<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/NCT02192905</url>
  </required_header>
  <id_info>
    <org_study_id>H17-237</org_study_id>
    <secondary_id>1R21DK098556-01</secondary_id>
    <nct_id>NCT02192905</nct_id>
  </id_info>
  <brief_title>Feasibility Trial of a Problem-Solving Weight Loss Mobile Application</brief_title>
  <official_title>Feasibility Trial of a Problem-Solving Weight Loss Mobile Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Worcester Polytechnic Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Connecticut</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research was to develop and test the feasibility of Habit, a weight loss&#xD;
      mobile application that was designed to coach patients through their weight loss challenges.&#xD;
      In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart&#xD;
      Coach mobile application when paired with a shortened online-delivered (8-week) behavioral&#xD;
      weight loss intervention. Feasibility outcomes included frequency and duration of usage of&#xD;
      the mobile app and each feature, recruitment, and retention. Post-intervention focus groups&#xD;
      discussed the feasibility and acceptability of the intervention. The investigators also&#xD;
      performed exploratory analyses comparing conditions on problem solving skills and weight loss&#xD;
      at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators developed and tested the feasibility of Habit, a weight loss mobile app&#xD;
      that includes common features such as self-monitoring, goal setting, and a social network,&#xD;
      but even more importantly, an avatar-facilitated, idiographic problem solving feature that&#xD;
      processes information intelligently to help patients identify solutions to their weight loss&#xD;
      problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of&#xD;
      the Habit mobile application when paired with a shortened (8 week) behavioral weight loss&#xD;
      intervention. Feasibility outcomes included frequency and duration of usage of the mobile app&#xD;
      and each feature, recruitment, and retention. The investigators also performed analyses on&#xD;
      problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent&#xD;
      randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted&#xD;
      brief behavioral weight loss intervention relative to a brief behavioral weight loss&#xD;
      intervention alone with 1 year follow-up. The investigators overarching goal is to develop&#xD;
      mobile technology that reduces the intensity of lifestyle interventions as far as possible&#xD;
      while preserving weight loss outcomes, to ultimately broaden reach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility (Total Uses)</measure>
    <time_frame>8-week follow-up</time_frame>
    <description>Mean total uses of the problem solving function of the mobile application</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility (Total Habits Attempted)</measure>
    <time_frame>8-week follow-up</time_frame>
    <description>Total amount of new habits attempted during the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility (Recruitment Rates)</measure>
    <time_frame>Baseline</time_frame>
    <description>Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility (Retention Rates)</measure>
    <time_frame>8-weeks</time_frame>
    <description>Total attendance at groups and total withdrawn from the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Problem Solving Inventory</measure>
    <time_frame>8-week follow-up</time_frame>
    <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Weight Change</measure>
    <time_frame>8-week follow-up</time_frame>
    <description>Measured in pounds with a digital scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Weight Change</measure>
    <time_frame>16 week follow-up</time_frame>
    <description>Measured in pounds with a digital scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Problem Solving Inventory</measure>
    <time_frame>16-week follow-up</time_frame>
    <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Behavioral Weight Loss + Habit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Prevention Program Lifestyle Intervention</intervention_name>
    <arm_group_label>Behavioral Weight Loss + Habit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion: Participants must 1) have a BMI between 30 and 45, 2) currently uses a&#xD;
        smartphone with Android software, 3) have connectivity to the internet at home and work, 4)&#xD;
        have PCP written clearance, and 5) age 18 or older.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Ages &lt;18&#xD;
&#xD;
          2. BMI &lt;30 and &gt;45&#xD;
&#xD;
          3. Does not currently use a smart phone with Android software version 4.4 or later&#xD;
&#xD;
          4. Does not use a smartphone supported by the app (will assess model and type of phone&#xD;
             for each participant)&#xD;
&#xD;
          5. Does not have connectivity to the internet at home and work; or wifi access at home&#xD;
&#xD;
          6. Does not use smart phone regularly throughout the day&#xD;
&#xD;
          7. Has not used Android smartphone for at least a year&#xD;
&#xD;
          8. Has not used a weight loss mobile app in the last 6 months&#xD;
&#xD;
          9. Does not have a Facebook account, uses it infrequently, or does not actively engage on&#xD;
             Facebook&#xD;
&#xD;
         10. Does not have a gmail account or is unwilling to create one&#xD;
&#xD;
         11. Does not have PCP written clearance&#xD;
&#xD;
         12. Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression&#xD;
&#xD;
         13. Pregnant or lactating&#xD;
&#xD;
         14. Had bariatric surgery&#xD;
&#xD;
         15. Medication affecting weight&#xD;
&#xD;
         16. Adults unwilling to provide consent&#xD;
&#xD;
         17. Prisoners&#xD;
&#xD;
         18. Unable to read or understand English&#xD;
&#xD;
         19. Has type 1 or 2 diabetes&#xD;
&#xD;
         20. Have concerns about being audiotaped&#xD;
&#xD;
         21. Unable to walk unaided&#xD;
&#xD;
