| CTRI Number |
CTRI/2024/09/074280 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on health status of siddhi tribes |
|
Scientific Title of Study
|
Assessment of Nutritional status and Prevalence of Malnutrition among the Households and Health seeking Behaviour of Siddhi Tribes in North Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshni |
| Designation |
Student |
| Affiliation |
Welcomegroup Graduate School of Hotel Administration, MAHE, Manipal |
| Address |
Welcomgroup Graduate School of Hotel Administration
Udupi Hebri Rd
near Kasturba Hospital Saralabettu Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9591620331 |
| Fax |
|
| Email |
roshni.wgshampl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusha Priyadarsini K |
| Designation |
Assistant Professor |
| Affiliation |
Welcomegroup Graduate School of Hotel Administration, MAHE, Manipal |
| Address |
Welcomgroup Graduate School of Hotel Administration
Udupi Hebri Rd
near Kasturba Hospital Saralabettu Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9600327498 |
| Fax |
|
| Email |
anusha.priyadarsini@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Priyadarsini K |
| Designation |
Assistant Professor |
| Affiliation |
Welcomegroup Graduate School of Hotel Administration, MAHE, Manipal |
| Address |
Welcomgroup Graduate School of Hotel Administration
Udupi Hebri Rd
near Kasturba Hospital Saralabettu Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9600327498 |
| Fax |
|
| Email |
anusha.priyadarsini@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Anthropometric measurement - height, weight, body composition, mid upper arm circumference, waist circumference, nutrition status. The instruments are provided by the college (MAHE, WGSHA). The measurements are taken in the study setting - Ankola, Yellapura, Uttar kannada pin code - 581314. |
| Anthropometric measurement - height, weight, body composition, mid upper arm circumference, waist circumference, nutrition status. The instruments are provided by the college. The measurements are taken in the study setting - yellapura |
|
|
Primary Sponsor
|
| Name |
Student self sponser |
| Address |
Welcomgroup of Higher Education Manipal Udupi Pin code 576101 |
| Type of Sponsor |
Other [Welcomgroup of Higher Education Manipal Udupi Pin code 576101 ] |
|
|
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 |
| Dr Anusha Priyadarsini K |
Yellapura Uttara Kannada |
Ankola Kannigeri Honsettikoppa Gullapura Kodse Manchikere Yellapura and Kanakanahalli Hallavali Malagaon Kalleshwara Ramanguli Uttara kannada
Uttara Kannada
KARNATAKA |
9600327498
anusha.priyadarsini@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
obesity, diabetes and hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
under 5 children
men and women between 18 - 59 years of age
subjects who will be consenting for the interview
|
|
| ExclusionCriteria |
| Details |
those who are unwilling to participate
subjects who are sick or bedridden and unable to answer |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of outcome will be high among under 5 children and women of reproductive age and other vulnerable groups. there may be inadequate dietary intake leading to triple burden of malnutrition |
1-2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the prevalence of obesity, diabetes, & hypertension will also be high due to intake of alcohol & urbanization of the study site |
1-2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
10/10/2024 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Based on the inclusion criterion, the participants are recruited from the Siddhi Tribes in the Uttara Karnataka District of Karnataka |