Protocol summary

Study aim
To determine the effectiveness of a teleconsultation package on physiological risk factors of preventable non-communicable diseases among Indonesian adults.
Design
A two-arm, double-blinded, parallel-group randomized controlled trial (RCT) conducted at a single center with multistage random sampling will be applied
Settings and conduct
The trial in Kalijaya Village, Indonesia, involves door-to-door recruitment. Participants undergo pretest assessments. The intervention group receives educational materials and teleconsultations for nine weeks, while the control group receives only educational materials. Double-blinded design ensures unbiased results. Study duration: 24 weeks, with assessments at baseline, post-intervention, and follow-up.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Indonesian adults (40-60 years) with teleconsultation technology and language comprehension. Exclusion Criteria: pregnant women, severe chronic conditions, mental health disorders, recent major surgery, current cancer treatment, lack of technology, language barriers, non-compliance, and other trial enrollment.
Intervention groups
Intervention Group: Participants will receive teleconsultations and educational materials (videos and posters) on physical activity and nutrition for nine weeks, including three weekly teleconsultation sessions via WhatsApp. Control Group: Participants will receive initial consultations and educational materials but no further teleconsultation sessions.
Main outcome variables
Main Outcome Measures: Blood pressure (BP), fasting blood sugar (FBS), blood total cholesterol (Chol), blood uric acid (UA), body weight (BW), waist-to-hip ratio (WHR), peripheral blood oxygen (SpO2), dietary intake, and frequency of physical activity. Assessed at baseline (pre-intervention), immediately post-intervention (week 12), and follow-up (week 24).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240608062042N2
Registration date: 2025-05-02, 1404/02/12
Registration timing: retrospective

Last update: 2025-05-02, 1404/02/12
Update count: 0
Registration date
2025-05-02, 1404/02/12
Registrant information
Name
Ardalan Shariat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 861 4772
Email address
ardalansh2002@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-18, 1403/11/30
Expected recruitment end date
2025-02-25, 1403/12/07
Actual recruitment start date
2025-02-18, 1403/11/30
Actual recruitment end date
2025-02-25, 1403/12/07
Trial completion date
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Scientific title
Effectiveness of Teleconsultation Package on Physiological Risk Factors of Preventable Non-Communicable Diseases among Indonesian Adults
Public title
Managing Risk Factors for Chronic Diseases through Online Consultations: A Clinical Study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indonesian adults aged 40 to 60 years. At risk of or currently managing preventable non-communicable diseases (NCDs) such as hypertension, diabetes, or obesity. Access to the necessary technology (e.g., smartphone, internet) to engage in teleconsultations. Ability to understand and communicate in the language used for the teleconsultation. Willingness to comply with the study protocols and interventions.
Exclusion criteria:
Pregnant women. Individuals with severe chronic conditions such as advanced heart disease or end-stage renal disease. Individuals with severe mental health disorders. Individuals who have undergone major surgery within the last six months. Participants currently undergoing treatment for cancer or other major non-communicable diseases. Individuals without access to necessary technology (e.g., smartphone, internet). Individuals with language barriers. Individuals with a history of non-compliance in previous studies. Participants currently enrolled in other clinical trials or studies that might interfere with the outcomes of this study.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 72
Actual sample size reached: 75
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized controlled trial (RCT), a multistage random sampling approach will be employed to ensure a robust and unbiased participant selection process. Initially, registration forms will be distributed to the population of Kalijaya village to gather demographic data and medical histories. Individuals who register and participate in the pretest will be selected through purposive sampling based on predefined inclusion and exclusion criteria. Eligible participants will then undergo simple randomization at the individual level, ensuring each participant has an equal chance of being allocated to either the intervention or control group. Stratified randomization may be applied, with strata based on key variables such as age and gender, to achieve balanced representation across groups. The randomization sequence will be generated using Google random number generator, ensuring precision and eliminating bias. The allocation process will be conducted entirely online, with participants being notified of their group assignments via WhatsApp once their eligibility is confirmed. This online mechanism ensures transparency and methodological rigor, while maintaining the validity of the trial outcomes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study employs a double-blinded design to ensure the integrity and validity of the results. In a double-blinded study, neither the participants nor the researchers administering the interventions are aware of the group assignments. This approach minimizes bias and enhances the reliability of the findings. Participants were randomly assigned to either the treatment group or the control group. Randomization was achieved using a computer-generated randomization sequence to ensure equal probability of assignment to each group. To maintain the double-blind nature of the study, the following measures were implemented: 1. Blinding of Participants: Participants were informed that they would receive either the intervention or control but were not told which one. 2. Blinding of Researchers: Researchers responsible for administering the intervention and assessing outcomes were also blinded to the group assignments. This was achieved by using coded labels for the treatments, which were only deciphered after the data collection was complete.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Tehran University of Medical Sciences
Street address
Poursina St., Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653955
Approval date
2024-10-02, 1403/07/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.313

2

Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine, Universitas Muhammadiyah Surabaya
Street address
No. 59, Sutorejo St., Surabaya, East Java, Indonesia
City
Surabya
Postal code
60113
Approval date
2025-01-30, 1403/11/11
Ethics committee reference number
007/KET/II.3/AU/2025