         22. Has any medical condition that precludes lifestyle changes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry L Pagoto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Connecticut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Connecticut</name>
      <address>
        <city>Storrs</city>
        <state>Connecticut</state>
        <zip>06269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>September 5, 2017</results_first_submitted>
  <results_first_submitted_qc>January 24, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 22, 2018</results_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Connecticut</investigator_affiliation>
    <investigator_full_name>Sherry Pagoto</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In order to begin the intervention, participants needed to complete: an online eligibility screener, a telephone screening, the consent process, a screening survey, medical clearance, and a webinar. Missing any of these components would be reason for exclusion.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Behavioral Weight Loss + Habit</title>
          <description>Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42">Reporting a minimum of current weight at 16-week follow-up</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Behavioral Weight Loss + Habit</title>
          <description>Individuals randomized to this condition will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.33" spread="11.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="202.02" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Social-Problem Solving Inventory-Revised</title>
          <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The total score is being reported in these results. The scoring range includes 28 to 140. The higher the score the higher the problem solving ability.</description>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107.3" spread="14.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Facebook Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Uses Facebook 5-6 times per week</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Uses Facebook daily or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility (Total Uses)</title>
        <description>Mean total uses of the problem solving function of the mobile application</description>
        <time_frame>8-week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility (Total Uses)</title>
          <description>Mean total uses of the problem solving function of the mobile application</description>
          <units>mean uses of the app</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility (Total Habits Attempted)</title>
        <description>Total amount of new habits attempted during the study</description>
        <time_frame>8-week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility (Total Habits Attempted)</title>
          <description>Total amount of new habits attempted during the study</description>
          <units>mean habits attempted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility (Recruitment Rates)</title>
        <description>Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)</description>
        <time_frame>Baseline</time_frame>
        <population>Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility (Recruitment Rates)</title>
          <description>Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)</description>
          <population>Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="559"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility (Retention Rates)</title>
        <description>Total attendance at groups and total withdrawn from the study</description>
        <time_frame>8-weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility (Retention Rates)</title>
          <description>Total attendance at groups and total withdrawn from the study</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Problem Solving Inventory</title>
        <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.</description>
        <time_frame>8-week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Problem Solving Inventory</title>
          <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.</description>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.64" spread="8.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-sample t-test testing the mean positive problem solving change from baseline to week 8.</non_inferiority_desc>
            <p_value>.63</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.64</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>8.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.34</ci_lower_limit>
            <ci_upper_limit>2.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Weight Change</title>
        <description>Measured in pounds with a digital scale</description>
        <time_frame>8-week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Individuals randomized to this condition will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>% Weight Change</title>
          <description>Measured in pounds with a digital scale</description>
          <units>percentage of pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-sample t-test testing the mean within-person percent weight change from baseline to week 8.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.019</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.0285</ci_lower_limit>
            <ci_upper_limit>-.0096</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Weight Change</title>
        <description>Measured in pounds with a digital scale</description>
        <time_frame>16 week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Individuals randomized to this condition will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>% Weight Change</title>
          <description>Measured in pounds with a digital scale</description>
          <units>percentage of pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.67" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-sample t-test testing the mean within-person percent weight change from baseline to week 16.</non_inferiority_desc>
