| CTRI Number |
CTRI/2019/02/017433 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Modifications in Dietary patterns in patients of Diabetes and Hypertension |
|
Scientific Title of Study
|
Effect of Nutrition Education Package On Dietary Modification In Patients of Diabetes and/or Hypertension attending non-communicable disease clinic at a rural health training centre in Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Katre |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Community Medicine,3rd Floor, Pathology Block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9685933382 |
| Fax |
|
| Email |
rohit.14octkatre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bratati Banerjee |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 328, Department Of Community Medicine, 3rd Floor, Pathology Block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604251 |
| Fax |
|
| Email |
bratati1@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Katre |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Community Medicine, 3rd Floor, Pathology Block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9685933382 |
| Fax |
|
| Email |
rohit.14octkatre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Katre |
| Address |
Department Of Community Medicine 3rd Floor Pathology Block Maulana Azad Medcial College |
| 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 Bratati Banerjee |
Maulana Azad Medical College |
Room No. 328, 3rd Floor, Department Of Community Medicine, Bahadur Shah Zafar Marg, New Delhi - 02
Central
DELHI |
9968604251
bratati1@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Nutrition Educational Package |
For Intervention, Individual and group approach will be followed. In individual approach, participants will be given nutrition education by investigator, by face to face counselling for dietary modifications in their daily life.
In group approach, nutrition education programme will be conducted for dietary modifications in group sessions by the investigator.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All persons aged 18 years and above attending Non-Communicable Disease clinic for past 2 months |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the mean serving of fruits/vegetables in the study population |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in awareness of recommended dietary practices for diabetes and/or hypertension management in the study population |
1 year |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
Final Enrollment numbers achieved (Total)= "95"
Final Enrollment numbers achieved (India)="95" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2019 |
| Date of Study Completion (India) |
31/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of this study is to bring about dietary modification through facility based nutrition education package in patients suffering from diabetes and/or hypertension attending non-communicable disease clinic of a rural health training centre in Delhi. It also aims to determine dietary practices of participants and to assess awareness and perceptions of study population regarding dietary intake recommended for diabetes and/or hypertension. One of the objective of the study is to study effect if any of nutrition education package on modification of practices, awareness and perceptions regarding recommended diet in study population. |