<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/NCT02228278</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400433</org_study_id>
    <nct_id>NCT02228278</nct_id>
  </id_info>
  <brief_title>Healthcare Text Messaging to Improve Diet, Physical Activity and Weight Loss in a Pediatric Lipid Clinic</brief_title>
  <acronym>Text4Fit</acronym>
  <official_title>Text 4 Fit Project: Healthcare Text Messaging to Improve Health Outcomes and Medication Compliance in Overweight and Obese Adolescents.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if health-related text messages sent from&#xD;
      healthcare providers to overweight and obese adolescents enrolled at a pediatric lipid clinic&#xD;
      will result in increased adherence to their nutrition and physical activity goals and improve&#xD;
      their weight loss. The study will also assess if the volume of texts per week impacts&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1: We will recruit 5 participants the from the UF Pediatric Lipid and Obesity clinic&#xD;
      for pre-intervention cognitive interviewing to assess acceptability of the intervention and&#xD;
      request their input on a representative sample of text messages. Then, 20 participants will&#xD;
      be recruited from the same clinic for the intervention (10 controls, 10 intervention&#xD;
      participants). Controls will receive current standard care - clinic visits every three months&#xD;
      anthropometric assessments and counseling on physical activity and nutrition goals by a&#xD;
      healthcare provider, typically with no patient-provider communication between visits. The&#xD;
      intervention group will receive the typical clinic visits plus daily text messages in between&#xD;
      visits with fitness and nutrition messages to support their health goals. All participants&#xD;
      will have anthropometric measurements at baseline, 3 and 6 months. Each participant will&#xD;
      complete a Schwartz Diet and Activity History at 0, 3 and 6 month visits, and a post&#xD;
      intervention survey will be completed at the 3 month time point.&#xD;
&#xD;
      Phase 2: The second phase will be a larger scale study to assess for statistically&#xD;
      significant effects of the text messaging intervention. One hundred participants will be&#xD;
      recruited from the UF Pediatric Lipid and Obesity Clinic, one hundred from the UF Pediatric&#xD;
      Headache Clinic and one hundred from the Congenital Heart Center for a total of three hundred&#xD;
      (n=300) participants at three clinic locations. Participants will be randomized at each&#xD;
      clinic location to one of two groups, Group A (immediate intervention, n=50) or Group B&#xD;
      (control group, delayed intervention, n=50).&#xD;
&#xD;
      Participants randomized to Group A will receive the typical clinic visits (which includes&#xD;
      anthropometric measures every three months, counselling on physical activity and nutrition&#xD;
      goals by a healthcare provider and for those prescribed medication for a chronic condition,&#xD;
      medication counseling by a healthcare provide) plus daily text messages in between visits for&#xD;
      3 months to support their health goals. Group B will initially act as the control and will&#xD;
      receive the typical clinic visits (which includes anthropometric measures every three months,&#xD;
      counseling on physical activity and nutrition goals by a healthcare provider, and for those&#xD;
      prescribed medication for a chronic condition, medication counseling by a healthcare&#xD;
      provider) with typically with no patient-provider communication between visits. After a&#xD;
      6-month delay, Group B will then receive the intervention which includes the typical clinic&#xD;
      visits as stated previously plus daily text messages in between visits for 3 months to&#xD;
      support their health goals. Participants will be seen in clinic at standard intervals for&#xD;
      routine follow up (typically every 3 months). Three months after participants finish&#xD;
      receiving the text messages, the same anthropometric and medication measures (for those&#xD;
      prescribed chronic medication) that were collected at baseline as part of routine care will&#xD;
      be repeated. Each participant will complete a Block Food Screener and Block Physical Activity&#xD;
      Screener at 0, 3, and 6 months. A post-intervention survey will be completed after the&#xD;
      participants have stopped receiving text messages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility and Acceptability of text message intervention (Phase 1)</measure>
    <time_frame>Change in baseline and 3 months</time_frame>
    <description>This will involve a pre-study interview with a small group of subjects to assess for their opinions on the text messages and study concept. Following this, we will perform a small scale trial of the program, involving 20 participants with 10 subjects in the intervention group and 10 controls. The number of participants will most likely not be adequate to reach statistical significance in detecting differences in healthy food choices, physical activity and BMI z-score between control and experimental groups. However, this study will help guide us in establishing if this healthcare texting system functions well. In addition, it may help determine if there are any trends in improvement of the target variables that would support the need for a future, larger study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline proportion of healthy food choices versus unhealthy choices</measure>
    <time_frame>Change in baseline, 3 and 6 months</time_frame>
    <description>Phase 1: We aim to have our adolescent subjects fill out a Schwartz Diet and Activity History at time points 0, 3 and 6 months. We will assess their baseline food choices and then assess for changes in food habits over time, with a prediction that this text message communication will help to decrease the &quot;negative&quot; food choices (sugars/syrups, non whole grain starches, processed foods, sugar sweetened beverages) and increase the &quot;positive&quot; food (fruits/vegetables, low fat dairy, water) choices by 10% (based on screener scores pre and post intervention).&#xD;
Phase 2: Each participant will complete a Block Food Screener and Block Physical Activity Screener, instead of the Schwartz Diet and Activity History, to assess the proportion of healthy food choices versus unhealthy choices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline time spent doing physical activity</measure>
