| CTRI Number |
CTRI/2024/11/077036 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing how nutrition affects daily activities in elderly people in Udupi district, Karnataka. |
|
Scientific Title of Study
|
Assessment of the nutritional status and its association with the activities of
daily living among the elderly population in Udupi District, 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 |
Deeksha |
| Designation |
MPH student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8431882993 |
| Fax |
|
| Email |
deeksha1.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Vyas |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9538126120 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha |
| Designation |
MPH student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8431882993 |
| Fax |
|
| Email |
deeksha1.psphmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deeksha |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Navya Vyas |
Udupi, Karnataka (Community based study) |
Department of Global Health Policy and Governance, Prasanna School of Public Health, MAHE, Manipal
Udupi
KARNATAKA |
9538126121
navya.vyas@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly people of age 60 years and above |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male and female of the age 60 years and above.
He/she should be a resident of Udupi District, Karnataka. |
|
| ExclusionCriteria |
| Details |
Elderly people who are terminally ill. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the nutritional status and the factors associated with it among elderly |
April 2025-May 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess activities of daily living (ADL) among elderly |
May 2025- June 2025 |
|
|
Target Sample Size
|
Total Sample Size="211"
Sample Size from India="211"
Final Enrollment numbers achieved (Total)= "211"
Final Enrollment numbers achieved (India)="211" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Nutrition plays a vital role in overall health and development, serving as an essential determinant of
health among the elderly. Older adults are at increased risk of malnutrition due to age-related changes
in body composition, higher protein and micronutrient needs, altered appetite, and declining sensory
function. The elderly population in India has grown by 35.5% over the past decade, increasing from 76 million in
2001 to 103 million in 2011, currently accounting for approximately 9% of the total population, with
projections indicating it will exceed 20% by 2050. The growing number of elderly individuals presents various challenges and shortcomings, and limited
studies focus on this demographic’s nutritional status and activities of daily living. Therefore, this study
aims to assess the nutritional status and its association with the activities of daily living among the
elderly. By understanding these factors, interventions can be tailored to improve nutritional status and
enhance the overall quality of life of the elderly. |