Health empowerment and information literacy program for people with metabolic syndrome

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

This program will try to improve how adults with metabolic syndrome find and use health information and support better self-care through training, peer support, and online coaching.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT07096102 on ClinicalTrials.gov

What this trial studies

The intervention delivers a 6-week combination of face-to-face and online sessions offering health information literacy training, medication and self-monitoring skills, diet and exercise education, personalized goal setting, incentives, and peer support. Participants are assigned to the ENRICH intervention or routine care and are regularly assessed for changes in health information literacy and metabolic health indicators. Weekly WeChat Q&A, family/community involvement, and role-model activities are used to reinforce learning and behavior change. Primary outcomes include literacy measures and clinical endpoints such as weight, waist circumference, BMI, blood pressure, blood glucose, HbA1c, and blood lipids.

Who should consider this trial

Good fit: Adults aged 18–75 with metabolic syndrome meeting at least three diagnostic criteria who are aware of their condition and have basic reading and communication skills are ideal candidates.

Not a fit: Individuals with severe liver or kidney dysfunction, active cancer, major cardiovascular or cerebrovascular disease, pregnancy, cognitive impairment, or those already enrolled in other research are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could help people with metabolic syndrome better manage their condition and improve weight, blood pressure, blood sugar, and cholesterol through improved knowledge and self-care.

How similar studies have performed: Similar health empowerment and literacy programs have improved knowledge and self-care in chronic conditions, although effects on metabolic biomarkers have been mixed.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Songzhuang Community Health Service Center — Beijing, Beijing Municipality, China (Recruiting)
• Yuqiao Subdistrict Community Health Service Center — Beijing, Beijing Municipality, China (Completed)
• Li Yuan Community Health Service Center in Tongzhou District, Beijing — Beijing, Beijing Municipality, China (Enrolling_by_invitation)
• Lucheng Subdistrict Community Health Service Center — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Meihua Ji, PhD — Capital Medical University School of nursing
• Study coordinator: Meihua Ji

Conditions Metabolic Syndrome