<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/NCT03302260</url>
  </required_header>
  <id_info>
    <org_study_id>REB17-1264</org_study_id>
    <nct_id>NCT03302260</nct_id>
  </id_info>
  <brief_title>Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial</brief_title>
  <acronym>IMPROVE</acronym>
  <official_title>IMPROVE (Identifying Methods for Postpartum Reduction of Vascular Events): Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</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>
      IMPROVE is a pilot RCT with a behavioral intervention component (CardioPrevent program). The&#xD;
      primary objectives of this pilot study are to assess the feasibility of the implementation of&#xD;
      a postpartum CVD prevention lifestyle program in women with a HDP as well as the&#xD;
      transferability and fidelity of the Ottawa-based CardioPrevent® program to a centre in&#xD;
      Calgary (following a &quot;Train the Trainer&quot; model). Secondary objectives include an initial&#xD;
      evaluation of the effectiveness of this intervention on clinical outcomes and measures of&#xD;
      microvascular function between study arms at one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background and Rationale&#xD;
&#xD;
           Cardiovascular disease (CVD) (i.e., coronary artery disease, stroke, and peripheral&#xD;
           arterial disease) is one of the leading causes of morbidity and mortality in Canada,&#xD;
           particularly amongst women. Women with hypertensive disorders of pregnancy (HDP)&#xD;
           represent one of the highest-risk populations for premature CVD and CVD mortality. The&#xD;
           2011 American Heart Association (AHA) Guidelines on the prevention of CVD in women now&#xD;
           include HDP as an independent CVD risk factor in the evaluation of CVD risk. To achieve&#xD;
           &quot;ideal cardiovascular health&quot; targets, healthy lifestyle modifications are suggested as&#xD;
           first-line therapy, with pharmacotherapy as second line. The immediate postpartum period&#xD;
           may be an early window of opportunity for early upstream CVD prevention, capitalizing on&#xD;
           a woman's increased motivation to improve her health. Despite these recommendations and&#xD;
           opportunity for early CVD prevention, there is little published data, and, in&#xD;
           particular, there are no randomized controlled trials (RCT) assessing the short-term or&#xD;
           long-term effectiveness of lifestyle interventions in women with HDP.&#xD;
&#xD;
           To address this important clinical problem and knowledge gap, the interdisciplinary&#xD;
           IMPROVE team adapted the evidence-based University of Ottawa Heart Institute&#xD;
           CardioPrevent® Lifestyle program to proactively address the unique barriers to, and&#xD;
           facilitators of behaviour change in early postpartum women with HDP. Prior to&#xD;
           undertaking a widespread evaluation of CardioPrevent® in a CVD prevention study for&#xD;
           women with HDP, a pre-assessment of the feasibility of this postpartum lifestyle program&#xD;
           using this research approach through a pilot study is essential. In addition, this pilot&#xD;
           study will provide important information on CardioPrevent®'s effectiveness on modifying&#xD;
           clinically-important cardiovascular-related clinical outcomes and novel, non-invasive&#xD;
           measures of microvascular function in early postpartum women with HDP to inform the&#xD;
           design of a larger CVD prevention study. This pilot RCT will be the first to assess the&#xD;
           feasibility and effects of a one-year postpartum-specific CVD prevention lifestyle&#xD;
           program in women with a HDP.&#xD;
&#xD;
        2. Research Questions &amp; Objectives&#xD;
&#xD;
           The primary objectives of this pilot study are to assess the feasibility of the&#xD;
           implementation of a postpartum CVD prevention lifestyle program in women with a HDP as&#xD;
           well as the transferability and fidelity of the Ottawa-based CardioPrevent® program to a&#xD;
           centre in Calgary (following a &quot;Train the Trainer&quot; model). Secondary objectives include:&#xD;
           an initial evaluation of the effectiveness of this intervention on clinical outcomes and&#xD;
           measures of microvascular function between study arms at one year.&#xD;
&#xD;
        3. Methods&#xD;
&#xD;
      Study Design: A 2-year, single centre, single-blind, pilot randomized controlled trial (RCT).&#xD;
&#xD;
      Study Population (Inclusion/Exclusion Criteria): Women with a HDP (i.e., preeclampsia,&#xD;
      eclampsia or gestational hypertension) delivering at the Foothills Medical Centre will be&#xD;
      invited to participate. Women with pre-existing chronic hypertension, diabetes (type 1 or&#xD;
      type 2), kidney disease or cardiovascular disease (coronary artery, cerebrovascular and&#xD;
      peripheral arterial) will be excluded.&#xD;
&#xD;
      Intervention: CardioPrevent® Program - a one year, evidence-based cardiovascular prevention&#xD;
      program that consists of 25 contacts (either in person or by phone) with a trained behaviour&#xD;
      change counsellor to facilitate desired lifestyle behaviours within the participants' own&#xD;
      social context.&#xD;
&#xD;
      Control: Standard clinical postpartum care. All Participants: Participants in both arms will&#xD;
      receive educational material about the risk of CVD and CVD prevention for women with HDP from&#xD;
      the Preeclampsia Foundation.&#xD;
&#xD;
      Sample size: A total of 84 women will be recruited (42 in each arm). Recruitment &amp; Retention:&#xD;
      There are over 7000 deliveries per year at the FMC. Using a conservative estimate of 7%&#xD;
      prevalence of HDP (as it is a tertiary care referral centre), approximately 245 women (10 per&#xD;
      week) will have HDP over our 6-month recruitment period. The investigators anticipate&#xD;
      recruiting 2-3 eligible women per week to reach the target sample size in 6 months. To&#xD;
      minimize loss to follow-up, they plan to use participant incentives such as covering the&#xD;
      costs of parking and childcare.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2019</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The nature of the intervention (i.e., the CardioPrevent® cognitive-behavioural lifestyle counsellor) does not lend itself to blinding of the participant. However, the research assistant responsible for the outcome assessments will be blinded to each participant's group allocation and will be instructed not to ask any questions pertaining to the study intervention. The study statistician will also be blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Study feasibility - recruitment</measure>
    <time_frame>2 years</time_frame>
    <description>Acceptance of the study by women with HDP (i.e., feasibility) measured by recruitment rate of ≥ 20% over a 6-month time period (as per weekly recruitment logs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study feasibility - adherence</measure>
    <time_frame>2 years</time_frame>
    <description>Acceptance of the study by women with HDP (i.e., feasibility) measured by participant adherence of ≥ 80% to the lifestyle program (i.e., 20/25 contacts with counsellor completed).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study feasibility - study completion</measure>
    <time_frame>2 years</time_frame>
    <description>Acceptance of the study by women with HDP (i.e., feasibility) measured by overall study completion rate of ≥ 75% of participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study feasibility - participant satisfaction</measure>
    <time_frame>2 years</time_frame>
