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临床试验/CTRI/2024/11/076683
CTRI/2024/11/076683招募中不适用

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

Sivanthiga G17 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年11月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
17
主要终点
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.

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Accredited Social Health Activists of Vadodara rural and Padara Taluka of Vadodara District.

排除标准

  • 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%.

结局指标

主要结局

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.

时间窗: 6 months

次要结局

  • 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)

研究者

发起方
Sivanthiga G
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sivanthiga G

Medical College,Baroda

研究点 (17)

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