| CTRI Number |
CTRI/2017/08/009394 [Registered on: 17/08/2017] Trial Registered Prospectively |
| Last Modified On: |
16/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Quasi Intervention |
| Study Design |
Other |
|
Public Title of Study
|
Impact of maternal Diet and Lifestyle on pregnancy and birth outcome. |
|
Scientific Title of Study
|
Impact of maternal Diet and Lifestyle on pregnancy and birth outcome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namratha T S |
| Designation |
Msc DAN 2 year Semester |
| Affiliation |
Manipal University |
| Address |
Dept of Allied Hospitality Studies,
WGSHA,
Manipal
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
7259232515 |
| Fax |
|
| Email |
namrathabhat3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Garg |
| Designation |
Asst Prof._ Selection Grade and HOD Msc Dietetics and Applied Nutrition |
| Affiliation |
Manipal University |
| Address |
Dept of Allied Hospitality Studies,
WGSHA,
Manipal
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
934316327 |
| Fax |
|
| Email |
meenakshi.garg@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jainee Kumbhani |
| Designation |
Msc DAN 2 year Semester |
| Affiliation |
Manipal University |
| Address |
Dept of Allied Hospitality Studies,
WGSHA,
Manipal
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9820632336 |
| Fax |
|
| Email |
jaineekumbhani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Meenakshi Garg |
| Address |
Asst.Prof._Selection Grade and HOD MSc Dietetics and Applied Nutrition,Department of Allied Hospitality Studies, WGSHA, Manipal- 576104 |
| Type of Sponsor |
Other [HOD of MSc DAN ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Namratha T S |
Kasturba Hospital |
OPD, Obstetric and Gynecology Department, Women and Child Block
Udupi
KARNATAKA |
7259232515
namrathabhat3@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 between 25th to 30th weeks Gestation at the time of enrolment |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
• Pregnant women registered for antenatal checkup under KMC/KH Manipal.
•Pregnant women between 25th to 30th weeks Gestation at the time of enrolment
|
|
| ExclusionCriteria |
| Details |
• Pregnant women who are not registered under KMC/KH Manipal.
• Pregnant women before 25th week and after 30th week of gestation and the ones who already entered the last month of pregnancy.
• Women having pregnancy related complications like Gestational Diabetes, Pregnancy induced hypertension, Hyperemesis gravidarum,
• Patients that are immunocompromised, suffering from terminal illness like HIV, cancer or those who are under medical treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Identifying the dietary and lifestyle risk factors responsible for adverse pregnancy and birth outcome. |
Pregnant women in 3rd trimester- First Visit for initial data collection,Second Visit- after 4 weeks for followup to observe if any changes and third Visit-post Delivery for outcome. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
28/08/2017 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Poor maternal nutritional status has been related to adverse birth outcomes; however, the association between maternal nutrition and birth outcome is complex and is influenced by many other lifestyle factors like biologic, socioeconomic, and demographic factors. The Objectives of this study are- To evaluate and assess the maternal diet and lifestyle habits and relevant obstetric history of pregnant mothers in their last trimester of pregnancy.To study the socio demographic characteristics and nutritional status based on the anthropometric data, biochemical parameters.To assess the impact of diet lifestyle and overall nutritional status on pregnancy and birth outcome.To impart nutritional and health education about optimum diet and lifestyle habits during pregnancy through educational material. |