Skip to main content
OpenTrials
Completed

NCT Number: NCT02147626

Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital;

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based educational and motivational modules

Behavioral

Information and Screening Group

Behavioral

Primary outcomes

  1. Eating Habits Confidence Survey

    Time frame: 9 months after intervention starts

    The Eating Habits Confidence Survey measures the self-efficacy of a patient to improve their diet. Scores range from 1 (low self-efficacy) to 5 (high self-efficacy). A higher score is a better outcome.

  2. Exercise Confidence Survey

    Time frame: 9 months after intervention starts

    The Exercise Confidence Survey measures self-efficacy of patient to increase physical activity Scores range from 1 (low self-efficacy) to 5 (high self-efficacy). A higher score is a better outcome.

  3. DASH Online Questionnaire

    Time frame: 9 months after intervention starts

    The DASH Online Questionnaire is a food frequency questionnaire that prompts recall of daily servings of foods and beverages consumed in the past 30 days. We calculate a DASH score based on daily intake of eight components (fruits, vegetables, nuts and legumes, whole grains, low-fat dairy, sodium, lean meats and poultry, and sweets). Quintile rankings were summed across components to obtain a summary DASH score for each participant that ranged from 8 to 40. A higher score indicates higher DASH compliance.

  4. Pregnancy Physical Activity Questionnaire

    Time frame: 9 months after intervention starts

    The Pregnancy Physical Activity Questionnaire is a validated questionnaire for women that includes activities relevant to caring for young children. Our measure ascertained type, duration, and frequency of recreational activity and childcare activity. It also measured inactivity (sedentary behavior), such as reading, using a computer, and watching television. The time spent in each activity is multiplied by its intensity measured in Metabolic Equivalent of Task Value (METS) to yield the average weekly energy expenditure related to that activity. The score ranged from 0 to 113 METS per week.

  5. Physical Inactivity in the Pregnancy Physical Activity Questionnaire

    Time frame: 9 months after intervention starts

    The Pregnancy Physical Activity Questionnaire is a validated questionnaire for women that includes activities relevant to caring for young children. Our measure ascertained type, duration, and frequency of recreational activity and childcare activity. It also measured inactivity (sedentary behavior), such as reading, using a computer, and watching TV. The time spent in each inactivity was summed. The hours per week of reported inactivity ranged from 0 to 85.

  6. Patient Knowledge of Cardiovascular Disease Risk

    Time frame: 9 months after intervention starts

    Adapted from 2012 American Heart Association National Survey of women's knowledge of their cardiovascular disease (CVD) risk; adaptation is knowledge of risk with respect to preeclampsia history. The score ranges from 1 (low knowledge) to 4 (high knowledge).

  7. Patient Control Over Cardiovascular Disease Risk

    Time frame: 9 months after intervention starts

    To assess women's sense of personal control over their health, we adapted Kim and Walker's survey on perception of chronic diabetes risk among women with a history of gestational diabetes, using factor analysis (with varimax rotation) to reduce seven items from the Kim scales to a single factor we named ''Personal Control over Cardiovascular Disease Risk.'' The resulting measure had a Cronbach's alpha of 0.73. The score ranges from 1 (low control) to 4 (high control). High control is a better outcome.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • Preeclampsia Foundation

Registry information

Official study title

Heart Health 4 Moms: Engaging Women With a Recent History of Preeclampsia to Reduce Their Cardiovascular Disease Risk

Acronym: HH4M

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 28, 2014
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.