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Trial registered on ANZCTR


Registration number
ACTRN12618001824257
Ethics application status
Approved
Date submitted
1/11/2018
Date registered
9/11/2018
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of health education intervention using health belief model on haemoglobin level among anaemic pregnant women in sepang
Scientific title
Effect of health education intervention using health belief model on haemoglobin level among anaemic pregnant women in sepang
Secondary ID [1] 296439 0
none
Universal Trial Number (UTN)
U1111-1223-1341
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anemia in pregnancy 310204 0
Condition category
Condition code
Blood 308948 308948 0 0
Anaemia
Reproductive Health and Childbirth 309035 309035 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health education
-The goal of this health educational intervention is for behavioural change (dietary iron intake and compliance towards iron supplementation).
-Intervention group : anaemic pregnant women at Dengkil Health clinic in Sepang district, Selangor, Malaysia

-Intervention strategies
This program will be implemented using three strategies: Pre and post intervention assessment and health education intervention. The pre-test assessment will be measured through standardised questionnaire given to the participating women before 24 weeks of gestation and followed by the health education intervention will be held within 12 weeks (3 month). There is a variety of learning activities during that period that include health talks, small group discussions, poster presentation and pamphlets. Post intervention evaluation will be measured between the 35th to 37th week of gestation in the third trimester.

-Baseline assessment
Prior to starting the intervention program, baseline or pre-test assessment need to be performed among the anaemic pregnant women at the selected health clinics to identify their baseline haemoglobin level, socio-demographic status, baseline status of their knowledge, perception towards anaemia in pregnancy, dietary iron status and level of compliance towards iron supplementation. A set of self-administrated pre-test questionnaire will be used to capture the baseline data. The questionnaires will be answered by all participants and their answers are made confidential. The questionnaires consist of four sections. All participants must give their consent prior to answering the questionnaires. The outcome of the activity is to determine a baseline level of knowledge, perception and anaemia preventive behaviour and haemoglobin level prior to health education program.
The approximate duration required to complete the baseline assessment is within 10 minutes.

-Post intervention assessment
After the completion of the twelve week intervention period, the impact and outcome evaluation of the intervention program will be carried out using a set of questionnaires. The same set of questionnaire that is used in the pre-intervention assessment, except their socio-demographic status, is distributed to the participants which consists of measurement of knowledge, HBM construct, dietary practices and compliance towards iron supplementation. The post intervention haemoglobin level will be taken from the participants’ antenatal book. The outcome of the activity is to determine a post-intervention level of knowledge, perception and anaemia preventive behaviour after health education program. The evaluations will be attained through comparing the result of pre and post the implementation of health education intervention program among and between both intervention and control groups. Evaluation of the health education process is also done to control, assure or improve the quality of the program

-Health education intervention
Health education interventions are implemented after a pre-intervention assessment has been conducted. The health education intervention periods will be held within 12 weeks. There is a variety of learning activities during that period. The methods and material of the theory based health intervention programme included health talk, small group discussion, poster presentation and pamphlets.

The health talk is given by the researcher on topics such as introduction to anaemia in pregnancy, predisposing factor of anaemia in pregnancy, sign and symptoms of anaemia in pregnancy, complication of anaemia in pregnancy, prevention of anaemia in pregnancy, benefit of taking iron supplementation, knowledge on wrong perception of anaemia and iron supplementation and knowledge on the various sources of food that contain high iron. It is later followed by question and answer session or activity. In this activity, participants are able to ask anything regarding anaemia in pregnancy and all questions will be answered with the simple way and easier for them to understand. The time required to complete health talk session is within 60 minutes. The outcome of the health talk would enable participants to gain knowledge on the facts of anaemia in pregnancy, complication of untreated anaemia and management of anaemia in pregnancy (Iron supplementation and dietary iron intake) and its importance.

The second activity of the health education intervention programme is small group discussion. A session on small group discussion will be conducted and facilitated by the researcher between two to four weeks after the health talk. The participants are divided into nine small groups with eight to ten participants in one group. Each group will encounter one session during the intervention period based on timing of the participants. This activity deals with the issues to enhance the compliance towards iron supplementation and to increase the dietary iron intake by identifying their barriers towards anaemia preventive behaviours. The outcome of the discussion would enable participants to understand the severity of anaemia in pregnancy, understand the susceptibility of anaemia in pregnancy, identify and overcome the barrier of not comply with iron supplement and dietary iron intake and identify the benefit of taking iron supplement and dietary iron intake. The participant also will be provided with the checklist on compliance for iron supplementation. The time required to complete group discussion session is within 60 minutes.

