Primary prevention guidelines emphasize the importance of lifestyle modification, but many at high-risk have suboptimal cardiovascular risk factor (CVRF) control. Text message support may improve control, but the evidence is sparse. Our objective was to determine the impact of text messages on multiple CVRFs in a moderate-high risk primary prevention cohort. This study was a single-blind randomized clinical trial comparing semi-personalized text message-based support to standard care. A random sample of adults with 10-year absolute cardiovascular risk score ≥10% and without coronary heart disease, referred from February 2019 to January 2020, were recruited from an outpatient cardiology clinic in a large tertiary hospital in Sydney, Australia. Patients were randomized 1:1 to intervention or control. Intervention participants received 4 texts per week over 6 months, and standard care, with content covering: diet, physical activity, smoking, general cardiovascular health, and medication adherence. Controls received standard care only. Content was semipersonalized (smoking status, vegetarian or not-vegetarian, physical ability, taking medications or not) and delivered randomly using automated software. The primary outcome was the difference in the proportion of patients who have ≥3 uncontrolled CVRFs (out of: low-density lipoprotein cholesterol >2.0 mmol/L, blood pressure >140/90 mm Hg, body mass index ≥25 kg/m, physical inactivity, current smoker) at 6 months adjusted for baseline. Secondary outcomes included differences in biomedical and behavioral CVRFs. Among 295 eligible participants, 246 (mean age, 58.6 ± 10.7 years; 39.4% female) were randomized to intervention (n = 124) or control (n = 122). At 6 months, there was no significant difference in the proportion of patients with ≥3 uncontrolled CVRFs (adjusted relative risk [RR] 0.98; 95% confidence interval [CI] 0.75-1.29; = .88). Intervention participants were less likely to be physically inactive (adjusted RR 0.72; 95% CI 0.57-0.92; .01), but there were no significant changes in other single CVRFs. More intervention participants reduced the number of uncontrolled CVRFs at 6-months from baseline than controls (86% vs 75%; RR 1.15; 95% CI 1.00-1.32; .04). In moderate-high cardiovascular risk primary prevention, text message-based support did not significantly reduce the proportion of patients with ≥3 uncontrolled CVRFs. However, the program did motivate behavior change and significantly improved cardiovascular risk factor control overall. Larger multicenter studies are needed.

中文翻译：

---

短信对心血管疾病的一级预防：TextMe2 随机临床试验

一级预防指南强调改变生活方式的重要性，但许多高危人群的心血管危险因素 (CVRF) 控制不佳。短信支持可能会改善控制，但证据很少。我们的目标是确定短信对中高风险一级预防队列中多个 CVRF 的影响。这项研究是一项单盲随机临床试验，比较基于半个性化短信的支持与标准护理。 2019 年 2 月至 2020 年 1 月转诊的 10 年绝对心血管风险评分≥10%且无冠心病的成年人随机样本是从澳大利亚悉尼一家大型三级医院的心脏病门诊招募的。患者按 1:1 的比例随机分配至干预组或对照组。干预参与者在 6 个月内每周收到 4 条短信和标准护理，内容涵盖：饮食、体力活动、吸烟、一般心血管健康和药物依从性。对照仅接受标准护理。内容是半个性化的（吸烟状况、素食或非素食、身体能力、是否服用药物）并使用自动化软件随机发送。主要结局是具有≥3个不受控制的CVRF的患者比例的差异（其中：低密度脂蛋白胆固醇>2.0mmol/L，血压>140/90mmHg，体重指数≥25kg/m，身体缺乏活动，当前吸烟者）在 6 个月时根据基线进行调整。次要结果包括生物医学和行为 CVRF 的差异。在 295 名符合条件的参与者中，246 名（平均年龄，58.6 ± 10.7 岁；39.4% 女性）被随机分为干预组 (n = 124) 或对照组 (n = 122)。 6 个月时，≥3 个未受控制 CVRF 的患者比例没有显着差异（调整后相对风险 [RR] 0.98；95% 置信区间 [CI] 0.75-1.29；= .88）。干预参与者不太可能缺乏身体活动（调整后 RR 0.72；95% CI 0.57-0.92；0.01），但其他单一 CVRF 没有显着变化。与对照组相比，更多干预参与者在 6 个月时减少了不受控制的 CVRF 数量（86% vs 75%；RR 1.15；95% CI 1.00-1.32；0.04）。在中高心血管风险一级预防中，基于短信的支持并未显着降低 CVRF ≥3 次不受控制的患者比例。然而，该计划确实激发了行为改变，并显着改善了心血管危险因素的总体控制。需要更大规模的多中心研究。