Efficacy of a Health Empowerment Theory Based Health Information Literacy Promotion Intervention in Individuals With Metabolic Syndrome

NCT ID: NCT07096102

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-12-30

Brief 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. 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:

1. 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.

2. 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.

3. 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ENRICH Intervention Group

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.

Group Type: EXPERIMENTAL

ENRICH Group

Intervention Type: BEHAVIORAL

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 Group

Receiving routine health education: distributing health education handbooks on metabolic syndrome and metabolic diseases, establishing WeChat groups, and delivering regular weekly health knowledge.

Group Type: ACTIVE_COMPARATOR

Routine Care Group

Intervention Type: BEHAVIORAL

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.

Interventions

ENRICH Group

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.

Intervention Type: BEHAVIORAL

Routine Care Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Luhe Teaching Hospital of the Capital Medical University

OTHER

Sponsor Role: collaborator

Meihua Ji

OTHER

Sponsor Role: lead

Responsible Party

Meihua Ji

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Meihua Ji, PhD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University School of nursing

Locations

Songzhuang Community Health Service Center

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Yuqiao Subdistrict Community Health Service Center

Beijing, Beijing Municipality, China

Site Status: COMPLETED

Li Yuan Community Health Service Center in Tongzhou District, Beijing

Beijing, Beijing Municipality, China

Site Status: ENROLLING_BY_INVITATION

Lucheng Subdistrict Community Health Service Center

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meihua Ji

Role: CONTACT

Mjshouyi@ccmu.edu.cn

86+15210434269

Facility Contacts

Xiaoyan Qi

Role: primary

qxyan0626@163.com

010-13501246401

Xiaoyan Qi

Role: primary

qxyan0626@163.com

010-13501246401

References

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.

Reference Type: RESULT

PMID: 16338915 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28408009 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15572438 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17443373 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35565900 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Main_RCT_ENRICH

Identifier Type: -

Identifier Source: org_study_id