Results Summary
What was the research about?
Preeclampsia is a health problem some women have during pregnancy. Symptoms are high blood pressure and a large amount of protein in the urine. Preeclampsia usually goes away after delivery. But women who’ve had preeclampsia have an increased risk of high blood pressure and heart disease later in life.
The research team created a program called Heart Health 4 Moms, or HH4M, to help women who’ve had preeclampsia reduce their risk of high blood pressure and heart disease. The program included
- Online lessons about diet and healthy lifestyle choices to help prevent heart disease
- Phone and email access to lifestyle coaching from a dietitian
- Access to an online forum to talk with the dietitian and others in the program
- Other resources, such as recipes and an exercise video
To test how well the program worked, the research team compared a group of women who took part in HH4M with a group of women who only had access to a website with educational information.
What were the results?
Compared with women who weren’t in HH4M, nine months after the study began, women in the HH4M group
- Had more confidence in their ability to change their eating habits
- Spent less time doing things that aren’t active, like watching television
- Knew more about risks for heart disease
- Felt more control over their risk for heart disease
Nine months after the study began, the two groups didn’t differ in how well women followed the recommended eating plan, how much confidence they had in their exercise habits, how much physical activity they took part in, blood pressure, or weight loss.
Who was in the study?
The study included 151 women who had preeclampsia within five years before starting the study. Of these, 82 percent were white, 3 percent were African American, 2 percent were Asian, and 2 percent were multiple races. The average age was 31, and 70 percent were college educated.
What did the research team do?
The research team assigned the women by chance to one of the two groups. The team asked women in the HH4M group to do one online lesson a week for 12 weeks and offered coaching, a forum, and other resources. The other group had access to a website with links to public websites about preeclampsia and heart disease.
At the start of the study, and again nine months later, the women filled out an online survey. The women also submitted their weight and blood pressure using electronic health devices at these same points in time.
Patient advocates who previously had preeclampsia, doctors, people working in social marketing and health care, and representatives from health and prenatal organizations worked with the team during the study.
What were the limits of the study?
Most women in the study were white and had a college degree. Results may differ for women with other backgrounds. In addition, nine months might not be enough time to see changes in weight or blood pressure.
Future research could see if a program like HH4M helps women from diverse backgrounds.
How can people use the results?
Doctors’ offices and others can use these results when considering how best to help women who’ve had preeclampsia avoid future high blood pressure and heart problems.
Professional Abstract
Objective
To evaluate whether an interactive online lifestyle modification program, Heart Health 4 Moms (HH4M), designed for and by women with a history of preeclampsia, helps women increase self-efficacy for a heart healthy lifestyle and reduce cardiovascular disease (CVD) risk factors compared with women who receive online access to publicly available information
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 151 women with a history of preeclampsia |
| Interventions/ Comparators |
|
| Outcomes |
Primary: healthy lifestyle self-efficacy, adherence to the DASH diet, physical activity and inactivity, CVD risk factor knowledge, personal control over CVD risk Secondary: blood pressure, weight |
| Timeframe | 9-month follow-up for primary outcomes |
This randomized controlled trial evaluated the effectiveness of HH4M compared with access to publicly available information online. HH4M included four components:
- Eighteen interactive behavioral and education modules, including topics such as the Dietary Approaches to Stop Hypertension (DASH) diet
- Personalized lifestyle coaching by phone and email from a registered dietician
- Community forum for the women to interact with each other and the coach
- Resources, including meal plans, recipes, and an exercise video tailored to women with children
Researchers asked women randomized to the HH4M group to watch one module a week for 12 weeks. The women also received six coaching phone calls during the nine-month study to help them set personal goals and action plans and to assess goal progress.
Women in the other group received access to a website with links to publicly available information about cardiovascular risks associated with preeclampsia and lifestyle recommendations to prevent CVD.
The study included 151 women who had experienced preeclampsia within five years of enrollment in the study. Of these, 82% were white, 3% were African American, 2% were Asian, and 2% were multiple races. The average age was 31, and 70% had a college degree. Average blood pressure was in the normal range.
Researchers collected survey data at baseline and again three and nine months later. Women also submitted weight and blood pressure data using electronic devices at each assessment point.
Patient advocates, clinicians, technology professionals, and representatives from health, payer, and prenatal organizations provided input throughout the study.
Results
Compared with women who did not take part in HH4M, the HH4M group
- Improved self-efficacy in healthy eating (p=0.01) and in increasing physical activity (p=0.02) at three months; at nine months, the HH4M group maintained increased self-efficacy in healthy eating (p=0.005) but not in physical activity
- Felt more informed about CVD risk at both three (p=0.04) and nine (p=0.002) months
- Reported feelings of increased personal control over CVD risk at nine months (p=0.03), but not at three months
- Reported less physical inactivity, for example, spending less time watching television, at both three (p=0.01) and nine (p <0.0001) months
Adherence to the DASH diet, level of physical activity, blood pressure, and weight did not differ significantly between groups at any assessment point.
Limitations
Some study measures appeared to show ceiling effects—women’s high baseline scores left little room for improvement. Nine months may not be enough time to observe changes in clinical outcomes. Most women in the study were white and college educated.
Conclusions and Relevance
The study found that HH4M improved women’s self-efficacy, CVD knowledge, and physical inactivity levels but did not improve women’s blood pressure, weight, adherence to the DASH diet, or rates of physical activity.
Future Research Needs
Future research could examine HH4M impact over longer time periods and with women with higher baseline blood pressures, different backgrounds, and varying education levels.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers said that the researchers stated the effects of the Heart Health 4 Moms program on self-efficacy, diet, and physical activity in terms of scales that would be hard for most readers to interpret. The researchers restated the outcomes to better convey the magnitude of the differences observed between the intervention group and the control group.
- Reviewers expressed concern that the study has limited generalizability because research participants were more highly educated and of higher socioeconomic status than the average population. Also, researchers restricted study participants to women with access to electronic devices and the internet. The researchers agreed that the relatively high socioeconomic status of participants limited the generalizability of the study, and they hope to test their Heart Health 4 Moms program in a higher risk population. But the researchers said Pew Research Center surveys show that the vast majority of women of reproductive age across social strata use smart, electronic devices.
- Reviewers noted that using an app on a mobile device would be easier than using a website. The researchers said they and the large majority of study participants agreed. The researchers plan to translate the Heart Health 4 Moms program into an app.