Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427096
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-18
Brief Title:
Effect of Healthy Family Program on Population Blood Pressure
Sponsor:
Heart Health Research Center
Organization:
Heart Health Research Center
Study Overview
Official Title:
Effect of Healthy Family Program on Population Blood Pressure A 11 Parallel Design Multi-Center Cluster Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 11 parallel design multi-center cluster-randomized control trial A total of 80 villages in Ruyang County Henan Province China will be randomly assigned to the intervention group or control group At least 100 participants from 30-50 families in each village will be included in this study The intervention group will engage in a variety of strategies including adopting a low-sodium diet managing weight participating in physical exercise monitoring blood pressure and undergoing antihypertensive treatment These efforts will be led by healthy family instructors from the community The control group will receive usual care The primary endpoint of this study is the change of systolic blood pressure from baseline to 6 months reported as the difference between intervention and control group
Detailed Description:
This cluster-randomized control trial aims to randomly allocate 80 villages in Ruyan County to either receive a multifaceted intervention led by family healthy 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 healthy family 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None