    <description>Acceptance of the study by women with HDP (i.e., feasibility) measured by participant satisfaction score of ≥ fair on the Client Satisfaction Questionnaire at the end of study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - audits</measure>
    <time_frame>2 years</time_frame>
    <description>Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by standardized audits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - clinical outcomes</measure>
    <time_frame>2 years</time_frame>
    <description>Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by similar clinical outcomes between sites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of weight (kg) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of BMI (kg/m^2) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-to-hip ratio</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of waist-to-hip ratio between both study arms at one year of follow-up .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking status</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of smoking status between both study arms at one year of follow-up (CO levels &lt;10ppm confirmatory for non-smoking).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum depression</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of postpartum depression between both study arms at one year of follow-up (measured by the Edinburgh Postnatal Depression Scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of blood pressure (mmHg) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lipids</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of fasting lipids (mmol/L) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of fasting glucose (mmol/L) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of HbA1C (%) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine albumin to creatinine ratio</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of urine albumin to creatinine ratio between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic syndrome</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of metabolic syndrome between both study arms at one year of follow-up measured by z-score (calculated using Adult Treatment Panel (ATP) III Criteria for Metabolic Syndrome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of CVD risk between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microvascular function - flow mediated dilation (FMD)</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of FMD between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microvascular function - brachial artery hyperemic velocity</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of brachial artery hyperemic velocity between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microvascular function - peripheral arterial tonometry (PAT)</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of PAT between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in amount of physical activity recorded in questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of amount of physical activity (IPAQ short form) logs between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in amount of physical activity recorded in activity logs</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of amount of physical activity (physical activity logs) logs between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in amount of physical activity captured by accelerometer</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of amount of physical activity (accelerometer data) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dietary behavior</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of eating behaviors (Rapid eating assessment of patients) questionnaire between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in nutrient status</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of nutrient status (measured by three days of prospective food logs) between both study arms at one year of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control arm will receive standard postpartum clinical care through the participants' usual healthcare providers. No intervention will be administered. Participants in both arms will receive educational material about the risk of CVD, and CVD prevention for women with HDP from the Preeclampsia Foundation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CardioPrevent® Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to standard care, participants randomized to the intervention arm will also receive the CardioPrevent® Program. This is a 1-year, evidence-based behaviour change lifestyle program that consists of 25 contacts (in person, by phone and in groups) with a trained lifestyle counsellor to facilitate desired lifestyle behaviours within the participants' own social context. Participants in both arms will receive educational material about the risk of CVD, and CVD prevention for women with HDP from the Preeclampsia Foundation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CardioPrevent® Program</intervention_name>
    <description>This is a 1-year, evidence-based behaviour change lifestyle program that consists of 25 contacts (in person, by phone and in groups) with a trained lifestyle counsellor to facilitate desired lifestyle behaviours within the participants' own social context.</description>
    <arm_group_label>CardioPrevent® Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult women aged 18 years or older;&#xD;
&#xD;
          -  diagnosis of a HDP (i.e., preeclampsia, eclampsia or gestational hypertension);&#xD;
&#xD;
          -  delivering at The Foothills Medical Centre (FMC) in Calgary, Alberta;&#xD;
&#xD;
          -  ability to read, write, understand, and provide informed consent in English; and&#xD;
&#xD;
          -  have telephone access.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-existing vascular disease (coronary artery disease [i.e., stable angina, unstable&#xD;
             angina,&#xD;
&#xD;
          -  myocardial infarction, percutaneous coronary intervention or coronary artery bypass&#xD;
             surgery],&#xD;
&#xD;
          -  cerebrovascular disease [i.e., ischemic stroke or transient ischemic attack], or&#xD;
             peripheral arterial&#xD;
&#xD;
          -  disease [i.e., known abnormal ankle-brachial indices, symptoms of intermittent&#xD;
             claudication, or&#xD;
&#xD;
          -  bypass surgery to the extremities]);&#xD;
&#xD;
          -  chronic hypertension;&#xD;
&#xD;
          -  diabetes (type 1 or type 2);&#xD;
&#xD;
          -  pre-pregnancy kidney disease;&#xD;
&#xD;
          -  planning another pregnancy within one year;&#xD;
&#xD;
          -  counselling may not be appropriate (i.e., impaired cognition);&#xD;
&#xD;
          -  live more than 200 km outside the Calgary region; and&#xD;
&#xD;
          -  planning to move outside the Calgary region within one year of randomization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kara Nerenberg</last_name>
    <phone>(403) 220-6376</phone>
    <email>kara.nerenberg@ucalgary.ca</email>
  </overall_contact>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>maternal health</keyword>
  <keyword>pregnancy</keyword>
  <keyword>pre-eclampsia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</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/NCT03302260
org study id: REB17-1264
nct id: NCT03302260
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
IMPROVE is a pilot RCT with a behavioral intervention component (CardioPrevent program). The
      primary objectives of this pilot study are to assess the feasibility of the implementation of
      a postpartum CVD prevention lifestyle program in women with a HDP as well as the
      transferability and fidelity of the Ottawa-based CardioPrevent® program to a centre in
      Calgary (following a "Train the Trainer" model). Secondary objectives include an initial
      evaluation of the effectiveness of this intervention on clinical outcomes and measures of
      microvascular function between study arms at one year.
1. Background and Rationale

