| CTRI Number |
CTRI/2025/03/082699 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Link Between Meal Patterns, Dietary Variety, and Health Issues in Women Aged 35–55 from the Dhobi Community in Raipur, Chhattisgarh |
|
Scientific Title of Study
|
Association of Meal Pattern and Dietary Diversity with
incidence of obesity and Non-communicable Diseases among Women (35 to 55 years)
belonging to the Dhobi community residing in Raipur city, Chhattisgarh. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
Smt. M.M.P. Shah Women’s College of Arts & Commerce, Matunga, Mumbai |
| Address |
Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
Smt. M.M.P. Shah Women’s College of Arts & Commerce, Matunga, Mumbai |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
Smt. M.M.P. Shah Women’s College of Arts & Commerce, Matunga, Mumbai |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhanuben Mahendra Nanavati College of Home Science Matunga, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Hemvarsha Nirmalkar |
| Address |
Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 |
| 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 |
| Dr Rishi Nirmalkar |
Smart Dhobi Ghat |
Narriya talab garden, Near Shiv Mandir,Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH |
9399456970
rishinirmalkar078@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee (IEC) 338 R.A Kidwai Road Matunga, Mumbai 19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no disease conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women between the ages of 35 to 55 years
Belonging to Dhobi community
Residents of Raipur city, Chhattisgarh
|
|
| ExclusionCriteria |
| Details |
Women residing outside Raipur city limits
Pregnant or lactating women
Women suffering from cancer or bed-ridden |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the meal pattern and dietary diversity among middle aged women 35-55 years of Dhobi community |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The assessment using the Minimum Dietary Diversity for Women (MDD-W) could show varying levels of dietary diversity, indicating which food groups are underrepresented and potential nutrient deficiencies. |
4 months |
|
|
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)
|
19/03/2025 |
| 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="0"
Months="10"
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
|
This study aims to investigate the association between meal patterns, dietary diversity, and the incidence of non-communicable diseases (NCDs) among middle-aged women (35-55 years) from the Dhobi community in Raipur city, Chhattisgarh. As women enter middle age, they face various health risks, including obesity, hypertension, diabetes, and anemia, exacerbated by dietary deficiencies. Despite the region’s rich agricultural diversity, which includes numerous rice varieties and nutrient-dense vegetables, health data indicate a concerning prevalence of these conditions. By examining dietary intake, meal patterns, and the consumption of iron-rich foods, this study seeks to identify community-specific factors contributing to the high burden of NCDs, ultimately informing targeted health interventions for this population. |