Efficacy of a Health Empowerment Theory Based Health Information Literacy Promotion Intervention in Individuals With Metabolic Syndrome

Meihua Ji

Status: Enrolling

Conditions: Metabolic Syndrome (MetS)

Treatments: Behavioral: Routine Care Group; Behavioral: ENRICH Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07096102

Main_RCT_ENRICH

Details and patient eligibility

About

The ENRICH study is aimed to Enpower patieNts with metabolic syndrome (Mets) to increase their Risk perception and to acquire health Information necessary for Capability building and promotion of Health information literacy, as well as health outcomes. The purpose of this clinical trial is to evaluate the efficacy of this health information literacy promotion intervention based on Health Empowerment Theory in individuals with metabolic syndrome. The study aims to answer the following questions:

Does the intervention improve health information literacy among study participants? Does the intervention lead to better health outcomes, including weight, waist circumference, BMI control, and metabolic health indicators (blood pressure, blood glucose, glycated hemoglobin, and blood lipids)?

Participants will:

Undergo the intervention program for 6 weeks (face to face and online) and will be assessed regularly to monitor changes in terms of their level of health information literacy and health outcomes.

Full description

Participants enrolled in the ENRICH study is planned to receive activities related to:

1. Health information management ability education based on health empowerment theory:①health information literacy intensive training;②medication management skills training;③self-monitoring skills practice;④diet and exercise management knowledge education.
2. Health behaviour motivation management based on health empowerment theory:①personalized goal setting: set learning goals with patients and clarify the weekly health information literacy improvement plan;②behavioural incentives and feedback: give spiritual recognition and physical rewards to patients who complete the health punch card on time and meet the monitoring targets;③peer support network construction: set up a discussion group to encourage patients to share their experiences in diet management and exercise practice, and enhance their knowledge of diet and exercise through group interaction;④Role model demonstration effect: patients with high health information literacy and remarkable self-management effects are set up as role models, and are invited to share their success stories.
3. Health management support system building based on the theory of health empowerment: ①online dynamic supervision: weekly Q&A sessions through WeChat groups to address issues such as health information screening, medication use, and interpretation of monitoring data;② collaborative family-community support: inviting family members to join the health management group to assist in dietary planning, supervise the implementation of exercise, and linking with the community health service centres to provide personalized guidance;③digital monitoring platforms Digital monitoring platform: Using the Concordia Medical Weight Loss applet and diet management WeChat group to push customised health advice;④Continuous supply of resources: Regularly updating links to authoritative channels, such as the website of the State Drug Administration and the China Public Health Network, to ensure that patients have access to reliable health information.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old and ≤ 75 years old;；
• Patients diagnosed with metabolic syndrome (meeting ≥3 criteria):
• Waist circumference ≥ 90 cm (men) / ≥ 85 cm (women)
• Fasting glucose ≥ 6.1 mmol/L or OGTT 2h-glucose ≥ 7.8 mmol/L and/or diabetes treatment
• Blood pressure ≥ 130/85 mmHg and/or hypertension treatment
• Fasting triglycerides (TG) ≥ 1.70 mmol/L
• Fasting HDL-C < 1.04 mmol/L；
• Aware of the condition, have basic reading and language communication skills, and voluntarily participate in this study

Exclusion criteria

• Patients with severe liver and kidney dysfunction, cancer, severe cardiovascular and cerebrovascular diseases, gout, etc., which seriously endanger life, have abnormal nutritional status and require special diet;
• Pregnant patients；
• Patients with a history of mental illness and cognitive impairment；
• Those currently participating in other research projects.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

ENRICH Intervention Group

Experimental group

Description:

A 6-week intervention programme was implemented for the health information literacy enhancement group, once a week, with each intervention lasting 30-40min, to enable the study participants to actively practice healthy behaviours through intervention techniques such as health awareness awakening, social resource building, and health-related skill empowerment, in order to enhance the health information literacy of the study participants, and ultimately to enable the study participants to perceive health in a programmatic manner.

Treatment:

Behavioral: ENRICH Group

Routine Care Group

Active Comparator group

Description:

Receiving routine health education: distributing health education handbooks on metabolic syndrome and metabolic diseases, establishing WeChat groups, and delivering regular weekly health knowledge.

Treatment:

Behavioral: Routine Care Group