Study protocol for the healthy family program on population blood pressure: A multicenter, parallel group, cluster randomized, controlled trial in rural China - 03/03/25

Doi : 10.1016/j.ahj.2025.01.014

Yangyang Tang, MD ^a,^b,^{^{#
Yangyang Tang and Chao Jiang contributed equally to this work.}}, Chao Jiang, MD ^a,^b,^c,^{^{#
Yangyang Tang and Chao Jiang contributed equally to this work.}}, Jiakun Guo, MSc ^c, Yueyuan Li, MAE ^c, Chi Wang, PhD ^c, Shuk Han Chu, MPH ^c, Zhiyan Wang, MD ^a,^b, Yanfang Wu, MD ^a,^b, Chang Hua, MD ^a,^b, Yanmei Lu, PhD ^d, Shuai Zhang, BS ^e,^f, Yanna Song, BS ^e,^f, Rong Han, ME ^c, Jianzeng Dong, MD ^a,^b,^g, Changsheng Ma, MD ^a,^b, Jun Cai, MD ^a,^b,^⁎ , Craig S. Anderson, MD PhD ^c,^h,^i,^j,^⁎ , Xin Du, MD PhD ^a,^b,^c,^f,^⁎
^a Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
^b National Clinical Research Center for Cardiovascular Diseases, Beijing, China
^c Heart Health Research Center, Beijing, China
^d Department of Pacing and Electrophysiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China
^e Ruyang County People's Hospital, Luoyang, Henan Province, China
^f Ruyang Rural Health Institute, Luoyang, Henan Province, China
^g Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
^h The George Institute for Global Health, Faculty of Medicine, University of New South Wales; Sydney, Australia
ⁱ Department of Neurology, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia
^j Institute for Science and Technology for Brain-inspired Intelligence, Fudan University, Shanghai, China

^⁎Reprint requests: Xin Du, MD, PhD and Jun Cai, MD, Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, China, 100029.Department of CardiologyBeijing Anzhen HospitalCapital Medical UniversityNo. 2, Anzhen Road, Chao Yang DistrictBeijing100029China^†Reprint requests: Craig S. Anderson, MD, PhD, Institute for Science and Technology for Brain-inspired Intelligence, Fudan University, No. 825 Zhangheng Road, Pudong New District, Shanghai, China, 201203.Institute for Science and Technology for Brain-inspired IntelligenceFudan UniversityNo. 825 Zhangheng RoadPudong New DistrictShanghai201203China

ABSTRACT

Background

We aim to determine the effectiveness of a community-based, health instructor led, multifaceted family intervention, as compared with usual care, on blood pressure (BP) management among Chinese rural residents, with or without hypertension.

Methods/Design

The Healthy Family Program is a cluster randomized controlled trial being undertaken in 80 villages (each with approximately 100 residents) with a target to enroll a total of 8000 older adults (aged 40-80 years). Villages were randomly assigned in a 1:1 ratio to either an intervention group to receive multifaceted strategies or a control group to continue with usual standard of care. The main components of the multifaceted intervention strategies include: (1) Establishing a BP management team led by family health instructors, with team members including family leaders and village doctors, and (2) Implementing an intervention that focused on 6 areas: education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension. The primary outcome is change in systolic BP from baseline to 6 months in all participants, reported as the absolute difference between intervention and control groups. After the 6-month intervention, support from the study coordination center and the distribution of low-sodium salt will be withdrawn, and all participants will be followed up until 12 months. As of December 31, 2024, 24 villages in the intervention group have completed the 6-month intervention.

Conclusion

The Healthy Family Program will provide critically important data on the effectiveness of a novel BP management strategy in rural China.

Trial Registration

The study is registered at ClinicalTrials.gov (NCT06427096).

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Vol 283

P. 70-80 - maggio 2025 Ritorno al numero

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Study protocol for the healthy family program on population blood pressure: A multicenter, parallel group, cluster randomized, controlled trial in rural China - 03/03/25

ABSTRACT

Background

Methods/Design

Conclusion

Trial Registration

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