| CTRI Number |
CTRI/2025/12/099631 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate the effect of enhanced lifestyle modifications (diet and exercise) during first three months of pregnancy in women at high risk for developing diabetes, to reduce the risk of developing diabetes in pregnancy and to improve pregnancy outcomes.
|
|
Scientific Title of Study
|
Impact of intensified lifestyle modification during first trimester for women at risk in preventing Gestational diabetes mellitus - A 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 |
Dr Rajshree Ramlal Somani |
| Designation |
DNB TRAINEE |
| Affiliation |
Fernandez Hospital |
| Address |
Room cubicle 1, ground floor, Obstetrics department, Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001
Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001
Hyderabad
TELANGANA
500027
India |
| Phone |
09421755900 |
| Fax |
|
| Email |
drrajshree.ramlal@myfernandez.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siri Yerubandi |
| Designation |
consultant |
| Affiliation |
Fernandez Hospital |
| Address |
Room cubicle 1, ground floor, Obstetrics department, Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001
Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001
Hyderabad
TELANGANA
500001
India |
| Phone |
09421755900 |
| Fax |
|
| Email |
drsiri_y@fernandez.foundation |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajshree Ramlal Somani |
| Designation |
DNB TRAINEE |
| Affiliation |
Fernandez Hospital |
| Address |
Room cubicle 1, ground floor, Obstetrics department, Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001
Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001
Hyderabad
TELANGANA
500027
India |
| Phone |
09421755900 |
| Fax |
|
| Email |
drrajshree.ramlal@myfernandez.in |
|
|
Source of Monetary or Material Support
|
| No external funding supported by institutional resources |
|
|
Primary Sponsor
|
| Name |
Dr Rajshree Ramlal Somani |
| Address |
105, Leelam residency, Barkatpura , Hyderabad 500027
Fernandez Hospital, 4-1-1230, Abids Road, Bogulkunta ,Hyderabad, Telangana-500001 |
| Type of Sponsor |
Other [Researcher] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajshree Ramlal Somani |
Fernandez Hospital |
room Cubicle 7, first floor, Obstetrics department, Abids Road, Bogulkunta
Hyderabad
TELANGANA |
09421755900
drrajshree.ramlal@myfernandez.in |
| Dr Rajshree Ramlal Somani |
Fernandez Hospital |
Room 201, second floor, Obstetric department, Fernandez OP clinic, Necklace Road
Hyderabad
TELANGANA |
09421755900
drrajshree.ramlal@myfernandez.in |
| Dr Rajshree Ramlal Somani |
Fernandez Hospital |
Ground Floor , cubicle 9, Hyderguda- basheerbagh road, Opposite MLA quarters,Himmayatnagar.
Hyderabad
TELANGANA |
09421755900
drrajshree.ramlal@myfernandez.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTE FERNANDEZ HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lifestyle modification |
dietary intervention -consultation with a dietician at 12-14 weeks is done to explain the dietary intervention. The dietician will advise a healthy diet according to the woman’s BMI and her eating habits. These women are asked to maintain a food dairy and are checked for compliance using PDAQ score to assess the food intake in the past one week. Early Oral Glucose Tolerance Test (OGTT) is advised around 4 weeks after the intervention. A follow-up is done through teleconsultation at 19 to 20 weeks. If OGTT is deranged, further advice is given according to the values. If early OGTT is normal, a repeat OGTT is done at 24 to 25 weeks. A physical consultation with a dietician is done at 26 to 28 weeks and advice given according to the results. If repeat OGTT is normal, a tele consultation for follow up compliance is done at 34 to 36 weeks.
The women who are alloted the control group will receive dietician counselling after doctors advise.
Physical activity intervention: Women who consented to participate in the study are also referred to Physiotherapist at 12 to 14 weeks who will then assess the women about their strength capacity and advised about exercises accordingly. A review visit is done after early OGTT if the values are normal. A follow up on their compliance is done by tele conversation and logbook entry. Consultation with Physiotherapist - walking 40 min to 1 hour per day – to be noted down in dairy. |
| Comparator Agent |
Standard antenatal lifestyle advice |
Standard antenatal care including routine lifestyle advice as per institutional protocol. Dietary and physical activity counselling is provided only if clinically indicated by the treating obstetrician. No structured or intensified lifestyle intervention is given. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women less than or equal to 12 weeks gestation, age 18 to 40 years, singleton pregnancy, at least one risk factor: maternal age more than 35, BMI more than or equal to 30, previous GDM, family history of diabetes, macrosomic baby |
|
| ExclusionCriteria |
| Details |
Pre-existing diabetes (Type 1 or 2), multifetal pregnancy, severe medical illness (cardiac, renal, liver), on steroids or metformin, substance abuse, physical disability, psychiatric disorder, unable to comply, language barrier, or history of mid trimester loss, PV bleed |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of GDM (by IADPSG criteria: FBS more than or equal to 92mg/dl, 1h more than oe equal to 180mg/dl, 2h more than or equal to 153mg/dl on OGTT at 16-20 and 24-26 weeks) |
Incidence of GDM (by IADPSG criteria: FBS more than or equal to 92mg/dl, 1h more than oe equal to 180mg/dl, 2h more than or equal to 153mg/dl on OGTT at 16-20 and 24-26 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal- Gestational weight gain, BP, mode of delivery, blood loss; Neonatal: Birth weight, gestational age, Apgar , neonatal complications; Others- Pre-eclampsia, achievement of intervention goals |
at birth |
|
|
Target Sample Size
|
Total Sample Size="616"
Sample Size from India="616"
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)
|
01/01/2026 |
| 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
|
This study evaluates the
impact of intensified lifestyle modification (individualized diet and exercise)
started in the first trimester on the prevention of GDM among high-risk Indian
pregnant women in a randomized controlled trial. Key outcomes are incidence of
GDM, maternal and neonatal health metrics. |