The Effectiveness of Educational Intervention Based on Health Belief Model Delivered Via WhatsApp on Oral Health Knowledge and Behaviors of Individuals With Type 2 Diabetes Mellitus; A Randomized Controlled Trial
Phase: NA
Conditions: Oral Health Knowledge, Oral Health Behavior Change, Diabetes Type 2
Sponsor: Dow University of Health Sciences

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Official Study Title:  
The Effectiveness of Educational intervention based on Health Belief Model Delivered 
via WhatsApp on Oral Health Knowledge and Behaviors of individuals with Type 2 
Diabetes Mellitus; A Randomized controlled Trial 
 
NCT Number: Not yet assigned  
 
Document Type: Study Protocol with Statistical Analysis Plan (SAP)  
 
Document Date:  2-August-2025 
 
Principal Investigator:  ILMA KIRAN 
 
Affiliation / Institution: Dow University of Health Sciences 
 
Ethics / IRB Approval: IRB-4057/DUHS/Approval/2025/294 
 
 
 
 
 
 

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ABSTRACT 
Background:  
Oral health is essential for overall wellbeing, particularly for those with chronic 
conditions like Diabetes Mellitus. Individuals with Diabetes face a higher risk of 
developing oral health complications, yet many lack adequate knowledge and proper 
practices to manage their oral health. Social media offers a potential platform for health 
education and can improve health behaviors. However, the effectiveness of using 
theory-based education, such as the Health Belief Model, through platforms like 
WhatsApp to improve oral health knowledge and behavior among individuals with 
diabetes remains underexplored. 
Objectives:  
This study aims to evaluate the effectiveness of a HBM based educational intervention 
delivered through WhatsApp in enhancing oral health knowledge and behaviors among 
individuals with Type 2 diabetes, compared to a control group receiving oral health 
education through educational brochure. 
Methods:  
This study utilized a quantitative randomized controlled trial approach with an 
intervention group and a control group. The Data were collected at baseline and one-
month post-intervention. The intervention group was provided with oral health 
education through WhatsApp videos based on the HBM, while control group received 
an educational brochure. Participants' oral health knowledge and behaviors were 
evaluated using a detailed questionnaire. Statistical analysis was performed to evaluate 
changes in the knowledge and behaviors of both groups over the study period. 
Key Words: Diabetes Mellitus, oral health, Health Belief Model, WhatsApp, 
knowledge, behaviors, educational intervention, social media

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INTRODUCTION 
Background 
Diabetes Mellitus is a chronic metabolic disease characterized by hyperglycemia which is caused 
by a defect in insulin secretion, function, or both. This condition often leads to complications such 
as retinopathy, kidney failure, coronary artery disease, poor wound healing, foot numbness, as well 
as oral diseases.(1,2). Even though there are no particular oral lesions linked to diabetes mellitus 
but persistent uncontrolled hyperglycemia can produce oral symptoms like burning in the oral 
mucosa, xerostomia, dental caries, and periodontal disease (gingivitis and periodontitis), which 
can lead to tooth loss. Diabetes and periodontitis exhibit a bidirectional relationship, where each 
condition can exacerbate the other.(3) Interestingly diabetes can also be screened for using 
periodontal disease. According to intervention studies, treating periodontal disease may help 
glycemic control of individuals with diabetes and, eventually, their general health.(4)  
As of 2019, there were 463 million people worldwide with Diabetes Mellitus, or 9.3% of the total 
population. It is predicted that this percentage will increase drastically to 10.9% (or 700 million 
people) by 2045.(5) Pakistan holds the third position in global diabetes prevalence. In Pakistan, 
more than 19 million people have diabetes.(6)  
A recent study conducted in Pakistan found that while most individuals with diabetes were aware 
of other complications of diabetes, such as foot ulcers and retinopathy, very few participants were 
aware of the oral manifestations. This could be caused by the failure of the doctors to provide oral 
health counseling or by patients' carelessness with regard to routine dental checkups.(4)WHO 
states that the mainstay of diabetes therapy is education. Indeed, studies have demonstrated that 
education is useful in controlling diabetes, and that appropriate educational training can lower 80% 
of diabetic complications.(7)  
According to research, although oral health education increases knowledge, it rarely results in 
long-lasting behavioral changes. The limited success of traditional health education has raised 
concerns about the knowledge-attitude-practice model, which has led to an investigation of 
psychological theories in an effort to better explain health behaviors.(8) One of the earliest 
behavior analytic models, The Health Belief Model has been applied to many studies on health 

