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Randomized trial to reduce cardiovascular risk in women with recent preeclampsia |
Rich-Edwards JW, Stuart JJ, Skurnik G, Roche AT, Tsigas E, Fitzmaurice GM, Wilkins-Haug LE, Levkoff SE, Seely EW |
Journal of Women's Health 2019 Nov;28(11):1493-1504 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: To reduce cardiovascular disease (CVD) risk, we tested an online intervention to improve healthy lifestyle for women with recent preeclampsia. MATERIALS AND METHODS: We conducted a randomized controlled 9-month clinical trial, Heart Health 4 Moms (HH4M), among 151 US 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. RESULTS: 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. CONCLUSIONS: 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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