Metabolic Syndrome (MetS)NCT07051733
Preliminary Effect of a Health Information Literacy Enhancement Program for Individuals With Metabolic Syndrome
A study testing Health Information Literacy Enhancement in people with Metabolic Syndrome (MetS), run by Meihua Ji at 1 site in China.
Trial summary
The purpose of this study is to evaluate the preliminary effect of a health-information literacy promotion program for individuals with Metabolic Syndrome (including its subtypes) based on the Health Empowerment Theory. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome (MetS)
- What is being tested?
- Health Information Literacy Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2025to Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 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
Show all 9Show fewer
- Fasting HDL-C < 1.04 mmol/L
- Individuals with ≥1 metabolic abnormality not meeting full metabolic syndrome criteria
- Cognitively aware with literacy skills and voluntary participation
Who cannot join
- Severe hepatic/renal dysfunction, cancer, or life-threatening diseases
- Mental disorders, visual/hearing impairments, or intellectual disabilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Li Yuan Community Health Service Center in Tongzhou District, Beijing
Beijing, Beijing Municipality, 101121
About this study
Official title: The Preliminary Effect of a Health Information Literacy Enhancement Program for Community-dwelling Individuals With Metabolic Syndrome: A Feasibility Study Based on the Health Empowerment Theory
The purpose of this study is to evaluate the preliminary effect of a health-information literacy promotion program for individuals with Metabolic Syndrome (including its subtypes) based on the Health Empowerment Theory. 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 their health information literacy and health outcomes.
Read the detailed description
- Health information management ability education based on health empowerment theory: ① health information literacy intensive training; ② medication management skills training; ③ self-monitoring skills practice; ④ diet and exercise management knowledge education.
- Health behaviour motivation management based on health empowerment theory: ① personalized goal setting: set learning goals with patients and clarify the weekly health information literacy improvement plan; ② peer 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; ③ Role 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 based on the theory of health empowerment: ① online 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; ③ digital 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
- Health Information Literacy Enhancement
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Information Literacy EnhancementBehavioural
Participants will undertake a six-week programme to enhance their health information literacy. The specific details are as follows:
- Capacity Building on Health Information Management via Health Education Based on the Health Empowerment Theory: ① Strengthening skills related to Health Information Literacy; ② Training on Medication Management Skills; ③ Practice of Self-Monitoring Skills; ④ Education on Diet and Exercise Management Knowledge.
- Health Behavior Motivation Management Based on the Health Empowerment Theory: ① Personalized Goal Setting; ② Behavioral Incentives and Feedback; ③ Construction of Peer Support Networks; ④ Demonstration Effect of Role Models.
- Health Management Support System Based on the Health Empowerment Theory: ① Online Dynamic Monitoring; ② Family-Community Collaborative Support; ③ Digital Monitoring Platform; ④ Continuous Supply of Resources.
| Study group | Role | What they receive |
|---|---|---|
| Health Information Literacy Enhancement 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: Health Information Literacy Enhancement |
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 29-145, with higher scores indicating higher levels of health information literacy. In the original study, the Cronbach's α coefficient for HILSS was 0.847, and the Cronbach's α coefficients for the dimensions.
Measured: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).
Secondary outcomes (6)
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 α) was 0.76.
Measured: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).
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 α coefficient of the scale is 0.957.
Measured: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
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 α coefficient is 0.911, and the Cronbach's α coefficients of each dimension range from 0.715 to 0.839.
Measured: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
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 α coefficient of 0.820, and an overall Cronbach's α coefficient of 0.845 in the Chinese population.
Measured: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
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 UI 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 taken once before the formal intervention and once after the intervention ends (at 6 weeks)
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'sａcoefficient of the scale is 0.893, and the content validity is 0.891, which is considered to be good.
Measured: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start8 May 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07051733
- Sponsor's protocol ID
- Z2023SY119
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang 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 35565900Hill-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 17443373Glasgow 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 15572438Luo 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 28408009Weiss 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 16338915
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preliminary Effect of a Health Information Literacy Enhancement Program for Community-dwelling Individuals With Metabolic Syndrome: A Feasibility Study Based on the Health Empowerment Theory
- ClinicalTrials.gov ID
- NCT07051733
- Acronym / sponsor ID
- Z2023SY119
- Conditions
- Metabolic Syndrome (MetS)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meihua JiUniversity, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University
- Study start
- 8 May 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 4 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 purpose of this study is to evaluate the preliminary effect of a health-information literacy promotion program for individuals with Metabolic Syndrome (including its subtypes) based on the Health Empowerment Theory. 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 their health information literacy and health outcomes.
Detailed description
- Health information management ability education based on health empowerment theory: ① health information literacy intensive training; ② medication management skills training; ③ self-monitoring skills practice; ④ diet and exercise management knowledge education.
- Health behaviour motivation management based on health empowerment theory: ① personalized goal setting: set learning goals with patients and clarify the weekly health information literacy improvement plan; ② peer 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; ③ Role 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 based on the theory of health empowerment: ① online 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; ③ digital 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Information Literacy Enhancement Group | Experimental | Behavioral: Health Information Literacy EnhancementA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 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 (2 listed)
- Severe hepatic/renal dysfunction, cancer, or life-threatening diseases
- Mental disorders, visual/hearing impairments, or intellectual disabilities
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 |
|---|---|---|
| Health Information Literacy EnhancementParticipants 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: ① Strengthening skills related to Health Information Literacy; ② Training on Medication Management Skills; ③ Practice of Self-Monitoring Skills; ④ Education on Diet and Exercise Management Knowledge. 2. Health Behavior Motivation Management Based on the Health Empowerment Theory: ① Personalized Goal Setting; ② Behavioral Incentives and Feedback; ③ Construction of Peer Support Networks; ④ Demonstration Effect of Role Models. 3. Health Management Support System Based on the Health Empowerment Theory: ① Online Dynamic Monitoring; ② Family-Community Collaborative Support; ③ Digital Monitoring Platform; ④ Continuous Supply of Resources. | Behavioural | Health Information Literacy Enhancement Group |
Primary outcome
Health Information Literacy
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).
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 29-145, with higher scores indicating higher levels of health information literacy. In the original study, the Cronbach's α coefficient for HILSS was 0.847, and the Cronbach's α coefficients for the dimensions.
6 secondary outcomes
Health Literacy
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).
Chronic Patient Self-Management Questionnaire
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
Health Problem-Solving
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
Chronic Illness Resources
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
Health-related Quality of Life
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
Nutrition Literacy
Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)
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 5 Sep 2025.
- 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.
- 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 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 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 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.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Information Literacy Enhancement in people with Metabolic Syndrome (MetS), run by Meihua Ji at 1 site 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 9 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Information Literacy (time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).). 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 NCT07051733, 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 5 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.