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behaviors, including type 2 diabetic mellitus (T2DM).(7) At present HBM is one of the most 
extensively adopted theories used to develop health behavior modifying interventions .(9) The 
HBM, was formulated by social psychologists in the 1950s, its purpose was to understand and 
predict individuals' engagement in preventive health behaviors. According to this model, to 
incorporate improved oral health practices, Individuals with diabetes must first perceive 
themselves as susceptible to oral complications and recognize the severity of these complications. 
Additionally, they should understand the benefits of oral healthcare and have the self-efficacy to 
overcome the barriers, while also being influenced by internal and external cues to action that 
inspire them to prioritize oral health. (7) 
Digital technological advancements, especially social media, have revolutionized public health 
communication. These platforms are useful for promoting public health since they are accessible, 
cost effective, and improve retention of information. Patients, particularly those with diabetes, can 
interact, exchange stories, and enhance their self-management using social media.(10)  
Significance of the problem 
Oral health receives limited attention in diabetes management, despite the fact that diabetes 
contributes to serious oral health complications. The purpose of this study is to use an educational 
intervention based on HBM to improve oral health awareness which encourage healthy behaviors 
among individuals with diabetes. Although HBM has been effectively used in earlier studies to 
improve health outcomes, this study intends to investigate its efficacy via social media, specifically 
WhatsApp. WhatsApp enables the easy, accessible and engaging communication which makes it 
an important delivery platform. This study aims to assess the effectiveness of an intervention 
(educational content delivered via WhatsApp) in improving oral health knowledge among 
individuals with T2DM. 
Objectives of the study 
The objectives of the study are to evaluate the impact of a WhatsApp-based HBM intervention on 
oral health knowledge and behavior of individuals with T2DM and to compare the effectiveness 
of WhatsApp based education with the education given via brochures. 

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Hypothesis 
Adults having T2DM who acquire HBM based educational intervention regarding oral health 
through WhatsApp will show a significant improvement in oral health knowledge and behaviors, 
as compared to those who receives the educational brochure.  
Operational Definitions 
Oral Hygiene-Related Behaviors: 
Participants' reported frequency and quality of oral health practices, including 
brushing, flossing, gingival health, and dental visits, measured on a scale of 
0(never) to 4(always) using performance related questions.  Higher scores will 
indicate better oral hygiene related behaviors. Pre and post intervention scores 
were compared, and cutoff levels were determined using the mean and standard 
deviation (SD).(7) 
Perceived Susceptibility: 
How much diabetic patients think they might get oral health complications, 
measured using a Likert scale. (1 = Strongly Disagree to 5 = Strongly Agree).  
Higher scores reflect a greater perceived susceptibility. Pre and post 
intervention scores were compared, with cutoff levels based on the mean ± SD.  
(7) 
Perceived Severity: 
Participants' perceptions of the severity of oral health complications and their 
potential impact on their overall wellbeing and diabetes management. Assessed 
through Likert scale statements rated from 1 (Strongly Disagree) to 5 (Strongly 
Agree). Higher scores indicate greater perceived severity. Pre and post scores 
will be compared using the mean and SD as cutoff criteria. (7) 
Perceived Benefits: 
Participants’ beliefs about the positive outcomes of engaging in oral hygiene 
behaviors, such as prevention of oral complications. Assessed using Likert -scale 
items from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher scores reflect 

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stronger perceived benefits. Pre and post intervention scores will be compared, 
and categorization will be done using the mean and SD. (7) 
Perceived Barriers:  
Perception of participants about different challenges that hindered their ability 
to maintain proper oral hygiene. These self-reported barriers consist of financial 
constraints, time constraints, and insufficient knowledge or awareness about oral 
health care. Measured using items rated from 1 (Strongly Disagree) to 5 
(Strongly Agree). Higher scores represent greater perceived barriers. Pre - and 
post-scores will be compared, with cutoffs based on mean ± SD.  (7) 
Self-Efficacy: 
Confidence in performing and maintaining oral hygiene behaviors. It will be 
assessed via Likert scale items scored from 1 (Strongly Disagree) to 5 (Strongly 
Agree). Higher scores indicate greater self-efficacy. Pre- and post-intervention 
results will be compared, with cutoff scores determined by mean and SD. (7) 
Cues to Action: 
Factors which include both Internal and external that motivate participants to 
involve in oral hygiene behaviors, such as family encouragement or healthcare 
provider advice. Assessed using a Likert scale. Higher scores denote stronger 
cues to action. Comparison of pre and post scores were done using the mean and 
SD for cutoff classification. (7) 
Awareness: 
The participant’s knowledge about the relationship between diabetes and oral 
health issues, assessed through binary questions (Yes = 1, No = 0).  Higher scores 
reflect higher awareness levels. Pre and post awareness scores will be compared, and cutoff scores 
will be calculated using the mean and SD. (7) 
 
 
 

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Health Belief Model Constructs: 
A theoretical framework which consists of perceived susceptibility, severity, 
benefits, barriers, self-efficacy, and internal and external cues to action, used to 
explain and predict oral hygiene behaviors.(7) 
 
CHAPTER 2 
REVIEW OF LITERATURE 
In relation to the oral health status among individuals with diabetes, Oktawati et al. (2024) 
observed that nearly half of individuals with diabetes presented with poor oral hygiene, with many 
diagnosed with gingivitis or periodontitis. Improved periodontal status was directly correlated to 
better oral health knowledge, which emphasizes the essential role of awareness in managing oral 
health among individuals with diabetes.(3) Sairat and Phoosuwan (2024) also reported poor oral 
health behaviors in individuals with diabetes , with an average Decayed, Missing, and Filled Teeth 
(DMFT) index of 10.6 and irregular tooth brushing. They found that higher oral health literacy, 
positive attitudes, and regular visits to the dentist were associated with improved behavior.(2)  
A scoping review was done by (Poudel et al., 2022) who explored oral health knowledge and 
practices of individuals with diabetes in South Asia based on literature search from January 2000 
to December 2021. Many participants did not know about the relationship between diabetes and 
oral health and reported that general practitioners do not provide enough information about oral 
health. This highlights the necessity of awareness raising initiatives. Furthermore, the participants 
stated that they would want to know more about oral health, especially from medical professionals 
like dentists and doctors. This review highlights the importance of making oral health education a 
fundamental part of diabetes care.(11)  
Khan et al. (2022) investigated the relationship between poor oral health and patients with T2DM 
in Pakistan. They found a significant connection between poor oral health and uncontrolled blood 
glucose levels as well as longer duration of disease. The study highlighted the need to improve 
oral health awareness and management in this population.(4) A cross-sectional descriptive survey, 
conducted by (Islam et al., 2021) through self-administered questionnaires on 400 participants with 

