| CTRI Number |
CTRI/2020/03/024339 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
to identify the nutritional status among young adolescent tribal girls |
|
Scientific Title of Study
|
“A study to determine the nutritional status, quality of life and explore the epidemiological
factors affecting nutrition among young adolescent tribal girls of Namkum block,
Jharkhand. A mixed method study.â€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Litna George |
| Designation |
Principal |
| Affiliation |
Manipal College of Nursing,MAHE,Manipal |
| Address |
Ideal School of Nursing
Daladali
Ranchi
jharkhand
Second year MPhil in Nursing Student
Manipal College of Nursing
MAHE,Manipal,Udupi,Karnataka
Ranchi
JHARKHAND
835222
India |
| Phone |
8521795430 |
| Fax |
|
| Email |
litna.george@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSonia RB Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal college of nursing,Manipal |
| Address |
Dept.of OBG nursing
Manipal College of Nursing
MAHE,Manipal,Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844732883 |
| Fax |
|
| Email |
sonia.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MsLitna george |
| Designation |
Principal |
| Affiliation |
Ideal school of nursing,Daladali |
| Address |
Ideal School of Nursing
Daladali,Ranchi,Jharkhand.
Ranchi
JHARKHAND
834002
India |
| Phone |
8521795430 |
| Fax |
|
| Email |
litna.george@gmail.com |
|
|
Source of Monetary or Material Support
|
| Student feed grant from MAHE,Manipal |
|
|
Primary Sponsor
|
| Name |
student feed grant from MAHEManipal |
| Address |
MAHE,Manipal,Udupi,Karnataka |
| Type of Sponsor |
Other [Student grant of RS/10000 from MAHE,Manipal] |
|
|
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 |
| Litna George |
all the schools of namkum block.jharkhand |
All the schools of Namkum block
Ranchi
JHARKHAND |
8521795430
litna.george@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Checking for malnutrition |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
1.All un married non-pregnant and non-lactating young adolescent tribal girls
2.Adolescent girls who are ready to participate
3.Girls aged between the age group 13-17 years
4.Adolescents who reside at Namkum block
|
|
| ExclusionCriteria |
| Details |
1.Adolescent who are malnourished due some other life threatening condition
2.Adolescent who are already diagnosed with malnutrition
3.Adolescent who are taking medication for malnutrition
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early identification of malnutrition among adolescent tribal girls |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving the quality of life |
5 years |
|
|
Target Sample Size
|
Total Sample Size="650"
Sample Size from India="650"
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)
|
01/04/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational,mixed method,multi- centre study to identify the the malnutrition among adolescent tribal girls between the age group 13-17 years of namkum block in Jharkhand state in India. Duration of this study will be 1 year.Data collection will be conducted between April 2020 to may 2020.Estimated sample size will be 650 .Primary outcome of this study is to identify the level of malnutrition among adolescent tribal girls and secondary outcome will be to improve the quality of life. |