Health conditions studied

1

Description of health condition studied
Healthy Indonesian Adults
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1.Blood Pressure (BP); 2.Fasting Blood Sugar (FBS); 3.Blood Total Cholesterol (Chol); 4.Blood Uric Acid (UA); 5.Body Weight (BW); 6.Waist-to-Hip Ratio (WHR); 7.Peripheral Blood Oxygen (SpO2); 8.Dietary Intake; 9.Frequency of Physical Activity.
Timepoint
before intervention and 12, 24 weeks after intervention
Method of measurement
1. Blood Pressure (BP): Sphygmomanometer; 2. Fasting Blood Sugar (FBS): 3-in-1 Glucose, Uric Acid, and Cholesterol Measurement Tool; 3. Blood Total Cholesterol (Chol): 3-in-1 Glucose, Uric Acid, and Cholesterol Measurement Tool; 4. Blood Uric Acid (UA): 3-in-1 Glucose, Uric Acid, and Cholesterol Measurement Tool; 5. Body Weight (BW): Digital Scale; 6. Waist-to-Hip Ratio (WHR): Measurement Tape; 7. Peripheral Blood Oxygen (SpO2): Pulse Oximeter; 8. Dietary Intake: SQFFQ (Semi-Quantitative Food Frequency Questionnaire); 9. Frequency of Physical Activity: IPAQ (International Physical Activity Questionnaire).

Secondary outcomes

1

Description
e-Health Literacy
Timepoint
before intervention and 12, 24 weeks after intervention
Method of measurement
eHealth Literacy Scale (e-HEALS)

Intervention groups

1

Description
The intervention group will engage in a nine-week program that will include teleconsultations and educational materials (videos and posters) focused on physical activity and nutrition. In addition to the educational materials, the program will also provide three weekly online consultations via WhatsApp regarding nutrition and physical activity. The intervention program will be designed using the ADDIE model, encompassing five phases: analysis, design, development, implementation, and evaluation. During the analysis phase, clinical guidelines (ACSM), physicians' feedback, literature reviews, and pretest records will be studied to create evidence-based content. Experts, including exercise therapists, nutritionists, and physicians, will collaborate to ensure the relevance of the materials. In the design phase, educational materials will be developed based on expert discussions, targeting specific objectives. Posters and videos will be created during the development phase, incorporating engaging visuals, practical tips, and real-life demonstrations. These materials will be tested on a pilot group to refine content and delivery. Posters will include QR codes linking to videos, and effectiveness will be assessed using surveys.Implementation will involve expert reviews and evaluations by normal individuals to confirm appropriateness and comprehensibility. Corrections will be made based on feedback before use in the intervention. Evaluation will focus on the content validity of posters and videos using Item-Content Validity Index (I-CVI) and Scale-Content Validity Index (S-CVI), ensuring methodological rigor. The nine-week intervention will target physical activity and nutrition modifications using five pairs of videos and posters, progressing in intensity weekly. Delivery will be managed via WhatsApp for both intervention and control groups. The intervention group will additionally receive teleconsultations three times per week.Teleconsultation materials will form a vital part of the intervention program and will complement educational posters and videos. Focused on physical activity and nutrition, the teleconsultations will provide detailed advice, including practical exercises tailored to participants' fitness levels, and personalized dietary recommendations based on pretest assessments. Teleconsultations will utilize WhatsApp for convenient delivery of text, voice messages, and video links. Sessions will be brief, approximately 10–15 minutes each, with interactive elements to address participant questions. They will be scheduled three times a week to ensure consistent guidance, and timing will be customized to suit participants’ schedules. These sessions will reinforce the materials provided in the posters and videos while offering individualized support for implementing lifestyle modifications effectively.
Category
Lifestyle

2

Description
Control group: Participants will receive educational materials (videos and posters) on physical activity and nutrition for nine weeks but will not receive any further teleconsultation sessions.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kalijaya Village, Bekasi City, West Java, Indonesia
Full name of responsible person
Muhammad Thaha
Street address
Musholla Nurul Iman, Kali Jeruk St,., Kalijaya Village, Bekasi City, West Java, Indonesia
City
Bekasi
Postal code
17530
Phone
+62 852-1983-3864
Email
muhammadthahapattahu23@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Universitas Muhammadiyah Surabaya
Full name of responsible person
Mundakir Mundakir
Street address
No. 59, Sutorejo St., Surabaya, East Java, Indonesia
City
Surabaya
Postal code
60113
Phone
+62 31 3811966
Email
rektorat@um-surabaya.ac.id
Web page address
https://www.um-surabaya.ac.id/contact
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Universitas Muhammadiyah Surabaya
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
ID
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
Assiatant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Digital Health
Street address
No. 21, Dameshgh St., Vali-e Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8896 5909
Email
ardalansh2002@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Digital Health
Street address
No. 21, Dameshgh St., Vali-e Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8896 5909
Email
ardalansh2002@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Laila Rahmah
Position
MSc Student
Latest degree
Medical doctor
Other areas of specialty/work
Digital Health
Street address
No. 48 Kali Jeruk St. Kalijaya Village, Bekasi City, West Java, Indonesia
City
Bekasi
Province
West Java
Postal code
17530
Phone
+98 905 717 5044
Email
lailarahmah8@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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