The materials used in the health education intervention programme are poster and pamphlets. Posters and pamphlets is designed specifically for this study and it based on health belief model. Poster and pamphlets will be designed to make teaching interesting and receptive. Two posters will be used in this activity. A large poster (A1 size) will be placed in the health clinic at all time during the intervention period. It will include information regarding the complication of anaemia and importance of taking iron supplementation and consumption of iron rich food. In addition, the participants will be given a small poster (A4 size) to bring home as their continuous learning material after the small group discussion session. The small poster will provide guidelines of various iron rich food. A checklist on compliance towards iron supplementation will be pasted in the maternal health record. Apart from that, a pamphlet also will be distributed to the participant as a self-learning tool and continuous material that aimed at enriching their information about anaemia after the health talk or small group discussion. It also helps to deliver take home messages to the participants about anaemia in pregnancy. It will cover the information regarding the definition, causes, complications and prevention of anaemia in pregnancy and examples of food rich of iron. These materials are also aiming to maintain adherence towards anaemia preventive behaviour.

This study uses a quasi-experimental study design. It will involve pre-post intervention with control study involving two groups of the antenatal mothers (control and intervention) from two health clinics in Sepang area. Through simple random sampling, pregnant women in Salak Health clinic will be recruited as the control and those at Dengkil Health clinic will be recruited as the interventional subject. Both groups will be receiving routine antenatal care and practice which included iron supplementation from their respective clinics. Additionally, the intervention group will be given theory-based health education intervention on anaemia in pregnancy.
Intervention code [1] 312765 0
Behaviour
Comparator / control treatment
Control group : anaemic pregnant women at other health clinic in Sepang district,
Control group will be receiving routine or standard care at their health clinic
Control group
Active

Outcomes
Primary outcome [1] 307911 0
haemoglobin level

the measurement of haemoglobin level is based on full blood count and will be analysed using automated haematology analyser which available in health clinic
Full blood count is routinely done to all pregnant women to identify their haemoglobin level
Timepoint [1] 307911 0
baseline and three months post intervention
Secondary outcome [1] 353301 0
compliance towards iron supplementation assessed using Morisky Green and Levine Scale
Timepoint [1] 353301 0
three months post intervention
Secondary outcome [2] 353613 0
dietary iron practice assessed using 3 days 24 hour diet recall
Timepoint [2] 353613 0
three month post intervention
Secondary outcome [3] 353614 0
knowledge related to anaemia assessed using knowledge questionnaire (designated specifically for this study)
Timepoint [3] 353614 0
three month post intervention
Secondary outcome [4] 353615 0
HBM construct (perceived susceptibility, perceived severity, perceived benefit, and perceived barrier) assessed using (HBM) perception questionnaire (designated specifically for this study)
Timepoint [4] 353615 0
three month post intervention

Eligibility
Key inclusion criteria
i.Malaysian
ii.Pregnant women booked before 24 weeks of pregnancy and want to continue their antenatal check-up at Salak and Dengkil clinics
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i.Known case of anaemia secondary to medical or haematological disorders (for example Thalassemia)
ii.Severe anaemia (Hb < 7g/dl)
iii.Multiple pregnancies.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size determination is based on formula used for two-arm with continous outcome measure. 20% non response rate is also taken into consideration.
Multivariate analysis such as Multivariate Analysis of Covariance (MANCOVA) will be used to assess the efficacy of research outcome for the differences with same group and between different groups

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2018
Date of last participant enrolment
Anticipated
Actual
2/04/2018
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
162
Accrual to date
Final
162
Recruitment outside Australia
Country [1] 20975 0
Malaysia
State/province [1] 20975 0
sepang,selangor

Funding & Sponsors
Funding source category [1] 301038 0
University
Name [1] 301038 0
Universiti Putra Malaysia
Country [1] 301038 0
Malaysia
Primary sponsor type
Individual
Name
Hasneezah Hassan
Address
Department of Community health, Faculty of Medicine and Health Sciences, 43400 UPM Serdang, Selangor,
Country
Malaysia
Secondary sponsor category [1] 300633 0
None
Name [1] 300633 0
Address [1] 300633 0
Country [1] 300633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301793 0
Medical research and ethics committee (MREC)
Ethics committee address [1] 301793 0
Ethics committee country [1] 301793 0
Malaysia
Date submitted for ethics approval [1] 301793 0
04/01/2017
Approval date [1] 301793 0
29/03/2017
Ethics approval number [1] 301793 0
NMRR-17-179-34162(IIR)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88122 0
Dr Hasneezah Hassan
Address 88122 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor.
Country 88122 0
Malaysia
Phone 88122 0
+60192898096
Fax 88122 0
Email 88122 0
drhasneezah.hassan@gmail.com
Contact person for public queries
Name 88123 0
Hasneezah Hassan
Address 88123 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor.
Country 88123 0
Malaysia
Phone 88123 0
+60192898096
Fax 88123 0
Email 88123 0
drhasneezah.hassan@gmail.com
Contact person for scientific queries
Name 88124 0
Rosliza Bt Abdul Manaf
Address 88124 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor.
Country 88124 0
Malaysia
Phone 88124 0
+603-89472404
Fax 88124 0
Email 88124 0
rosliza_abmanaf@upm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
78Ethical approval    376266-(Uploaded-01-11-2018-15-50-06)-Study-related document.pdf
79Informed consent form    376266-(Uploaded-01-11-2018-15-53-04)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.