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Updated: Jan 23, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Randomized Trial to Reduce Cardiovascular Risk in Women with Recent Preeclampsia
Janet W Rich-Edwards1,2, Jennifer J Stuart1,2, Geraldine Skurnik1
1Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
To reduce cardiovascular disease (CVD) risk, we tested an online intervention to improve healthy lifestyle for women with recent preeclampsia. We conducted a randomized controlled 9-month clinical trial, Heart Health 4 Moms (HH4M), among 151 U.S. women with preeclampsia within 5 years. Sample size was planned to detect differences of 0.5 standard deviation units in primary outcomes between study arms. Preeclampsia history was validated by medical records; women with chronic hypertension were excluded. The intervention included online educational modules, a community forum, and communication with a lifestyle coach. The control group received internet links to CVD risk reduction information. Primary outcomes were self-efficacy to eat a healthy diet and increase physical activity; change in physical in/activity; adherence to the Dietary Approaches to Stop Hypertension (DASH) diet; and knowledge of and personal control over CVD risk. Secondary outcomes were weight and blood pressure. In the intervention arm, 84% of participants accessed at least one online educational module; 89% completed at least three scheduled calls with the coach. At 9 months, intervention participants reported significantly greater knowledge of CVD risk factors (corrected p = 0.01), increased self-efficacy for healthy eating (p = 0.03), and less physical inactivity than controls (p = 0.0006). The groups did not differ in sense of personal control of CVD risk factors, adherence to the DASH diet, self-efficacy for physical activity, or reported physical activity. There were no differences in secondary outcomes between groups. The HH4M program improved CVD risk knowledge, self-efficacy to achieve a healthy diet, and reduced physical inactivity among women with recent preeclampsia.
To reduce cardiovascular disease (CVD) risk, we tested an online intervention to improve healthy lifestyle for women with recent preeclampsia. We conducted a randomized controlled 9-month clinical trial, Heart Health 4 Moms (HH4M), among 151 U.S. women with preeclampsia within 5 years. Sample size was planned to detect differences of 0.5 standard deviation units in primary outcomes between study arms. Preeclampsia history was validated by medical records; women with chronic hypertension were excluded. The intervention included online educational modules, a community forum, and communication with a lifestyle coach. The control group received internet links to CVD risk reduction information. Primary outcomes were self-efficacy to eat a healthy diet and increase physical activity; change in physical in/activity; adherence to the Dietary Approaches to Stop Hypertension (DASH) diet; and knowledge of and personal control over CVD risk. Secondary outcomes were weight and blood pressure. In the intervention arm, 84% of participants accessed at least one online educational module; 89% completed at least three scheduled calls with the coach. At 9 months, intervention participants reported significantly greater knowledge of CVD risk factors (corrected p = 0.01), increased self-efficacy for healthy eating (p = 0.03), and less physical inactivity than controls (p = 0.0006). The groups did not differ in sense of personal control of CVD risk factors, adherence to the DASH diet, self-efficacy for physical activity, or reported physical activity. There were no differences in secondary outcomes between groups. The HH4M program improved CVD risk knowledge, self-efficacy to achieve a healthy diet, and reduced physical inactivity among women with recent preeclampsia.
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