           Cardiovascular disease (CVD) (i.e., coronary artery disease, stroke, and peripheral
           arterial disease) is one of the leading causes of morbidity and mortality in Canada,
           particularly amongst women. Women with hypertensive disorders of pregnancy (HDP)
           represent one of the highest-risk populations for premature CVD and CVD mortality. The
           2011 American Heart Association (AHA) Guidelines on the prevention of CVD in women now
           include HDP as an independent CVD risk factor in the evaluation of CVD risk. To achieve
           "ideal cardiovascular health" targets, healthy lifestyle modifications are suggested as
           first-line therapy, with pharmacotherapy as second line. The immediate postpartum period
           may be an early window of opportunity for early upstream CVD prevention, capitalizing on
           a woman's increased motivation to improve her health. Despite these recommendations and
           opportunity for early CVD prevention, there is little published data, and, in
           particular, there are no randomized controlled trials (RCT) assessing the short-term or
           long-term effectiveness of lifestyle interventions in women with HDP.

           To address this important clinical problem and knowledge gap, the interdisciplinary
           IMPROVE team adapted the evidence-based University of Ottawa Heart Institute
           CardioPrevent® Lifestyle program to proactively address the unique barriers to, and
           facilitators of behaviour change in early postpartum women with HDP. Prior to
           undertaking a widespread evaluation of CardioPrevent® in a CVD prevention study for
           women with HDP, a pre-assessment of the feasibility of this postpartum lifestyle program
           using this research approach through a pilot study is essential. In addition, this pilot
           study will provide important information on CardioPrevent®'s effectiveness on modifying
           clinically-important cardiovascular-related clinical outcomes and novel, non-invasive
           measures of microvascular function in early postpartum women with HDP to inform the
           design of a larger CVD prevention study. This pilot RCT will be the first to assess the
           feasibility and effects of a one-year postpartum-specific CVD prevention lifestyle
           program in women with a HDP.

