<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/NCT03304782</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR3883</org_study_id>
    <nct_id>NCT03304782</nct_id>
  </id_info>
  <brief_title>Fitbit Activity Tracker to Predict Risk of Preterm Birth</brief_title>
  <official_title>Quantitative Activity Levels and Gestational Age at Delivery: A Prospective Cohort Study Among Nulliparous Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
      Almost half of all deliveries in the United States are of nulliparous patients. They have&#xD;
      been identified as an at-risk population for preterm birth. Historically, the most&#xD;
      significant risk factor for preterm birth is a prior history of preterm birth, which cannot&#xD;
      be applied to a nulliparous population. Forecasting adverse outcomes in first time moms is&#xD;
      difficult to predict and prevent. Historically, physicians have prescribed a restriction in&#xD;
      activity level for those at risk for preterm delivery. The utility of this intervention has&#xD;
      yet to be prospectively and quantitatively studied. The Fitbit activity tracker is a wearable&#xD;
      device that has been extensively used in medical research, in an attempt to quantitatively&#xD;
      identify how patient activity levels can improve medical outcomes. The study uses the Fitbit&#xD;
      device in nulliparous patients, remotely track their activity levels throughout pregnancy,&#xD;
      and assess pregnancy outcomes. Because of the significant and long-standing health disparity&#xD;
      in the incidence of preterm delivery, the investigators will use the &quot;Everyday Discrimination&#xD;
      Scale&quot;, a validated battery of racism and health to see how a patient's stress related to&#xD;
      perceived discrimination may modify the risk of preterm delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm birth (PTB) remains one of the leading causes of neonatal morbidity and mortality,&#xD;
      with a variety of modifiable and non-modifiable risk factors. In an attempt to prevent PTB,&#xD;
      activity restriction is one of the most commonly prescribed interventions in obstetrics, with&#xD;
      the idea that decreasing activity will mitigate the risk of a preterm delivery (PTD).&#xD;
      However, there has been a lack of evidence in the literature to support this theory. In fact,&#xD;
      multiple studies have demonstrated that decreased activity levels have decreased time to&#xD;
      delivery in both women with a short cervix, as well as nulliparous patients at increased risk&#xD;
      for PTB.&#xD;
&#xD;
      Approximately 40% of deliveries in the United States are nulliparous. For this overwhelming&#xD;
      large portion of women, a knowledge gap exists in assessing their risk for PTB. The most&#xD;
      powerful risk factor for PTB, a previous PTB, is not applicable to this cohort of women. The&#xD;
      precise etiology of PTB in nulliparous women remains unknown but factors found to be&#xD;
      associated have included health behaviors , as well as being part of disadvantaged&#xD;
      populations. Studies have demonstrated a significant racial disparity in PTB, contributing to&#xD;
      the disproportionally worse fetal outcomes in minority populations. Institutional racism,&#xD;
      reported stress levels and discrimination have all been identified as risk factors for PTB.&#xD;
&#xD;
      Interventions to prevent PTB have thus far found to be ineffective, and therein likes an&#xD;
      opportunity to identify risk factors in this largely unstudied population and create&#xD;
      measures, focusing on behavior modification and acknowledging related risks of health&#xD;
      disparities to impact maternal and neonatal outcomes.&#xD;
&#xD;
      Currently there are no published prospective studies using quantitative measures to evaluate&#xD;
      physical activity in relation to gestational age at delivery. Based on a cohort design, our&#xD;
      objective is to use a Fitbit activity tracking device, and assess nulliparous patients. Our&#xD;
      hypothesis is that higher physical activity measured in steps per day will be associated with&#xD;
      a later gestational age at delivery.&#xD;
&#xD;
      Each participant will be given a Fitbit, complementary of participating in the study. Women&#xD;
      will be instructed to wear the Fitbit to measure physical activity throughout the duration of&#xD;
      the entire pregnancy, 24 hours a day. The Fitbit has been shown to be valid measure of steps&#xD;
      under laboratory conditions. Also, the Fitbit provides estimates of &quot;sedentary&quot;, &quot;light&quot;,&#xD;
      &quot;fairly active&quot; and &quot;very active&quot; minutes as daily accumulated totals. All data from the&#xD;
      Fitbit device will be acquired using the Fitabase software system. Fitabase is a research&#xD;
      software platform that collects data from devices remotely in near real time as devices sync&#xD;
      and update to the Fitabase dashboard. It creates spreadsheet exports of reported data, which&#xD;
      can be retrieved remotely by investigators. Fitabase stores the data collected in high&#xD;
      security data centers, and only permitted research personnel can access the data.&#xD;
&#xD;
      Upon enrollment in the study, researchers will administer the Fitbit device to each study&#xD;
      participant. Researchers will register participants with the Fitabase software system, giving&#xD;
