Effect of Healthy Family Program on Population Blood Pressure

This cluster-randomized control trial aims to randomly allocate 80 villages in Ruyan County to either receive a multifaceted intervention led by family health instructors or continue with usual care. Each village will recruit around 100 individuals aged 40-80 years, with or without hypertension. In intervention villages, a blood pressure management team, headed by family health instructors and family leaders, will implement various strategies including promoting a low-sodium diet, weight management, physical exercise, blood pressure monitoring, and administering antihypertensive treatment. The intervention will span 6 months, followed by another 6-month follow-up period. The primary hypothesis posits that the mean systolic blood pressure change from baseline to 6 months will be higher in the intervention group compared to the control group. The objective of this "Health Family Program" is to evaluate the efficacy of a non-healthcare provider-led multifaceted intervention in enhancing healthy lifestyles and managing blood pressure among rural residents, regardless of their hypertension status, in China.

• Village screening:

Villages were eligible for inclusion if they had ≥200 permanent households, with ≥60 households comprising ≥2 family members.

• Inclusion and Exclusion Criteria for the Family

Inclusion criteria

• At least 2 participants between the age of 40-80 years meet the inclusion and exclusion criteria of family members and willing to participate in this study;
• At least one family member can use the smartphone to upload BP values.

Exclusion criteria

• Any family member participated in the other hypertension-related programs;
• Inappropriate for the study decided by the healthy family instructor.

3.Inclusion and Exclusion Criteria for the Family Member

Inclusion criteria

• 40-80 years old, regardless of BP level and antihypertensive treatment;
• No travel plan for more than 1 month during the study period;
• Written or fingerprinted informed consent form.

Exclusion criteria

• Significant cognitive dysfunction;
• With advanced tumor, dialysis, or other serious diseases;
• Lying in bed for a long time or unable to take care of themselves;
• Diagnosed of secondary hypertension;
• Having birth plans in the next six months, pregnant or lactating women;
• Other ineligible circumstances judged by the investigators.