Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

NCT ID: NCT02147626

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-21
• Study Completion Date: 2017-05-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Information and Screening Group

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

Group Type: ACTIVE_COMPARATOR

Information and Screening Group

Intervention Type: BEHAVIORAL

HH4M Intervention Arm

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.

Group Type: EXPERIMENTAL

Web-based educational and motivational modules

Intervention Type: BEHAVIORAL

Information and Screening Group

Intervention Type: BEHAVIORAL

Interventions

Web-based educational and motivational modules

Intervention Type: BEHAVIORAL

Information and Screening Group

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Preeclampsia Foundation

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Janet Rich-Edwards

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet Rich-Edwards, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Ellen Seely, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital;

Boston, Massachusetts, United States

Countries

United States

References

Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.

Reference Type: BACKGROUND

PMID: 3432232 (View on PubMed)

Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004 Oct;36(10):1750-60. doi: 10.1249/01.mss.0000142303.49306.0d.

Reference Type: BACKGROUND

PMID: 15595297 (View on PubMed)

Mosca L, Ferris A, Fabunmi R, Robertson RM; American Heart Association. Tracking women's awareness of heart disease: an American Heart Association national study. Circulation. 2004 Feb 10;109(5):573-9. doi: 10.1161/01.CIR.0000115222.69428.C9. Epub 2004 Feb 4.

Reference Type: BACKGROUND

PMID: 14761901 (View on PubMed)

Kim C, McEwen LN, Piette JD, Goewey J, Ferrara A, Walker EA. Risk perception for diabetes among women with histories of gestational diabetes mellitus. Diabetes Care. 2007 Sep;30(9):2281-6. doi: 10.2337/dc07-0618. Epub 2007 Jun 15.

Reference Type: BACKGROUND

PMID: 17575087 (View on PubMed)

Apovian CM, Murphy MC, Cullum-Dugan D, Lin PH, Gilbert KM, Coffman G, Jenkins M, Bakun P, Tucker KL, Moore TJ. Validation of a web-based dietary questionnaire designed for the DASH (dietary approaches to stop hypertension) diet: the DASH online questionnaire. Public Health Nutr. 2010 May;13(5):615-22. doi: 10.1017/S1368980009991996. Epub 2009 Nov 16.

Reference Type: BACKGROUND

PMID: 19912673 (View on PubMed)

Rich-Edwards JW, Stuart JJ, Skurnik G, Roche AT, Tsigas E, Fitzmaurice GM, Wilkins-Haug LE, Levkoff SE, Seely EW. Randomized Trial to Reduce Cardiovascular Risk in Women with Recent Preeclampsia. J Womens Health (Larchmt). 2019 Nov;28(11):1493-1504. doi: 10.1089/jwh.2018.7523. Epub 2019 Jun 19.

Reference Type: RESULT

PMID: 31215837 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CER-1306-02603

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2014P002765

Identifier Type: -

Identifier Source: org_study_id