Type 2 Diabetes MellitusNCT06197360

Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study

A study testing Based on BCW Theory of Health Education and General diabetes health education in people with Type 2 Diabetes Mellitus and Fear of Hypoglycemia, run by Yangzhou University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibility, acceptability, and initial effects of the program. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, Fear of Hypoglycemia, Health Education
What is being tested?: Based on BCW Theory of Health Education and General diabetes health education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteChina
Study dates: 1 Aug 2021to 31 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Yangzhou University
Yangzhou, Jiangsu, 225000

Other trials in China

About this study

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

Read the 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 4-week follow-up period, for a total of 8 weeks.

Conditions: Type 2 Diabetes Mellitus, Fear of Hypoglycemia, Health Education, Impaired Awareness of Hypoglycemia, Self-Management
Being tested: Based on BCW Theory of Health Education, General diabetes health education
Keywords: Type 2 Diabetes Mellitus, Fear of hypoglycemia, Behavior Change Wheel theory, Impaired Awareness of Hypoglycemia, Self-Management
Medical subject headings: Diabetes Mellitus, Type 2, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Based on BCW Theory of Health EducationBehavioural
Questionnaire collection, face-to-face interview, and interpretation of the manual on the first day of admission; diabetes self-management teaching on the second day; and hypoglycemia-related lectures and hands-on teaching on the fourth day. Day 6 hypoglycemia fear case discussion. Face-to-face teaching and formulation of blood glucose management plan on the first day before discharge; WeChat push or telephone return visit one week and two weeks after discharge; WeChat push, telephone return visit and questionnaire collection three weeks after discharge.
General diabetes health educationBehavioural
Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.

Study groups in NCT06197360
Study group	Role	What they receive
General diabetes health education	Placebo comparator	Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support. Receives: Behavioral: General diabetes health education
Based on BCW Theory of Health Education	Experimental	A FOH intervention program based on BCW theory was implemented on top of the control group. Receives: Behavioral: Based on BCW Theory of Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Hypoglycemia Fear Behavioral
Hypoglycemia Fear Survey - Behavior Scale consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 (lowest) to 95 (highest), with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia.
Measured: Baseline, immediately after the intervention and after the 4 weeks follow-up
Hypoglycemia Fear Worry
Hypoglycemic fear Survey - Worry Scale was used to evaluate the patients' hypoglycemic feelings in the past 6 months. There were 13 items in the scale, using 5-point Likert scale, with scores ranging from low to high 0-4, and the total score ranging from 0 (lowest) to 52 (highest). The higher the score, the higher the patient's fear of hypoglycemia.
Measured: Baseline, immediately after the intervention and after the 4 weeks follow-up

Secondary outcomes (3)

Gold Rating
Gold Score was first proposed by Professor Gold in the UK in 1994. It is the most commonly used assessment method for Impaired Awareness of Hypoglycemia, which reflects patients' awareness of hypoglycemia at the same time. The only question with this approach is, "Do you know when your low blood sugar started?" Likert scores 7 on a scale of "1" (always aware) to "7" (never aware), with an overall score from 1 (lowest) to 7 (highest). An overall score of 1-3 is considered normal hypoglycemic self-awareness, and a score of ≥4 indicates the presence of IAH.
Measured: Baseline, immediately after the intervention and after the 4 weeks follow-up
The Patients Assessment Chronic Illness Care( PACIC)
The Patient Assessment Chronic Care Scale was developed with support from the Johnson Foundation to assess the quality of care provided by healthcare organizations. Patients use this scale to report their perceived level of medical support. The PACIC scale consists of five dimensions and 20 questions, each of which is rated on a 5-point Likert scale (1 to 5), with higher scores (close to 5) indicating greater support from healthcare professionals. The score for each dimension is calculated based on the average score of the items it contains, and the total table score is calculated based on the average score of all 20 items, with a minimum score of 1 and a maximum score of 5. Total scale score ≤1.75 is classified as low level of medical support; An overall average score of 1.75 to 3.5 indicates moderate medical support; Total mean score ≥3.5 was classified as high medical support.
Measured: Baseline, immediately after the intervention and after the 4 weeks follow-up
The Self-management Attitude Scale for Diabetes Patients
The Self-Management Attitude Scale for Diabetic Patients is a sub-scale of the Self-Management Knowledge, Attitude and Behavior Assessment Scale for Diabetic Patients compiled by the Chinese Center for Prevention and Control of Chronic Noncommunicable Diseases (CPCNCD). The scale included five items that assessed patients' attitudes toward diabetes health education, diet control, physical activity, medication adherence, and blood glucose monitoring. The 5-point Likert scale was used, with 1 indicating "very important" and 5 indicating "very unimportant", and the scores were divided into 0.2, 0.4, 0.6, 0.8 and 1.0 in order from low to high. The total score of the five items is the total self-management attitude score (range 1-5), and a score below 3.0 indicates a poor self-management attitude. A score of 3.0 to 4.25 indicates an average self-management attitude, while a score of 4.25 or above indicates a good self-management attitude.
Measured: Baseline, immediately after the intervention and after the 4 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202131 Jan 2022

First posted9 Jan 2024
Study start1 Aug 2021
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06197360
Sponsor's protocol ID: YZUHL20210088
Status last verified: Jan 2025
First submitted: 21 Dec 2023
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plans to provide IPD.

