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Not yet recruitingNCT07265193Updated Dec 4, 2025

The Workplace-Based Hypertension Management Program

An interventional study of Workplace-based Multicomponent Hypertension Management Program and Routine workplace health education and management according to current guidelines. in Hypertension, sponsored by Guangxi Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Guangxi Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
512
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • workplace health
  • behavioral intervention
  • randomized controlled trial
  • Kailuan study
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Severe cardiovascular or renal disease at baseline
  • Psychiatric disorders affecting compliance
  • Pregnant or lactating women
  • Participation in other intervention trials
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
512 participants (estimated)

Study arms

  • 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.

  • 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

Interventions

  • BehavioralWorkplace-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.

  • OtherRoutine 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.

05

What researchers measure

Primary outcomes

  1. Change in systolic and diastolic blood pressure

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

    Time frame: up to 12 months

Secondary outcomes

  1. Changes in hypertension-related health behaviors

    Changes in hypertension-related health behaviors (dietary intake, physical activity, medication adherence) at 12 months

    Time frame: up to 12 months

  2. Change in body mass index (BMI)

    Change in body mass index (BMI) at 12 months

    Time frame: up to 12 months

  3. 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

    Time frame: up to 12 months

06

Study locations

1 site
  • Yan-Feng Zhou
    Nanning, Guangxi 530021, China
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 28, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual participant data will be available upon reasonable request after publication of main trial results.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT07265193
Lead sponsor
Guangxi Medical University
Responsible party
Yan-Feng Zhou (School of Public Health, Guangxi Medical University) — Principal investigator
First posted
Dec 4, 2025
Start date
Jan 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Dec 4, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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