<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/NCT03784612</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr: 2018/652-31</org_study_id>
    <nct_id>NCT03784612</nct_id>
  </id_info>
  <brief_title>The Healthy Eating With APP technologY Study</brief_title>
  <acronym>HAPPY</acronym>
  <official_title>The HAPPY-study: Digital Support for Healthier Eating Habits in Patients With Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the effect of using new app-based technology to&#xD;
      improve dietary habits, compared to usual care in patients with type 2 diabetes. The&#xD;
      hypothesis is that the intervention, i.e. using the new technology an an app-based course for&#xD;
      healthy eating habits, will have a greater positive effect on dietary habits and biological&#xD;
      markers, including HbA1c and serum lipids, than usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dietary intake</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>Change in dietary intake assessed using a four day food record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>mmol/mol, Heamoglobin A1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>kg/m2, measured height and weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>kg, measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: Body fat</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>Body fat (kg), measured using a bioelectrical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: Fat free mass</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>Fat free mass (kg), measured using a bioelectrical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: Muscle mass</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>Muscle mass (kg), measured using a bioelectrical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: Total body water</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>Total body water (kg), measured using a bioelectrical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>cm, measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline and month 3, and 6</time_frame>
    <description>mmHg, measured</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in dietary intake and eating habits</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using a 94 item food frequency questionnaire (FFQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using a 21-item questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in physical activity assessed using the Active-Q questionnaire</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-reported medication use</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in tobacco use habits</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Two questions regarding smoking and Swedish snuff use</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in sleeping habits</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using a modified 13-item Karolinska Sleep questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in perceived purpose in Life (PIL)</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using 6-item questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in perceived stress levels</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using the 14-item perceived stress scale (PSS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-reported diabetes self-efficacy</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using a 20-item questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in health related quality of life</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using the 36-item RAND-36 questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in perceived social support from family and friends for healthy eating habits</measure>
    <time_frame>Baseline and month 3, 6 and 12</time_frame>
    <description>Assessed using a 3-item questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Dietary Habits</condition>
  <arm_group>
    <arm_group_label>App-technology group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the App-technology group arm will use a newly developed smartphone application (&quot;app&quot;), containing a 12-week healthy eating program.&#xD;
Intervention: App-technology for healthy eating habits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>App-technology for healthy eating habits</intervention_name>
    <description>Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.</description>
    <arm_group_label>App-technology group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of type 2 diabetes&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Ability to communicate in Swedish&#xD;
&#xD;
          -  Own and use a smartphone with a personal digital ID&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - No specific exclusion criteria apply&#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>Stephanie E Bonn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie E Bonn, PhD</last_name>
    <phone>0046851779173</phone>
    <email>stephanie.bonn@ki.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie E Bonn, PhD</last_name>
      <email>stephanie.bonn@ki.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Stephanie Bonn</investigator_full_name>
    <investigator_title>PhD, Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Smartphone application</keyword>
  <keyword>HbA1c</keyword>
  <keyword>Blood lipids</keyword>
  <keyword>Dietary intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03784612
org study id: Dnr: 2018/652-31
nct id: NCT03784612
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effect of using new app-based technology to
      improve dietary habits, compared to usual care in patients with type 2 diabetes. The
      hypothesis is that the intervention, i.e. using the new technology an an app-based course for
      healthy eating habits, will have a greater positive effect on dietary habits and biological
      markers, including HbA1c and serum lipids, than usual care.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in dietary intake
time frame: Baseline and month 3, and 6
description: Change in dietary intake assessed using a four day food record
measure: HbA1c
time frame: Baseline and month 3, and 6
description: mmol/mol, Heamoglobin A1c
measure: Total cholesterol
time frame: Baseline and month 3, and 6
description: mmol/L
measure: HDL-cholesterol
time frame: Baseline and month 3, and 6
description: mmol/L
measure: Triglycerides
time frame: Baseline and month 3, and 6
description: mmol/L
measure: Body Mass Index (BMI)
time frame: Baseline and month 3, and 6
description: kg/m2, measured height and weight
measure: Body weight
time frame: Baseline and month 3, and 6
description: kg, measured
measure: Body composition: Body fat
time frame: Baseline and month 3, and 6
description: Body fat (kg), measured using a bioelectrical scale
measure: Body composition: Fat free mass
time frame: Baseline and month 3, and 6
description: Fat free mass (kg), measured using a bioelectrical scale
measure: Body composition: Muscle mass
time frame: Baseline and month 3, and 6
description: Muscle mass (kg), measured using a bioelectrical scale
measure: Body composition: Total body water
time frame: Baseline and month 3, and 6
description: Total body water (kg), measured using a bioelectrical scale
measure: Waist circumference
time frame: Baseline and month 3, and 6
description: cm, measured
measure: Blood pressure
time frame: Baseline and month 3, and 6
description: mmHg, measured
measure: Change in dietary intake and eating habits
time frame: Baseline and month 3, 6 and 12
description: Assessed using a 94 item food frequency questionnaire (FFQ)
measure: Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)
time frame: Baseline and month 3, 6 and 12
description: Assessed using a 21-item questionnaire
measure: Change in physical activity assessed using the Active-Q questionnaire
time frame: Baseline and month 3, 6 and 12
description: Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise
measure: Change in self-reported medication use
time frame: Baseline and month 3, 6 and 12
description: One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels
measure: Change in tobacco use habits
time frame: Baseline and month 3, 6 and 12
description: Two questions regarding smoking and Swedish snuff use
measure: Change in sleeping habits
time frame: Baseline and month 3, 6 and 12
description: Assessed using a modified 13-item Karolinska Sleep questionnaire
measure: Change in perceived purpose in Life (PIL)
time frame: Baseline and month 3, 6 and 12
description: Assessed using 6-item questionnaire
measure: Change in perceived stress levels
time frame: Baseline and month 3, 6 and 12
description: Assessed using the 14-item perceived stress scale (PSS)
measure: Change in self-reported diabetes self-efficacy
time frame: Baseline and month 3, 6 and 12
description: Assessed using a 20-item questionnaire
measure: Change in health related quality of life
time frame: Baseline and month 3, 6 and 12
description: Assessed using the 36-item RAND-36 questionnaire
measure: Change in perceived social support from family and friends for healthy eating habits
time frame: Baseline and month 3, 6 and 12
description: Assessed using a 3-item questionnaire
arm group label: App-technology group
arm group type: Experimental
description: Participants in the App-technology group arm will use a newly developed smartphone application ("app"), containing a 12-week healthy eating program.
Intervention: App-technology for healthy eating habits.
arm group label: Control group
arm group type: No Intervention
description: The control group will receive standard care.
intervention type: Behavioral
intervention name: App-technology for healthy eating habits
description: Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.
arm group label: App-technology group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephanie E Bonn, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Stephanie E Bonn, PhD
phone: 0046851779173
email: stephanie.bonn@ki.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Stephanie Bonn
investigator title: PhD, Assistant professor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No