Metabolic Syndrome (MetS)NCT07096102
Efficacy of a Health Empowerment Theory Based Health Information Literacy Promotion Intervention in Individuals With Metabolic Syndrome
A study testing ENRICH Group and Routine Care Group in people with Metabolic Syndrome (MetS), run by Meihua Ji at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome (MetS)
- What is being tested?
- ENRICH Group and Routine Care Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 4 sitesChina
- Study dates
- 31 Aug 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 3 recruiting
- Recruiting
Songzhuang Community Health Service Center
Beijing, Beijing Municipality, 101100
Xiaoyan Qi, 010-13501246401, qxyan0626@163.com
- Completed
Yuqiao Subdistrict Community Health Service Center
Beijing, Beijing Municipality, 101100
- Enrolling by invitation
Li Yuan Community Health Service Center in Tongzhou District, Beijing
Beijing, Beijing Municipality, 101121
- Recruiting
Lucheng Subdistrict Community Health Service Center
Beijing, Beijing Municipality
Xiaoyan Qi, 010-13501246401, qxyan0626@163.com
About this study
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)?
Read more
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.
Read the detailed description
Participants enrolled in the ENRICH study is planned to receive activities related to:
- 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.
- 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.
- 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.
- Conditions
- Metabolic Syndrome (MetS)
- Being tested
- ENRICH Group, Routine Care Group
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENRICH GroupBehavioural
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 GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| ENRICH Intervention Group | Experimental | 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. Receives: Behavioral: ENRICH Group |
| Routine Care Group | Active comparator | Receiving routine health education: distributing health education handbooks on metabolic syndrome and metabolic diseases, establishing WeChat groups, and delivering regular weekly health knowledge. Receives: Behavioral: Routine Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Total Cholesterol（TC）, Triglyceride（TG）, High Density Lipoprotein-Cholesterol（HDL-C）, Low-Density Lipoprotein Cholesterol（LDL-C）
- 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.
- 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.
- 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.
- 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.
Measured: 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.
General Physical Examination- Height
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.
Measured: 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.
General Physical Examination- Weight
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.
Measured: 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.
General Physical Examination- Body Mass Index（BMI）
According to the internationally recognized BMI calculation formula:
BMI = weight (kg) / height (m)²
Measured: 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.
General Physical Examination- Waist Circumstance
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.
Measured: 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.
General Physical Examination- Blood Pressure
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.
Measured: 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.
General Physical Examination- Blood Glucose
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.
Measured: 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.
Secondary outcomes (7)
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.
Measured: 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 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Knowledge of Metabolic Syndrome Scale (K-MS scale)
The scale consists of 10 entries in 3 dimensions: disease definition, hazards, and prevention and treatment (all single-choice questions with 5 choices each). The scale is scored by calculating the percentage of correct answers, with one correct answer counting for 10 points and a total score of 0-100, with higher scores being better. The total Cronbach's a coefficient of the scale was 0.69, the Cronbach's a coefficient of each entry was 0.63-0.73, the re-test reliability was 0.56 (P=0.0002), the content validity (CVI) was 98.1%, and the measurements were in line with the hypothesised construct validity (P<0.0001).
Measured: 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.
Nutrition Literacy
The Food and Nutrition Literacy Questionnaire, developed by the School of Public Health at Peking University, will be used for assessment. The current status of nutrition literacy includes four dimensions: knowledge and concepts related to food, selecting food, preparing food, and consuming food. The questionnaire has a score of 100 points, and the critical value of this questionnaire is 80 points, and a score of 80 points or more represents nutritional literacy, and the proportion of patients with nutritional literacy is the level of nutritional literacy. The Cronbach's a coefficient of the scale is 0.893, and the content validity is 0.891, which is considered to be good.
Measured: 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-related Quality of Life
A health-related quality of life scale, the EQ-5D-5L, developed by the EuroQol Group, will be used to measure individuals quality of life. It comprises the EQ-5D descriptive system and the EQ-5D Visual Analog Scale (EQ VAS). The five dimensions assess participants' mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension having five levels: no difficulties, slight difficulties, moderate difficulties, severe difficulties, and extreme difficulties/unable to perform. the Ul scores ranged from -0.391 to 1. The EQ VAS records a participant's self-assessed health status on a vertical visual analogue scale labelled Your best imagined health (100 points)' and 'Your worst imagined health (0 points)'. The EQ VAS provides a quantitative description of the respondent's perception of their overall health. Higher scores indicate higher quality of life. EQ-5D-5L has been validated by Chinese scholars with a Cronbach coefficient of 0.624.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome (MetS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meihua Ji
- Sponsor type
- University, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University
- Responsible party
- Sponsor-investigator, Meihua Ji, Capital Medical University
- Investigators
- Meihua Ji, PhD, Principal investigator, Capital Medical University School of nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096102
- Sponsor's protocol ID
- Main_RCT_ENRICH
- Status last verified
- Nov 2025
- First submitted
- 16 Jul 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA, Pignone MP, Mockbee J, Hale FA. Quick assessment of literacy in primary care: the newest vital sign. Ann Fam Med. 2005 Nov-Dec;3(6):514-22. doi: 10.1370/afm.405.
