NCT07265193

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
8mo left

Started Jan 2026

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

November 19, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 19, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Hypertensionworkplace healthbehavioral interventionrandomized controlled trialKailuan study

Outcome Measures

Primary Outcomes (1)

  • Change in systolic and diastolic blood pressure

    Change in systolic and diastolic blood pressure from baseline to 12 months

    up to 12 months

Secondary Outcomes (3)

  • Changes in hypertension-related health behaviors

    up to 12 months

  • Change in body mass index (BMI)

    up to 12 months

  • Work productivity and quality of life scores

    up to 12 months

Study Arms (2)

Standard Workplace Health Management

ACTIVE COMPARATOR

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.

Workplace-based Multicomponent Hypertension Management Program

EXPERIMENTAL

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

Interventions

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.

Workplace-based Multicomponent Hypertension Management Program

Routine workplace health education and management according to current guidelines, including routine health education, standard hypertension counseling, and usual workplace health services.

Standard Workplace Health Management

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yan-Feng Zhou

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Public Health

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 4, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be available upon reasonable request after publication of main trial results.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations