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Trial registered on ANZCTR


Registration number
ACTRN12620000299909
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
5/03/2020
Date last updated
27/09/2021
Date data sharing statement initially provided
5/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Local wisdom-based counseling on preventing iron deficiency anemia among pregnant women
Scientific title
The effectiveness of local wisdom-based counseling on preventing iron deficiency anemia among pregnant women in Aceh Besar District, Indonesia
Secondary ID [1] 300125 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anemia prevention among pregnant women 315654 0
Condition category
Condition code
Blood 313943 313943 0 0
Anaemia
Public Health 313944 313944 0 0
Health promotion/education
Reproductive Health and Childbirth 313945 313945 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: The local wisdom-based counseling intervention group: This group consisted of 50 pregnant women as participants identified by cluster random sampling technique. The intervention is given to the participants for 1 months (6 sessions) with 1-week intervals. The duration for each sessions is 45-75 minutes:
Session 1: Introduction and research explanations, including Hemoglobin (Hb) examination.
Session 2: Mutual trust building and pregnancy overview.
Session 3: Counseling on iron deficiency anemia and explanation about Hb examination with the cultural approach.
Session 4: Counseling on the iron tablets intake with the cultural approach.
Session 5: Counseling on husband's supporting role for the iron tablets intake control with the cultural approach.
Session 6: Review, follow up, and Hb examination.
The method used in session 1 and session 6 is a group counseling method attended by all participants, while the method used in sessions 2 through session 5 is a group counseling method, each group consisting of 7-9 participants.

Arm 2: The health-based counseling intervention group: This group consisted of 50 pregnant women as participants identified by cluster random sampling technique. The intervention is given to the participants for 1 months (6 sessions) with 1-week intervals. The duration for each sessions is 45-75 minutes:
Session 1: Introduction and research explanations, including Hemoglobin (Hb) examination.
Session 2: Mutual trust building and pregnancy overview.
Session 3: Counseling on iron deficiency anemia and explanation about Hb examination.
Session 4: Counseling on the iron tablets intake.
Session 5: Counseling on husband's supporting role for the iron tablets intake control.
Session 6: Review, follow up, and Hb examination.
The method used in session 1 and session 6 is a group counseling method attended by all participants, while the method used in sessions 2 through session 5 is a group counseling method, each group consisting of 7-9 participants.

Arm 3: The control group: This group consisted of 50 pregnant women as participants identified by cluster random sampling technique. Standard antenatal counseling will be applied for 1 months. Participants will also receive a pretest and posttest questionnaires and Hb examinations.

Both intervention given to the participants is carried out by trained nurse-midwives who worked at the Public Health Center that receive training from the researcher for 2 days with 45-75 minutes for each session. The training will be conducted in 6 sessions given to the counselor and the training step is same as the intervention program that they will do for the participant. The interventions will be given through face-to-face meetings in groups with 5-6 participants by counselors. The difference between the two types of counseling will be given:
1. The counseling module as a guide that has been designed for the two intervention groups in content differs between each other.
2. Counselors are recruited and selected from different Public Health Center (PHC), which are three PHCs for counselors based on local wisdom and three PHCs for counselors based on health. The one that providing the counseling is different between each intervention group.

The process of providing interventions will follow the ethical principles of health research.
Strategies used to assess the adherence to the interventions in these three groups are:
1. By checking the attendance list for each session attended by pregnant women.
2. By assessing the control card for monitoring iron tablets consumption during the intervention given and during the follow-up 1 (2 weeks after the intervention) and follow-up 2 (4 weeks after follow up 1).
Intervention code [1] 316398 0
Prevention
Intervention code [2] 316399 0
Lifestyle
Comparator / control treatment
The control group will be recruited the same way as the intervention group. Participants in the control group will receive standard antenatal counseling. In Indonesia, there is maternal and child health books published by Indonesian Health Ministry that used by health workers in Public Health Center in providing antenatal care. Based on its content, this book discusses about pregnant women and problems in pregnancy including anemia and iron administration. The counseling recommended in this book concerns in all aspects, such as maternal health, healthy life behavior, the role of husband in pregnancy, danger signs of pregnancy, balanced nutritional intake, initiation of early breastfeeding, and many other things, while the module used in this study will specially focused on anemia and how to prevent it during pregnancy.
Control group
Active

Outcomes
Primary outcome [1] 322341 0
Hemoglobin (Hb) levels will be measured using a Hemoglobinometer. A little whole blood from finger tip will be taken by the field workers by a disposable tool and it will be entered into the test strip. In few seconds, the result could be read at the screen.
Timepoint [1] 322341 0
In both intervention groups, hemoglobin examination will be carried out before the counseling intervention, at the end of the intervention, and at the follow up. In the control group, Hb examination will be carried out during the pre-test and post-test.
Secondary outcome [1] 378152 0
Knowledge, attitude, and behaviors about iron deficiency anemia prevention during pregnancy assessed by self-report questionnaire prepared specifically for the use in this study based on the educational material to be delivered during counseling programs. Some of the questions is internalized from Leininger Theory.
Timepoint [1] 378152 0
Before and after the intervention programs, two weeks after the intervention completion and four weeks after the follow up 2.

