| CTRI Number |
CTRI/2025/03/082496 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Improving Awareness of a Millet-Based Healthy Diet for Managing High Blood Pressure in Urban Mysuru: A Study on Its Impact |
|
Scientific Title of Study
|
Effect of Millet Based DASH Diet Awareness Intervention Among Hypertensive Adults in Urban Mysuru, Karnataka: A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Bisht |
| Designation |
Masters of Public Health |
| Affiliation |
JSS Academy of higher education and research |
| Address |
Postgraduate student, Masters in Public Health, School of Public Health, JSS Medical College division of JSSAHER, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570004, India
Mysore
KARNATAKA
570004
India |
| Phone |
9315134224 |
| Fax |
|
| Email |
mansi.2023mph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu B |
| Designation |
Professor, Department of Community Medicine |
| Affiliation |
JSS Academy of higher education and research |
| Address |
Professor,Department of Community Medicine, JSS Medical College division of JSSAHER, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570004, India
Mysore
KARNATAKA
570004
India |
| Phone |
9480134678 |
| Fax |
|
| Email |
madhub@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu B |
| Designation |
Professor, Department of Community Medicine |
| Affiliation |
JSS Academy of higher education and research |
| Address |
Professor,Department of Community Medicine, JSS Medical College division of JSSAHER, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570004, India
Mysore
KARNATAKA
570004
India |
| Phone |
9480134678 |
| Fax |
|
| Email |
madhub@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| Government Primary Health Center, 218, Bannimantap, Mysuru, Karnataka 570015, India
and JSS Primary Health Center, 3rd Main Rd, Medar Block, Mysuru, Karnataka 570021, India |
|
|
Primary Sponsor
|
| Name |
Mansi Bisht |
| Address |
Postgraduate student, Masters in Public Health, School of Public Health, JSS Medical College division of JSSAHER, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570004, India |
| 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 |
| Mansi Bisht |
Government Primary Health Center and JSS Urban Health Center |
218, Bannimantap, Mysuru, Karnataka 570015, India and 8JHV+M54, 3rd Main Rd, Medar Block, Mysuru, Karnataka 570021, India
Mysore
KARNATAKA |
9315134224
mansi.2023mph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Millet-DASH Video Education Intervention |
Millet-DASH Video Education Intervention is a pre-recorded educational video (2-3minutes) designed for hypertensive adults. It explains hypertension, the benefits of millets in a heart-healthy diet, and dietary recommendations based on the DASH diet. The video is shared via digital platform in every alternate days for 1month, aiming to improve knowledge, attitude, and dietary practices for better blood pressure management with a weekly followup call. The video is provided in Hindi and Kannada, allowing participants to receive it in their preferred language for better understanding and engagement. |
| Comparator Agent |
Regular Routine Care |
The comparator group receives standard weekly followup advice on general diet(no Millet DASH diet), physical activity, sleep & rest, socialization, mental health without the video intervention. This could include general guidelines on hypertension management but without the focused millet-based DASH diet education. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years - 70 years
2. Medically diagnosed with elevated hypertension & stage 1 hypertension [according to JNC7 classification]
3. Have smartphone access to WhatsApp
4. Willing to participate & provide informed consent in the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant & lactating mothers
2. People with cognitive impairment, physical disability, or unable to adhere to follow-up requirements
3. People with advanced medical disease (dialysis, liver failure, other systematic diseases)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge, attitude, and practice (KAP) scores related to hypertension management and millet-based DASH diet before and after the intervention. |
Baseline before intervention and after 4 weeks, post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Initiation of Behavioural change related to hypertension management & millet-based DASH diet |
Initiation of behavioural change after 4 weeks of baseline survey
|
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Effect of Nutritional Awareness Intervention towards Millet-Based DASH Diet among Hypertensive Adults in Mysuru, Karnataka: A Quasi-experimental study
OBJECTIVE - To assess the effectiveness of nutritional awareness intervention on Millet-Based DASH diet among hypertensive adults.
DESIGN- The baseline assessment (pre test) will be done on day 1. The intervention group(bannimantap block) will receive Millet-DASH Video Education Intervention for a month in their preferred language (Hindi/ Kannada) via digital platform (WhatsApp). Whereas the control group (Medar Block) receives standard weekly followup advice without the video intervention. After a month, post test will be done from both the blocks.
PARTICIPANTS - • Adults aged 18 years - 70 years • Medically diagnosed with elevated hypertension (SBP- 120-139 mmHg & DBP- <80- 89mmHg) & stage 1 hypertension (SBP- 140-159 mmHg & DBP- 90-99mmHg) [according to JNC7 classification] • Have smartphone access to WhatsApp • Willing to participate & provide informed consent in the study.
INTERVENTION - The Millet-DASH Video Education Intervention is a pre-recorded educational video (2-3minutes) designed for hypertensive adults. It covers hypertension, the benefits of millets, and dietary recommendations based on the DASH diet. The video is provided in Hindi and Kannada, allowing participants to receive it in their preferred language for better understanding and engagement.
OUTCOME- Change in knowledge, attitude, and practice (KAP) scores related to hypertension management and millet-based DASH diet before and after the intervention.
SIGNIFICANCE - This study highlights the importance of nutritional awareness and millet-based DASH diet in managing hypertension. A video-based intervention in Hindi and Kannada ensures easy accessibility, promoting dietary behavior change. The findings can support Public health programs by encouraging millet consumption for better hypertension control. |