Construction and Preliminary Verification of interventionImpact of an IMB Theory-based Health Education Intervention on Hypoglycemic Coping in Patients With Type 2 Diabetes: a Pilot Study
Phase: NA
Conditions: Type 2 Diabetes Mellitus, Hypoglycemia, Health Education
Sponsor: Yating Liu

 
 
Impact of an IMB theory-based health education intervention on hypoglycemic 
coping in patients with type 2 diabetes: a pilot study 
 
 
 
 
 
 
 
August 01, 2023 
 
 

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 
Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study 
3. Flow chart of the implementation of the study 
 

 
Specific intervention program for T2DM hypoglycemic coping styles based on IMB modeling 
Level 1 
indicators 
Level 1 
indicators 
Level 1 indicators（Content of the intervention） 
Objectives of 
intervention 
Forms of 
intervention 
intervention 
time 
implementers 
information 
base case 
Patients completed the questionnaire within 3 hours 
of admission. 
1、Perfect hypoglycemic 
cognition. 
2 、Correct incorrect 
hypoglycemic cognition 
and 
rebuild 
the 
hypoglycemic cognitive 
system. 
3 、Re-understand the 
different 
outcomes 
of 
different 
hypoglycemic 
coping styles. 
4、Master the skills of 
hypoglycemic 
coping 
styles. 
5、Improve the negative 
cognition, 
positive 
coping. 
poll 
Within 3 
hours of 
admission 
nurse 
practitioner-
in-charge 
Hypoglycemia 
Handbook 
Distribute hypoglycemia brochures and assist 
patients in developing individualized blood glucose 
management plans. 
written form 
Day 1 of 
admission 
nurse 
practitioner-
in-charge 
Specialized 
Lectures 
Centralized 
in-departmental 
hypoglycemia 
education in the form of a PowerPoint presentation 
by a specialist nurse. 
PPT (location: 
demonstration 
room, time: 8 
minutes) 
Day 2 of 
admission 
Principal 
Investigator 
peer education 
Introduce patients to recognize the pre-symptoms 
of hypoglycemia and how to deal with them, and 
show the dangers of wrong ways of coping with 
hypoglycemia with examples. Utilize the peer 
effect to allow people to share their experiences of 
hypoglycemia 
management 
and 
exchange 
experiences. 
PPT presentation 
(15min) 
Peer exchange 
(20min) 
3rd day of 
admission 
(and every 
Friday 
afternoon 
thereafter, 
after the end 
of 
treatment) 
Principal 
Investigator 
WeChat 
Information 
Dissemination 
Patients and their families join the WeChat group 
on admission, and every Tuesday and Thursday, we 
push out the graphic and video knowledge related 
to diabetes mellitus hypoglycemia (the content 
involves diabetes mellitus specialty knowledge, 
diet, exercise, blood glucose testing, hypoglycemia 
coping, psychological debugging, etc.). 
WeChat form 
From the 
first week of 
admission 
Principal 
Investigator 
and Charge 
Nurse 

