| 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
|
|
|
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
|
|
|
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 |