Clinical trial NCT02147626: Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia
Official title: Heart Health 4 Moms: Engaging Women With a Recent History of Preeclampsia to Reduce Their Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Preeclampsia
Hypertension
Post-partum Weight Retention
Keywords: preeclampsia
cardiovascular disease
health behaviors
behavioral intervention
web-based
Hypertension
Post-partum Weight Retention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Preeclampsia Foundation
First posted: 2014-05-28
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Eating Habits Confidence Survey
timeFrame: 9 months after intervention starts
measure: Exercise Confidence Survey
timeFrame: 9 months after intervention starts
measure: DASH Online Questionnaire
timeFrame: 9 months after intervention starts
measure: Pregnancy Physical Activity Questionnaire
timeFrame: 9 months after intervention starts
measure: Physical Inactivity in the Pregnancy Physical Activity Questionnaire
timeFrame: 9 months after intervention starts
measure: Patient Knowledge of Cardiovascular Disease Risk
timeFrame: 9 months after intervention starts
measure: Patient Control Over Cardiovascular Disease Risk
timeFrame: 9 months after intervention starts
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital;
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Janet Rich-Edwards, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Ellen Seely, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.