Knowledge 
Contest with 
Prizes 
Conduct a contest on knowledge related to coping 
with hypoglycemia, with small gifts awarded to the 
top three winners. 
In the form of a 
group activity 
(duration: 30 
minutes) 
1 day before 
discharge 
Principal 
Investigator 
motives 
Health belief 
formation 
Based on the results of the patient's hypoglycemic 
coping style questionnaire on admission, the 
intervener will give corrections for the diabetic 
patient's misperceptions, assist in setting goals for 
the next week, and give positive psychological 
interventions 
1、(No-intention period) 
Change their negative 
hypoglycemia 
coping 
mentality and establish 
correct health beliefs. 
2 、(Intentional period) 
Enhance their confidence 
in 
coping 
with 
hypoglycemia positively 
and recognize the harm 
of negative coping. 
Questionnaires, 
one-on-one 
exchanges (20 
minutes long) 
Day 1 of 
admission 
nurse 
practitioner-
in-charge 
Family 
member 
support 
Face-to-face communication with patients and their 
families was conducted 1 day before discharge to 
understand the family status of the patients after 
discharge and inform their families of the 
importance of family support in coping with 
diabetes mellitus, instructing the patients' families 
to control their diets and their behaviors, to do a 
good job of family support, to play a good 
supervisory and nursing care, and at the same time, 
informing the patients of the path of professional 
counseling and the convenience of the community 
resources and so on. 
1 、(Preparation period) 
Include family members 
and 
act 
together 
to 
provide family support 
for patients 
2 、(Change 
period) 
Make 
full 
use 
of 
resources 
at 
home, 
hospitals, 
communities, 
pharmacies, 
etc. 
to 
promote 
behavioral 
change 
3
、
(Sustainability 
Period) Guide patients to 
think about the benefits 
gained 
from 
healthy 
behaviors, instruct them 
Face-to-face 
exchanges (20 
minutes in length) 
1 day before 
discharge 
nurse 
practitioner-
in-charge 
Medical staff 
support 
1, 2, 3 weeks after discharge, every Tuesday and 
Thursday through the WeChat group to push the 
knowledge related to diabetic hypoglycemia, and 
encourage patients to actively share their own 
experience 
of 
successfully 
coping 
with 
hypoglycemia in the group, in order to play the role 
WeChat or Phone 
1, 2, 3 
weeks after 
discharge 
Principal 
Investigator 

of an example. For patients with difficulties in 
coping, contact them by phone or WeChat, and 
according to the actual situation of the patients, 
analyze the reasons and assist in the development 
of a coping plan, and modify the plan in a timely 
manner according to the actual situation of the 
patients during the implementation of the plan. 
to effectively use social 
and family resources, and 
establish 
internal 
and 
external 
environments 
conducive to the long-
term implementation of 
the program to encourage 
patients to continue to 
adhere to it. 
social security 
(pensions, 
medical 
insurance) 
The group education and feedback were conducted 
in the 4th week after discharge from the hospital at 
the Diabetes Clinic of Chuzhou First People's 
Hospital. 
Group offline 
lectures (duration: 
1 hour) 
4th week 
after 
discharge 
Principal 
Investigator 
behavioral 
skill 
Health 
Information 
Access Skills 
Patients are admitted to the hospital for an 
explanation of ways to acquire knowledge about 
diabetes, and the WeChat group pushes out 
specialized websites for patients to view, or they 
can go to the hospital's diabetes specialist clinic for 
consultation. 
1、Guide them to adopt 
a correct and scientific 
way of obtaining disease 
information. 
2 、Enhance the coping 
ability 
to 
deal 
with 
hypoglycemia. 
3 、Perform diabetes 
outpatient 
information 
consultation 
and 
sensitization, so that they 
can obtain professional 
knowledge 
in 
the 
professional window. 
4 、Guide patients with 
psychological disorder to 
moderate psychological 
counseling in order to 
enhance confidence. 
Questionnaire, 
PPT presentation, 
WeChat 
Day 2 of 
admission 
nurse 
practitioner-
in-charge 
Self-
conditioning 
skills 
Post-discharge WeChat pushes examples of the 
dangers of incorrect response to hypoglycemia on 
Tuesdays and Thursdays, as well as knowledge of 
insulin injection techniques, diet, exercise skills, 
and blood glucose testing; patients are asked to 
keep a diabetes diary every month. 
WeChat, written 
1, 2, 3 
months after 
discharge 
nurse 
practitioner-
in-charge 
Peer 
experience 
sharing 
Regular monthly communication with discharged 
patients, patients with more serious problems, one-
on-one communication at the end of the lecture, 
weekly and monthly plans; praise for better 
performance and let them talk about their coping 
experience. 
Lecture (duration: 
1 hour) 
1, 2, 3 
months after 
discharge 
Principal 
Investigator 
 
 

