NCT05185661

Brief Summary

Adolescent girls are the highly vulnerable group to develop anemia due to reproductive immaturities, poor personal hygiene, lack of nutritional intake, and lack of health education in the rural area of Bangladesh. Rapid advantage of technology, eHealth is the promising tool to overcome the barriers and provide appropriate health guidelines in distant rural communities by developing knowledge, attitude, and practice to reduce anemia and mitigate risk among the school-going adolescent girls. This research aims (1) To evaluate eHealth education's impact on reducing anemia among adolescent girls in rural Bangladesh. (2) To assess the effect of eHealth education to change the knowledge, attitude, and practice among adolescent girls regarding anemia. A Randomized Control Trial study will be conducted from May 22, 2022, to January 21, 2023, in the two schools at the Chandpur district, Bangladesh. During the 8th months' intervention, will be provided eHealth education by the trained community health worker. The participant will be allocated who will be diagnosed as anemic through the blood hemoglobin screening. The sample size was calculated, and the total sample is 138. In this study, one school will be considered an intervention group and another school control group through the simple coin toss randomization technique. Then random sampling technique will be used to select study participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

December 4, 2021

Last Update Submit

February 26, 2024

Conditions

Keywords

eHealth educationAnemiaAdolescents girlBangladesh

Outcome Measures

Primary Outcomes (1)

  • Impact of eHealth education to change the anemia level among school-going adolescent girls in rural areas of Bangladesh

    Individuals school-going adolescent girls will be measured anemia level (No anemic, mild, moderate, and severe anemia) through the blood hemoglobin screening by the auto-hematology analyzer. According to WHO, 10-11 years adolescent girls Hb \<11.5g/dl will be considered anemic, and \<10-11.4, 7.0-9.9 g/dl, \<7.0 g/dl will be considered mild, moderate, and severe anemia, respectively. Non-pregnant adolescent girls (12-19 years) Hb level \< 12 g/dl will be considered suffering any form of anemia, and 10.0-11.9 g/dl, 7.0-9.9 g/dl, and \<7.0 g/dl will be considered mild, moderate, and severe anemia, respectively. After eHealth education intervention, changes will be assessed (e.g., anemic to non-anemic, severe to mild/ moderate/non-anemic, moderate to mild/non-anemic, mild to non-anemic) from the baseline of anemia level among the school-going adolescent girls.

    8 months after intervention

Secondary Outcomes (1)

  • Changes of knowledge, attitude, and practice regarding anemia among the school-going adolescent girls in rural areas of Bangladesh

    8 months after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

1. Two surveys: Demographic, lifestyle, hygiene-related (1) \& knowledge, attitude, and practice (2) regarding anemia at baseline and end line of study. 2. Investigations and physical examination will perform for CBC blood test except ESR, urine R/E, stool R/E, Height, weight for BMI, waist circumference, hip circumference, hip - waist ratio, and mid-upper arm circumference (MUAC) at baseline, mid-line, and end-line of study.

Behavioral: eHealth education

Control Group

NO INTERVENTION

1. Two surveys: Demographic, lifestyle, hygiene-related (1) \& knowledge, attitude, and practice (2) regarding anemia at baseline and end line of study. 2. Investigations and physical examination will perform for CBC blood test except ESR, urine R/E, stool R/E, Height, weight for BMI, waist circumference, hip circumference, hip - waist ratio, and mid-upper arm circumference (MUAC) at baseline, mid-line, and end-line of study.

Interventions

eHealth education intervention regarding the dietary plan, healthy-lifestyle, and hygiene: 1. Group-wise eHealth education through online PowerPoint presentation session among study participants with their guardian: Two times (Before starting the intervention and mid-line; end of 4th-month intervention) 2. eHealth education through phone calls \& SMS * 1st to 4th month: 4 times in a month * 5th to 6th month: 3 times in a month * 6th to 8th month: 2 times in a month 3. Control group will not get care and education

Intervention Group

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe adolescent girl whose age is 10-19 years.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Who is diagnosed with mild and moderate anemia in the baseline screening of the study.
  • Who gives written consent to participate in the study through the legal guardian/participants.
  • Who is living and studying Chandpur district with assigned school for the study.

You may not qualify if:

  • Participants whose guardians/participants do not have a mobile phone will be excluded from the study.
  • Who is pregnant will be excluded from our study.
  • Who are physically and mentally sick will be excluded from our study.
  • \. Disagree to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baburhat high school and Zubaida girl school

Chāndpur, 3603, Bangladesh

Location

Related Publications (3)

  • Jalambo M, Karim N, Naser I, Sharif R. Effects of iron supplementation and nutrition education on haemoglobin, ferritin and oxidative stress in iron-deficient female adolescents in Palestine: randomized control trial. East Mediterr Health J. 2018 Jul 29;24(6):560-568. doi: 10.26719/2018.24.6.560.

    PMID: 30079951BACKGROUND
  • Sunuwar DR, Sangroula RK, Shakya NS, Yadav R, Chaudhary NK, Pradhan PMS. Effect of nutrition education on hemoglobin level in pregnant women: A quasi-experimental study. PLoS One. 2019 Mar 21;14(3):e0213982. doi: 10.1371/journal.pone.0213982. eCollection 2019.

    PMID: 30897129BACKGROUND
  • Rahman MJ, Rahman MM, Sarker MHR, Matsuyama R, Kakehashi M, Tsunematsu M, Ali M, Ahmed A, Hawlader MDH, Kawasaki H, Shimpuku Y. Impact of mobile health-based nutritional education on hemoglobin levels in anemic adolescent girls in rural Bangladesh: a randomized controlled trial. BMC Public Health. 2025 Jul 28;25(1):2567. doi: 10.1186/s12889-025-23687-z.

Related Links

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
One school will be considered as an intervention group and another school control group to reduce the health education information bias between the intervention and control group participants through the coin toss simple randomization technique. Then computer-generated simple random sampling technique will be used to select anemic study participants for both the intervention and control group from the schools
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized control trial (RCT) study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher, Graduate School of Biomedical and Health Sciences

Study Record Dates

First Submitted

December 4, 2021

First Posted

January 11, 2022

Study Start

May 22, 2022

Primary Completion

February 1, 2023

Study Completion

January 30, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations