| CTRI Number |
CTRI/2025/02/080904 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [traditional nutritional counselling and mobile application based counselling] |
| Study Design |
Other |
|
Public Title of Study
|
comparing nutrition counselling during hospital visits versus counselling through mobile application |
|
Scientific Title of Study
|
Dietary passport- A mobile application to help monitor the growth parameters and
calorie tracking in children.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chethan S |
| Designation |
Post graduate, Paediatrics |
| Affiliation |
saveetha medical college |
| Address |
Department of Paediatrics, first floor, Saveetha Medical College and Hospital, Thandalam, kancheepuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8489386182 |
| Fax |
|
| Email |
chethansrinivasan02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
LAL DV |
| Designation |
Professor, Program Director Saveetha CDC, Paediatrics |
| Affiliation |
saveetha medical college |
| Address |
Department of Paediatrics, first floor, Saveetha Medical College and Hospital, Thandalam, kancheepuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7299938038 |
| Fax |
|
| Email |
drlaldv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chethan S |
| Designation |
Post graduate, Paediatrics |
| Affiliation |
saveetha medical college |
| Address |
Department of Paediatrics, first floor, Saveetha Medical College and Hospital, Thandalam, kancheepuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8489386182 |
| Fax |
|
| Email |
chethansrinivasan02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Thandalam, Kancheepuramdistrict, Tamilnadu 602105, India |
|
|
Primary Sponsor
|
| Name |
Chethan S |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Kancheepuram District, Tamilnadu-602105 |
| 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 Chethan S |
Saveetha Medical College and Hospital |
Depatrment of paediatrics, first floor, Saveetha Nagar, Thandalam, 602105
Kancheepuram
TAMIL NADU |
8489386182
chethansrinivasan02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL, UNDERWEIGHT AND OVERWEIGHT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutritional counselling through Nutri Growth Mobile Application |
This group of children will receive Nutritional Counselling through Nutri Growth Mobile Application. This app contains features like calorie tracking, growth monitoring and allows patients to interact with doctors when needed
counselling will be given trough the mobile application in the form of text messages
and weight, height and BMI will be monitored and recorded in the app and the improvement in the nutritional status will assessed at the end of 1 years |
| Comparator Agent |
Traditional Nutrition Counselling |
This group of children will receive traditional nutritional counselling during scheduled hospital visits and anthropometry will be assessed during the hospital visits and the improvement in the nutritional status of the child will be compared with the intervention group at the end of study period |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1-18 years underweight, overweight, or normal weight for age and sex.Parents or guardians with smartphone access, willing to participate for 12 months.Parents or guardians literate in English orTamil. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the mean weight of children with conventional hospital based nutritional counseling and mobile application based nutritional counselling and to compare the mean weight between the two groups |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the parent involvement between the two groups |
1 year |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/03/2025 |
| 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="1"
Months="0"
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
|
This study aims to analyze and compare the mean weight of children and parent involvement between the traditional nutritional counselling group and nutritional counselling by Nutri growth mobile application group . Children between the age of 1 to 18 years will be recruited for this study based on the inclusion criteria. The duration of this study is 1 year. |