NCT07323771

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 8, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

Type 2 Diabetes MellitusDental Health EducationHealth Belief ModelDigital HealthSocial Media

Outcome Measures

Primary Outcomes (1)

  • Oral Health Knowledge Score

    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 Outcomes (2)

  • Health Belief Model Construct Scores

    Baseline and 4 weeks after intervention

  • Oral Hygiene Behavior Score

    Baseline and 4 weeks after intervention

Study Arms (2)

Educational Brochure Group

OTHER

Participants in this group receive oral health education through an educational brochure

Behavioral: Educational Brochure Group

Health Belief Model Based WhatsApp Oral Health Education Program

OTHER

Participants receive a Health Belief Model (HBM) based oral health education program through WhatsApp videos for four weeks.

Behavioral: Health Belief Model (HBM) Based WhatsApp Oral Health Education Program

Interventions

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.

Health Belief Model Based WhatsApp Oral Health Education Program

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

Educational Brochure Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Diabetes & Endocrinology

Karachi, Sindh, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 38668142BACKGROUND
  • 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.

    PMID: 36523250BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Health Belief Model

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative TechniquesModels, Psychological

Study Officials

  • ILMA KIRAN, BDS, MPH

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPH Trainee and Lecturer

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 7, 2026

Study Start

September 15, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The study does not include a plan to make individual participant data (IPD) available due to privacy considerations and absence of participant consent for public data sharing.

Locations