PubMed 16338915Luo N, Liu G, Li M, Guan H, Jin X, Rand-Hendriksen K. Estimating an EQ-5D-5L Value Set for China. Value Health. 2017 Apr;20(4):662-669. doi: 10.1016/j.jval.2016.11.016. Epub 2017 Feb 9.
PubMed 28408009Glasgow RE, Toobert DJ, Barrera M Jr, Strycker LA. The Chronic Illness Resources Survey: cross-validation and sensitivity to intervention. Health Educ Res. 2005 Aug;20(4):402-9. doi: 10.1093/her/cyg140. Epub 2004 Nov 30.
PubMed 15572438Hill-Briggs F, Gemmell L, Kulkarni B, Klick B, Brancati FL. Associations of patient health-related problem solving with disease control, emergency department visits, and hospitalizations in HIV and diabetes clinic samples. J Gen Intern Med. 2007 May;22(5):649-54. doi: 10.1007/s11606-006-0091-2.
PubMed 17443373Zhang Y, Zhang Z, Xu M, Aihemaitijiang S, Ye C, Zhu W, Ma G. Development and Validation of a Food and Nutrition Literacy Questionnaire for Chinese Adults. Nutrients. 2022 May 5;14(9):1933. doi: 10.3390/nu14091933.
PubMed 35565900
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Health Empowerment Theory Based Health Information Literacy Promotion Intervention in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07096102
- Acronym / sponsor ID
- Main_RCT_ENRICH
- Conditions
- Metabolic Syndrome (MetS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Meihua JiUniversity, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants enrolled in the ENRICH study is planned to receive activities related to:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENRICH Intervention Group | Experimental | Behavioral: ENRICH GroupA 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. |
| Routine Care Group | Active comparator | Behavioral: Routine Care GroupReceiving routine health education: distributing health education handbooks on metabolic syndrome and metabolic diseases, establishing WeChat groups, and delivering regular weekly health knowledge. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENRICH GroupParticipants 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. | Behavioural | ENRICH Intervention Group |
| Routine Care Group①Distribute 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. | Behavioural | Routine Care Group |
Primary outcome
Health Information Literacy
Time frame: 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
Time frame: 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 )
Time frame: 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）
Time frame: 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
Time frame: 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
Time frame: 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）
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Health Literacy
Time frame: 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 Problem Solving
Time frame: 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.
Chronic Illness Resources
Time frame: 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.
Chronic Disease Self-Efficacy Scale
Time frame: 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.
Knowledge of Metabolic Syndrome Scale (K-MS scale)
Time frame: 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.
Nutrition Literacy
Time frame: 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-related Quality of Life
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 16338915Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA, Pignone MP, Mockbee J, Hale FA. Quick assessment of literacy in primary care: the newest vital sign. Ann Fam Med. 2005 Nov-Dec;3(6):514-22. doi: 10.1370/afm.405.
- Results publication: PubMed 28408009Luo N, Liu G, Li M, Guan H, Jin X, Rand-Hendriksen K. Estimating an EQ-5D-5L Value Set for China. Value Health. 2017 Apr;20(4):662-669. doi: 10.1016/j.jval.2016.11.016. Epub 2017 Feb 9.
- Results publication: PubMed 15572438Glasgow RE, Toobert DJ, Barrera M Jr, Strycker LA. The Chronic Illness Resources Survey: cross-validation and sensitivity to intervention. Health Educ Res. 2005 Aug;20(4):402-9. doi: 10.1093/her/cyg140. Epub 2004 Nov 30.
- Results publication: PubMed 17443373Hill-Briggs F, Gemmell L, Kulkarni B, Klick B, Brancati FL. Associations of patient health-related problem solving with disease control, emergency department visits, and hospitalizations in HIV and diabetes clinic samples. J Gen Intern Med. 2007 May;22(5):649-54. doi: 10.1007/s11606-006-0091-2.
- Results publication: PubMed 35565900Zhang Y, Zhang Z, Xu M, Aihemaitijiang S, Ye C, Zhu W, Ma G. Development and Validation of a Food and Nutrition Literacy Questionnaire for Chinese Adults. Nutrients. 2022 May 5;14(9):1933. doi: 10.3390/nu14091933.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meihua Ji, PhD principal investigator
Capital Medical University School of nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENRICH Group and Routine Care Group in people with Metabolic Syndrome (MetS), run by Meihua Ji at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meihua Ji (86+15210434269, Mjshouyi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Information Literacy (time frame: 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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096102, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.