      them a unique anonymous patient identifier, which will link each patient and their Fitbit to&#xD;
      the Fitabase software system. User accounts will be created by the enrolling researcher for&#xD;
      each participant account authorizing access to the Fitbit data for study personnel only. The&#xD;
      data collected from the Fitbit is continuously uploaded remotely from the wearable device to&#xD;
      the Fitabase software; new information is uploaded every 20 minutes. The device only holds a&#xD;
      total of 7 days of patient activity information, so the participant will be required to sync&#xD;
      their device to the software system every 7 days. This is done by an app, which is downloaded&#xD;
      on the participants' phone at the enrollment of the study. Of note, Fitbit data (ie: steps,&#xD;
      activity monitoring) will be blinded to the participants; the Fitbit device has no visible&#xD;
      monitoring screen. Research assistants will monitor compliance of participants to syncing&#xD;
      their Fitbit and will be sent an email reminder if they do not sync the Fitbit within the&#xD;
      last five days. Days with '0' minutes of registered activity will be considered non-valid and&#xD;
      set to missing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in number of steps</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>The difference in steps per day between women that deliver preterm versus those that deliver at term will be analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average number of steps for those women who deliver prior to 37 weeks gestation</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>Average number of steps for those women who deliver prior to 37 weeks gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of steps for those women who delivery prior to 34 weeks gestation</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>Average number of steps for those women who delivery prior to 34 weeks gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in steps per week</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>Change in steps per week over each trimester</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of triage visits</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>Number of triage visits for threatened preterm labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of inpatient hospitalizations</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>Number of inpatient hospitalizations for threatened preterm labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse maternal outcomes</measure>
    <time_frame>Duration of pregnancy (&lt;9months)</time_frame>
    <description>Incidence of adverse maternal outcomes including pre-eclampsia, diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse fetal outcomes</measure>
    <time_frame>Duration of pregnancy (&lt;9months)</time_frame>
    <description>Incidence of adverse fetal outcomes including Intrauterine growth restriction (IUGR), oligohydramnios, placental abruption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cesarean section</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>Incidence of cesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy physical activity questionnaire (PPAQ)</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>The PPAQ is a validated, self-administered questionnaire that takes on average 10-15 minutes to complete, and has been used to assess the current physical activity levels of pregnant women. This questionnaire is composed of 32 questions, grouped into different types of activities. an estimated average metabolic equivalent (MET-hr/wk) value will be calculated. Clinical practice guidelines have shown that achieving 8.5 MET-hr/wk is associated with healthy gestational weight gain (GWG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Duration of pregnancy (&lt; 9months)</time_frame>
    <description>The PSS is a classic stress assessment instrument. For each question, the answers are ranked as follows: 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often, 4 - very often. A calculated total score can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 - low stress; 14-26 - moderate stress; 27-40 - high perceived stress.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Preterm Birth</condition>
  <condition>Preterm Delivery</condition>
  <arm_group>
    <arm_group_label>Preterm birth</arm_group_label>
    <description>Data collected using Fitbit activity tracker from women with delivery prior to 37 weeks gestation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full-term birth</arm_group_label>
    <description>Data collected using Fitbit activity tracker from women with delivery after 37 weeks gestation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fitbit activity tracker</intervention_name>
    <description>Wearable device that records the number of steps a person takes throughout the day</description>
    <arm_group_label>Full-term birth</arm_group_label>
    <arm_group_label>Preterm birth</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are having their first baby, and have a low risk pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented single viable intrauterine pregnancy at the time of enrollment&#xD;
&#xD;
          -  Nulliparous women&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Access to a smartphone or computer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected major congenital anomalies or aneuploidy&#xD;
&#xD;
