FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076683 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   The effect of Health education and nutritional counselling in improving compliance  
Scientific Title of Study   The effect of Health education and nutritional counselling in improving compliance of Iron and Folic Acid Tablet supplementation to improve anaemia status in ASHA workers in Central Gujarat -an interventional study in Western India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sivanthiga G 
Designation  Second Year Post Graduate Resident 
Affiliation  Medical College,Baroda 
Address  Department of Community Medicine, Medical College,Anandpura,Baroda

Vadodara
GUJARAT
390001
India 
Phone  07373057587  
Fax    
Email  sivanthigagunasekaran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sangita V Patel 
Designation  Addditional Professor 
Affiliation  Medical College ,Baroda 
Address  Department of Community Medicine, Medical College,Anandpura,Baroda

Valsad
GUJARAT
390001
India 
Phone  6351074662  
Fax    
Email  sangita_psm@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Sangita V Patel 
Designation  Addditional Professor 
Affiliation  Medical College ,Baroda 
Address  Department of Community Medicine, Medical College,Anandpura,Baroda

Valsad
GUJARAT
390001
India 
Phone  6351074662  
Fax    
Email  sangita_psm@yahoo.co.in  
 
Source of Monetary or Material Support  
Medical College,Baroda Anandpura,Vadodara-390001,Gujarat,India 
 
Primary Sponsor  
Name  Sivanthiga G 
Address  Department of Community Medicine,Medical College,Baroda,Anandpura,Vadodara 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sivanthiga G  PHC Angadh- Vadodara Taluka  93PJ+2GW, Unnamed Road, Anagad, Gujarat 391345
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC Mujpur-Padra Taluka  6XWV+WF2, Effluent Canal Project Rd, Mahuvad, MUJPUR, Gujarat 391440
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
DrSivanthiga G  PHC Ranoli- Vadodara Taluka  C42J+5R2, Ranoli GIDC, Ranoli, Vadodara, Gujarat 391350
Vadodara
GUJARAT 
7373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC Sadhi-Padra Taluka  53H3+MCV, Vadodara, Gujarat 391445
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sicvanthiga G  PHC,Asoj-Vadodara Taluka  F97V+7X8, Hansapura, Asoj, Gujarat 391510
Vadodara
GUJARAT 
7373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Chansad-Padra Taluka  Primary Health Center, Phc Chansad, Padra, Vadodara District, Gujarat, 391440
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Dabka-Padra Taluka  PHC Dabka Rajavi Gandhi HallNear Telephone Exchange Dabka TalukaPadra DistVadodara. Location Padra. PINCODE 391440.
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Kanzat-Padra Taluka  4V4W+653, Kanzat, Abhol, Gujarat 391421
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Karakhdi-Padra Taluka  6W53+5P2, Road, Kareli, Karakhadi, Gujarat 391450
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Kelanpur-Vadodara Taluka  67Q9+8VJ, GJ SH 11, Kelanpur, Gujarat 391760
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Koyali-Vadodara Taluka  9467+98F, Koyali, Vadodara, Gujarat 391330
Vadodara
GUJARAT 
7373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Mobha-Padra Taluka  4XP8+H9X, Mobha, Gujarat 391430
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Raipura- Vadodara Taluka  73FW+GFV, Vadodara, Gujarat 391410
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Sankarda-Vadodara Taluka  C4HC+V7J, Sankarda - Bhadarva Rd, Sankarda, Gujarat 391745
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Sokhda- Vadodara Taluka  C597+WM8, Vadodara, Gujarat 391745
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  PHC,Varanama- Vadodara Taluka  PHC Varnama, varnama, Vadodara, Gujarat 391243
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
Dr Sivanthiga G  Uraban PHC,Padra-Padra Taluka  63RP+F69, Manek Nagar, Shashtri Pol, Padra, Gujarat 391440
Vadodara
GUJARAT 
07373057587

sivanthigagunasekaran@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Instituitional Ethical Committee for Biomedical and Health Research(IECBHR) Medical College & S.S.G Hospital,Baroda  Approved 
Instituitional Ethics Committee for Biomedical and Health Research(IECBHR) Medical College & S.S.G Hospital,Baroda  Approved 
Taluka Health Office,Padra  No Objection Certificate 
Taluka Health Office,Vadodara  No Objection Certificate 
Taluka Health Office,Vadodara  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Accredited Social Health Activists without anaemia  
Patients  (1) ICD-10 Condition: D508||Other iron deficiency anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health education and nutritional counselling along with Iron Folic Acid Tablet supplementation according to Haemoglobin levels  Health education and nutritional counselling will be delivered once at the beginning regarding Iron and Folic Acid tablet ( 1IFA -60mg elemental Iron and Folic Acid 500 mcg)supplementation and Iron rich food intake.1Iron and Folic Acid tablet weekly for non anaemic participants,1 Iron and Folic Acid tablets daily for anaemic participants with mild and moderate anaemia.1 Tablet Albendazole 400mg will be advised for anaemic and non-anaemic participants at the beginning.All tablets will be advised to be taken through oral route. Participants will be advised to take Tablet Albendazole stat at the beginning and Tablet IFA for 100 days 
Comparator Agent  Iron and Folic Acid tablet Supplementation   Iron and Folic Acid tablet Supplementation as 1IFA -60mg elemental Iron and Folic Acid 500 mcg).1Iron and Folic Acid tablet weekly for non anaemic participants,1 Iron and Folic Acid tablet daily for anaemic participants with mild and moderate anaemia. 1 Tablet Albendazole 400mg will be advised for the anaemic and the non-anaemic participants at the beginning. All tablets will be advised to be taken through oral route. Participants will be advised to take Tablet Albendazole stat at the beginning only and Tablet IFA for 100 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Accredited Social Health Activists of Vadodara rural and Padara Taluka of Vadodara District 
 
