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
Phase: NA
Conditions: Type 2 Diabetes Mellitus, Fear of Hypoglycemia, Health Education, Impaired Awareness of Hypoglycemia, Self-Management
Sponsor: Yangzhou University

 
 
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 
 
 
 
 
 
 
 
 
January 14, 2021 
 
 

Study Protocol 
1. Integrity Statement 
(1) Ensure that the operation is in strict accordance with the test protocol and the 
authenticity of the data records; (2) No conflict of interest with other projects. 
2. Title of the study 
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 
3. Flow chart of the implementation of the study 

 
Specific implementation elements of the Intervention programme 
Behavioural analysis with the BCW 
theory 
Intervention 
function 
Specific interventions 
Implementation 
modalities 
Implementation time 
Motivations 
Spontaneous motivation 
Intensive 
daily 
diabetes 
management 
to 
change 
attitudes and habits. 
Education, 
training, 
persuasion, 
modelling 
1. Fill in the hypoglycaemia fear scale on the first day of 
admission, grasp the obstacles in blood glucose 
management and hypoglycaemia cognition, correct the 
wrong cognition on a one-to-one basis, and establish the 
scientific concept of blood glucose management. 
 
2. Introduce the knowledge of diabetes, hypoglycaemia 
and fear of hypoglycaemia to patients through PPT 
teaching. 
 
3. 1-3 weeks after discharge, describe blood glucose 
management management and how to respond when 
hypoglycaemia occurs through patient diaries. Encourage 
patients to upload and share their hypoglycaemic fear and 
diet and exercise diaries in WeChat group, and patients 
with good psychological status to share their feelings. 
Questionnaires, face-to-
face interviews 
 
 
 
 
PPT lectures and video 
learning 
 
 
WeChat or telephone 
communication 
 
Day 1 of admission, 
duration 15min 
 
 
 
 
Days 2, 4 and 6 of 
admission, each 60 
min long 
 
Weeks 1, 2 and 3 after 
discharge, 1 time per 
week, 15min each time 
Introspective motivation 
Understand the negative 
consequences of fear of 
hypoglycaemia, 
improve 
hypoglycaemia awareness 
and self-regulation skills, 
set blood glucose control 
goals to maintain stable 
blood glucose and reduce 
the occurrence of abnormal 
blood glucose. 
1. 
Personalised 
guidance 
on 
knowledge 
about 
hypoglycaemia was pushed through WeChat to reshape, as 
far as possible, their sense of self-efficacy in relation to 
glycaemic control. 
 
2. Use examples to illustrate the dangers of excessive 
avoidance 
behaviours 
caused 
by 
the 
fear 
of 
hypoglycaemia. 
 
3. Encourage patients with stable glycaemic management 
to share their experiences and set an example for other 
patients. 
WeChat 
 
 
 
 
WeChat 
 
 
 
WeChat or telephone 
communication 
 
Every Monday of the 
1st, 2nd and 3rd week 
after discharge 
 
 
60min on the 6th day 
of admission 
 
 
Every 3rd week after 
discharge 
15min 
duration 

 
 (Continued) 
Behavioural analysis with the BCW 
theory 
Intervention 
function 
Specific interventions 
Implementation 
modalities 
Implementation time 
Capability 
Mental capacity 
Raise 
awareness 
of 
hypoglycaemia, 
detect 
hypoglycaemia in a timely 
manner, acquire scientific 
knowledge 
about 
hypoglycaemia, 
and 
understand 
the 
health 
problems associated with 
the fear of hypoglycaemia. 
Education, 
training, 
realisation 
1. Fill in the questionnaire on the first day of admission to 
understand the patient's psychological state and knowledge 
of hypoglycaemia fear. 
 
2. Introduce patients to diabetes mellitus as well as 
knowledge about hypoglycaemia and hypoglycaemia fear 
and the impact it has on diabetes mellitus. 
 
3. Help patients to look for clues to the occurrence of 
hypoglycaemia and the causes and consequences of 
impaired awareness of hypoglycaemia, and instruct 
patients on how to reduce hypoglycaemia exposure. 
 
