UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060743 |
|---|---|
| Receipt number | R000069465 |
| Scientific Title | Prevalence and associated factors of anemia and impact of mHealth education on hemoglobin level among pregnant women with anemia in rural Bangladesh. |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/26 11:06:18 |
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Basic information
Public title
Prevalence of Anemia Among Pregnant Women in Rural Bangladesh, Associated Factors, and the Impact of Mobile Device Utilization on Hemoglobin Levels
Acronym
Effectiveness of Mobile Applications on Anemia Improvement Among Pregnant Women in Rural Bangladesh
Scientific Title
Prevalence and associated factors of anemia and impact of mHealth education on hemoglobin level among pregnant women with anemia in rural Bangladesh.
Scientific Title:Acronym
Effectiveness of mHealth Education for Anemic Pregnant Women in Rural Bangladesh
Region
| Asia(except Japan) |
Condition
Condition
Anemia
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the baseline prevalence of anemia, anemia-related knowledge, attitudes, and practices (KAP) levels, and nutritional status among pregnant women in rural Bangladesh.
Basic objectives2
Others
Basic objectives -Others
Evaluating the effect of anemia-related mHealth education on improving hemoglobin levels in anemic pregnant women in Bangladesh
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Impact of mHealth education on hemoglobin level
Key secondary outcomes
1. Assess the prevalence of anemia and identify associated factors.
2. Assess improvement of knowledge, attitudes, and practices (KAP) regarding anemia.
3. Assess improvements in the nutritional status including mid-upper arm circumference (MUAC) and dietary scores.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention consists of a mobile-based health education program focused on anemia management. The intervention period is 16 weeks. The intervention period was set at 16 weeks because its completion coincides with mid-pregnancy, a stage of moderate plasma volume expansion, allowing for appropriate assessment of hemoglobin changes before the significant blood dilution that occurs in late pregnancy. Additionally, completing the intervention before reaching the third trimester ensures participants have sufficient time to respond adequately to the intervention.
This program delivers information via phone calls and SMS messages to the mobile phones of pregnant women diagnosed with anemia. The content covers anemia, its effects, signs, causes, and prevention methods. The educational content for this intervention program was selected in accordance with the Bangladesh National Strategy for Prevention and Management of Anemia, developed by the Institute of Public Health Nutrition (IPHN). This strategy proposes six priority strategies for anemia prevention and management, and this educational program implements five of these strategies. It also covers basic information about anemia (causes, symptoms, signs, reasons pregnant women are at risk, and impacts on the mother and newborn).Additionally, participants in the intervention group will be provided with a booklet summarizing all information shared via SMS during the intervention period.
Interventions/Control_2
The control group receives routine prenatal care. After the final evaluation, they will be provided with the same booklet given to the intervention group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Individuals diagnosed with a gestational age of less than 10 weeks and diagnosed with mild to moderate anemia (hemoglobin level 7 g/dL to 10.9 g/dL)
2. Individuals who are permanent residents of the study area
3. Individuals aged 18 years or older
4. Individuals whose household possesses at least one operational mobile phone
5. Individuals who have provided written consent to participate in the study
Key exclusion criteria
1. Individuals who are hospitalized at the time of registration or who have a pregnancy complicated by bleeding, severe nausea, vomiting, or other complications
2. Individuals with a history of, or suspected to have, chronic or congenital diseases such as blood inflammation, diabetes, thalassemia, hypertension, or mental illness
3. Individuals with severe anemia
4. Individuals who may leave the study area during the study period
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Mohammad |
| Middle name | Delwer Hossain |
| Last name | Hawlader |
Organization
North South University, Bangladesh
Division name
Department of Public Health
Zip code
1229
Address
Plot 15, Block B, Bashundhara R/A, Dhaka 1229, Bangladesh
TEL
880255668200
mohammad.hawlader@northsouth.edu
Public contact
Name of contact person
| 1st name | Mohammad |
| Middle name | Delwer Hossain |
| Last name | Hawlader |
Organization
North South University, Bangladesh
Division name
Department of Public Health
Zip code
1229
Address
Plot 15, Block B, Bashundhara R/A, Dhaka 1229, Bangladesh
TEL
880255668200
Homepage URL
mohammad.hawlader@northsouth.edu
Sponsor or person
Institute
North South University, Bangladesh
Institute
Department
Personal name
Mohammad Delwer Hossain Hawlader
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hiroshima University
Name of secondary funder(s)
Hiroshima University
IRB Contact (For public release)
Organization
North South University
Address
Plot-15, Block-B, Bashundhara, Dhaka-1229, Bangladesh.
Tel
880255668200
dipak.mitra@northsouth.edu
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069465
