Comparison of the effect of using ANEDOC APP and daily educative message reminder in knowledge, consumption of anemia prevention diet and Fe Supplement, and hemoglobin level on pregnant women
comparing the effectiveness of using the ANEDOC APP application daily educational messages given through WhatsApp and the control group in increasing anemia prevention knowledge and behavior in pregnant women
Design
Three-arm parallel-group pilot randomized controlled trial. Open-label trial. Randomization was computerized with concealed randomization sequence carried out by field officer.
Settings and conduct
This pilot RCT will be conducted in 2 Health centers in Surakarta regency
Participants/Inclusion and exclusion criteria
Inclusion criteria are 1) pregnant women with 18-30 weeks gestational age at the time of the study, 2) who did ANC at the Puskesmas Sangkrah and Kratonan Health Center (Surakarta Regency), 3) had an android based smartphone, 4) are active WhatsApp users, and 5) are willing to be research respondents.
The exclusion criteria are pregnant woman who had serious gestational complications such as antepartum hemorrhage, severe preeclampsia, and cardiovascular disease
Intervention groups
There are 2 interventions groups in this study. 1) ANEDOC APP intervention. Respondents are guided to install ANEDOP APP on their mobile phones and activate the education and reminder feature of the ANEDOC APP. The duration of the intervention was 6 weeks. 2) Daily messages reminder. Respondents will receive daily educational and reminder messages through WhatsApp. The short message delivered in visual graphics consists of two sentences. The first sentence contains educational content about the symptoms, impacts, and prevention of anemia. The last sentence is a persuasion message to do the anemia prevention behaviors. There will be 21 different messages that will be sent twice in 6 weeks period.
The control group will receive standard Antenatal Care from the health centers.
Main outcome variables
knowledge, consumption of anemia prevention diet and Fe Supplement, and hemoglobin level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220320054334N1
Registration date:2022-04-17, 1401/01/28
Registration timing:registered_while_recruiting
Last update:2022-04-17, 1401/01/28
Update count:0
Registration date
2022-04-17, 1401/01/28
Registrant information
Name
Izzatul Arifah
Name of organization / entity
The University of Muhammadiyah Surakarta
Country
Indonesia
Phone
+62 271 717417
Email address
izzatul.arifah@ums.ac.id
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-08, 1401/01/19
Expected recruitment end date
2022-04-30, 1401/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using ANEDOC APP and daily educative message reminder in knowledge, consumption of anemia prevention diet and Fe Supplement, and hemoglobin level on pregnant women
Public title
Effect of mHealth intervention in preventing pregnancy anemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with 18-30 weeks gestational age at the time of the study
Pregnant woman who did the Antenatal Care at the Sangkrah and Kratonan Health Center (Puskesmas) in Surakarta Regency, Central Java, Indonesia
Had an android based smartphone
Active WhatsApp users
willing to be research respondents
Exclusion criteria:
had serious gestational complications such as hypertension, preeclampsia, and cardiovascular disease
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is block randomization. Unit of randomization is individual. Tools used in randomization is web-based software. A combination of 4 in 1 block and 2 in 1 block is used to built the sequence. The allocation concealment was not carried out
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Medicine, University of Muhammadiyah Surakarta
Street address
No. 1 Pos Tromol street, Gonilan, Surakarta city. Faculty of Medicine, University of Muhammadiyah Surakarta
City
Surakarta
Postal code
57102
Approval date
2022-04-05, 1401/01/16
Ethics committee reference number
4208/B.2/KEPK-FKUMS/IV/2022
Health conditions studied
1
Description of health condition studied
anemia in pregnant women
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anemia, unspecified
Primary outcomes
1
Description
Knowledge, consumption of anemia prevention diet and Fe supplement
Timepoint
Before intervention and 1 week after intervention
Method of measurement
Measuring knowledge, consumption of anemia prevention diet, and Fe supplement using questionnaires.
Secondary outcomes
1
Description
Hemoglobin level
Timepoint
Before intervention and 1 weeks after intervention
Method of measurement
Measuring the hemoglobin level using Sahli's Haemoglobinometer
Intervention groups
1
Description
Intervention group 1: ANEDOC APP intervention. Respondents are guided to install ANEDOP APP on their mobile phones. They will be given instructions to fill in the data needed to run the application and activated the education and reminder feature of the ANEDOC APP. They will be monitored using this application through the WhatsApp Group. The duration of the intervention was 6 weeks.
Category
Treatment - Other
2
Description
Intervention group 2: Daily messages reminder. Respondents will receive daily educational and reminder messages through WhatsApp. The short message delivered in visual graphics consists of two sentences. The first sentence contains educational content about the symptoms, impacts, and prevention of anemia. The last sentence is a persuasion message to do the anemia prevention behaviors. There will be 21 different messages that will be sent twice in 6 weeks period.
Category
Treatment - Other
3
Description
Control group: The control group will receive standard Antenatal Care from the Primary Health Care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kratonan Primary Health care
Full name of responsible person
Gigih Dewi Jayanti
Street address
No. 34 Pringgondani Street, Kratonan, Serengan, Surakarta City
City
Surakarta
Postal code
57153
Phone
+62 271 655539
Email
izzatul.arifah@ums.ac.id
2
Recruitment center
Name of recruitment center
Sangkrah Primary Health Care
Full name of responsible person
Lilia Fitrianingsih
Street address
Sungai Indragiri Streets, Sangkrah, Pasar Kliwon, Surakarta City
City
Surakarta
Postal code
57199
Phone
+62 271 655061
Email
izzatul.arifah@ums.ac.id
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Muhammadiyah Surakarta
Full name of responsible person
Dr. Umi Budi Rahayu, S.Ft
Street address
No.1 Tromol Pos street, Gonilan, Surakarta City
City
Surakarta
Postal code
57102
Phone
+62 271 717417
Email
ums@ums.ac.id
Web page address
https://www.ums.ac.id/
Grant name
Tri Dharma College Integration Grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Muhammadiyah Surakarta
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Muhammadiyah Surakarta
Full name of responsible person
Izzatul Arifah
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
No 1. Tromol Pos Street. Gonilan, Surakarta city
City
Surakarta
Province
Central Java
Postal code
57102
Phone
+62 271 717417
Email
izzatul.arifah@ums.ac.id
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Muhammadiyah Surakarta
Full name of responsible person
Izzatul Arifah
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
No 1. Tromol Pos Street. Gonilan, Surakarta city
City
Surakarta
Province
Central Java
Postal code
57102
Phone
+62 271 717417
Email
izzatul.arifah@ums.ac.id
Person responsible for updating data
Contact
Name of organization / entity
University of Muhammadiyah Surakarta
Full name of responsible person
Izzatul Arifah
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
No 1. Tromol Pos Street. Gonilan, Surakarta city
City
Surakarta
Province
Central Java
Postal code
57102
Phone
+62 271 717417
Email
izzatul.arifah@ums.ac.id
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study protocol of the Pilot RCT of using mHealth for anemia prevention on pregnant women
When the data will become available and for how long
starting in November 2022
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
for academic purpose
From where data/document is obtainable
requested at personal email: izzatul.arifah@ums.ac.id
What processes are involved for a request to access data/document
Sending a letter of request, and reviewing the request