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diabetes at Abbasi Shaheed Hospital, which is  the largest government hospital in Karachi, 
Pakistan revealed that the connection between diabetes and periodontal disease were not well 
understood by participants. Several participants did not practice recommended oral hygiene 
practices, such as brushing and flossing. A significant number visited dentists only rarely, due to 
their busy schedule or financial difficulties. Most participants prefer Television for information 
related to risk factors, to maintain good health. In order to improve diabetic patients' knowledge 
and awareness of periodontal risk and encourage good oral health practices, the study highlights 
the need for targeted educational interventions. (12) 
Barriers to providing comprehensive oral health care for individuals with diabetes has also been 
addressed by Poudel et al. (2020) who found out in his research that while general practitioners 
know the importance of oral health, their involvement was often limited to encouraging dental 
appointments and basic recommendations. Challenges such as time limitations, complicated 
referral processes, and insufficient training hindered effective collaboration between general 
practitioners and dental professionals. The study suggested that simplified referrals and improved 
training can better integrate oral health into diabetes management.(13)  
Oral health and Diabetes are closely related, making targeted interventions important to address 
oral health problems in this population. Malekmahmoodi et al. found that an educational 
intervention based on the HBM improved oral hygiene practices among individuals with T2DM, 
with the intervention group showing statistically significant improvements as compared to the 
control group.(7) Similarly, Sowmya and Sangavi (2024) reported a 61% improvement in oral 
health outcomes after oral health education intervention, highlighting the value of educational 
programs in providing comprehensive care for individuals with diabetes.(5)  
Building on these findings, Haghdoost et al. demonstrated that social media-based interventions 
were better than traditional pamphlet or routine-based methods in enhancing oral health 
awareness.(10) Regardless of patients' health literacy levels, diabetes education through WhatsApp 
showed promising results, according to a randomized, two-arm parallel interventional study 
conducted by Al Omar, Hasan, Palaian, & Mahameed, in 2020 with a 6-month patient follow-up 
that evaluated the effect of a patient centered diabetes education program delivered via WhatsApp 
on glycosylated hemoglobin (HbA1c) values. (14) 

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Extending the discussion of interventions, Mesbahi and Aleksejuniene (2024) used the HBM to 
guide an SMS based reminder strategy aimed at improving oral health behaviors among 
adolescents. This intervention, comprising educational sessions and text message reminders, 
significantly enhanced oral self-care practices and increased duration of tooth brushing. A 100% 
participation rate underscored the feasibility and acceptability of this approach.(9)  
In spite of the well-recognized oral health challenges faced by individuals with diabetes, there are 
noticeable gaps in Pakistan to address these challenges. The lack of awareness and poor adherence 
to oral health practices among individuals with diabetes has been documented in researches like 
that of Islam et al., 2021and Khan et al. (2022).(4,12) Despite this, very few studies offer actionable 
strategies to improve oral health behavior among people with diabetes. Theory based interventions 
like HBM, have proven effective in shaping health interventions globally, but they are seldomly 
used for oral health education in Pakistan. Using WhatsApp, a widely accessible and familiar 
platform, this study aims to fill the gaps by encouraging lasting improvements in oral health 
behaviors among individuals with diabetes. 
 
CHAPTER 3 
METHODOLOGY 
Study Design 
This study utilized a quantitative, randomized controlled trial approach to 
evaluate the impact of a HBM based educational intervention delivered through 
WhatsApp on oral health knowledge and behaviors among adults with T2DM. 
Participants were randomly assigned into two groups: an intervention group that 
received HBM-based education and a control group that received an educational 
brochure that includes information on oral health.  
Study Population/Settings 
The study population includes patients with a confirmed diagnosis of T2DM, 
verified through diabetes clinic records, who are regular attendees at National 

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institute of diabetes and Endocrinology at Dow University of Health Sciences 
Karachi. 
Sampling Technique and Randomization 
A convenience sampling technique was used to recruit participants from the 
outpatient diabetes clinic at DUHS. Patients who are present at the clinic for 
their routine appointments and meet the eligibility criteria was approached. They 
were informed about the study objectives and procedures, and those who agreed 
to participate was asked to provide written informed consent. After enrollment, 
participants were randomly assigned to either the intervention group or the 
control group, following a 1:1 allocation ratio. The randomization process was 
stratified based on three key characteristics including gender, educational level, 
and duration of diabetes, to ensure balanced distribution and to minimize 
potential bias. 
Randomization was conducted using random number generator where each 
participant was assigned a random number, then participants were allocated 
equally into either Intervention Group which received HBM based education via 
WhatsApp or control Group which received an educational brochure. This study 
was single blinded in which participants were not informed about the presence 
of two distinct groups; they were only aware about receiving education related 
to oral health. 
 