    <time_frame>Change in baseline, 3 and 6 months</time_frame>
    <description>Phase 1: We aim to have our adolescent subjects complete a Schwartz Diet and Activity History at time points 0, 3 and 6 months. We will assess their baseline physical activity and then assess for changes in physical activity over time, with a prediction that this text message communication will help to decrease their sedentary time (and TV time) and increase their physical activity by 10% (based on screener scores pre and post intervention).&#xD;
Phase 2: Each participant will complete a Block Physical Activity Screener, instead of the Schwartz Diet and Activity History, to assess physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline BMI Z-score</measure>
    <time_frame>Change in baseline, 3 months and 6 months</time_frame>
    <description>Subjects will have assessments of height, weight, age and sex at 0, 3 and 6 month clinic visits. Researchers will assess for any changes in BMI Z-score across time points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A will receive the typical clinic visits plus daily text messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group B will act as the control and will receive the typical clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group A</intervention_name>
    <description>Phase 1: Group A will receive the typical clinic visits plus daily text messages for 12 weeks.&#xD;
Phase 2: Group A will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider and for those prescribed medication for a chronic condition, medication counseling by a healthcare provide) plus daily text messages in between visits for 3 months to support their health goals.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group B</intervention_name>
    <description>Phase 1: Group B will receive current standard care - clinic visits every three months anthropometric assessments and counseling on physical activity and nutrition goals by a healthcare provider, typically with no patient-provider communication between visits.&#xD;
Phase 2: Group B will initially act as the control and will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider, and for those prescribed medication for a chronic condition, medication counseling by a healthcare provider) with typically with no patient-provider communication between visits. After a 6-month delay, Group B will then receive the intervention which includes the typical clinic visits as stated previously plus daily text messages in between visits for 3 months to support their health goals.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase 1:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents age 13-17&#xD;
&#xD;
          -  Overweight or obese (BMI &gt; 85th percentile)&#xD;
&#xD;
          -  Attend or will start attending UF Pediatric Lipid Clinic during the study period&#xD;
&#xD;
          -  Own a cell phone that can receive text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of a psychiatric eating disorder (anorexia nervosa or bulimia)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Medical disease that would contraindicate moderate physical activity, as determined by&#xD;
             clinician (MD or NP) from the Lipid Clinic&#xD;
&#xD;
        Phase 2:&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  Ages 11-21&#xD;
&#xD;
          -  Overweight or obese (BMI &gt; 85th percentile)&#xD;
&#xD;
          -  Attend or will start attending UF Health Pediatric Lipid and Obesity Clinic,UF Health&#xD;
             Pediatric Headache Clinic or UF Health Congenital Heart Center during the study period&#xD;
&#xD;
          -  Own a cell phone that can receive text messages (or parent owns a cell phone that can&#xD;
             receive text messages)&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Current diagnosis of a psychiatric eating disorder (anorexia nervosa or bulimia)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Medical disease that would contraindicate moderate physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lindsay Thompson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida Health Shands Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristin A Dayton, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Florida Shands Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Gerold L Schiebler Children's Medical Services Center, Pediatric Lipid and Obesity Clinic</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Shands Medical Plaza, Pediatric Lipid and Obesity Clinic</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health and Congenital Heart Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Texting</keyword>
  <keyword>Text message</keyword>
  <keyword>SMS</keyword>
  <keyword>Diet</keyword>
  <keyword>Weight Loss</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Physical activity</keyword>
  <keyword>BMI z-score</keyword>
  <keyword>BMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</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/NCT02228278
org study id: IRB201400433
nct id: NCT02228278
lead sponsor: 
has dmc: No
The purpose of this study is to determine if health-related text messages sent from
      healthcare providers to overweight and obese adolescents enrolled at a pediatric lipid clinic
      will result in increased adherence to their nutrition and physical activity goals and improve
      their weight loss. The study will also assess if the volume of texts per week impacts
      outcomes.
Phase 1: We will recruit 5 participants the from the UF Pediatric Lipid and Obesity clinic
      for pre-intervention cognitive interviewing to assess acceptability of the intervention and
      request their input on a representative sample of text messages. Then, 20 participants will
      be recruited from the same clinic for the intervention (10 controls, 10 intervention
      participants). Controls will receive current standard care - clinic visits every three months
      anthropometric assessments and counseling on physical activity and nutrition goals by a
      healthcare provider, typically with no patient-provider communication between visits. The
      intervention group will receive the typical clinic visits plus daily text messages in between
      visits with fitness and nutrition messages to support their health goals. All participants
      will have anthropometric measurements at baseline, 3 and 6 months. Each participant will
      complete a Schwartz Diet and Activity History at 0, 3 and 6 month visits, and a post
      intervention survey will be completed at the 3 month time point.