          -  Fetal demise&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Known maternal medical complications (increasing patient risk for indicated (planned)&#xD;
             preterm delivery:&#xD;
&#xD;
               -  Pre-gestational diabetes White's Class D or worse&#xD;
&#xD;
               -  Cancer (undergoing treatment)&#xD;
&#xD;
               -  Current hyperthyroidism if not adequately controlled&#xD;
&#xD;
               -  Renal disease with altered renal function (serum creatinine &gt; 1.5)&#xD;
&#xD;
               -  Systemic lupus, scleroderma, polymyalgia rheumatica&#xD;
&#xD;
               -  Active liver disease (acute hepatitis, chronic active hepatitis, persistently&#xD;
                  abnormal liver enzymes)&#xD;
&#xD;
               -  Platelet or red blood cell disorder&#xD;
&#xD;
               -  Chronic pulmonary disease (aside from asthma)&#xD;
&#xD;
               -  Structural, functional or ischemic heart disease. Neither mitral valve prolapse&#xD;
                  nor paroxysmal supraventricular tachycardia are considered exclusions.&#xD;
&#xD;
               -  Known HIV positive with viral load greater than 1,000 copies/ml or cluster of&#xD;
                  differentiation 4 (CD4) count less than 350/mm3&#xD;
&#xD;
               -  Current or planned cerclage&#xD;
&#xD;
               -  Planned delivery prior to 37 weeks&#xD;
&#xD;
               -  Planned delivery at a non-participating hospital&#xD;
&#xD;
          -  Patients who do not have regular access to a smart phone or computer&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Cynthia Gyamfi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</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 9, 2017</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Cynthia Gyamfi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Preterm Birth</keyword>
  <keyword>Fitbit</keyword>
  <keyword>Preterm Delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03304782
org study id: AAAR3883
nct id: NCT03304782
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Almost half of all deliveries in the United States are of nulliparous patients. They have
      been identified as an at-risk population for preterm birth. Historically, the most
      significant risk factor for preterm birth is a prior history of preterm birth, which cannot
      be applied to a nulliparous population. Forecasting adverse outcomes in first time moms is
      difficult to predict and prevent. Historically, physicians have prescribed a restriction in
      activity level for those at risk for preterm delivery. The utility of this intervention has
      yet to be prospectively and quantitatively studied. The Fitbit activity tracker is a wearable
      device that has been extensively used in medical research, in an attempt to quantitatively
      identify how patient activity levels can improve medical outcomes. The study uses the Fitbit
      device in nulliparous patients, remotely track their activity levels throughout pregnancy,
      and assess pregnancy outcomes. Because of the significant and long-standing health disparity
      in the incidence of preterm delivery, the investigators will use the "Everyday Discrimination
      Scale", a validated battery of racism and health to see how a patient's stress related to
      perceived discrimination may modify the risk of preterm delivery.
Preterm birth (PTB) remains one of the leading causes of neonatal morbidity and mortality,
      with a variety of modifiable and non-modifiable risk factors. In an attempt to prevent PTB,
      activity restriction is one of the most commonly prescribed interventions in obstetrics, with
      the idea that decreasing activity will mitigate the risk of a preterm delivery (PTD).
      However, there has been a lack of evidence in the literature to support this theory. In fact,
      multiple studies have demonstrated that decreased activity levels have decreased time to
      delivery in both women with a short cervix, as well as nulliparous patients at increased risk
      for PTB.

      Approximately 40% of deliveries in the United States are nulliparous. For this overwhelming
      large portion of women, a knowledge gap exists in assessing their risk for PTB. The most
      powerful risk factor for PTB, a previous PTB, is not applicable to this cohort of women. The
      precise etiology of PTB in nulliparous women remains unknown but factors found to be
      associated have included health behaviors , as well as being part of disadvantaged
      populations. Studies have demonstrated a significant racial disparity in PTB, contributing to
      the disproportionally worse fetal outcomes in minority populations. Institutional racism,
      reported stress levels and discrimination have all been identified as risk factors for PTB.

      Interventions to prevent PTB have thus far found to be ineffective, and therein likes an
      opportunity to identify risk factors in this largely unstudied population and create
      measures, focusing on behavior modification and acknowledging related risks of health
      disparities to impact maternal and neonatal outcomes.

      Currently there are no published prospective studies using quantitative measures to evaluate
      physical activity in relation to gestational age at delivery. Based on a cohort design, our
      objective is to use a Fitbit activity tracking device, and assess nulliparous patients. Our
      hypothesis is that higher physical activity measured in steps per day will be associated with
      a later gestational age at delivery.

