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CTRI Number  CTRI/2025/02/080499 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Individualized Intervention Package (Dietary modification, Disease related counselling, Lifestyle modification by yoga therapy & health education material) for improving undernutrition among the elderly population residing in selected areas in rural Puducherry 
Scientific Title of Study   Assessment of nutritional status and effectiveness of Individualized Intervention Package for improving undernutrition among the elderly population residing in selected areas in rural Puducherry – a mixed method study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sindu Kanagalingam 
Designation  Junior Resident / Postgraduate student 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Community Medicine, College block, 2nd floor, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry, Puducherry, India

Pondicherry
PONDICHERRY
607403
India 
Phone    
Fax    
Email  drsindukanagalingam95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Premkumar Ramasubramani 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Community Medicine, College block, 2nd floor, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry, Puducherry, India

Pondicherry
PONDICHERRY
607403
India 
Phone    
Fax    
Email  prem8015r@gmail.com  
 
Details of Contact Person
Public Query  
Name  Premkumar Ramasubramani 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Community Medicine, College block, 2nd floor, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry, Puducherry, India

Pondicherry
PONDICHERRY
607403
India 
Phone    
Fax    
Email  prem8015r@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry, Puducherry, India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pavithran M  Mahatma Gandhi Medical College and Research Institute  Department of Community Medicine, College block, 2nd floor, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry, Puducherry, India
Pondicherry
PONDICHERRY 		 8015271223

drpavithran08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Mahatma Gandhi Medical College and Research Institute  Approved 
Mahatma Gandhi Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undernutrition  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Intervention Package  Individualized Intervention package with the following components for three months • Dietary components (addressing the undernutrition) • Disease-related intervention component (chronic illness such as diabetes, hypertension, etc.,) • Lifestyle modification for mental health by yoga therapy • Health education material  
Comparator Agent  Traditional health education   As per the GoI guidelines for the geriatric care in peripheral health centers for three months 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  People more than 60 years residing in same area for more than 6 months 
 
ExclusionCriteria 
Details  1. People with terminal illness, disability and patients with any mental disorders
2. People with Nutritional diseases like celiac disease, lactose intolerance, short bowel syndrome, tuberculosis and any other (self-reported)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Prevalence of undernourishment - Frequency and proportion  Baseline assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of individualized intervention package in improving the undernutrition
1. Increase in BMI - Mean difference
2. Increase in the score of Mini Nutritional Scale Assessment - Mean difference 		 3 months 
Facilitating & barriers of adherence to individualized intervention package for improving undernutrition among the intervention group - Thematic analysis  Endline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   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  

After obtaining consent from Institute Research Committee (IRC) and Institute Ethical Committee (IHEC), the assessment of Nutritional status in Geriatric population of the selected village is done with MNA (Mini Nutritional Assessment) tool. Also, the factors contributing for the undernutrition is also assessed. Based on the inference got from the survey, the under nourished population is divided into two groups by block Randomization. One group is given traditional health education and the other group is given with Individual Intervention Package which is formulated by assessing various domains that contributes to under nutrition like Dependency, Socio-economic status, Diseases & Disabilities, Diet pattern, Eating habits, Life style & Physical activity. Post intervention the nutritional status is assessed on 3rd month. Finally, both the groups are compared to assess the improvement in nutritional status. In the intervention group by In Depth Interview (IDI) the facilitating & barriers of adherence to individualized intervention package for improving undernutrition is assessed.

 
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