Clinical Trial: Prevalence and associated factors of anemia and impact of mHealth education on hemoglobin level among pregnant women with anemia in rural Bangladesh (Japan)

Tokyo, Feb. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060743) titled 'Prevalence of Anemia Among Pregnant Women in Rural Bangladesh, Associated Factors, and the Impact of Mobile Device Utilization on Hemoglobin Levels' on Feb. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - North South University, Bangladesh

Condition: Condition - Anemia Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 132

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069465

Disclaimer: Curated by HT Syndication.