      Each participant will be given a Fitbit, complementary of participating in the study. Women
      will be instructed to wear the Fitbit to measure physical activity throughout the duration of
      the entire pregnancy, 24 hours a day. The Fitbit has been shown to be valid measure of steps
      under laboratory conditions. Also, the Fitbit provides estimates of "sedentary", "light",
      "fairly active" and "very active" minutes as daily accumulated totals. All data from the
      Fitbit device will be acquired using the Fitabase software system. Fitabase is a research
      software platform that collects data from devices remotely in near real time as devices sync
      and update to the Fitabase dashboard. It creates spreadsheet exports of reported data, which
      can be retrieved remotely by investigators. Fitabase stores the data collected in high
      security data centers, and only permitted research personnel can access the data.

      Upon enrollment in the study, researchers will administer the Fitbit device to each study
      participant. Researchers will register participants with the Fitabase software system, giving
      them a unique anonymous patient identifier, which will link each patient and their Fitbit to
      the Fitabase software system. User accounts will be created by the enrolling researcher for
      each participant account authorizing access to the Fitbit data for study personnel only. The
      data collected from the Fitbit is continuously uploaded remotely from the wearable device to
      the Fitabase software; new information is uploaded every 20 minutes. The device only holds a
      total of 7 days of patient activity information, so the participant will be required to sync
      their device to the software system every 7 days. This is done by an app, which is downloaded
      on the participants' phone at the enrollment of the study. Of note, Fitbit data (ie: steps,
      activity monitoring) will be blinded to the participants; the Fitbit device has no visible
      monitoring screen. Research assistants will monitor compliance of participants to syncing
      their Fitbit and will be sent an email reminder if they do not sync the Fitbit within the
      last five days. Days with '0' minutes of registered activity will be considered non-valid and
      set to missing.
observational model: Cohort
time perspective: Prospective
measure: Difference in number of steps
time frame: Duration of pregnancy (< 9months)
description: The difference in steps per day between women that deliver preterm versus those that deliver at term will be analyzed.
measure: Average number of steps for those women who deliver prior to 37 weeks gestation
time frame: Duration of pregnancy (< 9months)
description: Average number of steps for those women who deliver prior to 37 weeks gestation
measure: Average number of steps for those women who delivery prior to 34 weeks gestation
time frame: Duration of pregnancy (< 9months)
description: Average number of steps for those women who delivery prior to 34 weeks gestation
measure: Change in steps per week
time frame: Duration of pregnancy (< 9months)
description: Change in steps per week over each trimester
measure: Number of triage visits
time frame: Duration of pregnancy (< 9months)
description: Number of triage visits for threatened preterm labor
measure: Number of inpatient hospitalizations
time frame: Duration of pregnancy (< 9months)
description: Number of inpatient hospitalizations for threatened preterm labor
measure: Incidence of adverse maternal outcomes
time frame: Duration of pregnancy (<9months)
description: Incidence of adverse maternal outcomes including pre-eclampsia, diabetes
measure: Incidence of adverse fetal outcomes
time frame: Duration of pregnancy (<9months)
description: Incidence of adverse fetal outcomes including Intrauterine growth restriction (IUGR), oligohydramnios, placental abruption
measure: Incidence of cesarean section
time frame: Duration of pregnancy (< 9months)
description: Incidence of cesarean section
measure: Pregnancy physical activity questionnaire (PPAQ)
time frame: Duration of pregnancy (< 9months)
description: The PPAQ is a validated, self-administered questionnaire that takes on average 10-15 minutes to complete, and has been used to assess the current physical activity levels of pregnant women. This questionnaire is composed of 32 questions, grouped into different types of activities. an estimated average metabolic equivalent (MET-hr/wk) value will be calculated. Clinical practice guidelines have shown that achieving 8.5 MET-hr/wk is associated with healthy gestational weight gain (GWG).
measure: Perceived Stress Scale (PSS)
time frame: Duration of pregnancy (< 9months)
description: The PSS is a classic stress assessment instrument. For each question, the answers are ranked as follows: 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often, 4 - very often. A calculated total score can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 - low stress; 14-26 - moderate stress; 27-40 - high perceived stress.
arm group label: Preterm birth
description: Data collected using Fitbit activity tracker from women with delivery prior to 37 weeks gestation
arm group label: Full-term birth
description: Data collected using Fitbit activity tracker from women with delivery after 37 weeks gestation
intervention type: Other
intervention name: Fitbit activity tracker
description: Wearable device that records the number of steps a person takes throughout the day
arm group label: Full-term birth
arm group label: Preterm birth
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia Gyamfi, M.D.
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Cynthia Gyamfi
investigator title: Principal Investigator
mesh term: Premature Birth
sharing ipd: No