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Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial (IMPROVE)

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ClinicalTrials.gov Identifier: NCT03302260
Recruitment Status : Not yet recruiting
First Posted : October 5, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Behavioral: CardioPrevent® Program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Other
Official Title: IMPROVE (Identifying Methods for Postpartum Reduction of Vascular Events): Pilot Randomized Controlled Trial
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: CardioPrevent® Program
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.
Behavioral: 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.



Primary Outcome Measures :
  1. Study feasibility - recruitment [ Time Frame: 2 years ]
    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).

  2. Study feasibility - adherence [ Time Frame: 2 years ]
    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).

  3. Study feasibility - study completion [ Time Frame: 2 years ]
    Acceptance of the study by women with HDP (i.e., feasibility) measured by overall study completion rate of ≥ 75% of participants.

  4. Study feasibility - participant satisfaction [ Time Frame: 2 years ]
    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.

  5. Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - audits [ Time Frame: 2 years ]
    Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by standardized audits.

  6. Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - clinical outcomes [ Time Frame: 2 years ]
    Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) measured by similar clinical outcomes between sites.


Secondary Outcome Measures :
  1. Weight [ Time Frame: 2 years ]
    Comparison of weight (kg) between both study arms at one year of follow-up.

  2. Body mass index (BMI) [ Time Frame: 2 years ]
    Comparison of BMI (kg/m^2) between both study arms at one year of follow-up.

  3. Waist-to-hip ratio [ Time Frame: 2 years ]
    Comparison of waist-to-hip ratio between both study arms at one year of follow-up .

  4. Smoking status [ Time Frame: 2 years ]
    Comparison of smoking status between both study arms at one year of follow-up (CO levels <10ppm confirmatory for non-smoking).

  5. Postpartum depression [ Time Frame: 2 years ]
    Comparison of postpartum depression between both study arms at one year of follow-up (measured by the Edinburgh Postnatal Depression Scale).

  6. Blood pressure [ Time Frame: 2 years ]
    Comparison of blood pressure (mmHg) between both study arms at one year of follow-up.

  7. Fasting lipids [ Time Frame: 2 years ]
    Comparison of fasting lipids (mmol/L) between both study arms at one year of follow-up.

  8. Fasting glucose [ Time Frame: 2 years ]
    Comparison of fasting glucose (mmol/L) between both study arms at one year of follow-up.

  9. HbA1C [ Time Frame: 2 years ]
    Comparison of HbA1C (%) between both study arms at one year of follow-up.

  10. Urine albumin to creatinine ratio [ Time Frame: 2 years ]
    Comparison of urine albumin to creatinine ratio between both study arms at one year of follow-up.

  11. Metabolic syndrome [ Time Frame: 2 years ]
    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).

  12. CVD risk [ Time Frame: 2 years ]
    Comparison of CVD risk between both study arms at one year of follow-up.

  13. Microvascular function - flow mediated dilation (FMD) [ Time Frame: 2 years ]
    Comparison of FMD between both study arms at one year of follow-up.

  14. Microvascular function - brachial artery hyperemic velocity [ Time Frame: 2 years ]
    Comparison of brachial artery hyperemic velocity between both study arms at one year of follow-up.

  15. Microvascular function - peripheral arterial tonometry (PAT) [ Time Frame: 2 years ]
    Comparison of PAT between both study arms at one year of follow-up.

  16. Changes in amount of physical activity recorded in questionnaire [ Time Frame: 2 years ]
    Comparison of amount of physical activity (IPAQ short form) logs between both study arms at one year of follow-up.

  17. Changes in amount of physical activity recorded in activity logs [ Time Frame: 2 years ]
    Comparison of amount of physical activity (physical activity logs) logs between both study arms at one year of follow-up.

  18. Changes in amount of physical activity captured by accelerometer [ Time Frame: 2 years ]
    Comparison of amount of physical activity (accelerometer data) between both study arms at one year of follow-up.

  19. Changes in dietary behavior [ Time Frame: 2 years ]
    Comparison of eating behaviors (Rapid eating assessment of patients) questionnaire between both study arms at one year of follow-up.

  20. Changes in nutrient status [ Time Frame: 2 years ]
    Comparison of nutrient status (measured by three days of prospective food logs) between both study arms at one year of follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult women aged 18 years or older;
  • diagnosis of a HDP (i.e., preeclampsia, eclampsia or gestational hypertension);
  • delivering at The Foothills Medical Centre (FMC) in Calgary, Alberta;
  • ability to read, write, understand, and provide informed consent in English; and
  • have telephone access.

Exclusion Criteria:

  • pre-existing vascular disease (coronary artery disease [i.e., stable angina, unstable angina,
  • myocardial infarction, percutaneous coronary intervention or coronary artery bypass surgery],
  • cerebrovascular disease [i.e., ischemic stroke or transient ischemic attack], or peripheral arterial
  • disease [i.e., known abnormal ankle-brachial indices, symptoms of intermittent claudication, or
  • bypass surgery to the extremities]);
  • chronic hypertension;
  • diabetes (type 1 or type 2);
  • pre-pregnancy kidney disease;
  • planning another pregnancy within one year;
  • counselling may not be appropriate (i.e., impaired cognition);
  • live more than 200 km outside the Calgary region; and
  • planning to move outside the Calgary region within one year of randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302260


Contacts
Contact: Kara Nerenberg (403) 220-6376 kara.nerenberg@ucalgary.ca

Sponsors and Collaborators
University of Calgary
  Study Documents (Full-Text)

Documents provided by University of Calgary:
Study Protocol  [PDF] September 25, 2017
Statistical Analysis Plan  [PDF] September 25, 2017
Informed Consent Form  [PDF] September 25, 2017


Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03302260     History of Changes
Other Study ID Numbers: REB17-1264
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Calgary:
maternal health
pregnancy
pre-eclampsia

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications