Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia (HH4M)

Mass General Brigham

Status: Completed

Conditions: Post-partum Weight Retention; Hypertension; Preeclampsia; Cardiovascular Disease

Treatments: Behavioral: Information and Screening Group; Behavioral: Web-based educational and motivational modules

Study type: Interventional

Funder types: Other

Identifiers

NCT02147626

2014P002765

CER-1306-02603 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Information and Screening Group

Active Comparator group

Description:

Intervention: The patient website will include the American Heart Association (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) Dietary Approaches to Stop Hypertension (DASH) website, and the NIH smoking cessation website

Treatment:

Behavioral: Information and Screening Group

HH4M Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Web-based educational and motivational modules

Behavioral: Information and Screening Group