Clinical trial NCT03302260: Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial
Official title: IMPROVE (Identifying Methods for Postpartum Reduction of Vascular Events): Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Keywords: maternal health
pregnancy
pre-eclampsia
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Study feasibility - recruitment
timeFrame: 2 years
measure: Study feasibility - adherence
timeFrame: 2 years
measure: Study feasibility - study completion
timeFrame: 2 years
measure: Study feasibility - participant satisfaction
timeFrame: 2 years
measure: Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - audits
timeFrame: 2 years
measure: Implementation and fidelity of CardioPrevent® at the University of Calgary (a second centre) - clinical outcomes
timeFrame: 2 years
Secondary outcomes:
measure: Weight
timeFrame: 2 years
measure: Body mass index (BMI)
timeFrame: 2 years
measure: Waist-to-hip ratio
timeFrame: 2 years
measure: Smoking status
timeFrame: 2 years
measure: Postpartum depression
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
measure: Fasting lipids
timeFrame: 2 years
measure: Fasting glucose
timeFrame: 2 years
measure: HbA1C
timeFrame: 2 years
measure: Urine albumin to creatinine ratio
timeFrame: 2 years
measure: Metabolic syndrome
timeFrame: 2 years
measure: CVD risk
timeFrame: 2 years
measure: Microvascular function - flow mediated dilation (FMD)
timeFrame: 2 years
measure: Microvascular function - brachial artery hyperemic velocity
timeFrame: 2 years
measure: Microvascular function - peripheral arterial tonometry (PAT)
timeFrame: 2 years
measure: Changes in amount of physical activity recorded in questionnaire
timeFrame: 2 years
measure: Changes in amount of physical activity recorded in activity logs
timeFrame: 2 years
measure: Changes in amount of physical activity captured by accelerometer
timeFrame: 2 years
measure: Changes in dietary behavior
timeFrame: 2 years
measure: Changes in nutrient status
timeFrame: 2 years
Other outcomes:
Locations:
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