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.
Age ≥ 18 years old and ≤ 75 years old;；
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
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.
Parallel
ENRICH Group
BehavioralParticipants 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
Behavioral①Distribute 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.
Health Information Literacy
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
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 )
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）
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.
Health Literacy
Health literacy refers to an individual's ability to obtain, process, and understand basic health information and services, and to make appropriate health decisions. Compared with health information literacy, the concept and scope of health literacy are more general and broader.In this study, the Newest Vital Sign scale will be used to assess individuals' overall health literacy levels. The measure has six questions assessing a person's reading, numeracy, and comprehension based on an ice cream nutritional label. 1 point for each correct answer, 6 questions in total, total score 0-6 points, the higher the score the higher the health literacy. The internal consistency (Cronbach's a) was 0.76.
Health Problem Solving
The Chinese version of the Health Problem-Solving Scale consists of 6 dimensions: rational/effective problem-solving, positive positive transfer problem-solving, avoidance problem-solving, impulsive/careless problem-solving, negative transfer/learning, and negative motivation/attitude. It includes 30 items. The Likert 5-point scoring method was used, with the lowest score being 0 and the highest score being 4. The higher the score, the better the health problem solving ability. The content validity index of the scale is 0.970, the content validity index of the items ranges from 0.830 to 1.000, the Cronbach's a coefficient is 0.911, and the Cronbach's a coefficients of each dimension range from 0.715 to 0.839.
Chronic Illness Resources
The Chronic Illness Resource Survey (CIRS) consists of 19 items measuring six aspects of social resources: individuals, family and friends, healthcare team, community, media policy and community organisations. The scale is scored on a 5-point Likert scale, ranging from 1 to 5. Higher scores indicate greater access to or use of resources. The scale had good reliability in the original study, with a Cronbach's a coefficient of 0.820, and an overall Cronbachs a coefficient of 0.845 in the Chinese population.
Chronic Disease Self-Efficacy Scale
The scale consists of 6 items in 2 dimensions, including patients' symptom management self-efficacy (measured by items 1-4) and patients' disease co-management self-efficacy (measured by items 5-6). The scale was rated on a 10-point positive scale, with a minimum score of 1 indicating that the patient was not at all confident in health self-management, a maximum score of 10 indicating that the patient was confident in health self-management, and a total score of the average of the 6 entries. The higher the score, the better. The original version of the scale had a Cronbach's a coefficient of 0.91.
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Meihua Ji
Lead sponsor
Capital Medical University
Sponsor institution
The Luhe Teaching Hospital of the Capital Medical University
Collaborator
