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CTRI Number  CTRI/2025/09/094556 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Dietary Patterns, Carbon Footprint, and Metabolic Health in Adults from Rural and Urban Maharashtra 
Scientific Title of Study   Exploring the Interrelationships Between Dietary Patterns, Carbon Footprint, and Metabolic Health Among Adults Across Rural and Urban Settings of Maharashtra 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
JCDC/BHRJ25/053  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuradha Khadilkar 
Designation  Deputy Director 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute 
Address  HCJMRI, Lower Ground Floor, Block V, Jehangir Hospital, 32 Sassoon Road, Pune 411 001.

Pune
MAHARASHTRA
411001
India 
Phone  9850244305  
Fax    
Email  dr.anuradha.khadilkar@hcjmri.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuradha Khadilkar 
Designation  Deputy Director 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute 
Address  HCJMRI, Lower Ground Floor, Block V, Jehangir Hospital, 32 Sassoon Road, Pune 411 001.

Pune
MAHARASHTRA
411001
India 
Phone  9850244305  
Fax    
Email  dr.anuradha.khadilkar@hcjmri.org.in  
 
Details of Contact Person
Public Query
 
Name  Taneem Abuji 
Designation  Doctoral Student 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute 
Address  HCJMRI, Lower Ground Floor, Block V, Jehangir Hospital, 32 Sassoon Road, Pune 411 001.

Pune
MAHARASHTRA
411001
India 
Phone  8806558769  
Fax    
Email  taneem.s.abuji@gmail.com  
 
Source of Monetary or Material Support  
Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Lower Ground Floor, Block V, Jehangir Hospital, 32 Sassoon Road, Pune 411 001, Maharashtra, India 
 
Primary Sponsor  
Name  Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI) 
Address  HCJMRI, Lower Ground Floor, Block V, Jehangir Hospital Premises, 32 Sassoon Road, Pune – 411001, Maharashtra, India. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anuradha Khadilkar  HCJMRI Ranjangaon Health Center  Q64W+2H9, Ranjangaon, Maharashtra 412209
Pune
MAHARASHTRA 
9850244305

dr.anuradha.khadilkar@hcjmri.org.in 
Dr Anuradha Khadilkar  Hirabai Cowasji Jehangir Medical Research Institute  Lower Ground Floor, Block V, Jehangir Hospital, 32 Sassoon Road, Pune 411 001.
Pune
MAHARASHTRA 
9850244305

dr.anuradha.khadilkar@hcjmri.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical and Health Research Ethics Committee, Jehangir Clinical Development Centre Pvt. Ltd.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  N/A 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Adults aged 20-40 years
2. Residing in urban and rural settings of Maharashtra.
3. Willing to provide written informed consent.
 
 
ExclusionCriteria 
Details  1. Severe metabolic diseases (diabetes, cardiovascular diseases, chronic kidney diseases, thyroid disorders, malignancy, autoimmune diseases) or mental health problems affecting diet or metabolism.
2. Pregnant or lactating women.
3. Participants with Grade 4 obesity or BMI of 32 kg/m2 or more.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of dietary carbon footprint and metabolic health indicators between urban and rural populations.  Baseline 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="850"
Sample Size from India="850" 
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)   01/10/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.anuradha.khadilkar@hcjmri.org.in].

  6. For how long will this data be available start date provided 01-03-2028 and end date provided 30-06-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study explores links between dietary patterns, carbon footprint, and metabolic health in adults from rural and urban Maharashtra. Objectives are to compare dietary carbon footprint and metabolic health between groups, assess associations between footprint and metabolic indices, develop an e-training module on sustainable diets, and evaluate its impact on knowledge, attitudes, practices, and footprint.

The study has two components: a cross-sectional survey and a pilot intervention. The baseline survey will include 850 adults aged 20–40 years (425 rural, 425 urban) selected randomly. Data will include demographics, lifestyle, anthropometry, blood parameters, and diet assessed through food frequency questionnaire and 24-hour recall. Dietary carbon footprint will be estimated using reported intake and emission factors, expressed in kg CO2e. Statistical analysis in SPSS will compare rural and urban groups and test associations using correlations, regression, and significance at p<0.05.

In the pilot intervention, 100 participants with high dietary carbon footprint will be randomized into intervention (50) and control groups (50). The intervention will consist of an online e-learning module developed in two parts: (1) awareness and concepts of sustainable diets and (2) practical strategies to reduce carbon footprint, with content adapted from reliable sources and reviewed by experts. Delivered through multimedia formats, the module aims to enhance knowledge and promote sustainable dietary practices, while the control group will receive a generic leaflet. Pre- and post-assessments will measure changes in dietary behaviour and footprint. Data will be analyzed using paired and independent tests, with ANCOVA to adjust for baseline.

This study aims to provide evidence to guide sustainable diet promotion for health and climate benefits.

 
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