 
 
 

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Figure 3.1. Flow diagram of patient selection and allocation into intervention 
and control groups 
Sample Size 
Sample size was calculated using OpenEpi online software, based on two independent sample t-
test by using mean and standard deviation of post intervention perceived susceptibility score 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent was obtained. 
stratification by gender and educational level and 
duration of diabetes 
A detailed questionnaire was completed at baseline by 
all participants 
Randomization 
Follow up for four weeks 
Same Questionnaire was completed at post 
intervention by all participants 
Intervention Group (n=49) 
received HBM-based education via 
WhatsApp for one month 
Control Group (n=49) 
Received information through 
educational brochure 
Adults aged 18-65 years with confirmed diagnosis of 
Type 2DM were approached with Non probability 
convenience sampling (n=98) 
   ENROLMENT 
    ALLOCATION 
     ANALYSIS 

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which were 4.09 ± 0.49 in intervention group and 3.64 ± 1.01 in control group in the study 
conducted by Malekmahmoodi et al. (2020)(7). A sample size of 49 achieved in each group, 
power 95% with a significance level (alpha) of 0.01. Total 98 patients have been recruited and 
divided into 49 patients in each group (two groups). 
Study Duration From date to date 
The study was conducted from July 2025 to December 2025, including participant recruitment, 
the delivery of the educational intervention, and the completion of post intervention assessments. 
Inclusion Criteria 
• Adults aged 18-65 years with a confirmed diagnosis of T2DM 
• Able to use WhatsApp for the study duration 
• Able to read and write in Urdu 
Exclusion Criteria 
• Edentulous  
• Individuals diagnosed with life-threatening diseases such as advanced cancer, end-stage 
renal disease, or severe cardiac failure 
• Diminished cognitive ability  
• Radiotherapy in head and neck region. 
• Planning to migrate during the study period. 
 
Ethical Considerations 
Ethical approval was obtained from the Institutional Review Board (IRB) of Dow University of 
health sciences prior to data collection. (IRB-4057/DUHS/Approval/2025/294)  
Data Collection Procedure 
Data were collected using a self-reported questionnaire delivered at two points: 
baseline (before intervention) and one-month post-intervention, to assess 
changes in oral health knowledge and behaviors. 

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At baseline, a detailed questionnaire was completed by all the participants. The 
intervention group then received educational training based on the HBM through 
WhatsApp videos, while the control group was provided with an educational 
brochure containing information related to oral health. Over a period of one 
month, participants were followed to monitor any changes.  
1-month follow-up aligns with Mesbahi and Aleksejuniene's (2024) strategy, 
where an initial 5-week follow-up assessed the efficiency of the intervention(9). 
At the end of this period, the questionnaires were again completed by both 
groups. 
Survey Instrument 
A structured, close-ended and self-reported questionnaire with a five-point 
Likert scale was used. The questionnaire was designed to measure HBM 
constructs (e.g. perceived susceptibility, severity, benefits, barriers, cues to 
action, and self-efficacy), awareness of oral health and oral hygiene related 
behaviors. A panel of four subject matter experts reviewed the instrument, 
including two dentists, a public health specialist and an endocrinologist.  Each 
expert independently evaluated the questionnaire items by using a four-point 
relevance scale, ranging from "not relevant" to "highly relevant." Their ratings 
were used to calculate content validity indices, Items with poor expert agreement 
(I-CVI ≤ 0.25) were removed, while items with minor disagreement (I -CVI = 
0.75) were revised for clarity. Items with strong relevance ratings (I-CVI = 1.00) 
were retained as it is in the final questionnaire. The S-CVI/Ave for the final 
instrument was 0.89, which indicates good content validity. The universal 
agreement index (S-CVI/UA) was 0.83, indicating that 83% of the items received 
unanimous relevance ratings from all four experts.(15) 
The final questionnaire consisted of three major sections, designed to assess 
oral-health knowledge, HBM constructs, and behaviors among individuals with 
Type 2 Diabetes. Section I comprised of 10 items assessing oral -health 
knowledge. Section II included the HBM constructs, which was subdivided into 