4. Re-completion of the questionnaire to understand the 
patient's knowledge of hypoglycaemia and fear of 
hypoglycaemia 
Questionnaire 
 
 
 
Interpretation 
of 
the 
Type 
2 
Diabetes 
Hypoglycaemia Health 
Education Manual 
Face-to-face Interview 
 
 
 
 
Questionnaire Survey 
Day 1 of admission, 
duration 15min 
 
 
Day 1 of admission, 
duration 15min 
 
 
Day 1 of admission, 
duration 15min 
 
 
 
Day 
1 
before 
discharge, 
duration 
15min 
Physical capability 
In 
the 
event 
of 
a 
hypoglycaemic 
event, 
patients know how to deal 
with it, how to monitor their 
blood glucose appropriately 
and how to calculate the 
amount of diet and exercise 
to maintain a stable blood 
glucose level. 
1. Introduce patients to proper diet, moderate exercise and 
rational use of medication, the correct way of monitoring 
blood 
glucose, 
identifying 
the 
pre-symptoms 
of 
hypoglycaemia, and how to deal with them. 
PPT lectures and video 
learning 
Days 2, 4 and 6 of 
admission, 
each 
lasting 60 min. 

 
 (Continued) 
Behavioural analysis with the BCW 
theory 
Intervention 
function 
Specific interventions 
Implementation 
modalities 
Implementation time 
Opportunity 
Social opportunities  
The external environment 
and medical support are 
facilitators of change in 
patients' 
hypoglycaemic 
fear-avoidance behaviour, 
and 
reasonable 
and 
effective diabetes support is 
provided 
with 
due 
consideration of external 
factors 
and 
their 
own 
opportunities. 
Environmental 
reconstruction, 
realisation 
1. Develop an individualised self-management plan based 
on the patient's glycaemic control, and commit the patient 
to follow this plan for self-management. 
 
2. Instruct the patient's family members to control their diet 
and behaviour, provide family support and play a good role 
in supervision and care. 
 
3. Discharged patients can join the WeChat group to push 
diabetes-related counselling. 
 
4. Regular nursing visits to the patients, recalling the recent 
life with the patients, finding out whether the patients have 
hypoglycemia and analysing the causes of hypoglycemia. 
Face-to-face interviews 
 
 
 
Face-to-face interviews 
 
 
 
Wechat 
 
 
WeChat or telephone 
communication 
Day 
1 
before 
discharge, 
duration 
15min 
 
Day 
1 
before 
discharge, 
duration 
15min 
 
Every Monday of the 
1st, 2nd and 3rd weeks 
after discharge 
Weeks 1, 2 and 3 after 
discharge, 1 time per 
week, duration 15min 
Physical opportunity 
Glucose 
management 
through WeChat platform, 
on-site 
teaching 
and 
guidance 
by 
specialist 
nurses 
to 
create 
opportunities for patients 
who 
can 
change 
excessive/avoidant 
behaviours. 
1. Specialist nurses on-site instructed patients on how to 
correctly monitor blood glucose, how to calculate daily 
diet and exercise, and how to correctly deal with abnormal 
blood glucose. 
 
2. Through the WeChat group peer communication, 
exchange insights and tips with patients who have ideal 
blood glucose control on-site, through the exchange of 
knowledge and provide assistance. 
On-site 
Practical 
Teaching 
 
 
 
WeChat 
group 
communication 
Questionnaire 
Day 4 of admission, 
60min per session 
 
 
 
