| CTRI Number |
CTRI/2022/06/043282 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
11/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Determining risk of diabetes among adults residing in Mumbai city. |
|
Scientific Title of Study
|
Risk Assessment of Diabetes in Young adults in Mumbai City using Indian Diabetes Risk Score (IDRS). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Sanjib Chowdhury |
| Designation |
Student- MSc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Postgraduate studies in Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Rd, Matunga.
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7756079230 |
| Fax |
|
| Email |
snehass094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Postgraduate studies in Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Rd, Matunga.
Mumbai
MAHARASHTRA
400019
India |
| Phone |
900302531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Chowdhury |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Postgraduate studies in Clinical Nutrition and Dietetics, 338, Rafi Ahmed Kidwai Rd, Matunga.
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7756079230 |
| Fax |
|
| Email |
snehass094@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 |
Sneha Chowdhury |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Sneha Chowdhury |
Dr. BMN College of Home Science |
Department of
Postgraduate studies in Clinical Nutrition and Dietetics, Matunga, Mumbai 400019
Mumbai
MAHARASHTRA |
7756079230
snehass094@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 Condition |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Nondiabetic individuals
Residence of Mumbai City |
|
| ExclusionCriteria |
| Details |
Individuals on weight management diets following fad diet, pregnancy/lactating stage, known diabetics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will identify young adult females who are at risk for developing diabetes and also will analyze subjects who are undiagnosed or pre-diabetic. Information on nutritional adequacies and inadequacies of diets consumed by these adults will also be obtained. According to the findings of the study, an effective intervention can be carried out for behavioral change or lifestyle modifications among these young adults. |
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/06/2022 |
| 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 Applicable |
| 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
|
|
Brief Summary
|
Aim: To assess the risk of diabetes in young adult females (aged 18-24 years) in Mumbai City using Indian Diabetic Risk Score.
Objectives: - To assess prevalence of diabetes risk among young adult female subjects aged 18 - 24 years in Mumbai city with IDRS (Indian Diabetic Risk Score).
To evaluate dietary diversity among young adult female subjects using Individual Dietary Diversity Score. To estimate HbA1c levels of subjects at higher risk of diabetes. To impart a Nutrition Education Program (NEP) through e-content among subjects at higher risk of diabetes. To determine effectiveness of the Nutrition Education Program (NEP) on knowledge and attitudes of subjects at higher risk of diabetes.
Materials and Methods:
Research Type: Quantitative Study Design: Cross-sectional descriptive study Target age group- Young adult females of 18-24 years Sample Size: 150 Sampling Method: Non probability convenience sampling technique - Data Collection tools:
- Section A: Demographic details- Anthropometric measurements (Height, weight, Body Mass Index)
- Section B: IDRS (Indian Diabetes risk Score)
- Section C: Dietary diversity score (DDS) questionnaire
- Section D: Biochemical parameter (HbA1c)
Hypothesis: There is no association between dietary diversity and Indian diabetic risk score with risk of diabetes among young adults. |