NCT07051733

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

June 2, 2025

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).

Secondary Outcomes (6)

  • Health Literacy

    Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks).

  • Chronic Patient Self-Management Questionnaire

    Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)

  • Health Problem-Solving

    Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)

  • Chronic Illness Resources

    Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)

  • Health-related Quality of Life

    Measurements will be taken once before the formal intervention and once after the intervention ends (at 6 weeks)

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Health Information Literacy Enhancement

Interventions

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 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.

Health Information Literacy Enhancement Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Yuan Community Health Service Center in Tongzhou District, Beijing

Beijing, Beijing Municipality, 101121, China

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Meihua Ji, PhD

    Capital Medical University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2025

First Posted

July 4, 2025

Study Start

May 8, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations