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CTRI Number  CTRI/2025/08/092973 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 06/05/2026
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  
Name  Address 
NIL  NIL 
 
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 & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 The study results will be submitted for publication in a peer-reviewed journal within 6–12 months of the completion of the trial 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shivanirawat301994@gmail.com].

  6. For how long will this data be available start date provided 01-12-2027 and end date provided 30-11-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This randomized controlled trial aims to determine the impact of an artificial intelligence–based intervention package (IIC-MP) on adherence to iron and folic acid (IFA) supplementation among anemic women aged 18–49 years who are non-pregnant and non-lactating in South-East Delhi. Participants in the intervention arm will receive digital support through a WhatsApp chatbot, IVR-based reminders, and health education videos, whereas those in the control arm will continue to receive standard care under the Anemia Mukt Bharat program. The study will assess changes in IFA adherence and hemoglobin levels to evaluate whether the digital intervention leads to improved outcomes compared to routine services. 
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