| CTRI Number |
CTRI/2025/08/093877 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using Mobile to Help Adolescent Girls in North East Delhi Improve Iron Tablet Use and Nutrition |
|
Scientific Title of Study
|
Behavioural Interventions Using m-Health for Adherence to
Iron Folic Acid Supplementation and Dietary Improvements Among
Adolescent Females Residing in North East Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no. 360, Department of Community Medicine
Pathology Block
Room no. 360,
Department of Community Medicine
Pathology Block
New Delhi
DELHI
110002
India |
| Phone |
8750647995 |
| Fax |
|
| Email |
bhatnagarnidhi.mamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no. 360,
Department of Community Medicine
Pathology Block
Room no. 360,
Department of Community Medicine
Pathology Block
New Delhi
DELHI
110002
India |
| Phone |
8750647995 |
| Fax |
|
| Email |
bhatnagarnidhi.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no. 360,
Department of Community Medicine
Pathology Block
Room no. 360,
Department of Community Medicine
Pathology Block
New Delhi
DELHI
110002
India |
| Phone |
8750647995 |
| Fax |
|
| Email |
bhatnagarnidhi.mamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council Of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council Of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Nidhi Bhatnagar |
Maulana Azad Medical College |
2, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI |
8750647995
bhatnagarnidhi.mamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NONE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioral |
Behavioural intervention using mobile health tools |
| Comparator Agent |
Regular Preventive Therapy |
iron and Folic Acid Supplementation with dietary face to face counseling |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
The participants having access to mobile phone with internet for at least 3 hours per
day. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of m-health based behavioral interventions in improving the IFA
adherence and dietary iron intake of the study participants. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Various nudge elements of the study participants which can motivate them for IFA
supplementation adherence & dietary improvements in the intervention phase of the
study. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Anemia is a serious health problem among adolescent girls in India, especially in Delhi, where many girls suffer from low hemoglobin levels. Iron and folic acid (IFA) tablets are provided under government programs, but many girls do not take them regularly due to reasons like forgetfulness, side effects, or lack of awareness. This study will test the use of mobile health (m-Health) tools such as text messages, videos, and reminders to improve IFA tablet use and healthy eating habits among adolescent girls in North East Delhi.
The study will be conducted in two phases:
-
Phase 1: Survey and interviews to find out how common anemia is, what barriers prevent girls from taking IFA tablets, and their dietary patterns.
-
Phase 2: A randomized trial where one group will receive regular counseling plus mobile-based reminders and health messages, while another group will receive only counseling.
We will compare the two groups to see if mobile health support improves regular IFA use, dietary iron intake, and hemoglobin levels. The results will help in designing better adolescent health programs using digital technology. |