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CTRI Number  CTRI/2025/05/087994 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 24/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the the effectiveness of health education at preventing Gestational Diabetes Mellitus in pregnant women at risk of Gestational Diabetes 
Scientific Title of Study   Effectiveness of a multicomponent modular intervention among pregnant women at high risk of developing Gestational Diabetes Mellitus--A hospital based randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Farha Mohammed 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Mangalore  
Address  Room no 2, 3rd Floor, Department of Community Medicine Kasturba Medical College, Mangalore 203, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9895341929  
Fax    
Email  community.kmcmlr@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Rekha T 
Designation  Professor 
Affiliation  Kasturba Medical College, Mangalore  
Address  Room no 2, 3rd Floor, Department of Community Medicine Kasturba Medical College, Mangalore 203, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449082214  
Fax    
Email  rekha.thapar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Farha Mohammed 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Mangalore  
Address  Room no 2, 3rd Floor, Department of Community Medicine Kasturba Medical College, Mangalore 203, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9895341929  
Fax    
Email  community.kmcmlr@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Farha Mohammed 
Address  Department of Community Medicine Kasturba Medical College, KMC Mercara Trunk Rd, Hampankatta, Mangaluru, Karnataka 575001  
Type of Sponsor  Other [Self] 
 
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 Farha Mohammed  Out Patient Department, Department of OBG   Ground floor, Lady Goschen Hospital Maidan Rd, Bhavathi, Hampankatta, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA 		 9895341929

community.kmcmlr@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational intervention + routine standard care   An educational intervention among pregnant women at risk of developing gestational diabetes, focusing on diet and exercise. Component 2: Flipchart/Video During a hospital visit or a home-visit, a fifteen-minute-long intervention will be delivered through flipcharts. In the situation that the intervention cannot be delivered in person, the intervention will be delivered via mobile, in the form of a video. This intervention will contain the following: Section A: Health education regarding Gestational Diabetes Mellitus--An introduction to GDM, complications of GDM, and the effects of GDM on both maternal and child health. Section B: Symptoms and Complications of GDM Section C: Diagnosis of GDM Section D: Prevention of GDM Based on their diet recorded through 24 hour diet recall, a tailormade diet based on current guidelines for pregnant women with GDM will be provided to them. Component 2: A Diet and Exercise Diary A diary to record their daily exercise and diet will be provided to the participants of the intervention arm. Component 3:M-Health Another component will be M-health, in which the participants will receive reminders through an electronic medium on a weekly basis. This consists of messages of designed for the aforementioned purpose and delivered through the messaging platform Whatsapp. 
Comparator Agent  Routine Standard care  Routine Standard care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  All adult pregnant women from Mangalore Taluk who consent to participate in the study, less than or equal to 12 weeks of gestation
with singleton pregnancy, and at least one or more risk factors for the development of GDM
The risk factors are as follows: BMI at first visit 23kg per m2, Age more than or equal to 25 years, First-degree relative with diabetes, Previous pregnancy with gestational diabetes mellitus, Previous pregnancy with large baby, Previous pregnancy with preeclampsia/eclampsia, History of PCOD or diseases with impaired fasting glucose
 
 
ExclusionCriteria 
Details  Individuals unwilling to participate in the study, Individuals found to have RBS values more than 200mg/dL at first visit, Prepregnancy diagnosis of Diabetes Mellitus, History of severe hyperemesis in the first trimester, Individuals on medications that interfere with glucose metabolism (eg. Metformin, steroids), History of recurrent first trimester spontaneous abortions, History of stillbirth, History of significant antepartum or postpartum haemorrhage in previous pregnancies, Multiple gestations in current pregnancy, Severe psychiatric disorder or cognitive impairment, Any renal, liver or thyroid dysfunction, Women in whom physical activity is an absolute contraindication during pregnancy as recommended by ACOG (heart disease, restrictive lung disease, incompetent cervix, pregnancies at risk of premature labour, placenta previa, gestational hypertension, severe anemia), Individuals without access to a smartphone
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
·Incidence of GDM in intervention arm and control arm

·Mean difference in physical activity scores between intervention arm and control arm

·Pattern of change in dietary habits pre-intervention and post-intervention

·Comparison of gestational weight gain between intervention arm and control arm 		 24 to 28 weeks of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   10/06/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 (Others) -  Data will be made available at an open repository - Open Science Framework (osf.io)

  6. For how long will this data be available start date provided 13-09-2026 and end date provided 13-06-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized single-centre open label control trial to test the effectiveness of a multicomponent modular educational intervention at averting the development of GDM among women at risk of developing Gestational Diabetes Mellitus. The sample size is 164, 82 in each arm. All participants will receive standard and routine care. Participants in the intervention arm will receive an educational intervention. Primary outcomes will be incidence of GDM in intervention arm and control arm, mean difference in physical activity scores between intervention arm and control arm, pattern of change in dietary habits pre-intervention and post-intervention and comparison of gestational weight gain between intervention arm and control arm. 
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