Week 
3 
after 
discharge, 
15min 
duration 
 

4.Background 
Fear of hypoglycemia (FoH) is becoming an important barrier to achieving good 
glycemic control in patients with type 2 diabetes. Clinical care professionals have been 
working to address FoH in patients with diabetes mellitus, and the behaviour change 
wheel (BCW) theory, which states that individuals must possess the three behavioral 
components of ability, opportunity, and motivation in order to develop behavioral 
change, helps interventionists analyze the behavioral components that are lacking in 
order to determine the focus of the intervention, and then select the most appropriate 
intervention based on the combination of the nine functions of the intervention and 
implement it. The purpose of this study was to develop a health education intervention 
program based on the BCW theory to reduce the level of fear of hypoglycemia in 
patients with type 2 diabetes and to investigate the feasibility, acceptability, and 
preliminary effects of the program. 
5. Research purpose 
The purpose of this study was to develop a health education intervention program based 
on the BCW theory to reduce the level of fear of hypoglycemia in patients with type 2 
diabetes and to investigate the feasibility, acceptability, and preliminary effects of the 
program. 
6. Inclusion and Exclusion Criteria 
Inclusion criteria: (1) Compliance with the 2020 Chinese guidelines for the prevention 
and treatment of type 2 diabetes mellitus patients[24] ; (2) Age ≥ 18 years; (3) Duration 
of diabetes mellitus ≥ 1 year; (4) According to the elevated item endorsement criterion 
(EI criterion) : Hypoglycaemic Fear-Worry Scale (HFS-WS) Any item ≥ 3 points was 
judged as FoH; (5) Have the ability to listen, read, write and walk, and be able to 
cooperate with the completion of the study; (6) Have a smart phone, and be able to use 
WeChat or phone to communicate proficiently; (7) Voluntarily participate in this study 
and sign the informed consent form. Exclusion Criteria: (1) Those who are combined 
with acute complications or other serious diseases or disorders of consciousness, such 
as diabetic hypertonic state, tumour, coma, etc.; (2) Those who are combined with 
psychiatric diseases or taking psychotropic drugs. (3) Patients who have recently or are 

participating in other studies on similar topics. 
7. Intervention process 
From August 2021 to January 2022, T2DM patients who met the inclusion and 
exclusion criteria were selected from 2 tertiary hospitals in Yangzhou City. The control 
group implemented conventional diabetes health education, and the intervention group 
implemented health education based on BCW theory on top of the control group. 
8. Sample size estimation 
According to the formula for calculating the sample content: n1=n2=2[(Zα+Zβ) σ/δ]2, 
n1, n2 are the required sample contents of the two groups, set α=0.05, β=0.1, check the 
boundary table Zα/2=1.96, Zβ=1.282. n1=n2 ≈ 22 cases according to the sample size 
estimation formula of the pre-experimental results substituted into the comparison of 
the two sample means, considering a 15% attrition rate, expert opinion and clinical 
situation, 25 patients in each group were finally determined. 
9. Randomisation 
Participants were identified through screening of medical records and face-to-face 
interviews, and participants signed a written consent form to participate in the study. 
After the baseline assessment, participants were randomly assigned to either the 
intervention or control group using a lottery method after drawing a labelled card in an 
opaque sealed envelope from an independent research assistant who was not involved 
in the recruitment and implementation of the study. 
10. Measurement index 
General information questionnaire: admission day 1; hypoglycaemia fear scale 
(primary indicator): admission day 1, 4 weeks post intervention, 8 weeks post 
intervention; impaired hypoglycaemia awareness score (secondary indicator): 
admission day 1, 4 weeks post intervention, 8 weeks post intervention; medical support 
scale (secondary indicator): admission day 1, 4 weeks post intervention, 8 weeks post 
intervention; diabetes self-management attitude scale (secondary indicator). Day 1 of 
admission, 4 weeks post-intervention, 8 weeks post-intervention.  
11. Ethical consideration 
The study was ethically approved by the Ethics Committee of the College of Nursing 

of Yangzhou University (YZUHL20210088). 
12. Statistical analysis of data 
SPSS 26.0 software was applied for data analysis. Describing the general demographic 
characteristics of the study population: Mean ± standard deviation (±s) was used to 
describe measures that conformed to normal distribution, and median and interquartile 
spacing M (QR) were used to describe skewed distribution; count data were expressed 
as frequencies and constitutive ratios. Homogeneity test: the chi-square test or Fisher's 
exact test was used for the count data of the two groups at baseline, non-parametric test 
was used for the rank count data, and t-test or non-parametric test was used for the 
measurement data. Repeated measures ANOVA was used to analyse the intervention 
effect of each indicator within groups, and two independent samples t-test was used to 
compare between groups at different time points before and after the intervention. The 
significance level P < 0.05 indicated that the difference was statistically significant.