| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - None of the above
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.anuradha.khadilkar@hcjmri.org.in].
- 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.
- 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. |