Overview

This trial is active, not recruiting.

Conditions cardiovascular disease, preeclampsia, hypertension, post-partum weight retention
Treatments web-based educational and motivational modules, information and screening group
Sponsor Brigham and Women's Hospital
Collaborator Patient-Centered Outcomes Research Institute
Start date July 2014
End date October 2016
Trial size 151 participants
Trial identifier NCT02147626, 2014P002765, CER-1306-02603

Summary

This study will compare two arms in a randomized clinical trial of cardiovascular risk prevention in women with a history of preeclampsia. The first arm will provide postpartum patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle Recommendations for women with a history of preeclampsia. The second arm will additionally receive access to a customized patient-informed online program with modules on how to achieve the AHA recommendations for diet, activity and weight management.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Intervention: The patient website will include the AHA Class I Lifestyle recommendations (translated to an 8th grade reading level and with a link to the publication), a link to the online National Institutes of Health (NIH) DASH website, and the NIH smoking cessation website
information and screening group
(Experimental)
Intervention: The HH4M patient website will include information and tools. These resources are customized to help new mothers achieve the AHA Class I Lifestyle recommendations for women with a history of preeclampsia.
web-based educational and motivational modules
information and screening group

Primary Outcomes

Measure
Personal health self-efficacy
time frame: 3 months after start of intervention
Adherence to DASH diet
time frame: 3 months after start of intervention
Physical activity
time frame: 3 months after start of intervention
Physical inactivity
time frame: 3 months after start of intervention
Family health self-efficacy
time frame: 3 months after start of intervention
Patient knowledge of cardiovascular disease risk
time frame: 3 months after start of intervention
Personal health self-efficacy
time frame: 9 months after intervention starts
Adherence to DASH diet
time frame: 9 months after intervention starts
Physical activity
time frame: 9 months after intervention starts
Physical inactivity
time frame: 9 months after intervention starts
Family health self-efficacy
time frame: 9 months after intervention starts
Patient knowledge of cardiovascular disease risk
time frame: 9 months after intervention starts

Secondary Outcomes

Measure
Postpartum weight retention
time frame: 3 months after start of intervention
Postpartum achievement of weight goal
time frame: 3 months after start of intervention
Systolic and diastolic blood pressure
time frame: 3 months after start of intervention
Postpartum weight retention
time frame: 9 months after start of intervention
Postpartum achievement of weight goal
time frame: 9 months after start of intervention
Systolic and diastolic blood pressure
time frame: 9 months after start of intervention

Eligibility Criteria

Female participants from 18 years up to 44 years old.

Inclusion Criteria: - Within 5 years of a live birth complicated by preeclampsia as determined by medical chart review - Age >=18 - Not pregnant - Normotensive or prehypertensive - Access to the internet via computer or mobile device - Able to communicate in English or Spanish at an 8th grade level. Exclusion Criteria: - Type 1 or Type 2 diabetes - Currently pregnant - Diagnosis of hypertension BP >140/90 mm Hg or on medications for treatment of hypertension

Additional Information

Official title Heart Health 4 Moms: Engaging Women With a Recent History of Preeclampsia to Reduce Their Cardiovascular Disease Risk
Principal investigator Janet Rich-Edwards, ScD
Description The study team will work with patients via focus groups to develop a novel internet-based program to provide information and tools for cardiovascular disease (CVD) risk reduction for women who are at increased risk of CVD by virtue of their history of preeclampsia, a common complication of pregnancy. The American Heart Association has recently issued guidelines that physicians should include history of the hypertensive pregnancy disorder, preeclampsia, as a risk factor for CVD. Indeed, research demonstrates that roughly 2 out of 3 women with a history of preeclampsia will die from CVD. This study will work with patients with prior preeclampsia and with the Preeclampsia Foundation, a patient- based organization, to create an online lifestyle modification program ( accessible by computer or smart phone) for women with recent preeclampsia to reduce CVD risk. The study is a randomized controlled trial to test the program's acceptability, use, and impact on diet, postpartum weight retention, physical activity, blood pressure, and patient knowledge and self-efficacy to improve health.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.