Publications

Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.
PubMed 35788767
Zhao Y, Zhang L, Pang J, Qiu J, He Y, Xu Z, Han M, Liu L, Wan X, Wang J, Zhang Y. Effects of a health education intervention based on the behavior change wheel on fear of hypoglycemia behavior in type 2 diabetes mellitus patients: a randomized controlled pilot trial. Acta Diabetol. 2025 Dec;62(12):2071-2084. doi: 10.1007/s00592-025-02549-5. Epub 2025 Jun 23.
PubMed 40548996

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Pilot Study
ClinicalTrials.gov ID: NCT06197360
Acronym / sponsor ID: YZUHL20210088
Conditions: Type 2 Diabetes Mellitus, Fear of Hypoglycemia, Health Education, Impaired Awareness of Hypoglycemia, Self-Management
Keywords: Type 2 Diabetes Mellitus, Fear of hypoglycemia, Behavior Change Wheel theory, Impaired Awareness of Hypoglycemia, Self-Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Yangzhou UniversityUniversity, hospital or other
Study start: 1 Aug 2021 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 9 Jan 2024 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
General diabetes health education	Placebo comparator	Behavioral: General diabetes health educationPatients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.
Based on BCW Theory of Health Education	Experimental	Behavioral: Based on BCW Theory of Health EducationA FOH intervention program based on BCW theory was implemented on top of the control group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (3 listed)

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

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
Based on BCW Theory of Health EducationQuestionnaire collection, face-to-face interview, and interpretation of the manual on the first day of admission; diabetes self-management teaching on the second day; and hypoglycemia-related lectures and hands-on teaching on the fourth day. Day 6 hypoglycemia fear case discussion. Face-to-face teaching and formulation of blood glucose management plan on the first day before discharge; WeChat push or telephone return visit one week and two weeks after discharge; WeChat push, telephone return visit and questionnaire collection three weeks after discharge.	Behavioural	Based on BCW Theory of Health Education
General diabetes health educationPatients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.	Behavioural	General diabetes health education

Primary outcome

Hypoglycemia Fear Behavioral
Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up
Hypoglycemia Fear Survey - Behavior Scale consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 (lowest) to 95 (highest), with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia.
Hypoglycemia Fear Worry
Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up
Hypoglycemic fear Survey - Worry Scale was used to evaluate the patients' hypoglycemic feelings in the past 6 months. There were 13 items in the scale, using 5-point Likert scale, with scores ranging from low to high 0-4, and the total score ranging from 0 (lowest) to 52 (highest). The higher the score, the higher the patient's fear of hypoglycemia.

3 secondary outcomes

Gold Rating
Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up
The Patients Assessment Chronic Illness Care( PACIC)
Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up
The Self-management Attitude Scale for Diabetes Patients
Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
General Diabetes Health Education	25	25
Based on BCW Theory of Health Education	25	25

Primary outcome: Hypoglycemia Fear Behavioral

Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up. Mean (Standard Deviation). Unit: score on a scale

Measure	General Diabetes Health Education n = 25	Based on BCW Theory of Health Education n = 25
Baseline	59.60 (11.61)	63.88 (11.63)
Immediately after the intervention	57.52 (12.33)	44.20 (5.59)
After the 4 weeks follow-up	55.16 (10.68)	39.72 (5.34)

Primary outcome: Hypoglycemia Fear Worry

Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up. Mean (Standard Deviation). Unit: score on a scale

Measure	General Diabetes Health Education n = 25	Based on BCW Theory of Health Education n = 25
Baseline	32.72 (4.09)	32.96 (2.89)
Immediately after the intervention	29.76 (2.64)	18.76 (3.63)
After the 4 weeks follow-up	27.16 (4.15)	15.44 (3.38)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
General Diabetes Health Education	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Based on BCW Theory of Health Education	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35788767Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.
Derived from this study: PubMed 40548996Zhao Y, Zhang L, Pang J, Qiu J, He Y, Xu Z, Han M, Liu L, Wan X, Wang J, Zhang Y. Effects of a health education intervention based on the behavior change wheel on fear of hypoglycemia behavior in type 2 diabetes mellitus patients: a randomized controlled pilot trial. Acta Diabetol. 2025 Dec;62(12):2071-2084. doi: 10.1007/s00592-025-02549-5. Epub 2025 Jun 23.
Individual participant dataSharing planned: No. No plans to provide IPD.

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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. This study is not recruiting at the moment.

Yueqi Zhao, Bachelor principal investigator

Yangzhou University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hypoglycemia Fear Behavioral (time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up). The study lists 2 primary outcomes in all. 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 NCT06197360, which also lists 2 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 10 Feb 2025.