- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323771
Improving Oral Health Knowledge and Habits in People With Diabetes Through a Theory Guided WhatsApp Education Program
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
The goal of this Educational interventional study is to test the usefulness of an educational program delivered through WhatsApp videos in increasing oral health knowledge and habits in people with Diabetes between the age of 18 and 65 years. The main question it aims to answer is:
Does a WhatsApp-based educational Program improve oral health knowledge and behaviors in people with diabetes, and is it more effective than education delivered through brochures? Participants in one group will receive educational videos through WhatsApp, while the other group receive a brochure containing oral health information. Researchers will then compare the groups to see if the intervention made a difference.
Participants will:
- Fill a baseline questionnaire to assess their current knowledge and behaviors.
- They then either participate in a one-month educational program delivered through WhatsApp, or receive an educational brochure.
- Wait for 1 month after the program to allow for application of knowledge.
- Fill a post intervention questionnaire to assess changes in knowledge and behavior.
Study Overview
Status
Detailed Description
The purpose of this study is to determine whether an educational intervention based on the Health Belief Model (HBM) and delivered through WhatsApp may improve diabetes patients' oral health behaviors and knowledge. This study is a randomized controlled trial (RCT) with two groups: an intervention group (WhatsApp-based education) and a control group (brochure-based education). Adults (18-65 years) with Type 2 Diabetes Mellitus from a diabetes clinic in Karachi were recruited. 98 participants (49 in each group) were selected through random allocation. The randomization process ensured that participants are evenly distributed between the groups based on key factors, specifically gender, educational level and duration of diabetes to reduce potential bias from these characteristics. This study was a single blinded study in which participants were not informed about the existence of two distinct groups. 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 sustain behavior change. Each week was focused on specific HBM constructs delivered through short, professionally scripted educational videos in Urdu. Each week was focused on specific HBM constructs. The control group received only an educational brochure.
A structured questionnaire was used to evaluate participants' knowledge and oral hygiene practices at two points: baseline (before intervention) and one-month post-intervention. The questionnaire was designed to measure HBM constructs (e.g. perceived susceptibility, severity, benefits, barriers, cues to action, and self-efficacy), awareness of oral care and oral hygiene related behaviors. Data were analyzed using SPSS Version 27.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan
- National Institute of Diabetes & Endocrinology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Educational Brochure Group
Participants in this group receive oral health education through an educational brochure
|
The Educational brochure provides information on the relationship between Type 2 Diabetes Mellitus and oral health and recommended oral hygiene practices.
No WhatsApp based videos are provided during the study period
|
|
Other: Health Belief Model Based WhatsApp Oral Health Education Program
Participants receive a Health Belief Model (HBM) based oral health education program through WhatsApp videos for four weeks.
|
The program includes short educational videos, weekly thematic content, reminders, and behavior-reinforcement messages aimed at enhancing oral health knowledge, HBM constructs, and oral hygiene behaviors among individuals with Type 2 Diabetes Mellitus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Health Knowledge Score
Time Frame: Baseline and 4 weeks after intervention
|
The participant's knowledge about the relationship between diabetes and oral health issues, will be assessed through a structured Questionnaire consisting of 10 binary items.
(Yes = 1, No = 0).
A total knowledge score ranging from 0 to 10 will be calculated by summing item responses, with higher scores indicating greater oral health knowledge.
Pre- and post-knowledge scores will be compared, and cutoff scores will be calculated using the mean and Standard Deviation.
|
Baseline and 4 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Belief Model Construct Scores
Time Frame: Baseline and 4 weeks after intervention
|
Health Belief Model constructs, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action, will be assessed using a structured Questionnaire.
Items will be measured on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Separate construct scores will be calculated by summing item responses within each domain, with higher scores indicating stronger beliefs or perceptions related to oral health behaviors.
|
Baseline and 4 weeks after intervention
|
|
Oral Hygiene Behavior Score
Time Frame: Baseline and 4 weeks after intervention
|
Participants' reported frequency and quality of oral health practices, including brushing, flossing, gingival health, and dental visits will be measured on a scale of 0(never) to 4(always) using a structured questionnaire.
Higher scores indicate better oral hygiene-related behaviors.
Pre- and post-intervention scores will be compared, and cutoff levels will be determined using the mean and standard deviation(SD).
|
Baseline and 4 weeks after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: ILMA KIRAN, BDS, MPH, Dow University of Health Sciences
Publications and helpful links
General Publications
- Omar MA, Hasan S, Palaian S, Mahameed S. The impact of a self-management educational program coordinated through WhatsApp on diabetes control. Pharm Pract (Granada). 2020 Apr-Jun;18(2):1841. doi: 10.18549/PharmPract.2020.2.1841. Epub 2020 May 3.
- Jacome-Hortua AM, Rincon-Rueda ZR, Sanchez-Ramirez DC, Angarita-Fonseca A. Effects of a WhatsApp-Assisted Health Educational Intervention for Cardiac Rehabilitation: A Randomized Controlled Clinical Trial Protocol. Methods Protoc. 2024 Apr 19;7(2):35. doi: 10.3390/mps7020035.
- Gao X, Wong ML, Kalhan AC, Xie JJ, Siti Hajar H, Yeo ABK, Allen PF. Theory-derived intervention to improve oral health of older adults: study protocol for a randomised controlled trial. BMJ Open. 2022 Dec 12;12(12):e064791. doi: 10.1136/bmjopen-2022-064791.
- Jeihooni AK, Jamshidi H, Kashfi SM, Avand A, Khiyali Z. The Effect of Health Education Program Based on Health Belief Model on Oral Health Behaviors in Pregnant Women of Fasa City, Fars Province, South of Iran. J Int Soc Prev Community Dent. 2017 Nov-Dec;7(6):336-343. doi: 10.4103/jispcd.JISPCD_339_17. Epub 2017 Dec 29.
- Haghdoost A, Bakhshandeh S, Tohidi S, Ghorbani Z, Namdari M. Improvement of oral health knowledge and behavior of diabetic patients: an interventional study using the social media. BMC Oral Health. 2023 Jun 3;23(1):359. doi: 10.1186/s12903-023-03007-w.
- Malekmahmoodi M, Shamsi M, Roozbahani N, Moradzadeh R. A randomized controlled trial of an educational intervention to promote oral and dental health of patients with type 2 diabetes mellitus. BMC Public Health. 2020 Mar 4;20(1):287. doi: 10.1186/s12889-020-8395-4.
Helpful Links
- Provides general information on the relationship between diabetes and oral health and guidance on maintaining good oral hygiene habits to prevent gum disease and oral complications.
- Provides concise information on how diabetes increases the risk of oral diseases such as gum infection and tooth decay, and emphasizes the importance of good oral hygiene and regular dental care as part of diabetes management.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB4057/DUHS/Approval/2025/294
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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