The Workplace-Based Hypertension Management Program

The Workplace-Based, Multicomponent Hypertension Management Program in Patients Aged 18-60 Years: A Randomized Controlled Trial

This study aims to evaluate the effectiveness of a workplace-based, multicomponent hypertension management program for newly diagnosed patients. Investigators will recruit 512 participants (256 pairs) from the Kailuan Study in Tangshan, China. Participants will be randomly assigned to receive a Workplace-based Multicomponent Hypertension Management Program or Standard Workplace Health Management. The primary objective is to assess improvements in blood pressure control and hypertension-related health behaviors.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Routine workplace health education and management according to current guidelines.; Behavioral: Workplace-based Multicomponent Hypertension Management Program

Detailed Description

Hypertension is a major public health issue worldwide, and workplace settings represent a critical intervention opportunity for middle-aged populations. Nudge theory provides a cost-effective and behaviorally informed approach to promote sustainable health behaviors. This randomized controlled trial (RCT) will explore mechanisms of health behavior promotion, evaluate the effectiveness of a nudge-based workplace health management strategy, and contribute to evidence-based hypertension prevention and control in China.

• Study Type: Interventional
• Enrollment (Estimated): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Yan-Feng Zhou
      • Contact: Yan-Feng Zhou; Phone Number: 15927422928; Email: yanfengzhou_h@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18-60 years
• Newly diagnosed hypertension (per 2024 Chinese hypertension guideline criteria)
• Employed in Kailuan Group workplace settings
• Able to provide informed consent

Exclusion Criteria:

• Severe cardiovascular or renal disease at baseline
• Psychiatric disorders affecting compliance
• Pregnant or lactating women
• Participation in other intervention trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Workplace Health Management; Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services.	Other: Routine workplace health education and management according to current guidelines.; Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services.
Experimental: Workplace-based Multicomponent Hypertension Management Program; Multicomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices.	Behavioral: Workplace-based Multicomponent Hypertension Management Program; Multicomponent strategies, including default scheduling of BP monitoring and counseling sessions, personalized reminders via workplace digital systems, social comparison feedback using anonymized peer data, small incentives and commitment devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic and diastolic blood pressure	Change in systolic and diastolic blood pressure from baseline to 12 months	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hypertension-related health behaviors	Changes in hypertension-related health behaviors (dietary intake, physical activity, medication adherence) at 12 months	up to 12 months
Change in body mass index (BMI)	Change in body mass index (BMI) at 12 months	up to 12 months
Work productivity and quality of life scores	Work productivity and quality of life scores (e.g., the European Quality of Life-5 Dimensions) at 12 months	up to 12 months

Collaborators and Investigators

• Sponsor: Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; Hypertension; behavioral intervention; workplace health; Kailuan study
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 82404393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be available upon reasonable request after publication of main trial results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No