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CTRI Number  CTRI/2024/04/065269 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Lifestyle modification intervention program for prevention of Gestational Diabetes mellitus using artificial intelligence based mobile application among high risk primi gravida women. 
Scientific Title of Study   Effect of artificial intelligence-based mobile application for lifestyle modification in prevention of Gestational diabetes mellitus among the high risk primigravida women in Central Referral Hospital of Gangtok, Sikkim 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Binita Khati 
Designation  Professor 
Affiliation  Sikkim Manipal College of Nursing 
Address  Sikkim Manipal College of Nursing 5th mile Tadong Gangtok Sikkim
5th Mile Tadong GangtokSikkim
East
SIKKIM
737102
India 
Phone  8001360843  
Fax    
Email  binita.k@smims.smu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Judith Angellita Noronha 
Designation  Dean 
Affiliation  Manipal College of Nursing 
Address  Room No. 101 Department of Obstetric and Gynaecological Nursing Manipal College of Nursing MAHE Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448506594  
Fax    
Email  judith.n@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Muralidhar V Pai 
Designation  Dean 
Affiliation  Sikkim Manipal Institute of Medical Sciences 
Address  Sikkim Manipal Institute of Medical Sciences Sikkim Manipal University 5th Mile Tadong Gangtok Sikkim

East
SIKKIM
737102
India 
Phone  9733186481  
Fax    
Email  mvpai@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Central Referral Hospital 5th Mile, Tadong, Gangtok Sikkim 
 
Primary Sponsor  
Name  Binita Khati 
Address  Sikkim Manipal College of Nursing 5th mile Tadong Gangtok Sikkim 
Type of Sponsor  Other [] 
 
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 
Dr Muralidhar V Pai  Central Referral Hospital  Out Patient Department. Department of Obstetrics and Gynaecology, Level 4.
East
SIKKIM 		 9733186481

mvpai@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sikkim Manipal Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O09||Supervision of high risk pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  artificial intelligence based mobile application education on lifestyle modification and tracking their diet and exercise through mobile application.  the experimental group refers to the women who are pregnant for the first time and are at risk of developing gestation diabetes mellitus assessed by the artificial intelligence technique using AI prediction model. The women who will be identified as high-risk women with any one or more of the factor (BMI≥30kg/m2, maternal age, family history of GDM/DM and PCOS) will be give the intervention of lifestyle modification (diet and exercise). The women will be assessed for development of GDM and the pregnancy outcomes for nine months of pregnancy. 
Comparator Agent  Standard care and Leaflet on lifestyle modification   The control group will receive the standard care as well as leaflet and they will be assessed for development of GDM and the pregnancy outcomes for nine months of pregnancy. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Phase 1
⮚ Women who are registered case in Central Referral hospital of Gangtok, Sikkim
⮚ Women who are primigravida.
⮚ Primigravida women who are at 7weeks+ days of gestation.
⮚ Primigravida who can speak, understand and write English, Nepali or Hindi
⮚ Primigravida women who can use android phone with mobile application.
Phase 2
⮚ Primi gravida women who are at risk of gestational diabetes mellitus
 
 
ExclusionCriteria 
Details  Phase 1
⮚ Primigravida women with any pre-existing medical condition
⮚ Primigravida women any Medical Legal Cases (MLC).
⮚ Primigravida women not willing to give consent for the participation in the study.
Phase 2
⮚ Antenatal women with any pre-existing medical condition 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out the incidence of gestational diabetes mellitus.  4 years 
 
Secondary Outcome  
Outcome  TimePoints 
maternal outcome:mode of delivery, nature of labour, postpartum haemorrhage. Fetal outcome: APGAR score, gestational age at birth, birth weight, levels of neonatal unit admission, neonatal glucose level, congenital malformation.  4 years 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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)   02/12/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  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 - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [binita.k@smims.smu.edu.in].

  6. For how long will this data be available start date provided 03-12-2028 and end date provided 03-12-2035?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study "Effect of artificial intelligence-based mobile application for lifestyle modification in prevention of Gestational diabetes mellitus among the high risk primigravida women in Central Referral Hospital of Gangtok, Sikkim" is aimed to find out the incidence of gestational diabetes mellitus among high risk primigravida women. With GDM, the pregnancy results are obviously worse for both the mother and the newborn. Mothers’ knowledge of GDM and its potential morbid consequences is extremely low and could be a target area to enhance the result. Thus, this study will help in prevention of GDM using artificial intelligence based mobile application leading to decrease in adverse pregnancy outcome. 
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