            <p_value>0.143</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.017</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>.011</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.039</ci_lower_limit>
            <ci_upper_limit>.006</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Social Problem Solving Inventory</title>
        <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.</description>
        <time_frame>16-week follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Behavioral Weight Loss + Habit</title>
            <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Social Problem Solving Inventory</title>
          <description>The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.</description>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.76" spread="13.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-sample t-test testing the mean positive problem solving change from baseline to week 16.</non_inferiority_desc>
            <p_value>.73</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.76</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>13.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.11</ci_lower_limit>
            <ci_upper_limit>3.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were in the study for 16 weeks and were monitored for the occurrence of adverse events throughout the study. Adverse events were documented during the interventions, at the 8-week assessment, and the 16-week assessment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Behavioral Weight Loss + Habit</title>
          <description>Participants will receive 8 weeks of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.&#xD;
Diabetes Prevention Program Lifestyle Intervention</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cold, flu, or virus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Previous condition worsening</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <description>Injured back while cleaning</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sherry Pagoto, Professor</name_or_title>
      <organization>University of Massachusetts Medical School</organization>
      <phone>508-856-5159</phone>
      <email>study@umassmed.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02192905
org study id: H17-237
secondary id: 1R21DK098556-01
nct id: NCT02192905
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this research was to develop and test the feasibility of Habit, a weight loss
      mobile application that was designed to coach patients through their weight loss challenges.
      In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart
      Coach mobile application when paired with a shortened online-delivered (8-week) behavioral
      weight loss intervention. Feasibility outcomes included frequency and duration of usage of
      the mobile app and each feature, recruitment, and retention. Post-intervention focus groups
      discussed the feasibility and acceptability of the intervention. The investigators also
      performed exploratory analyses comparing conditions on problem solving skills and weight loss
      at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.
The investigators developed and tested the feasibility of Habit, a weight loss mobile app
      that includes common features such as self-monitoring, goal setting, and a social network,
      but even more importantly, an avatar-facilitated, idiographic problem solving feature that
      processes information intelligently to help patients identify solutions to their weight loss
      problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of
      the Habit mobile application when paired with a shortened (8 week) behavioral weight loss
      intervention. Feasibility outcomes included frequency and duration of usage of the mobile app
      and each feature, recruitment, and retention. The investigators also performed analyses on
      problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent
      randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted
      brief behavioral weight loss intervention relative to a brief behavioral weight loss
      intervention alone with 1 year follow-up. The investigators overarching goal is to develop
      mobile technology that reduces the intensity of lifestyle interventions as far as possible
      while preserving weight loss outcomes, to ultimately broaden reach.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility (Total Uses)
time frame: 8-week follow-up
description: Mean total uses of the problem solving function of the mobile application
measure: Feasibility (Total Habits Attempted)
time frame: 8-week follow-up
description: Total amount of new habits attempted during the study
measure: Feasibility (Recruitment Rates)
time frame: Baseline
description: Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)
measure: Feasibility (Retention Rates)
time frame: 8-weeks
description: Total attendance at groups and total withdrawn from the study
measure: Problem Solving Inventory
time frame: 8-week follow-up
description: The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.
measure: % Weight Change
time frame: 8-week follow-up
description: Measured in pounds with a digital scale
measure: % Weight Change
time frame: 16 week follow-up
description: Measured in pounds with a digital scale
measure: Social Problem Solving Inventory
time frame: 16-week follow-up
description: The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.
arm group label: Behavioral Weight Loss + Habit
arm group type: Experimental
description: Participants will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.
intervention type: Behavioral
intervention name: Diabetes Prevention Program Lifestyle Intervention
arm group label: Behavioral Weight Loss + Habit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sherry L Pagoto, PhD
role: Principal Investigator
affiliation: University of Connecticut
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Connecticut
investigator full name: Sherry Pagoto
investigator title: Professor
mesh term: Body Weight
mesh term: Weight Loss
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 