<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/NCT03302377</url>
  </required_header>
  <id_info>
    <org_study_id>CFM281R</org_study_id>
    <nct_id>NCT03302377</nct_id>
  </id_info>
  <brief_title>Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)</brief_title>
  <acronym>FFT</acronym>
  <official_title>Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the feasibility of an intervention to increase physical activity&#xD;
      in pregnant women with diabetes by incorporating a brief in-person counseling session and&#xD;
      Fitbit activity trackers into routine clinical care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a small, one-armed pilot study testing a physical activity intervention for pregnant&#xD;
      patients with diabetes. The intervention will use both counseling and technology (a FitBit&#xD;
      physical activity tracker and smartphone app) to create an individualized, interactive&#xD;
      program for each patient. The primary aims of the study are to assess the feasibility of&#xD;
      recruiting patients and implementing the program in the clinical setting, and the&#xD;
      acceptability of the program for patients and clinicians. Participants will receive a&#xD;
      counseling session based on the principles of motivational interviewing to help them set&#xD;
      physical activity and step goals, then the interventionist will help them personalize the&#xD;
      Fitbit app to their goals. Participants are instructed to continue adaptive goal setting and&#xD;
      email their goals and activity weekly to their physicians. In addition to assessing&#xD;
      feasibility and acceptability, we will also evaluate change in activity to explore potential&#xD;
      efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>
    <intervention_model_description>As this is a feasibility study, all participants will receive the intervention</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Determined by retention (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Determined by participant feedback (% indicating satisfaction with intervention)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of recruitment</measure>
    <time_frame>baseline</time_frame>
    <description>Determined by percent of those screened who enroll in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity change</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Physical Activity</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Physical activity intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an individual counseling session in the clinic to help them set physical activity and step goals. They will then receive a Fitbit wrist monitor and help personalizing the Fitbit app. They will send weekly emails to their physicians reporting their goals and current activity. They will return at 12 weeks to engage in a semi-structured interview to give their overall impressions of the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>physical activity counseling &amp; Fitbit</intervention_name>
    <description>Participants will receive individual counseling &amp; guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features</description>
    <arm_group_label>Physical activity intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with type 2 diabetes or gestational diabetes&#xD;
&#xD;
          -  currently pregnant&#xD;
&#xD;
          -  in week 5-25 of gestation&#xD;
&#xD;
          -  under active (&lt;100 minutes/week of physical activity)&#xD;
&#xD;
          -  access to a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any medical condition that would make unsupervised activity unsafe or unfeasible, as&#xD;
             determined by their physician&#xD;
&#xD;
          -  moving from the area within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This study is for pregnant patients, so all participants will be female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Britta Larsen</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared with other researchers</ipd_description>
  </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/NCT03302377
org study id: CFM281R
nct id: NCT03302377
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate the feasibility of an intervention to increase physical activity
      in pregnant women with diabetes by incorporating a brief in-person counseling session and
      Fitbit activity trackers into routine clinical care
This is a small, one-armed pilot study testing a physical activity intervention for pregnant
      patients with diabetes. The intervention will use both counseling and technology (a FitBit
      physical activity tracker and smartphone app) to create an individualized, interactive
      program for each patient. The primary aims of the study are to assess the feasibility of
      recruiting patients and implementing the program in the clinical setting, and the
      acceptability of the program for patients and clinicians. Participants will receive a
      counseling session based on the principles of motivational interviewing to help them set
      physical activity and step goals, then the interventionist will help them personalize the
      Fitbit app to their goals. Participants are instructed to continue adaptive goal setting and
      email their goals and activity weekly to their physicians. In addition to assessing
      feasibility and acceptability, we will also evaluate change in activity to explore potential
      efficacy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: As this is a feasibility study, all participants will receive the intervention
primary purpose: Prevention
masking: None (Open Label)
measure: Retention
time frame: 12 weeks
description: Determined by retention (%)
measure: Acceptability
time frame: 12 weeks
description: Determined by participant feedback (% indicating satisfaction with intervention)
measure: Feasibility of recruitment
time frame: baseline
description: Determined by percent of those screened who enroll in the study
measure: Physical activity change
time frame: 12 weeks
description: Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline
arm group label: Physical activity intervention
arm group type: Experimental
description: Participants will receive an individual counseling session in the clinic to help them set physical activity and step goals. They will then receive a Fitbit wrist monitor and help personalizing the Fitbit app. They will send weekly emails to their physicians reporting their goals and current activity. They will return at 12 weeks to engage in a semi-structured interview to give their overall impressions of the intervention.
intervention type: Behavioral
intervention name: physical activity counseling & Fitbit
description: Participants will receive individual counseling & guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features
arm group label: Physical activity intervention
criteria: 
gender: Female
gender based: Yes
gender description: This study is for pregnant patients, so all participants will be female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Britta Larsen
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: Individual participant data will not be shared with other researchers