| CTRI Number |
CTRI/2025/08/092973 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using an AI-based program to help anemic women in a Delhi community take iron-folic acid tablets regularly
|
|
Scientific Title of Study
|
An Artificial-Intelligence-Based Intervention To Improve Iron Folic Acid (IFA) Adherence Among Anemic Women In An Urban Community: A Randomized Control Trial In South- 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 |
Shivani Rawat |
| Designation |
PhD (Public Health) Scholar |
| Affiliation |
Hamdard Institute of Medical Sciences and Research (HIMSR) |
| Address |
Department of Community Medicine, Hamdard Institute of Medical Sciences and Research, Guru Ravidas Marg, Near Majeedia Hospital, Hamdard Nagar, New Delhi – 110044, India
Department of Community Medicine, Hamdard Institute of Medical Sciences and Research, Guru Ravidas Marg, Near Majeedia Hospital, Hamdard Nagar, New Delhi – 110044, India
South
DELHI
110044
India |
| Phone |
09068531938 |
| Fax |
|
| Email |
ShivaniRawat301994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Farzana Islam |
| Designation |
Professor & HOD, Department of Community Medicine |
| Affiliation |
Hamdard Institute of Medical Sciences and Research (HIMSR) |
| Address |
Department of Community Medicine, Hamdard Institute of Medical Sciences and Research, Guru Ravidas Marg, Near Majeedia Hospital, Hamdard Nagar
New Delhi
South
DELHI
110044
India |
| Phone |
9560067059 |
| Fax |
|
| Email |
hod.cmedicine@himsr.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farzana Islam |
| Designation |
Professor & HOD, Department of Community Medicine |
| Affiliation |
Hamdard Institute of Medical Sciences and Research (HIMSR) |
| Address |
Department of Community Medicine, Hamdard Institute of Medical Sciences and Research, Guru Ravidas Marg, Near Majeedia Hospital, Hamdard Nagar
New Delhi
South
DELHI
110044
India |
| Phone |
9560067059 |
| Fax |
|
| Email |
hod.cmedicine@himsr.co.in |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of Medical Sciences and Research (HIMSR), Guru Ravidas Marg, Near Majeedia Hospital, Hamdard Nagar, New Delhi – 110044, India |
|
|
Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research HIMSR |
| Address |
Hamdard Institute of Medical Sciences and Research (HIMSR), Guru Ravidas Marg, Near Majeedia Hospital, Hamdard Nagar, New Delhi – 110044, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shivani Rawat |
Urban Health Training Centre(UHTC), Hamdard Health Centre |
Department of Community Medicine, Urban Health Training Centre (UHTC), Sharma Market Road, Block C, Pulpharadpur, Block B, Pul Pehlad Pur, New Delhi – 110044, India
South
DELHI |
09068531938
ShivaniRawat301994@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hamdard Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI-based adherence support package (including WhatsApp chatbot, IVR calls, digital and manual reminder tools) |
Participants in the intervention arm will receive an AI-based adherence support package for a total duration of 6 months consisting of:
Daily reminders through WhatsApp chatbot and IVR calls
Monthly home visits
Manual and digital diary for self-monitoring
Health education videos
Quarterly hemoglobin assessments
|
| Comparator Agent |
Routine Iron and Folic Acid (IFA) services provided |
Participants will receive routine care provided under the Anemia Mukt Bharat (AMB) program for a total duration of 6 months. This includes:
Weekly IFA tablet distribution
Basic counseling on anemia and diet
No additional reminders, digital tools, or monitoring interventions
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. Non pregnant or non lactating women in reproductive age (18 years or above) with mild to moderate anemia.
2. Women residing in the study area since the last 6 months and are not planning to move out from the study area in the next 6 months.
3. Women having access to mobile phones with internet services.
4. Women willing to participate in the study and giving written informed consent |
|
| ExclusionCriteria |
| Details |
1.Women with severe anemia.
2.Women with a history of repeated blood transfusion, hemolytic anemia, chronic diarrhoea, stomach ulcer, heart surgery/prosthetic valves, cancer, tuberculosis, CKD, thalassemia, IBD, Liver disorders, colon cancers.
3.Women currently undergoing medical therapy known to interfere with iron or folic acid absorption/metabolism including tetracyclines, anticoagulants, proton pump inhibitors, antiepileptics, or immunosuppressants etc. will be excluded to ensure outcome validity and participant safety.
4.Women who are already benefiting from existing nutritional supplementation health schemes/on treatment from any medical facility.
5.Women who are unable to understand and provide written informed consent will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in hemoglobin levels (pre-post comparison)
2.Reduction in prevalence of anemia (intervention vs control)
3.Improved compliance of IFA intake (intervention vs control)
|
1.Baseline (Week 0) and Endline (Week 24 / 6 months) 2.Baseline (Week 0) and Endline (Week 24 / 6 months) 3.Daily monitoring over 6 months; final assessment at Week 24 (6 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
1.Continuously monitored throughout the intervention period (Week 0 to Week 24); final assessment at Week 24 |
Adherence to a full intervention package (counseling, reporting, diary, etc.)
Motivational factors and challenges in IFA intake
|
2.Baseline (Week 0) and Endline (Week 24) |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
28/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Study results will be published in a peer reviewed journal after completion of the trial. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This randomized controlled trial will evaluate the effectiveness of an Artificial Intelligence-based Intensive IFA Compliance Monitoring Package (IIC-MP) in improving iron-folic acid (IFA) adherence among anemic non-pregnant, non-lactating women aged 18–49 years in South-East Delhi. Participants in the intervention group will receive AI-enabled adherence support, reminders, and health education, while the control group will receive routine care under the Anemia Mukt Bharat programme. The primary outcomes will be IFA adherence and change in hemoglobin levels over the study period. |