| CTRI Number |
CTRI/2023/07/055381 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition education] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcome of nutrition education on Iron deficiency anaemia among pregnant women |
|
Scientific Title of Study
|
Evaluation of outcome of nutrition education on Knowledge, Attitude and
Practice of Iron deficiency anaemia among pregnant women in Nilgiris district Tamil Nadu |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TDU/IEC/13E/2023/PR50 VERSION:V3 DATED: 23.03.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDRA DAS |
| Designation |
PG student |
| Affiliation |
The University of Trans-Disciplinary Health sciences and Technology |
| Address |
Centre for Community Health,
Clinical Research and Education, Vyasa block,
TDU, 74/2 Jarakabande kaval, Attur post via Yelahanka, Bangalore
Bangalore
KARNATAKA
560064
India |
| Phone |
8547129650 |
| Fax |
|
| Email |
sandra.d@tdu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
BN Prakash |
| Designation |
Associate professor |
| Affiliation |
The University of Trans-Disciplinary Health sciences and Technology |
| Address |
Centre for Community Health,
Clinical Research and Education, Vyasa block,
TDU, 74/2 Jarakabande kaval, Attur post via Yelahanka, Bangalore
Bangalore
KARNATAKA
560064
India |
| Phone |
8547129650 |
| Fax |
|
| Email |
bn.prakash@tdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SANDRA DAS |
| Designation |
PG student |
| Affiliation |
The University of Trans-Disciplinary Health sciences and Technology |
| Address |
TDU, 74/2 Jarakabande kaval, Attur post via Yelahanka, Bangalore
KARNATAKA
560064
India |
| Phone |
8547129650 |
| Fax |
|
| Email |
sandra.d@tdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Rural India Supporting Trust (RIST)
2000 Town Center
1500 South Field
MI 48075, New York, USA
|
|
|
Primary Sponsor
|
| Name |
Rural India Supporting Trust |
| Address |
The University of Trans-Disciplinary Health Sciences and Technology, 74/2 Jarakabande kaval,Attur post,Yelahanka, Bangalore |
| Type of Sponsor |
Other [University] |
|
|
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 |
| Sandra Das |
PHC (Public Health Centre) |
Kattabattu PHC, Kotagiri taluk, The Nilgiris, Tamil Nadu
The Nilgiris
TAMIL NADU |
8547129650
sandra.d@tdu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee TDU |
Approved |
| Institutional Ethics Committee Trans Disciplinary University |
Approved |
| Institutional Ethics Committee Trans Disciplinary University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
| Patients |
(1) ICD-10 Condition: O20-O29||Other maternal disorders predominantly related to pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Nutrition education |
The intervention package consists of nutrition education and anaemia related knowledge.
Nutrition education: This consists of topics on importance of nutrition food during pregnancy; Information on the locally available plants/foods which are having high iron content and the foods which increases and decreases iron absorption.
Anaemia and its consequences: Knowledge on general information on anaemia, its
causes, the signs and symptoms, prevalence of IDA, Iron-haemoglobin connection,
anaemia in pregnancy will be shared with the participants.
The participants will receive training on nutrition education and prevention and
management of Iron Deficiency Anaemia over a period of 8 weeks (weekly once)
through Information, Education and Communication materials in Tamil language using
flipchart brochure, audio and video clippings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Pregnant women of first and second trimester.
2) Participants who are going to stay in the same village during the intervention period.
3) Willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Pregnant women who are in their third trimester will be exempted from the study as they
can’t participate in the whole intervention period due to their nearby delivery date. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• A baseline report on KAP on iron deficiency anaemia by pregnant women in Nilgiris
district.
|
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Outcome of nutrition education program on Knowledge Attitude & Practice on iron deficiency anaemia & its management by the pregnant women will be the secondary outcome which is measured using a endline questionnaire after completing the study of 8 weeks
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/07/2023 |
| 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="2"
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
|
Anaemia is a condition when there are not enough red blood cells or there is not enough haemoglobin in them. The capacity of the blood to transfer oxygen to the body’s tissues will be reduced if you have too few or malformed red blood cells, not enough haemoglobin, or both. Haemoglobin is required to carry oxygen. This leads to signs including exhaustion, weakness, light-headedness, and shortness of breath, among others. Age, sex, elevation of habitation, smoking habits, and pregnancy status all affect the ideal haemoglobin concentration required to meet physiologic needs. The most common causes of anaemia include nutritional deficiencies, particularly iron deficiency. When the body lacks enough iron, which is required for the production of haemoglobin, iron deficiency anaemia (IDA) develops. As our diet is the primary source of iron, inadequate dietary intake of iron, issues with iron absorption, blood loss that causes iron loss, and other medical illnesses, such as kidney failure and inflammation, etc., are the main causes of iron deficiency anaemia. The effects of anaemia on a woman’s ability to produce and have children are severe, and this has serious consequences. Due to menstrual iron loss and the high iron requirements of a developing foetus during pregnancy, which are roughly twice as high as those in the non-pregnant state, women are more likely than men to have iron deficiency. Worldwide, it is estimated that about 20 per cent of maternal deaths are caused by anaemia; in addition, anaemia contributes partly to 50 percent of all maternal deaths. Several studies have identified anaemia as a risk factor for intrauterine foetal death, premature birth, low birth weight and other adverse neonatal outcomes. It has been observed in earlier studies that nutrition education to anaemic patients have played significant role in improving their knowledge, attitude and practice towards anaemia and its management. The present study proposes to evaluate the outcome of a nutrition education among pregnant women on improving the KAP on iron deficiency anaemia in Nilgiris district of Tamil Nadu. |