| CTRI Number |
CTRI/2025/07/090248 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Digital health- nutrition education ] |
| Study Design |
Other |
|
Public Title of Study
|
How Digital Health Tools Improve Employee Knowledge, Habits, and body measurement. |
|
Scientific Title of Study
|
Impact of Digital Health Interventions on Literacy, Behavior, and Body Composition Changes Among Employees. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chavi Bansal |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education |
| Address |
Chanakya 2, first floor, Department of Dietetics And Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8980542338 |
| Fax |
|
| Email |
chavi.wgshampl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Mahesh Shettigar |
| Designation |
Assistant Professor Selection grade, Coordinator |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education |
| Address |
Chanakya 2, first floor, Department of Dietetics And Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9591273054 |
| Fax |
|
| Email |
pallavi.wgsha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Mahesh Shettigar |
| Designation |
Assistant Professor Selection grade, Coordinator |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education |
| Address |
Chanakya 2, first floor, Department of Dietetics And Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9591273054 |
| Fax |
|
| Email |
pallavi.wgsha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Udupi, Karnataka, India, 576104. |
|
|
Primary Sponsor
|
| Name |
Chavi Bansal |
| Address |
Chanakya 2, first floor, department of dietetics and applied nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Roshni |
Trescon |
H(23), 5th floor, Pragathi business district, above Reliance trends, laxmindra nagar, manipal, udupi, karnataka, India. 576104
Udupi
KARNATAKA |
6366130837
roshni@tresconglobal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics committee |
Approved |
| Trescon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BMI 23 to 35 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional method. Duration of 2 months. |
nutritional education through conventional method- booklet for 2 months |
| Intervention |
Digital health intervention. Duration of 2 months.
|
nutritional education through social media post and video using nudging. intervention period 2 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Corporate workers.
BMI- 23 to 35. |
|
| ExclusionCriteria |
| Details |
People with severe illnesses.
High doses on medications
Went through any types of recent surgery
With unstable heart conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study will have differences in literacy, along with improvement in the body composition, diet behavior and modifications in lifestyle. |
data collection will be 3 times, pre, during and post(day 0, day 30 and day 60). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
No applicable |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="8"
Days="16" |
|
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
|
After the IEC approval, participants will be recruited based on the selection criteria. The participants will be into two groups using Quasi experimental design – ex post facto design. Group A- Experimental group and Group B- control group, which will be done after matching their age and gender. Now the participants will be administered with the standard interventions containing information about body composition (Tool which will be used to measure body composition. Body composition refers to the proportions of fat, bone, muscle, and water that make up the human body. It can be broken down into fat mass, lean mass, also known as fat-free mass. The parameters the tool will measure are : BMI, Skeletal muscle, body weight, body fat, visceral fat, Segmental Subcutaneous Fat & Skeletal Muscle Percentage), lifestyle changes and dietary changes. Group A will be educated through digital health intervention, where social media platform will be used. Nudging will be done on a weekly basis.
Group B is educated through conventional didactic method where booklet will be distributed to the participants. The pamphlets will contain information about the similar topics used for the experimental group. There will be no nudging done for this particular group. After a period of two months intervention, questionnaire will be distributed to answer different scales to measure nutritional literacy, body composition, dietary choices and physical activity level. The collected data will be processed, analysed and findings will be compiled in a report. |