| CTRI Number |
CTRI/2025/05/087147 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Digital Nutrition Education on Millet Consumption in Diabetics |
|
Scientific Title of Study
|
Effect of digital nutritional education intervention on millet consumption among diabetics |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Appala Tejaswini |
| Designation |
Masters in 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
Mysore
KARNATAKA
570004
India |
| Phone |
8328399041 |
| Fax |
|
| Email |
misstejaswini383@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
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
Mysore
KARNATAKA
570004
India |
| Phone |
9480134678 |
| Fax |
|
| Email |
madhub@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| JSS Hospital, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka,India- 570004 |
|
|
Primary Sponsor
|
| Name |
Appala Tejaswini |
| 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 |
| Appala Tejaswini |
JSS Hospital |
JSS Hospital First floor, General OPD Room no-2,3, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA |
8328399041
misstejaswini383@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: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Presentation |
Millet based Intervention in the form of presentation with a weekly follow for 1 month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetic mellitus patients
Fasting blood sugar should be more than 110mg/dL
Postprandial sugar should be less than 140mg/dL |
|
| ExclusionCriteria |
| Details |
People who are unable to respond due to cognitive impairments
People with extreme co morbidity
Admitted in emergency care units. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome: Improvement in knowledge, attitude, and practice regarding millet consumption.
Secondary Outcomes: Changes in blood sugar levels, adoption of healthier eating habits, and improved quality of life.
|
Baseline before intervention and after 4 weeks, post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in blood sugar level , adoption of healthier eating habits & improved quality of life |
Initiation of behavioural change after 4 weeks of baseline survey
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/05/2025 |
| 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
|
Title: Effect of Digital Nutritional Education Intervention on Millet Consumption Among Diabetics Summary: The study evaluates the impact of a digital nutrition education intervention on millet consumption among individuals with type 2 diabetes. Objectives: Primary: To assess the effect of nutrition education intervention on consumption of millet among diabetics. Secondary: To assess the dietary pattern among diabetics with reference to consumption of millets. To assess the knowledge, attitude and practice of millet consumption among study participants Study Design: A pre-post intervention study. Participants will first complete a questionnaire covering socio-demographics, medical history, and KAP related to millet consumption. They will then receive a digital nutrition education intervention via PowerPoint slides, followed by a one-month intervention period with four follow-ups. The same questionnaire will be administered post-intervention. Participants: Individuals diagnosed with type 2 diabetes, regardless of disease duration. Fasting Blood Sugar (FBS) >110 mg/dL. Postprandial Blood Sugar (PPS) <140 mg/dL. Intervention: All participants will receive a digital presentation explaining the benefits of millet consumption for diabetic patients. Outcomes: Primary Outcome: Improvement in knowledge, attitude, and practice regarding millet consumption. Secondary Outcomes: Changes in blood sugar levels, adoption of healthier eating habits, and improved quality of life. Significance: This study aims to promote millet consumption and enhance nutritional awareness among diabetic patients, potentially contributing to better diabetes management. |