| CTRI Number |
CTRI/2025/08/093787 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Diet and Exercise During Pregnancy Affect Mothers’ Health |
|
Scientific Title of Study
|
Impact of dietary modification and exercise program during pregnancy on maternal outcomes:a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bavana |
| Designation |
Junior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Obstetrics and gynecology department,
AIIMS Jodhpur
Obstetrics and gynecology department
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8220164912 |
| Fax |
|
| Email |
bavanaragava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navdeep Kaur Ghuman |
| Designation |
Additional professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of obstetrics and gynecology,
AIIMS Jodhpur
Department of Obstetrics and gynecology,
AIIMS Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8107096747 |
| Fax |
|
| Email |
drnavdeepghuman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navdeep Kaur Ghuman |
| Designation |
Additional professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of obstetrics and gynecology, AIIMS jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8107096747 |
| Fax |
|
| Email |
drnavdeepghuman@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
AIIMS Jodhpur |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bavana |
AIIMS |
AIIMS Jodhpur
Jodhpur
RAJASTHAN |
8220164912
bavanaragava@gmail.com |
| Bavana |
AIIMS Jodhpur |
Department of Obstetrics and Gynecology,
Jodhpur
RAJASTHAN |
8220164912
bavanaragava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diet modification |
Dietary chart which includes adequate intake of carbohydrates,proteins ,fibres and macronutrients and decreased intake of foods high in saturated fats |
| Intervention |
Exercise |
Upper limb exercises and walking for 30 minutes at least five times a week |
| Comparator Agent |
No intervention |
Routine antenatal care |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
Pregnant women with medical comorbidities,pregnant women more than 20 weeks gestation in booking visit, not willing to participate,women with history of previous preterm labour,cervical encirclage.previous history of GDM,eclampsia,type 1 diabetes in family first degree relative. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gdm, Pregnant eclampsia spectrum,maternal weight gain,musculoskeletal pain,birth weight,Apgar,nicu admissions |
Initially weekly for 3 weeks and then monthly |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="262"
Sample Size from India="262"
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)
|
07/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Poor pregnancy outcomes which includes macrosomia,stillbirth,gestational hypertension,gestational diabetes,increased cesarean section rates are frequently linked to excessive weight gain during pregnancy interventions focusing on modifying the diet,incorporating exercise routines,or a combined approach have shown promise in mitigating the risks associated with excessive weight gain during pregnancy. |