| CTRI Number |
CTRI/2022/09/045382 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of nutritional status of the elderly under different living conditions |
|
Scientific Title of Study
|
A cross-sectional study on the assessment of nutritional status of the elderly under different living conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanvi Jiwani |
| Designation |
Student - M. Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9158007477 |
| Fax |
|
| Email |
tanvijiwani2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Amrita Behel |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892974370 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanvi Jiwani |
| Designation |
Student - M. Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
|
| Fax |
|
| Email |
tanvijiwani2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science Matunga Department of Postgraduate studies in Clinical Nutrition and Dietetics |
|
|
Primary Sponsor
|
| Name |
Tanvi Jiwani |
| Address |
Dr. BMN College of Home Science Matunga a Department of
Postgraduate studies in Clinical Nutrition and Dietetics |
| Type of Sponsor |
Other [[Self]] |
|
|
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 |
| Tanvi Jiwani |
Dr. BMN College Of Home science |
Department of Postgraduate studies in Clinical Nutrition and Dietetics, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
9158007477
tanvijiwani2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No Medical History |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Elderly 60-85 years age group |
|
| ExclusionCriteria |
| Details |
Elderly individuals with serious medical conditions |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
This study will assess the influence of living conditions ,socio-economic status and nutrient intake on nutritional status of the elderly
|
15 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/09/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
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Brief Summary
|
Aim: To assess the nutritional status and factors influencing nutrient intake of study population
Objective of the study: 1. To assess the nutritional status of elderly under different living conditions. 2. To understand the factors influencing nutrient intake of the elderly. 3. To study the correlation between nutritional status of the elderly and their living conditions
HYPOTHESIS: There may be an association between the nutritional status of the elderly and their different living conditions.
Material and Methods : Cross-sectional study using the Survey method. Formulating a structured questionnaire to elicit information on: 1.Socio-demographic details of the study population using the Kuppuswami Scale (2021)
2. Nutritional assessment using the MNAQ (Morley JE. Rapid Geriatric Assessment: Secondary Prevention to Stop Age-Associated Disability. Clin Geriatr Med. 2017 Aug;33(3):431-440. doi: 10.1016/j.cger.2017.03.006. Epub 2017 May 13. PMID: 28689573.)
3. Assessment of Anorexia of aging using SNAQ & CNAQ (Margaret- Mary G Wilson, David R Thomas, Laurence Z Rubenstein, John T Chibnall, Stephanie Anderson, Amy Baxi, Marilyn R Diebold, John E Morley, Appetite assessment: simple appetite questionnaire predicts weight loss in community- dwelling adults and nursing home residents, The American Journal of Clinical Nutrition, Volume 82, Issue 5, November 2005, Pages 1074–1081,)
3. Assessment of body composition using calibrated, portable body composition analyser (Tanita model no. MA 420 with a Tetrapolar 8- Point Tactile Electrode System) which works on the principle of bioelectrical impedance (BIA).
Sample Size- 200 Sampling Method: Purposive Convenience Sampling . Inclusion Criteria: Elderly 60-85 years age group Exclusion Criteria: Elderly individuals with serious medical conditions Data Collection: After taking informed written consent from the eligible participants
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