Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia; Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia; Nepal Development Society, Chitwan, Bagmati Province, Nepal.
Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.
Lancet Glob Health. 2023 Jul;11(7):e1086-e1095. doi: 10.1016/S2214-109X(23)00214-0.
The sustainability and scalability of limited-duration interventions in low-income and middle-income countries remain unclear. We aimed to investigate the sustainability in reduction of blood pressure through a 12-month lifestyle intervention led by community health workers to reduce blood pressure in Nepal, 4 years after the intervention ceased.
The Community-Based Intervention for Control of Hypertension in Nepal (COBIN) trial was a non-blinded, cluster-randomised trial done in Kaski, Nepal. Adults aged 25-65 years were eligible. People were excluded if they declined consent, were severely ill, unlikely to be in the community throughout the intervention, or pregnant. During the 12-month intervention, female community health volunteers (FCHVs) visited participants in the intervention groups and provided lifestyle counselling and blood pressure measurement every 4 months. At the end of the 12-month intervention, systolic blood pressure was significantly lower in the intervention group than in the usual care group in all cohorts, ranging from -2·3 mm Hg (95% CI -3·8 to -0·8) lower in those with normal blood pressure to -4·9 mm Hg (-7·8 to -2·0) in the hypertensive cohort. The primary outcome for this follow-up study was a mean change in systolic blood pressure from baseline to follow-up at 60 months. We did an intention-to-treat analysis.
Between April 1, 2015, and Dec 31, 2015, 1638 participants were recruited in COBIN (939 [57·3%] assigned to intervention and 699 [42·7%] assigned to usual care). Of the 1468 (89·6%) who completed the 12-month assessments, we followed up 1352 (92·1%) participants at 60 months, between Oct 11, 2020, and May 5, 2022. 964 (71·3%) participants were women and 388 (28·7%) were men. From baseline to 60 months, the mean systolic blood pressure increased by 10·4 mm Hg (95% CI 9·1-11·6) in the intervention group and 6·0 mm Hg (4·6-7·5) in the usual care group (adjusted mean difference 4·1 mm Hg [2·2 to 5·8]).
Lifestyle counselling and blood pressure monitoring by community health workers is effective in substantially reducing blood pressure while adults are being monitored in a trial but, following cessation of the intervention, this benefit is not maintained in the long term, with potential for harm. This finding could have important implications for funders and research communities to regularly target participants for education and follow-up at an optimal timepoint to reduce any likelihood of harm.
Monash University (Melbourne, VIC, Australia) and the Jayanti Memorial Trust (Kathmandu, Nepal).
For the Nepali translation of the abstract see Supplementary Materials section.
在中低收入国家，持续时间有限的干预措施的可持续性和可扩展性仍不清楚。我们旨在研究通过由社区卫生工作者领导的为期 12 个月的生活方式干预来降低血压的可持续性，该干预在尼泊尔停止 4 年后，降低血压。
社区主导的尼泊尔高血压控制干预试验（COBIN）是在尼泊尔卡斯基进行的一项非盲、整群随机试验。年龄在 25-65 岁之间的成年人有资格参加。如果他们拒绝同意、病情严重、在干预期间不太可能在社区中、或怀孕，则被排除在外。在 12 个月的干预期间，女性社区卫生志愿者（FCHV）每 4 个月对干预组的参与者进行一次生活方式咨询和血压测量。在 12 个月的干预结束时，与对照组相比，所有队列中干预组的收缩压均显著降低，正常血压组的降幅为-2.3mmHg（95%CI-3.8 至-0.8），高血压组的降幅为-4.9mmHg（-7.8 至-2.0）。本随访研究的主要结局是从基线到 60 个月时的收缩压平均变化。我们进行了意向治疗分析。
2015 年 4 月 1 日至 12 月 31 日期间，COBIN 招募了 1638 名参与者（939 名[57.3%]被分配到干预组，699 名[42.7%]被分配到对照组）。在完成 12 个月评估的 1468 名（89.6%）参与者中，我们在 60 个月时对 1352 名（92.1%）参与者进行了随访，时间为 2020 年 10 月 11 日至 2022 年 5 月 5 日。964 名（71.3%）参与者为女性，388 名（28.7%）为男性。从基线到 60 个月，干预组的收缩压平均增加 10.4mmHg（95%CI9.1-11.6），对照组增加 6.0mmHg（4.6-7.5）（调整后的平均差异为 4.1mmHg[2.2 至 5.8]）。
在试验中，当成年人接受监测时，社区卫生工作者提供的生活方式咨询和血压监测可有效显著降低血压，但在干预停止后，这种益处不会长期维持，而且存在潜在的危害。这一发现可能对资助者和研究界具有重要意义，需要定期为参与者提供教育和随访，以在最佳时间点减少任何潜在的危害。
莫纳什大学（澳大利亚墨尔本）和 Jayanti Memorial Trust（尼泊尔加德满都）。