ExclusionCriteria 
Details  Those Accredited Social Health Activists planning for pregnancy and or those who are pregnant and or those who are known cases of Sickle Cell Anaemia or Thalassemia or any Chronic illness and or those with Hb status less than 8 g% 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.The effect of health education and nutritional counselling on anaemia prevention, change in haemoglobin level, compliance towards IFA tablets supplementation and Knowledge, attitude and Practice related to Weekly Iron and Folic acid Supplementation in ASHA workers.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To enumerate the reasons for low compliance towards IFA tablet and various methods of improvement in haemoglobin status and Iron and Folic Acid supplementation compliance  6 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   18/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Title: -

The effect of Health education and nutritional counselling in improving compliance of Iron and Folic Acid Tablet supplementation to improve anaemia status in ASHA workers in Central Gujarat -an interventional study in Western India.

Background:-

Community health Volunteer i.e., Accredited Social Health Activist (ASHAs) are the grass root level workers forming the backbone of primary healthcare in India. ASHAs are the depot holders of Iron Folic Acid, they have drug kits and equipment kits to serve the community, they counsel the community on nutrition, mobilise and facilitate them in accessing health and health related services at Anganwadi /subcentre (3)

They deliver health care services to the community they log into ‘triple shift’ spread-out as home, health centres and community. They may not sleep enough, eat well and hence are at risk of anaemia, malnutrition and non-communicable diseases. (4)

Purpose of the study:

Iron and Folic Acid Tablets are provided free of cost to the community and ASHA workers advocate and distribute the same. It has been advised to be given on weekly basis prophylactically.

Despite being the service providers themselves ASHAs seem to be anaemic and do not follow IFA supplementation. Not many interventional studies have been carried in the view of finding ways to improve compliance of IFA supplementation among ASHA workers which would improve haemoglobin levels in them who are involved more in community health activity.

Objectives:

1.    1.To evaluate the effect of health education and nutritional counselling on anaemia prevention, change in haemoglobin level, compliance towards IFA tablets supplementation and Knowledge, attitude and Practice related to Weekly Iron and Folic acid Supplementation in ASHA workers.

2.      2.To enumerate the reasons for low compliance towards IFA tablet and various methods of improvement in haemoglobin status and Iron and Folic Acid supplementation compliance

Materials and Methods

Study design: Non-Randomized Control Trial

Study population: Accredited Social Health Activists belonging to Padara and Vadodara taluka.

Sampling technique and sample size:

 2 Talukas will be randomly selected

All Accredited Social Health Activists working in the above mentioned talukas will be selected and those fulfilling the inclusion criteria will be included in the study.

Inclusion criteria:

1)                  All ASHAs who consent to participate in the study

2)                  All those who have a smartphone with access to Whatsapp.

Exclusion criteria:

1)                   ASHAs those who are not willing to participate

2)                  Those ASHAs whose Hb is less than 8g%

3)                  Those ASHAs who are pregnant or planning for pregnancy

4)                  Those ASHAs with chronic medical illness as cardiac/renal illness/known cases of Sickle Cell Anaemia and thalassemia.

After obtaining Institutional Ethics committee clearance and permission from Chief District Health officer (CDHO), data collection will be started.

ASHAs of both the Talukas will be contacted over phone and will be explained about the study and requested to come. After obtaining written informed consent from the eligible participants the study will be started.

After having applied the inclusion and exclusion criteria, in both the groups baseline questionnaires will be filled and Blood Haemoglobin estimation using Sahli’s Haemoglobinometers will be done and the Accredited Social Health Activists will be grouped into anaemic and non-anaemic groups based on their haemoglobin levels and appropriate dosage of Iron and Folic Acid will be advised accordingly.

In the Intervention Group the  Accredited Social Health Activists will be given Health education and Nutritional Counselling which will be the intervention in the study.

The study participants will be followed up 4 months after the baseline survey and the questionnaire will be filled by them. During this visit a repeat Blood Haemoglobin estimation will be done for them .

Data analysis

 The collected data will be entered in excel sheet and the data will be analysed using Jamovi. The Descriptive data will be expressed in terms of frequency and percentage.The quantitative data’s normalcy will be checked and if normally distributed Paired- t-test will be used for comparing the before and after Hb values of the same group and independent sample t test will be used for comparing Hb values between the groups(intervention and control) and for compliance Mc Nemar’s chi square test will be used for comparison before and after intervention.

If the quantitative data is not normally distributed Wilcoxon sign rank test will be used for comparing Hb values before and after in the same group and Mann Whitney U will be the test of significance for comparison between control and intervention groups.

The expected outcome will be measured as:

1.Improvement in Hb level

2.     2.Improvement in compliance

3.     3.Improvement of KAP

4. 4.Proportion of ASHAs in whom anaemia prevented/anaemia status improved

 
Close