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

NCT03302260 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

  • Pre-Eclampsia

Interventions

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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2019-11-30
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302260 on ClinicalTrials.gov