<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/NCT03749746</url>
  </required_header>
  <id_info>
    <org_study_id>18080007</org_study_id>
    <nct_id>NCT03749746</nct_id>
  </id_info>
  <brief_title>Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia</brief_title>
  <acronym>HH4NM</acronym>
  <official_title>Heart Health 4 New Moms: A Randomized Controlled Trial of a Lifestyle Intervention and Home Blood Pressure Monitoring Following Preeclampsia in Overweight and Obese Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high&#xD;
      recurrence risk and a rapid, occult progression to cardiovascular disease after delivery.&#xD;
      There is a critical need for effective interventions to reduce these risks. This is a pilot&#xD;
      randomized controlled trial of a novel postpartum lifestyle intervention compared to women&#xD;
      who take home blood pressure measurements and women with usual care who are overweight and&#xD;
      obese in the first year after preeclampsia. The investigators hypothesize that the&#xD;
      intervention will lead to improved weight loss and blood pressure in the first year&#xD;
      postpartum, which has broad implications for future pregnancy and long-term cardiovascular&#xD;
      health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of this study is to conduct a pilot trial of an internet-based&#xD;
      lifestyle intervention and home blood pressure monitoring in the year after delivery among&#xD;
      overweight and obese women with preeclampsia to evaluate feasibility, acceptability and to&#xD;
      assess the effect of the intervention. The investigators hypothesize that compared to usual&#xD;
      care, an internet-based lifestyle intervention implemented in the immediate postpartum period&#xD;
      in overweight and obese women with preeclampsia improves weight loss at one year postpartum.&#xD;
      150 overweight or obese women with preeclampsia will be randomized into internet-based&#xD;
      lifestyle intervention plus home blood pressure monitoring, home blood pressure monitoring&#xD;
      alone, or usual care groups in the postpartum period. The investigators will assess&#xD;
      feasibility by the proportions of women who are eligible, enroll, and remain in the study at&#xD;
      one year. The effect of home blood pressure monitoring on blood pressure and progression to&#xD;
      sustained hypertension will also be explored. A successful outcome of this study would have a&#xD;
      direct impact to improve cardiovascular health and future pregnancy health in women who have&#xD;
      had preeclampsia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>4-8 weeks postpartum to 8-12 months postpartum</time_frame>
    <description>weight change between two study visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>8-12 months postpartum</time_frame>
    <description>Systolic blood pressure at study visit 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>8-12 months postpartum</time_frame>
    <description>Diastolic blood pressure at study visit 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension</measure>
    <time_frame>8-12 months postpartum</time_frame>
    <description>Proportion of women with hypertension by AHA guidelines</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Preeclampsia</condition>
  <condition>Gestational Hypertension</condition>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <condition>Overweight and Obesity</condition>
  <condition>Pregnancy Complications</condition>
  <condition>Pregnancy Toxemia</condition>
  <condition>Postpartum Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Blood Pressure Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to usual care outlined above, each participant will receive a Bluetooth-enabled blood pressure cuff along with a checklist of proper technique and instructions on use. Women will be prompted to measure their BP across the first week of each month during the intervention. Based on guidelines, participants will take their blood pressure in the morning and evening, each time taking two readings separated by one minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart Health 4 New Moms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this group will receive instruction on the use of Heart Health 4 New Moms internet-based lifestyle intervention and home blood pressure monitoring. The internet-based intervention is comprised of four key components: an online curriculum with modules on healthy eating and physical activity, a self-monitoring and tracking program, a registered dietitian will act as a lifestyle coach for participants and a customized online toolbox.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Blood Pressure Monitoring</intervention_name>
    <description>Each participant will receive 1:1 training by the project staff in all aspects of home blood pressure monitoring (HBPM). Throughout the study, they will be asked to monitor home blood pressures for the first week of each month with Bluetooth-enabled blood pressure cuffs.</description>
    <arm_group_label>Heart Health 4 New Moms</arm_group_label>
    <arm_group_label>Home Blood Pressure Monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Heart Health 4 New Moms</intervention_name>
    <description>The intervention is comprised of four key components: (1) The online curriculum consists of 12 modules on healthy eating and physical activity adapted from the Diabetes Prevention Program and specifically targeting postpartum women. (2) Self-monitoring and tracking program, in which participants will be provided with a Bluetooth-enabled blood pressure cuff and digital scale and will be provided real-time feedback on their blood pressure and weight trends. (3) A registered dietitian will act as a lifestyle coach for participants with regular review of progress and provision of coaching notes, support and suggestions. (4) Finally participants will have access to a customized online toolbox, including dietary tracking sheets and recipes from the American Heart Association (AHA).</description>
    <arm_group_label>Heart Health 4 New Moms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pre-pregnancy body mass index ≥25 kg/m2&#xD;
&#xD;
          -  diagnosed with preeclampsia or gestational hypertension&#xD;
&#xD;
          -  access to internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple gestation&#xD;
&#xD;
          -  medical co-morbidities: chronic kidney disease, active liver disease (acute hepatitis,&#xD;
             chronic active hepatitis), active cardiac disease, pre-pregnancy diabetes mellitus,&#xD;
             chronic hypertension diagnosed prior to pregnancy&#xD;
&#xD;
          -  pregnancy prior to randomization&#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>Alisse Hauspurg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Magee-Womens Hospital of University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Magee-Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Alisse Hauspurg</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT03749746
org study id: 18080007
nct id: NCT03749746
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Preeclampsia causes devastating maternal and neonatal morbidity and mortality with a high
      recurrence risk and a rapid, occult progression to cardiovascular disease after delivery.