Eligibility
Key inclusion criteria
Pregnant women without complications, willing to participate in this study, Acehnese, and domiciled in Aceh Besar District.
Minimum age
19 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women in the selected Public Health Center working area with pregnancy complications.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1). Listed public health center numbers
2). Generated group code
3). Generated random numbers using Microsoft Excel
4). Sorted, copied, and pasted the random numbers with the group code
5). Summarized the result.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
-
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The population in this study is all pregnant women in the working area of the Public Health Center selected in this study, which are Publich Health Centers in the Kutabaro, Darussalam, Baitussalam, Mesjid Raya, Darul Kamal, Simpang Tiga, Kuta Malaka, Krueng Barona Jaya, and Lambaro, Aceh Besar District, Aceh, Indonesia. These selection considerations are based on the number of pregnant women in each area, the high prevalence of anemia during pregnancy, accessibility, ease of reaching the locations, and similar cultural views.
Participants is identified according to the inclusion criterias. The determination of the number of participants is based on power analysis with a medium effect size and power (0.08), a confidence level (95%) and alpha (0.05), with d value equals to 0.60. The size of the participants is 50 participants for each group. After randomizing the Public Health Centers, 50 pregnant women who met the criteria would be selected for each group.
Research analysis will be using descriptive and inferential statistics. Descriptive statistics which will be used is frequency, percentage, mean and standard deviation while the inferential statistics that will used is independent t-test with pre-post control group design to compare the mean score before and after the intervention in the 3 (three) groups. Repeated measure one way ANOVA also will be used to compare the mean scores of pre-test, post-test, first follow-up and second follow-up in both intervention groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2020
Actual
20/02/2020
Date of last participant enrolment
Anticipated
24/05/2020
Actual
23/04/2020
Date of last data collection
Anticipated
26/06/2020
Actual
7/05/2020
Sample size
Target
150
Accrual to date
Final
144
Recruitment outside Australia
Country [1] 22191 0
Indonesia
State/province [1] 22191 0
Aceh

Funding & Sponsors
Funding source category [1] 304565 0
University
Name [1] 304565 0
Universitas Syiah Kuala
Country [1] 304565 0
Indonesia
Primary sponsor type
University
Name
Universitas Syiah Kuala
Address
Teuku Nyak Arief Street, Kopelma Darussalam, Syiah Kuala District, Banda Aceh, Aceh 23111
Country
Indonesia
Secondary sponsor category [1] 304847 0
None
Name [1] 304847 0
Address [1] 304847 0
Country [1] 304847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304991 0
Komite Etik Fakultas Keperawatan
Ethics committee address [1] 304991 0
Ethics committee country [1] 304991 0
Indonesia
Date submitted for ethics approval [1] 304991 0
12/12/2018
Approval date [1] 304991 0
26/12/2018
Ethics approval number [1] 304991 0
113004111218

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

Contacts
Principal investigator
Name 98886 0
Mrs Darmawati Darmawati
Address 98886 0
Nursing Faculty, Universitas Syiah Kuala
Teungku Tanoh Abee Street, Kopelma Darussalam
Syiah Kuala District, Banda Aceh, Aceh 23111
Country 98886 0
Indonesia
Phone 98886 0
+62 823 67568943
Fax 98886 0
Email 98886 0
[email protected]
Contact person for public queries
Name 98887 0
Darmawati Darmawati
Address 98887 0
Nursing Faculty, Universitas Syiah Kuala
Teungku Tanoh Abee Street, Kopelma Darussalam
Syiah Kuala District, Banda Aceh, Aceh 23111
Country 98887 0
Indonesia
Phone 98887 0
+62 823 67568943
Fax 98887 0
Email 98887 0
[email protected]
Contact person for scientific queries
Name 98888 0
Darmawati Darmawati
Address 98888 0
Nursing Faculty, Universitas Syiah Kuala
Teungku Tanoh Abee Street, Kopelma Darussalam
Syiah Kuala District, Banda Aceh, Aceh 23111
Country 98888 0
Indonesia
Phone 98888 0
+62 823 67568943
Fax 98888 0
Email 98888 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6220Informed consent form  [email protected] 378957-(Uploaded-17-12-2019-16-32-19)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AITHE EFFECTIVENESS OF LOCAL WISDOM-BASED COUNSELING TO PREVENT IRON DEFICIENCY ANEMIA AMONG PREGNANT WOMEN: A PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL2020https://doi.org/10.33546/bnj.1080
N.B. These documents automatically identified may not have been verified by the study sponsor.