NCT07552571

Brief Summary

Chronic diseases such as hypertension, diabetes, and dyslipidemia are major contributors to mortality and healthcare burden worldwide. Despite high awareness of health risks, many patients fail to adopt proactive health behaviors due to behavioral inertia and a gap between knowledge and action. This study aims to investigate the evolution and driving mechanisms of proactive health behavior in patients with chronic diseases based on goal commitment theory. By integrating prospect theory and evolutionary game theory, this study will explore how behavioral strategies evolve under different levels of goal commitment. In addition, a behavioral intervention based on the Stimulus-Organism-Response (SOR) model will be developed to enhance patient activation and promote adherence to proactive health behaviors. A parallel controlled intervention study will be conducted to evaluate the effectiveness of the goal commitment-based intervention. The findings of this study are expected to provide theoretical and practical evidence to improve chronic disease management and promote proactive health behaviors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
32mo left

Started May 2025

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
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 Progress27%
May 2025Dec 2028

Study Start

First participant enrolled

May 15, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

April 16, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Proactive Health BehaviorGoal CommitmentChronic Disease ManagementBehavioral InterventionPatient ActivationSOR Model

Outcome Measures

Primary Outcomes (1)

  • Change in Proactive Health Behavior Score

    The primary outcome is the difference in the mean change of proactive health behavior scores between the intervention group and the control group at 6 months after the intervention. Proactive health behaviors will be assessed using a validated Proactive Health Behavior Scale, including overall score and component scores.

    Baseline to 6 months after intervention

Secondary Outcomes (12)

  • Change in Metabolic Syndrome (MetS) Score

    Baseline to 6 months after intervention

  • Change in Proactive Health Behavior Score at 3 Months

    Baseline to 3 months after intervention

  • Change in Fasting Blood Glucose (FBG) at 3 Months

    Baseline to 3 months after intervention

  • Change in Fasting Blood Glucose (FBG)

    Baseline, 3 months, and 6 months after intervention

  • Change in Triglycerides (TG)

    Baseline, 3 months after intervention, and 6 months after intervention

  • +7 more secondary outcomes

Study Arms (2)

Goal Commitment Intervention Group

EXPERIMENTAL

Participants in this group will receive a goal commitment-based behavioral intervention designed to enhance proactive health behaviors. The intervention includes structured goal-setting, behavioral activation strategies, and continuous support to improve adherence to chronic disease management.

Behavioral: Goal Commitment-Based Behavioral Intervention

Usual Care Control Group

ACTIVE COMPARATOR

Participants in this group will receive routine chronic disease management or standard health education without additional behavioral intervention.

Other: Usual Care

Interventions

This intervention is a structured behavioral program based on goal commitment theory, designed to promote proactive health behaviors in patients with chronic diseases. The intervention includes goal setting, personalized action planning, behavioral activation, and continuous follow-up support. Participants will receive guidance to enhance motivation, strengthen commitment to health goals, and improve adherence to chronic disease management through regular monitoring and feedback.

Goal Commitment Intervention Group

Participants in the control group will receive routine chronic disease management or standard health education without additional structured behavioral intervention.

Usual Care Control Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residents living in the study area for at least 1.5 years
  • Diagnosed with at least one chronic disease, including hypertension, diabetes mellitus, or dyslipidemia
  • Conscious and able to communicate effectively
  • Educational level of primary school or above
  • Able to use a smartphone and common mobile applications (e.g., WeChat)
  • Willing to participate and provide written informed consent

You may not qualify if:

  • Non-residents of the study area
  • Unable to participate in group-based intervention activities
  • Currently hospitalized
  • Diagnosed with severe cognitive impairment, dementia, or psychiatric disorders
  • Participants with severe comorbidities that may interfere with study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine and Health Management Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

HypertensionDiabetes MellitusDyslipidemiasPatient Participation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be assigned to either an intervention group or a control group in a parallel design. The intervention group will receive a goal commitment-based behavioral intervention, while the control group will receive routine chronic disease management or standard health education.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 27, 2026

Study Start

May 15, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) will be shared upon reasonable request. De-identified data supporting the findings of this study will be made available to qualified researchers after publication of the primary results. Data access will be subject to approval by the corresponding author and institutional review, in accordance with ethical and data protection regulations.

Locations