The Workplace-Based, Multicomponent Hypertension Management Program in Patients Aged 18-60 Years: A Randomized Controlled Trial
Phase: NA
Conditions: Hypertension
Sponsor: Guangxi Medical University

Study Protocol and Statistical Analysis Plan (version 1.0, 18 November 2025) 
1. Title of the Study 
The Workplace-Based, Multicomponent Hypertension Management Program in Patients Aged 
18-60 Years: A Randomized Controlled Trial 
2. Study Identifier 
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Organization’s Unique Protocol ID: 82404393 
3. Background and Rationale 
Hypertension remains a major preventable contributor to global cardiovascular morbidity and 
mortality. Workplace populations represent a critical setting for early intervention among 
middle-aged adults. Behavioral economics—particularly nudge theory—offers promising 
strategies to address behavioral determinants of hypertension management through subtle 
modifications of choice architecture. However, limited randomized controlled trial evidence 
exists within workplace settings. 
The Kailuan Cohort, a well-established occupational population in Tangshan, Hebei, provides 
an ideal platform to test a nudge-based workplace health management model among 
individuals newly diagnosed with hypertension. This intervention was referred to as the 
workplace-based multicomponent hypertension management program. 
4. Study Objectives 
Primary Objective 
To evaluate the effectiveness of a workplace-based multicomponent hypertension 

management program on blood pressure control at 12 months among newly diagnosed 
hypertensive adults. 
Secondary Objectives 
(1) To evaluate improvements in hypertension-related health behaviors (diet, physical activity, 
medication adherence). 
(2) To assess changes in body mass index (BMI) and other cardiometabolic indicators. 
(3) To examine quality of life and work productivity outcomes. 
5. Study Design 
This is a randomized, parallel-group, open-label controlled trial embedded in the Kailuan 
Cohort. A total of 512 participants (256 per arm) will be enrolled and randomly assigned 1:1. 
Study Flow 
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Screening and enrollment 
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Baseline assessment 
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Randomization 
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Intervention period: 12 months 
Allocation 
Participants will be randomly assigned using computer-generated block randomization 
stratified by sex and age group. 
6. Study Setting 

Kailuan Group workplace facilities and community health centers (Tangshan, Hebei, China). 
7. Study Population 
Inclusion Criteria 
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Age 18–60 years. 
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Newly diagnosed hypertension (per 2024 Chinese hypertension guidelines). 
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Employed at Kailuan Group. 
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Willing to participate and sign informed consent. 
Exclusion Criteria 
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Severe cardiovascular or renal disease. 
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Psychiatric illness affecting compliance. 
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Pregnant or lactating women. 
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Participation in other intervention trials. 
8. Interventions 
Experimental Group: Workplace-based Multicomponent Hypertension Management Program 
Includes: 
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Default scheduling of blood pressure monitoring and counseling sessions. 
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Personalized reminders via workplace digital systems. 
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Social comparison feedback using anonymized peer data. 

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Small incentives and commitment devices. 
Control Group: Standard Workplace Health Management 
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Routine health education. 
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Standard hypertension counseling. 
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Usual workplace health services. 
9. Outcome Measures 
Primary Outcome 
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Change in systolic and diastolic blood pressure from baseline to 12 months. 
Secondary Outcomes 
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Changes in health behaviors. 
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Change in BMI. 
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Medication adherence. 
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European Quality of Life-5 Dimensions’ scores. 
10. Sample Size Calculation 
Sample size assumes: 
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Expected between-group difference in systolic blood pressure (SBP) reduction: 4 
mmHg. 
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Standard deviation (SD) = 12 mmHg. 

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Alpha = 0.05, power = 0.80. 
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Allowing 15% attrition. Total sample required: 512 participants (256 per arm). 
11. Statistical Analysis Plan 
General Principles 
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All analyses will follow the intention-to-treat (ITT) principle. 
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A secondary per-protocol analysis will be conducted. 
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Two-sided tests with α = 0.05. 
Baseline Analysis 
Baseline characteristics will be compared using: 
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Mean ± SD or median (interquartile range) for continuous variables. 
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Counts and percentages for categorical variables. 
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No formal statistical testing will be used for baseline differences. 
Primary Outcome Analysis 
A mixed-effects linear regression model will be used: 
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Dependent variable: SBP/diastolic blood pressure (DBP) change from baseline. 
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Fixed effects: intervention group, time, sex, age, baseline blood pressure. 
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Random intercepts for participants. 
Effect estimates will be reported as mean difference with 95% CI. 

Secondary Outcomes Analysis 
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Behavior outcomes: logistic or linear regression depending on scale. 
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BMI: linear regression or mixed-effects model. 
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Quality of life: ANCOVA adjusting for baseline values. 
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Cost-effectiveness: the incremental cost-effectiveness ratio between the intervention 
group and control group during the study period. 
Missing Data Management 
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Multiple imputation under missing-at-random (MAR) assumption. 
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Sensitivity analyses using complete-case analysis. 
Subgroup Analyses (Exploratory) 
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Sex (male/female) 
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Age category (18–44, 45–60) 
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Baseline SBP level 
Interim Analysis 
No interim analyses are planned. 
12. Ethical Considerations 
The study will comply with: 
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Declaration of Helsinki 

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Good Clinical Practice (GCP) standards Ethical approval will be obtained from Hebei 
Medical University Institutional Review Board. 
13. Data Management and Monitoring 
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Data will be entered into a password-protected electronic data capture system. 
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Range and logic checks will be programmed. 
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Independent data monitoring committee (DMC) will oversee safety. 
14. Dissemination Plan 
Findings will be published in peer-reviewed journals and presented at scientific conferences. 
De-identified individual participant data will be available upon reasonable request following 
main publication. 
15. Timeline 
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Start date: January 2026 (planned) 
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Primary completion: January 2027 
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Study completion: January 2028