      Phase 2: The second phase will be a larger scale study to assess for statistically
      significant effects of the text messaging intervention. One hundred participants will be
      recruited from the UF Pediatric Lipid and Obesity Clinic, one hundred from the UF Pediatric
      Headache Clinic and one hundred from the Congenital Heart Center for a total of three hundred
      (n=300) participants at three clinic locations. Participants will be randomized at each
      clinic location to one of two groups, Group A (immediate intervention, n=50) or Group B
      (control group, delayed intervention, n=50).

      Participants randomized to Group A will receive the typical clinic visits (which includes
      anthropometric measures every three months, counselling on physical activity and nutrition
      goals by a healthcare provider and for those prescribed medication for a chronic condition,
      medication counseling by a healthcare provide) plus daily text messages in between visits for
      3 months to support their health goals. Group B will initially act as the control and will
      receive the typical clinic visits (which includes anthropometric measures every three months,
      counseling on physical activity and nutrition goals by a healthcare provider, and for those
      prescribed medication for a chronic condition, medication counseling by a healthcare
      provider) with typically with no patient-provider communication between visits. After a
      6-month delay, Group B will then receive the intervention which includes the typical clinic
      visits as stated previously plus daily text messages in between visits for 3 months to
      support their health goals. Participants will be seen in clinic at standard intervals for
      routine follow up (typically every 3 months). Three months after participants finish
      receiving the text messages, the same anthropometric and medication measures (for those
      prescribed chronic medication) that were collected at baseline as part of routine care will
      be repeated. Each participant will complete a Block Food Screener and Block Physical Activity
      Screener at 0, 3, and 6 months. A post-intervention survey will be completed after the
      participants have stopped receiving text messages.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility and Acceptability of text message intervention (Phase 1)
time frame: Change in baseline and 3 months
description: This will involve a pre-study interview with a small group of subjects to assess for their opinions on the text messages and study concept. Following this, we will perform a small scale trial of the program, involving 20 participants with 10 subjects in the intervention group and 10 controls. The number of participants will most likely not be adequate to reach statistical significance in detecting differences in healthy food choices, physical activity and BMI z-score between control and experimental groups. However, this study will help guide us in establishing if this healthcare texting system functions well. In addition, it may help determine if there are any trends in improvement of the target variables that would support the need for a future, larger study.
measure: Changes from baseline proportion of healthy food choices versus unhealthy choices
time frame: Change in baseline, 3 and 6 months
description: Phase 1: We aim to have our adolescent subjects fill out a Schwartz Diet and Activity History at time points 0, 3 and 6 months. We will assess their baseline food choices and then assess for changes in food habits over time, with a prediction that this text message communication will help to decrease the "negative" food choices (sugars/syrups, non whole grain starches, processed foods, sugar sweetened beverages) and increase the "positive" food (fruits/vegetables, low fat dairy, water) choices by 10% (based on screener scores pre and post intervention).
Phase 2: Each participant will complete a Block Food Screener and Block Physical Activity Screener, instead of the Schwartz Diet and Activity History, to assess the proportion of healthy food choices versus unhealthy choices.
measure: Changes from baseline time spent doing physical activity
time frame: Change in baseline, 3 and 6 months
description: Phase 1: We aim to have our adolescent subjects complete a Schwartz Diet and Activity History at time points 0, 3 and 6 months. We will assess their baseline physical activity and then assess for changes in physical activity over time, with a prediction that this text message communication will help to decrease their sedentary time (and TV time) and increase their physical activity by 10% (based on screener scores pre and post intervention).
Phase 2: Each participant will complete a Block Physical Activity Screener, instead of the Schwartz Diet and Activity History, to assess physical activity
measure: Changes from baseline BMI Z-score
time frame: Change in baseline, 3 months and 6 months
description: Subjects will have assessments of height, weight, age and sex at 0, 3 and 6 month clinic visits. Researchers will assess for any changes in BMI Z-score across time points.
arm group label: Group A
arm group type: Experimental
description: Group A will receive the typical clinic visits plus daily text messages
arm group label: Group B
arm group type: Other
description: Group B will act as the control and will receive the typical clinic visits.
intervention type: Behavioral
intervention name: Group A
description: Phase 1: Group A will receive the typical clinic visits plus daily text messages for 12 weeks.
Phase 2: Group A will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider and for those prescribed medication for a chronic condition, medication counseling by a healthcare provide) plus daily text messages in between visits for 3 months to support their health goals.
arm group label: Group A
intervention type: Other
intervention name: Group B
description: Phase 1: Group B will receive current standard care - clinic visits every three months anthropometric assessments and counseling on physical activity and nutrition goals by a healthcare provider, typically with no patient-provider communication between visits.
Phase 2: Group B will initially act as the control and will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider, and for those prescribed medication for a chronic condition, medication counseling by a healthcare provider) with typically with no patient-provider communication between visits. After a 6-month delay, Group B will then receive the intervention which includes the typical clinic visits as stated previously plus daily text messages in between visits for 3 months to support their health goals.
arm group label: Group B
criteria: 
gender: All
minimum age: 11 Years
maximum age: 21 Years
healthy volunteers: No
last name: Lindsay Thompson, MD
role: Principal Investigator
affiliation: University of Florida Health Shands Children's Hospital
last name: Kristin A Dayton, MD
role: Study Director
affiliation: University of Florida Shands Children's Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: No