| CTRI Number |
CTRI/2025/02/080942 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Health Beliefs Influence Preventive Actions Against Long-Term Diseases |
|
Scientific Title of Study
|
Assessing the association between the Health Beliefs and Preventive Behaviors Against Non-Communicable Diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rishabh Sharma |
| Designation |
Post graduaution student |
| Affiliation |
Prasanna school of public health |
| Address |
Department of healthcare and Hospital management,Prasanna school of public health, Manipal academy of higher education, madhav nagar, manipal, Udupi, karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
7678392068 |
| Fax |
|
| Email |
rishabh.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathi KS |
| Designation |
Associate Professor |
| Affiliation |
Prasanna school of public health |
| Address |
Department of healthcare and Hospital management,Prasanna school of public health, Manipal academy of higher education, madhav nagar, manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9481749911 |
| Fax |
|
| Email |
swathi.ks@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi KS |
| Designation |
Associate Professor |
| Affiliation |
Prasanna school of public health |
| Address |
Department of healthcare and Hospital management,Prasanna school of public health, Manipal academy of higher education, madhav nagar, manipal, Udupi, Karnataka-576104
KARNATAKA
576104
India |
| Phone |
9481749911 |
| Fax |
|
| Email |
swathi.ks@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of healthcare and Hospital management,Prasanna school of public health, Manipal academy of higher education, madhav nagar, manipal, Udupi, karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Rishabh Sharma |
| Address |
Department of healthcare and Hospital management,Prasanna school of public health, Manipal academy of higher education, madhav nagar, manipal, Udupi, karnataka-576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr swathi KS |
Prasanna School of public health |
Department of healthcare and Hospital management, Manipal academy of higher education
Udupi
KARNATAKA |
9481749911
swathi.ks@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical College and Kasturba Hospital Institutional Ethics committee -2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non communicable Diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria shall include being an Indian individual above the age of 18 years who are willing
to participate. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria shall exclude non-Indians or Indian residents under the age of 18 years and
individuals with cognitive impairment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess perceived susceptibility, severity, benefits, barriers, cues to action, and self-efficacy in relation to preventive behaviors for NCDs among the Indian population. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze the interrelationships among Health Belief Model constructs and their combined impact on preventive behaviors. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
Final Enrollment numbers achieved (Total)= "421"
Final Enrollment numbers achieved (India)="421" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2025 |
| Date of Study Completion (India) |
14/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/03/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Aim:
To investigate how health beliefs influence preventive behaviors against non-communicable diseases (NCDs) among individuals in India using the Health Belief Model (HBM). Objectives: - Assess perceived susceptibility, severity, benefits, and barriers related to NCDs among the Indian population.
- Evaluate the role of cues to action and self-efficacy in promoting preventive behaviors.
- Analyze the interrelationships among HBM constructs and their combined impact on preventive behaviors.
Tools Used:
Three structured and validated questionnaires from previous studies on health beliefs and perceived behaviors were adapted to suit the current context. Faculty experts validated the modified tools for relevance, clarity, and accuracy. Statistical Tool:
Jamovi will be used for statistical analysis. Procedure/Processes:
This cross-sectional study involves a survey-based design. Institutional Review Committee (IRC) and Institutional Ethics Committee (IEC) approvals will be obtained. Participants aged 18 years and above who are Indian citizens will be recruited through convenient sampling. Surveys will be distributed via social media platforms (WhatsApp, SMS, email) and in-person for those facing literacy barriers, using Google Forms and physical questionnaires. Participants will receive detailed information about the study, including its objectives, procedures, and potential risks and benefits. Those providing consent will complete the self-reported questionnaire, which includes demographic details (age, gender, education, etc.) and questions on health beliefs and preventive behaviors. Data Collection and Analysis:
Quantitative data will be collected using standardized, validated questionnaires and analyzed using appropriate statistical methods in Jamovi. The study aims to provide insights into the relationship between health beliefs and preventive behaviors for NCDs. |