| CTRI Number |
CTRI/2020/01/022672 [Registered on: 09/01/2020] Trial Registered Prospectively |
| Last Modified On: |
21/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional status of Adolescent girls in Warangal District |
|
Scientific Title of Study
|
Assessment of nutritional status of adolescent girls residing in rural areas of Warangal District, Telangana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yara Shireesha |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9989693291 |
| Fax |
|
| Email |
siribabbly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Vyas |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9538126121 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yara Shireesha |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9989693291 |
| Fax |
|
| Email |
siribabbly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Individual (self),
Department of Health Policy Prasanna School of Public Health, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yara Shireesha |
Rural areas of 6 blocks of Warangal District, Telangana |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal.
Warangal
TELANGANA |
9989693291
siribabbly@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 |
not applicable |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls (10-19) years residing in the rural areas of Warangal District since 1 year. |
|
| ExclusionCriteria |
| Details |
NO EXCLUSION CRITERIA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessing the Nutritional status of Adolescent girls in rural areas.
Nutritional status determined based on anthropometry
|
February2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of socio-demographic factors with nutritional status of adolescent girls |
April 2020 |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "384"
Final Enrollment numbers achieved (India)="384" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2020 |
| Date of Study Completion (India) |
20/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A cross sectional study will be conducted to assess the association between socio-demographic profile and nutrtional status of adolescent girls of age (10-19) years residing in rural areas of Wrangal District, Telangana. A total number of 384 adolescent girls will be selected from rural areas of Warangal District. out of 11 mandals/bolcks 6 will be selected based on stratification of rural population in the district and selection of villages/clusters in each block using probability proportional to size.The households will be randomly selected from obtained villages/clusters with the help of anganwadi workers and selection of respondents from households will be by eligibility criteria of age (10-19) years adolescent girls. After providing them participant information sheet and obtaining their informed consent/ascents data collection will include questionnaire and anthropometric measurements. Validated interview administered questionnaire will be used to obtain participant’s socio-demographic characteristics and participant’s weight is measured using digital weight machine and height by portable stadiometer. By obtaining weight and height, body mass index (BMI) will be calculated. Second part of the questionnaire includes 24 hour recall method which will be used to calculate the protein and calorie intake of each participant. |