| CTRI Number |
CTRI/2019/07/020143 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the factors that influence the patients with heart disease to not being able to follow the prescribed diet. |
|
Scientific Title of Study
|
Assessment of dietary adherence and its determinants among patients with coronary artery disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajol Fofaria |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9768508571 |
| Fax |
|
| Email |
kfofaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pallavi Mahesh Shettigar |
| Designation |
Asst. Professor selection grade. |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9591273054 |
| Fax |
|
| Email |
pallavi.wgsha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rose Jose |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8281875294 |
| Fax |
|
| Email |
roseperavoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kajol Fofaria
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Kajol Fofaria |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal |
| 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 |
| Kajol Fofaria |
Kasturba Hospital |
Department of Cardiology,
Room no.36, 3rd floor
Division - Medicine
Udupi
KARNATAKA |
9768508571
kfofaria@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients proven to have cardiovascular diseases including coronary artery disease by CAG and by ECHO |
|
| ExclusionCriteria |
| Details |
patients with Arrhythmia, Rheumatic Heart Disease and Heart Failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Dietary Adherence score among Coronary Artery Disease patients. |
single interaction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the relationship between dietary adherence, determinants and biochemical parameters |
single interaction |
|
|
Target Sample Size
|
Total Sample Size="306"
Sample Size from India="306"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="207" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
15/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="17" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cardiovascular disease is a leading cause for many health related problems worldwide. Nutrition plays an important role for the development of cardiovascular disease (CVD) and atherosclerosis.Improper balance diet with high energy intake results in elevated cholesterol levels in serum blood, overweight, hypertension, diabetes thereby increasing the risk of cardiovascular disease. Dietary management is an integral part of management of Coronary artery disease. Research evidence indicates that poor diet adherence leads to biochemical abnormalities so the current study aims at assessing the prevalence of dietary adherence and determinants. Also to evaluate the relationship between dietary adherence and selected biochemical abnormalities among Coronary artery patients and to develop,validate Dietary Adherence Questionnaire .This would enable the dieticians and other health care team to focus on these factors to improve the dietary adherence and thereby the reduce risk of further complications.This study will be carried out in Kasturba Hospital in Manipal. Sample will be selected and participants will be interviewed by direct interview. The participants will be given a participants information sheet which contains information about the study, study duration and benefits etc.A common questionnaire consisting of personal detail, diet recall, anthropometric measures (weight, height and waist circumference, hip circumference) ,socio demographic status using Kuppuswami scale and cardiovascular diseases related biochemical parameters and their food frequency record will be taken.A detailed query is done using the 24 hour recall and food frequency questionnaire. Biochemical parameter (lipid profile, blood glucose levels, and troponin-T) will be taken from the existing record.Questionnaire based on Dietary Guidelines will be used to assess Dietary Adherence and it will be validate during pilot study.Once the data is collected, the data analysis is done using S.P.S.S and diet cal for diet analysis. |