      There is a critical need for effective interventions to reduce these risks. This is a pilot
      randomized controlled trial of a novel postpartum lifestyle intervention compared to women
      who take home blood pressure measurements and women with usual care who are overweight and
      obese in the first year after preeclampsia. The investigators hypothesize that the
      intervention will lead to improved weight loss and blood pressure in the first year
      postpartum, which has broad implications for future pregnancy and long-term cardiovascular
      health.
The overall objective of this study is to conduct a pilot trial of an internet-based
      lifestyle intervention and home blood pressure monitoring in the year after delivery among
      overweight and obese women with preeclampsia to evaluate feasibility, acceptability and to
      assess the effect of the intervention. The investigators hypothesize that compared to usual
      care, an internet-based lifestyle intervention implemented in the immediate postpartum period
      in overweight and obese women with preeclampsia improves weight loss at one year postpartum.
      150 overweight or obese women with preeclampsia will be randomized into internet-based
      lifestyle intervention plus home blood pressure monitoring, home blood pressure monitoring
      alone, or usual care groups in the postpartum period. The investigators will assess
      feasibility by the proportions of women who are eligible, enroll, and remain in the study at
      one year. The effect of home blood pressure monitoring on blood pressure and progression to
      sustained hypertension will also be explored. A successful outcome of this study would have a
      direct impact to improve cardiovascular health and future pregnancy health in women who have
      had preeclampsia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Weight loss
time frame: 4-8 weeks postpartum to 8-12 months postpartum
description: weight change between two study visits
measure: Systolic blood pressure
time frame: 8-12 months postpartum
description: Systolic blood pressure at study visit 2
measure: Diastolic blood pressure
time frame: 8-12 months postpartum
description: Diastolic blood pressure at study visit 2
measure: Hypertension
time frame: 8-12 months postpartum
description: Proportion of women with hypertension by AHA guidelines
arm group label: Usual care
arm group type: Active Comparator
description: Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.
arm group label: Home Blood Pressure Monitoring
arm group type: Experimental
description: In addition to usual care outlined above, each participant will receive a Bluetooth-enabled blood pressure cuff along with a checklist of proper technique and instructions on use. Women will be prompted to measure their BP across the first week of each month during the intervention. Based on guidelines, participants will take their blood pressure in the morning and evening, each time taking two readings separated by one minute.
arm group label: Heart Health 4 New Moms
arm group type: Experimental
description: Participants randomized to this group will receive instruction on the use of Heart Health 4 New Moms internet-based lifestyle intervention and home blood pressure monitoring. The internet-based intervention is comprised of four key components: an online curriculum with modules on healthy eating and physical activity, a self-monitoring and tracking program, a registered dietitian will act as a lifestyle coach for participants and a customized online toolbox.
intervention type: Behavioral
intervention name: Home Blood Pressure Monitoring
description: Each participant will receive 1:1 training by the project staff in all aspects of home blood pressure monitoring (HBPM). Throughout the study, they will be asked to monitor home blood pressures for the first week of each month with Bluetooth-enabled blood pressure cuffs.
arm group label: Heart Health 4 New Moms
arm group label: Home Blood Pressure Monitoring
intervention type: Behavioral
intervention name: Heart Health 4 New Moms
description: The intervention is comprised of four key components: (1) The online curriculum consists of 12 modules on healthy eating and physical activity adapted from the Diabetes Prevention Program and specifically targeting postpartum women. (2) Self-monitoring and tracking program, in which participants will be provided with a Bluetooth-enabled blood pressure cuff and digital scale and will be provided real-time feedback on their blood pressure and weight trends. (3) A registered dietitian will act as a lifestyle coach for participants with regular review of progress and provision of coaching notes, support and suggestions. (4) Finally participants will have access to a customized online toolbox, including dietary tracking sheets and recipes from the American Heart Association (AHA).
arm group label: Heart Health 4 New Moms
intervention type: Other
intervention name: Usual care
description: Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.
arm group label: Usual care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alisse Hauspurg, MD
role: Principal Investigator
affiliation: Magee-Womens Hospital of University of Pittsburgh Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Alisse Hauspurg
investigator title: Assistant Professor
mesh term: Toxemia
mesh term: Pre-Eclampsia
mesh term: Pregnancy Complications
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
mesh term: Obesity
mesh term: Overweight
sharing ipd: No