CTRI/2025/12/098333 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On:
01/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Behavioral
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Nutritional Chatbot for Postnatal Mothers
Scientific Title of Study
Development and Efficacy Evaluation of an AI Chatbot for Personalized Nutrition Counseling Among Postnatal Mothers: A Mixed-Methods Randomized Controlled Trial
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
nil
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Neha Dsouza
Designation
Assistant Professor
Affiliation
Sapthagiri Institute of Medical Sciences and Research Centre
Address
Department of Community Medicine
Sapthagiri Institute of Medical Sciences and Research Centre
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka
Bangalore KARNATAKA 560090 India
Phone
8618684440
Fax
Email
drnehadsouza94@gmail.com
Details of Contact Person Scientific Query
Name
Neha Dsouza
Designation
Assistant Professor
Affiliation
Sapthagiri Institute of Medical Sciences and Research Centre
Address
Department of Community Medicine
Sapthagiri Institute of Medical Sciences and Research Centre
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka
Bangalore KARNATAKA 560090 India
Phone
8618684440
Fax
Email
drnehadsouza94@gmail.com
Details of Contact Person Public Query
Name
Neha Dsouza
Designation
Assistant Professor
Affiliation
Sapthagiri Institute of Medical Sciences and Research Centre
Address
Department of Community Medicine
Sapthagiri Institute of Medical Sciences and Research Centre
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka
Bangalore KARNATAKA 560090 India
Phone
8618684440
Fax
Email
drnehadsouza94@gmail.com
Source of Monetary or Material Support
Sapthagiri Institute of Medical Sciences
Primary Sponsor
Name
Sapthagiri Institute of Medical Sciences and Research Centre
Sapthagiri Institute of Medical Sciences & Research Centre, Bengaluru
Research Lab, Department of Community Medicine, Sapthagiri Institute of Medical Sciences & Research Centre, Bengaluru
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 Bangalore KARNATAKA
AI chatbot–based personalized counseling along with standard care
Personalized diet advice (based on postpartum week, breastfeeding status, affordability)
Supplementation reminders (iron/calcium)
Two-way chat support with pre-validated responses
Weekly nudges/check-ins
Safety alerts for red-flag symptoms and referral to CHW or clinic
Comparator Agent
Standard postnatal counselling only (routine CHW or clinic-based education)
Promotion and support for early initiation of breastfeeding and exclusive breastfeeding techniques (positioning and attachment).
Management of common breastfeeding problems.
Guidance on appropriate complementary feeding (after six months).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
49.00 Year(s)
Gender
Female
Details
Willing to give written informed consent
Mothers aged more than or equal to 18 years, 0–6 months postpartum,
Having smartphone access
ExclusionCriteria
Details
Severe postpartum complications
Severe illness requiring hospitalization
Cognitive or language impairment preventing chatbot use
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Change in Nutrition Knowledge Score
baseline and 4 weeks.
Secondary Outcome
Outcome
TimePoints
Dietary diversity
baseline and 4 weeks
Supplement adherence
baseline and 4 weeks
Breastfeeding self-efficacy
baseline and 4 weeks
System Usability Scale (SUS) scores for intervention users
4 weeks
Engagement analytics
continous
Safety/adverse events
continous
Target Sample Size
Total Sample Size="150" Sample Size from India="150" 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 2
Date of First Enrollment (India)
15/01/2026
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 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
Title: Development and Evaluation of an AI-Powered Multilingual Nutrition Chatbot for Personalized Counseling Among Postnatal Mothers: A Randomized Controlled Trial
Background and Rationale:
Inadequate nutrition knowledge and poor dietary adherence are common among postnatal mothers, particularly in underserved communities. Mobile health (mHealth) tools can bridge this gap. This study aims to develop and test an AI-based WhatsApp chatbot that provides personalized, evidence-based nutrition counseling in Kannada, Tamil, Hindi, and English.
Objectives:
To assess the effectiveness of a multilingual AI nutrition chatbot in improving maternal nutrition knowledge, dietary diversity, and supplement adherence among postnatal mothers.
To evaluate user satisfaction, usability, and engagement with the chatbot.
Study Design:
Parallel-group, randomized controlled trial (1:1 allocation) with 150 postnatal mothers recruited from urban and semi-urban Anganwadi centres in Bengaluru.
Intervention:
Participants in the intervention arm will receive access to an AI-driven WhatsApp chatbot providing personalized nutrition counseling, reminders, and education messages for 4 weeks. The control group will receive standard government nutrition IEC materials.
Outcomes:
Primary Outcome: Change in mean nutrition knowledge score from baseline to 4 weeks.
Secondary Outcomes: Dietary diversity, supplement adherence, breastfeeding self-efficacy, and System Usability Scale (SUS) scores.
Duration:
14 months total (Nov 2025 – Dec 2026); active intervention Jan – Aug 2026.
Sample Size:
150 participants (75 per arm), powered at 80% to detect a moderate effect size (Cohen’s d = 0.5).
Inclusion Criteria:
Postnatal mothers (0–12 months postpartum), smartphone users with WhatsApp access, able to read or understand one of the study languages.
Exclusion Criteria:
Mothers with severe illness, non-consent, or without mobile access.
Setting:
Anganwadi centres and community health facilities under the urban feild practice area
Ethical Approval:
Approved by the Institutional Ethics Committee, Sapthagiri Institute of Medical Sciences & Research Centre, Bengaluru (Phone: 080-22188702).
Principal Investigator:
Dr. Neha Dsouza, Assistant Professor, Department of Community Medicine,
Sapthagiri Institute of Medical Sciences & Research Centre, Bengaluru.
Email: drnehadsouza94@gmail.com | Phone: 8618684440