        2. Research Questions & Objectives

           The primary objectives of this pilot study are to assess the feasibility of the
           implementation of a postpartum CVD prevention lifestyle program in women with a HDP as
           well as the transferability and fidelity of the Ottawa-based CardioPrevent® program to a
           centre in Calgary (following a "Train the Trainer" model). Secondary objectives include:
           an initial evaluation of the effectiveness of this intervention on clinical outcomes and
           measures of microvascular function between study arms at one year.

        3. Methods

      Study Design: A 2-year, single centre, single-blind, pilot randomized controlled trial (RCT).

      Study Population (Inclusion/Exclusion Criteria): Women with a HDP (i.e., preeclampsia,
      eclampsia or gestational hypertension) delivering at the Foothills Medical Centre will be
      invited to participate. Women with pre-existing chronic hypertension, diabetes (type 1 or
      type 2), kidney disease or cardiovascular disease (coronary artery, cerebrovascular and
      peripheral arterial) will be excluded.

      Intervention: CardioPrevent® Program - a one year, evidence-based cardiovascular prevention
      program that consists of 25 contacts (either in person or by phone) with a trained behaviour
      change counsellor to facilitate desired lifestyle behaviours within the participants' own
      social context.

      Control: Standard clinical postpartum care. All Participants: Participants in both arms will
      receive educational material about the risk of CVD and CVD prevention for women with HDP from
      the Preeclampsia Foundation.

