individuals' energy and willpower.</description>
    <arm_group_label>JOOL-Only</arm_group_label>
    <arm_group_label>JOOL-Plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Invited to participate in a DPP by the participant's health plan, but have not engaged&#xD;
             in a program at least 6 months after receiving the first letter of invitation&#xD;
&#xD;
          -  Wireless internet access&#xD;
&#xD;
          -  Personal smartphone access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals currently participating in another lifestyle or behavior change program or&#xD;
             research study&#xD;
&#xD;
          -  Inability to read, write, or speak English&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Women who are pregnant or intend to become pregnant during the intervention period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Griauzde, MD</last_name>
    <role>Study Director</role>
    <affiliation>Robert Wood Johnson Clinical Scholars Program (VA Scholar)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michele Heisler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Robert Wood Johnson Clinical Scholars Program</affiliation>
  </overall_official>
  <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>April 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Mary Ellen Michele Heisler</investigator_full_name>
    <investigator_title>Dr. Michele Heisler, MD</investigator_title>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Mobile health</keyword>
  <keyword>Autonomous motivation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025607
org study id: 2420.PIRAP
nct id: NCT03025607
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical
      activity, yet its prevalence continues to rise. This trend may be due in part to low rates of
      participation in evidence-based lifestyle change programs such as the Diabetes Prevention
      Program (DPP). New strategies are needed to promote healthy behaviors among individuals at
      risk for T2DM, and mobile health technologies may be an effective and scalable approach to
      achieve this. One promising tool is JOOL Health, a mobile phone-based application that
      leverages principles from Self-Determination Theory to help individuals understand how
      certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue
      their core values and purpose in life. Through personalized messaging and feedback, JOOL
      Health aims to increase autonomous motivation, a form of motivation closely associated with
      the initiation and maintenance of healthy behaviors.

      In this mixed methods pilot randomized controlled trial, the investigators will test whether
      the JOOL Health mobile phone-based application -- used alone and in conjunction with other
      mobile health technologies to track weight and physical activity -- can increase autonomous
      motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who
      previously declined participation in a Diabetes Prevention Program (DPP).
This 12-week pilot randomized controlled trial aims to recruit 156 individuals with
      prediabetes who declined participation in a formal DPP despite invitation to participate at
      no out-of-pocket cost by their health plan. Participants will be randomized to 1 of 3 study
      arms: (1) a group that receives information on prediabetes, evidence-based strategies to
      decrease progression to diabetes, and a list of resources for mHealth tools for monitoring
      diet, physical activity, and weight (control group); (2) a group that receives the JOOL
      Health mobile phone application; and (3) a group that receives the JOOL Health mobile phone
      application and other mHealth tools (e.g. Fitbit activity tracker and wireless-enabled scale)
      whose results can be uploaded into JOOL.

      The investigators will use a mixed methods approach with a sequential explanatory design,
      which is to say that quantitative data and qualitative data will be collected in 2
      consecutive phases within the study. Specifically, in the first phase, investigators will
      collect and analyze qualitative data (e.g. focus groups) from a purposive sample of
      participants with differing levels of engagement and success. The rationale for this approach
      is that the quantitative data will provide a general overview of the intervention's efficacy
      and limitations, and the qualitative data will help to explain these findings by exploring
      participants' experiences and perspectives in more depth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Autonomous Motivation to Prevent T2DM
time frame: 12 Weeks
description: Change from baseline mean score on a scale of 1 - 7 as assessed by the Treatment Self Regulation Questionnaire- Autonomous Section survey instrument where 1 means little autonomous motivation and 7 means high autonomous motivation.
measure: Change in self-reported weight
time frame: Baseline to 12-week follow-up
measure: Change in HbA1c
time frame: Baseline to 12-week follow-up
measure: Change in psychosocial measures
time frame: Baseline to 12-week follow-up
description: Overall motivation to prevent T2DM; purpose in life; perceived competence to prevent T2DM; social support; eating behavior; self-reported physical activity; patient activation; willingness to participate in a Diabetes Prevention Program
arm group label: Control
arm group type: No Intervention
description: Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes as well as a list of resources for mHealth tools for monitoring diet, physical activity, and weight.
arm group label: JOOL-Only
arm group type: Experimental
description: Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, and will receive the JOOL Health mobile phone application.
arm group label: JOOL-Plus
arm group type: Experimental
description: Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, the JOOL Health mobile phone application, a digital scale, and a Fitbit.
intervention type: Device
intervention name: JOOL Health Mobile Phone Application
description: JOOL Health is a mobile phone-based application that aims to increase autonomous motivation to prevent T2DM by helping individuals make connections between certain health behaviors and the energy and willpower needed to achieve personal goals. On a daily basis, JOOL Health users chart the following health behaviors: Sleep, Presence, Activity, Creativity, and Eating. On a weekly basis, JOOL Health users are asked to record how well they lived according to their purpose and values. Through the integration of user-entered information with contextual data, JOOL Health provides tailored messaging and daily predictions of individuals' energy and willpower.
arm group label: JOOL-Only
arm group label: JOOL-Plus
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Dina Griauzde, MD
role: Study Director
affiliation: Robert Wood Johnson Clinical Scholars Program (VA Scholar)
last name: Michele Heisler, MD
role: Principal Investigator
affiliation: Robert Wood Johnson Clinical Scholars Program
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Mary Ellen Michele Heisler
investigator title: Dr. Michele Heisler, MD
mesh term: Prediabetic State
sharing ipd: No