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Effects of a Health Intervention on Fear of Hypoglycemia | Clinical Trials | Clareo Health

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Effects of a Health Intervention on Fear of Hypoglycemia

Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study

NCT06464900•Yangzhou University

View on ClinicalTrials.gov

Summary

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

Detailed Description

In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;
•Age ≥18 years;
•Duration of diabetes mellitus ≥1 year;
•FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);
•Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;
•Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;
•Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria

•Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;
•Patients with comorbid psychiatric diseases or taking psychotropic drugs;
•Patients who have recently or are participating in other studies on similar topics.

Locations (1)

Yangzhou University

Yangzhou, Jiangsu, China

Key Dates

Start Date

July 1, 2024

Primary Completion Date

January 1, 2025

Completion Date

January 1, 2025

Last Updated

July 9, 2024

Enrollment

ESTIMATED participants

Conditions

Health-Related BehaviorHealth EducationFear of HypoglycemiaImpaired Awareness of HypoglycemiaSelf-ManagementType2 Diabetes Mellitus

Interventions

Routine Care

BEHAVIORAL

Based on BCW Theory of Health Education

BEHAVIORAL

Contacts

Ma Hongxin, Master

CONTACT

+86 87974902 007032@yzu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of a Health Intervention on Fear of Hypoglycemia

Inclusion Criteria

Exclusion Criteria

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