ENRICH Group: Participants will undertake a six-week programme to enhance their health information literacy. The specific details are as follows: (1) Capacity Building on Health Information Management via Health Education Based on the Health Empowerment Theory:①Strengthening skills related to Health Information Literacy; ②Training on Medication Management Skills;③ Practice of Self-Monitoring Skills;④Education on Diet and Exercise Management Knowledge. (2) Health Behavior Motivation Management Based on the Health Empowerment Theory:① Personalized Goal Setting;②Behavioral Incentives and Feedback;③Construction of Peer Support Networks;④Demonstration Effect of Role Models. (3) Health Management Support System Based on the Health Empowerment Theory:①Online Dynamic Monitoring;②Family-Community Collaborative Support;③Digital Monitoring Platform;④Continuous Supply of Resources.
Routine Care Group: ①Distribute 3-5 push publics on screening health information and health disinformation in the first week；②Distribute 3-5 push publics on medicine knowledge in the second week；③Distribute 3-5 push publics on self-monitoring knowledge in the third week；④Distribute 3-5 publics on exercise knowledge in week 4；⑤Distribute 3-5 push publics on dietary knowledge in week 5 and week 6.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Health Information Literacy — Measurements will be conducted before the intervention (baseline measurement), at the end of the intervention (immediate measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. Health information literacy (HIL) is essential to assist individuals in health decision-making. In this study, health information literacy will be measured using the Health Information Literacy Self-rating Scale.A 5-point Likert scale was used, with scores ranging from 1-5 for 'strongly disagree to 'strongly agree', and a total scale score ranging from 0-29, with higher scores indicating higher levels of health information literacy. In the original study, the Cronbach's a coefficient for HILSS was 0.847, and the Cronbach's a coefficients for the dimensions was 0.783～0.917.
Chronic Patient Self-Management Questionnaire — Measurements will be conducted before the intervention (baseline measurement), at the end of the intervention (immediate measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. The Self-Management Questionnaire for Chronic Patients used to assess the self-management level of patients with chronic diseases. The scale includes five aspects: dietary habits, exercise management, medication adherence, emotional management, and family and social support, and adopts the Likert 5-point rating method. The questionnaire consists of 20 multiple choice questions with a total score of 100 points. The scoring criteria are: between 20 and 60 points is a poor level of self-management; between 60 and 80 points is a medium level of management; between 80 and 100 points is a high level of self-management. The Cronbach's a coefficient of the scale is 0.957.
Glycosylated Hemoglobin（HbA1c ) — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. The glycosylated hemoglobin level is determined by past, rather than immediate, blood glucose concentrations. The glycosylated hemoglobin concentration is generally considered to be a valid reflection of the average blood glucose level over the past 8 to 12 weeks.
Total Cholesterol（TC）, Triglyceride（TG）, High Density Lipoprotein-Cholesterol（HDL-C）, Low-Density Lipoprotein Cholesterol（LDL-C） — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. 1. Total cholesterol is the sum of the cholesterol in all lipoproteins in the blood. If this indicator is high, it may be related to physiological factors such as smoking and stress, or disease factors such as familial hypercholesterolaemia and diabetes mellitus.
2. Triglyceride (TG) is a type of fat in the blood, which is mainly derived from fat in food and synthesised by the liver. High levels of triglycerides are one of the risk factors for cardiovascular disease.
3. High-density lipoprotein cholesterol (HDL-C) is a beneficial cholesterol that removes LDL cholesterol from the blood vessels and reduces the risk of cardiovascular disease.
4. Low-density lipoprotein cholesterol (LDL-C) is a harmful cholesterol and is one of the major risk factors for cardiovascular disease.The higher the LDL cholesterol level, the greater the risk of cardiovascular disease.
General Physical Examination- Height — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. The participants shall be measured bareheaded and barefoot using a vertical stadiometer with an accuracy of 0.1 cm. During the measurement process, each indicator is required to be measured using uniform standards and instruments.
General Physical Examination- Weight — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. The measurement shall be conducted using a metrologically certified weighing scale, with the participant standing calmly at the center of the platform, distributing weight evenly on both legs, and measured bareheaded and barefoot. During the measurement process, each indicator is required to be measured using uniform standards and instruments.
General Physical Examination- Body Mass Index（BMI） — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. According to the internationally recognized BMI calculation formula:
BMI = weight (kg) / height (m)²
General Physical Examination- Waist Circumstance — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. The measurement shall be performed by marking the midpoint between the lower edge of the rib cage at the midaxillary line and the iliac crest on both sides. A flexible measuring tape shall be placed horizontally around the body at the marked points, maintaining gentle contact with the skin without compression. The reading shall be taken at the end of normal expiration. During the measurement process, each indicator is required to be measured using uniform standards and instruments.
General Physical Examination- Blood Pressure — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. Blood pressure measurement shall be performed after the subject has rested quietly in a seated position for at least 5 minutes, with the upper arm positioned at heart level. Using a standard sphygmomanometer, two consecutive measurements of upper arm blood pressure shall be taken at 1-2 minute intervals, with the final result recorded as the average of the two readings. During the measurement process, each indicator is required to be measured using uniform standards and instruments.
General Physical Examination- Blood Glucose — Measurements will be conducted before the intervention (baseline measurement), 3 months after the start of the intervention, and 6 months after the start of the intervention. The subject's meal consumption status and timing shall be inquired and recorded, followed by random fingertip blood glucose measurement using a standardized glucometer. During the measurement process, each indicator is required to be measured using uniform standards and instruments.
Trial sites (4)
Facility
City
Region
Status
Songzhuang Community Health Service Center
Beijing
Beijing Municipality
Recruiting
Yuqiao Subdistrict Community Health Service Center
Beijing
Beijing Municipality
Completed
Li Yuan Community Health Service Center in Tongzhou District, Beijing
Beijing
Beijing Municipality
Enrolling By Invitation
Lucheng Subdistrict Community Health Service Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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