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Enrolling by invitation NCT07051733

Preliminary Effect of a Health Information Literacy Enhancement Program for Individuals With Metabolic Syndrome

No phase Interventional Metabolic Syndrome (MetS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Information Literacy Enhancement.
Who it may be relevant to
Registry conditions: Metabolic Syndrome (MetS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

1. 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. 2. 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. 3. 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.

Interventions

  • Behavioral Health Information Literacy Enhancement
    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: 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 th

Primary outcome measures

  • Health Information Literacy [Time frame: Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).]
Secondary outcome measures (6)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • Severe hepatic/renal dysfunction, cancer, or life-threatening diseases
  • Mental disorders, visual/hearing impairments, or intellectual disabilities

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Li Yuan Community Health Service Center in Tongzhou District, Beijing — Beijing

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. PMID 35565900
  • Hill-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. PMID 17443373
  • Glasgow 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. PMID 15572438
  • Luo 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. PMID 28408009
  • 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. PMID 16338915

Identifiers

NCT: NCT07051733 · Z2023SY119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