 
4.Background 
Hypoglycemia, as one of the common complications in patients with diabetes mellitus, not only leads to an increase in the incidence of 
cardiovascular events and all-cause mortality, but also imposes a serious psychological burden on them, so much so that patients make 
behavioral changes such as increasing food intake, decreasing insulin dosage, and restricting physical activity in order to prevent hypoglycemia, 
which are not conducive to the management of the disease and accelerate the adverse regression of the disease, therefore, it is urgent to change 
the erroneous Hypoglycemic coping is urgent, and IMB theory, which states that individuals must have three behavioral components, namely 
information, motivation, and behavioral skills, in order to produce behavioral change, can help interveners to analyze the behavioral components 
that are lacking in order to determine the focus of the intervention, select appropriate interventions, and implement them. The purpose of this 
study was to develop a health education intervention program based on the IMB theory to change erroneous hypoglycemic coping styles and to 
validate the feasibility, acceptability, and initial effectiveness of the program. 
5. Research purpose 
The purpose of this study was to develop a health education intervention program based on the IMB theory to change the erroneous 
hypoglycemic coping styles of patients with type 2 diabetes and to validate the feasibility, acceptability, and initial effectiveness of the program. 
6. Inclusion and Exclusion Criteria 
Inclusion criteria: (1) meet the 2018 edition of ADA Diabetes Medical Diagnosis and Treatment Criteria and diagnosed with T2DM; (2) patients 
using insulin or sulfonylureas; (3) disease duration ≥1 year, age ≥18 years; (4) history of hypoglycemia occurrence in the past 6 months; (5) 

patients with a tendency of avoidance and compromise in T2DM Hypoglycemic Coping Styles Inventory; (6) good communication and verbal 
skills; (7) have a smartphone and know how to use it; and (8) voluntarily participate in this study. Exclusion Criteria: (1) patients with type 1 
diabetes mellitus; (2) patients with severe complications in combination with T2DM; and (3) patients who are participating in studies on other 
topics. 
7. Intervention process 
From August 2023 to January 2024, T2DM patients who met the inclusion and exclusion criteria were selected from 1 tertiary hospital in 
Chuzhou City. The control group implemented conventional diabetes health education, and the intervention group implemented health education 
based on IMB theory on the basis of the control group. 
8. Sample size estimation 
In this study, a randomized controlled trial was conducted to investigate the effect of intervention based on IMB model on the hypoglycemic 
coping style of T2DM patients, which was randomly divided into the control group and the intervention group, and the main observation index 
was the hypoglycemic coping style after the intervention. According to previous studies in similar literature, the control group was 30.14±5.08, 
and the intervention group was 34.40±5.36, with α = 0.05, power = 0.95, and 1:1 parallel control. According to the formula for calculating the 
sample size of the mean value of the two groups, the sample size of the two groups was calculated to be 41 cases in each group, and at least 50 
cases should be included in each group at the baseline, taking into account the 15% dropout rate, which made the total number of cases to be 100 
in total. 
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: day 1 of admission; Hypoglycemia Coping Styles Scale for Patients with Type 2 Diabetes Mellitus (primary 
indicator): day 1 of admission, 4 weeks post-intervention, 8 weeks post-intervention, and 12 weeks post-intervention; Fear of Hypoglycemia 
Scale Score (secondary indicator): day 1 of admission, 4 weeks post-intervention, 8 weeks post-intervention, and 12 weeks post-intervention; 
Health Information Acquisition Behavior Scale (secondary indicator): day 1 of admission, 4 weeks post-intervention Day 1, 4 weeks post-
intervention, 8 weeks post-intervention, 12 weeks post-intervention; Type 2 Diabetes Knowledge Scale (secondary indicator). Day 1 of 
admission, 4 weeks post-intervention, 8 weeks post-intervention, and 12 weeks post-intervention. 
11. Ethical consideration 
The study was ethically approved by the Ethics Committee of the College of Nursing of Yangzhou University (YZUHL20220047). 
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.