      Sample size: A total of 84 women will be recruited (42 in each arm). Recruitment & Retention:
      There are over 7000 deliveries per year at the FMC. Using a conservative estimate of 7%
      prevalence of HDP (as it is a tertiary care referral centre), approximately 245 women (10 per
      week) will have HDP over our 6-month recruitment period. The investigators anticipate
      recruiting 2-3 eligible women per week to reach the target sample size in 6 months. To
      minimize loss to follow-up, they plan to use participant incentives such as covering the
      costs of parking and childcare.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: The nature of the intervention (i.e., the CardioPrevent® cognitive-behavioural lifestyle counsellor) does not lend itself to blinding of the participant. However, the research assistant responsible for the outcome assessments will be blinded to each participant's group allocation and will be instructed not to ask any questions pertaining to the study intervention. The study statistician will also be blinded to group allocation.
measure: Study feasibility - recruitment
time frame: 2 years
description: Acceptance of the study by women with HDP (i.e., feasibility) measured by recruitment rate of ≥ 20% over a 6-month time period (as per weekly recruitment logs).
measure: Study feasibility - adherence
time frame: 2 years
description: Acceptance of the study by women with HDP (i.e., feasibility) measured by participant adherence of ≥ 80% to the lifestyle program (i.e., 20/25 contacts with counsellor completed).
measure: Study feasibility - study completion
time frame: 2 years
description: Acceptance of the study by women with HDP (i.e., feasibility) measured by overall study completion rate of ≥ 75% of participants.
measure: Study feasibility - participant satisfaction
time frame: 2 years
description: Acceptance of the study by women with HDP (i.e., feasibility) measured by participant satisfaction score of ≥ fair on the Client Satisfaction Questionnaire at the end of study.
measure: Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - audits
time frame: 2 years
description: Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by standardized audits.
measure: Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - clinical outcomes
time frame: 2 years
description: Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by similar clinical outcomes between sites.
measure: Weight
time frame: 2 years
description: Comparison of weight (kg) between both study arms at one year of follow-up.
measure: Body mass index (BMI)
time frame: 2 years
description: Comparison of BMI (kg/m^2) between both study arms at one year of follow-up.
measure: Waist-to-hip ratio
time frame: 2 years
description: Comparison of waist-to-hip ratio between both study arms at one year of follow-up .
measure: Smoking status
time frame: 2 years
description: Comparison of smoking status between both study arms at one year of follow-up (CO levels <10ppm confirmatory for non-smoking).
measure: Postpartum depression
time frame: 2 years
description: Comparison of postpartum depression between both study arms at one year of follow-up (measured by the Edinburgh Postnatal Depression Scale).
measure: Blood pressure
time frame: 2 years
description: Comparison of blood pressure (mmHg) between both study arms at one year of follow-up.
measure: Fasting lipids
time frame: 2 years
description: Comparison of fasting lipids (mmol/L) between both study arms at one year of follow-up.
measure: Fasting glucose
time frame: 2 years
description: Comparison of fasting glucose (mmol/L) between both study arms at one year of follow-up.
measure: HbA1C
time frame: 2 years
description: Comparison of HbA1C (%) between both study arms at one year of follow-up.
measure: Urine albumin to creatinine ratio
time frame: 2 years
description: Comparison of urine albumin to creatinine ratio between both study arms at one year of follow-up.
measure: Metabolic syndrome
time frame: 2 years
description: Comparison of metabolic syndrome between both study arms at one year of follow-up measured by z-score (calculated using Adult Treatment Panel (ATP) III Criteria for Metabolic Syndrome).
measure: CVD risk
time frame: 2 years
description: Comparison of CVD risk between both study arms at one year of follow-up.
measure: Microvascular function - flow mediated dilation (FMD)
time frame: 2 years
description: Comparison of FMD between both study arms at one year of follow-up.
measure: Microvascular function - brachial artery hyperemic velocity
time frame: 2 years
description: Comparison of brachial artery hyperemic velocity between both study arms at one year of follow-up.
measure: Microvascular function - peripheral arterial tonometry (PAT)
time frame: 2 years
description: Comparison of PAT between both study arms at one year of follow-up.
measure: Changes in amount of physical activity recorded in questionnaire
time frame: 2 years
description: Comparison of amount of physical activity (IPAQ short form) logs between both study arms at one year of follow-up.
measure: Changes in amount of physical activity recorded in activity logs
time frame: 2 years
description: Comparison of amount of physical activity (physical activity logs) logs between both study arms at one year of follow-up.
measure: Changes in amount of physical activity captured by accelerometer
time frame: 2 years
description: Comparison of amount of physical activity (accelerometer data) between both study arms at one year of follow-up.
measure: Changes in dietary behavior
time frame: 2 years
description: Comparison of eating behaviors (Rapid eating assessment of patients) questionnaire between both study arms at one year of follow-up.
measure: Changes in nutrient status
time frame: 2 years
description: Comparison of nutrient status (measured by three days of prospective food logs) between both study arms at one year of follow-up.
arm group label: Control
arm group type: No Intervention
description: Participants in the control arm will receive standard postpartum clinical care through the participants' usual healthcare providers. No intervention will be administered. Participants in both arms will receive educational material about the risk of CVD, and CVD prevention for women with HDP from the Preeclampsia Foundation.
arm group label: CardioPrevent® Program
arm group type: Experimental
description: In addition to standard care, participants randomized to the intervention arm will also receive the CardioPrevent® Program. This is a 1-year, evidence-based behaviour change lifestyle program that consists of 25 contacts (in person, by phone and in groups) with a trained lifestyle counsellor to facilitate desired lifestyle behaviours within the participants' own social context. Participants in both arms will receive educational material about the risk of CVD, and CVD prevention for women with HDP from the Preeclampsia Foundation.
intervention type: Behavioral
intervention name: CardioPrevent® Program
description: This is a 1-year, evidence-based behaviour change lifestyle program that consists of 25 contacts (in person, by phone and in groups) with a trained lifestyle counsellor to facilitate desired lifestyle behaviours within the participants' own social context.
arm group label: CardioPrevent® Program
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kara Nerenberg
phone: (403) 220-6376
email: kara.nerenberg@ucalgary.ca
responsible party type: Sponsor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
sharing ipd: No