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seven domains: Perceived Susceptibility (7 items), Perceived Severity (10 
items), Perceived Barriers (6 items), Perceived Benefits (6 items), Self -Efficacy 
(7 items), Internal Cues to Action (4 items) and External Cues to Action (5 
items). Section III was focused on oral-hygiene behaviors, comprising 10 items 
which measured the frequency and consistency of participants’ oral -health 
behaviors. 
The Cronbach’s alpha value of the final instrument was calculated after the pilot 
study in which 30 participants filled the questionnaire which was 0.783. (16) 
Scoring 
The awareness questions section was scored such that each correct answer 
received 1 point, and each incorrect answer received 0 points. The total score 
for the awareness section was calculated based on maximum score of 10. The 
HBM constructs were assessed using five-point Likert scale, with response 
options ranging from "strongly agree" to "strongly disagree" and scored from 1 
to 5, respectively. The scores for each model construct were calculated and 
reported within the range of 1 to 5. Similarly, the behavior questions were scored 
on a 5-point Likert scale of behavior evaluation, with responses ranging from 
"never" to "always" and scored from 0 to 4. In this study, higher scores indicate 
higher levels of awareness, perceived susceptibility, perceived sever ity, 
perceived benefits, perceived barriers, cues to action, self -efficacy, and 
performance of oral hygiene practices among diabetic patients.  
Intervention 
The intervention consisted of a four-week WhatsApp-based oral health education 
program based on HBM. The WhatsApp based intervention consisted of 12 short 
educational videos, each approximately 3 to 5 minutes in duration, these videos 
were sent individually to each participant every alternate day from Monday to 
Friday, resulting in three videos per week over a period of one month, Reminders 
were sent the following day after each video to encourage engagement and 

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sustain behavior change. Each week was focused on specific HBM constructs 
delivered through short, professionally scripted educational videos in Urdu.  
In Week 1, participants were introduced to the link between diabetes and oral 
health and the importance of maintaining good oral hygiene. Week 2 focused on 
perceived susceptibility and severity by highlighting the increased vulnerability 
of diabetic patients to oral complications and the consequences of poor hygiene 
practices. Week 3 addressed perceived benefits, perceived barriers, and cues to 
action 
by 
explaining 
how 
adopting 
oral-health 
behaviors 
can 
reduce 
complications, improve comfort, and minimize treatment costs, while also 
identifying common challenges and strategies to overcome them. Week 4 
strengthened perceived self-efficacy by demonstrating correct oral-care 
techniques, such as brushing technique, flossing, tongue cleaning, and gum 
massage, enabling participants to confidently perform these 
behaviors 
independently. 
All educational materials underwent expert review by dentists, public health 
specialist and Endocrinologist prior to implementation to ensure clarity, cultural 
sensitivity, and scientific accuracy. Adherence to the intervention was 
monitored through WhatsApp by sending follow-up messages and engaging 
reminders. The control group received only a printed brochure containing basic 
oral-health information and routine care during the study period. However, after 
the study concluded, the control group was also provided access to the same 
educational videos to ensure ethical equity and allow them to benefit from the 
intervention content. 

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Figure 3.2: Educational brochure given to the control group, containing oral-health information 
related to diabetes mellitus. 

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  (a)
 (b)
 
(c)
    (d) 
    
Figure 3.3: Some Screenshots from oral-health educational intervention videos shared via 
WhatsApp, illustrating a. demonstrations of link between diabetes and oral health, b.  proper 
brushing technique, c. oral complication of diabetes and d. flossing technique. 
 

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Data Analysis Procedure 
Data were analyzed through a statistical package for Social Sciences (SPSS) version 26. Frequency 
and percentages were reported for qualitative variables. Mean and standard deviations were 
reported for normally distributed quantitative variables while median and interquartile ranges were 
reported for non-normally distributed quantitative variables. Normality of quantitative variables 
were assessed using Shapiro-wilk’s test of normality. The Independent sample t-test was 
conducted to compare the mean scores of perceived barriers and behavior between the intervention 
and control groups. For all other constructs, which were not normally distributed, the Mann-
Whitney U test was applied. For within-group comparisons of pre and post scores of behaviors 
and perceived barriers, the Paired sample t-test was used. The Wilcoxon signed rank test, was used 
for the remaining variables that were not normally distributed. Stratification was carried out based 
on gender, diabetes duration, and education level to see the effect of these modifiers on outcome 
(control vs. intervention) using Chi-square test. A p value less than and equal to 0.05 was 
considered as significant. 
 
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