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CTRI Number  CTRI/2026/01/100281 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral
Other (Specify) [Advice on Medical Nutrition Therapy and Physical activity]  
Study Design  Cluster Randomized Trial 
Public Title of Study   A Digital Tool to Help front line health providers to Detect and Manage Diabetes and High Blood Pressure During Pregnancy” 
Scientific Title of Study   Development and Evaluation of a Culturally Tailored Digital Decision Support System (DSS) for Early Screening, Medical Nutrition Therapy, and Integrated Management of GDM and HDP in Primary Care Settings in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Teena Dasi 
Designation  Scientist D 
Affiliation  ICMR NIN, HYDERABAD 
Address  Department of Maternal and child helath Nutrition, Room NO: 16, ICMR-NIN, TARNAKA

Hyderabad
TELANGANA
500007
India 
Phone  08897950177  
Fax    
Email  teenarajeev@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sai Ram C 
Designation  Scientist E 
Affiliation  ICMR NIN, HYDERABAD 
Address  Department of Maternal and child health Nutrition, Room NO: 6, ICMR-NIN TARNAKA

Hyderabad
TELANGANA
500007
India 
Phone  9618774603  
Fax    
Email  drsairamnin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Kumar Banjara 
Designation  Scientist E 
Affiliation  ICMR NIN, HYDERABAD 
Address  Department of Maternal and child health Nutrition, Room NO: 5, ICMR-NIN, TARNAKA

Hyderabad
TELANGANA
500007
India 
Phone  9885767609  
Fax    
Email  drsantoshkumar999@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Nutrition, ICMR 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, IndiaNew Delhi 
Type of Sponsor  Government funding agency 
 
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 
Teena Dasi  National Institute of Nutrition  Department of Maternal and Child Health Nutrition, Room NO: 16, Tarnaka, OPP Metro station, Hyderabad.
Hyderabad
TELANGANA 		 08897950177

teenarajeev@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ICMR NIN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Digital decision support tool will be provided to front line health providers with role based modules  Rolling recruitment of 1000 consented pregnant women will be done who will be followed up from the first point of contact till 6 months postpartum. The front-line health providers will be trained to deliver early screening, MNT and physical activity as per the digital decision support tool from the first point of contact till 6 months postpartum. 
Comparator Agent  Standard of Care  Frontline health providers will continue routine practice for screening, counselling and referral as per existing government/state guidelines. No training on the digital decision support tool will be provided and no additional study-specific materials will be introduced. Data for study outcomes will be collected in the same manner as the intervention arm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women less than or equal to 20 weeks gestation at the time of ANC registration at study PHC and CHC

Willing to provide informed consent

Plan to remain in the catchment area for the duration of pregnancy and postpartum. 
 
ExclusionCriteria 
Details  Women with pre-existing diabetes or chronic hypertension diagnosed prior to pregnancy,

Referred or transferred out before initial assessment

Known diagnosis of diabetes mellitus prior to current screening (for pregnancy-related studies: pre-existing type 1 or type 2 diabetes).

Severe comorbid illness limiting participation (e.g., advanced chronic kidney disease, severe cardiac disease).

Unable to provide informed consent.

Planning to move away from study area during the study period 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of women diagnosed with GDM by 20 weeks gestational age using OGTT  At baseline, midline at the time of delivery and postpartum 6 weeks and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Neonatal Outcomes:

Birth weight and incidence of macrosomia.



Rates of NICU admission and neonatal hypoglycemia 		 At the time of delivery and postpartum 6 weeks and 6 months. 
Glycemic Control

Blood Pressure Control

Treatment Needs and Adherence

Maternal Complications 		 At baseline, midline at the time of delivery and postpartum 6 weeks and 6 months. 
System and Provider Outcomes:
Fidelity: DSS usage fidelity (percentage of prompts followed).


Knowledge: Provider knowledge scores before and after training.


Referrals: Appropriateness and timeliness of referrals for high-risk cases.



Acceptability: Overall usability and satisfaction with the DSS 		 From midline to end of the study 
Qualitative Outcomes:

Perceived empowerment among frontline workers (ANMs/ASHAs).

User feedback on the ease of providing Medical Nutrition Therapy (MNT) and Physical Activity (PA) counseling 		 Pre-intervention and post-intervention 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   01/09/2026 
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="2"
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  
Title: Digital Decision Support System for Improving Management of Gestational Diabetes and Hypertensive Disorders in Pregnancy
Background / Objective: Gestational Diabetes Mellitus (GDM) and Hypertensive Disorders of Pregnancy (HDP) are common medical conditions that increase risks for both mother and child—including preterm birth, stillbirth, and long-term health problems like type 2 diabetes and heart disease. Although India has national guidelines for screening and managing these conditions, many primary health centers lack resources like trained nutritionists or structured dietary advice. As a result, many women do not receive timely, personalized care. This project aims to address these gaps by developing a Digital Decision Support System (DSS) that helps frontline health workers (Medical Officers, ANMs, ASHAs) screen, counsel, and manage GDM and HDP effectively using a culturally tailored, protocol-based approach.
Novelty: This will be the first study in India to develop and evaluate a real-time DSS that integrates region-specific Medical Nutrition Therapy (MNT), structured care pathways, and digital prompts for health workers to manage both GDM and HDP.
Hypothesis / Research Question: Can integrating a culturally adapted, protocol-driven DSS at the PHC level improve early screening, initiation of Medical Nutrition Therapy, and follow-up management for GDM and HDP?
Study Objectives:
1. To develop and evaluate a culturally tailored DSS for MNT and care of GDM and HDP.
2. To assess its feasibility and acceptability among frontline health providers.
3. To measure improvements in adherence to national protocols and patient outcomes.
4. To integrate the DSS with existing digital systems like the RCH Portal.
5. To evaluate improvement in patient knowledge and treatment continuity.
Methods: A mixed-methods implementation study will be conducted across PHCs in India. The DSS will be co-designed with stakeholders, piloted, and evaluated for effectiveness using quantitative and qualitative methods.
Expected Outcome: The DSS is expected to improve timely identification, personalized dietary counseling, and better continuity of care for women with GDM and HDP, while reducing over-referral and empowering frontline health workers.
 
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