UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061265 |
|---|---|
| Receipt number | R000069625 |
| Scientific Title | Impact of mHealth Education for Improving Nutritional status, Preconception Health and Self-Efficacy among Adolescent Girls with Parental Involvement in Rural Bangladesh |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/15 09:47:58 |
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Basic information
Public title
Impact of mHealth Education for Improving Nutritional status, Preconception Health and Self-Efficacy among Adolescent Girls with Parental Involvement in Rural Bangladesh
Acronym
Impact of mHealth Education with Parental Involvement on Nutritional Status, Preconception Health, and Self-Efficacy among Adolescent Girls
Scientific Title
Impact of mHealth Education for Improving Nutritional status, Preconception Health and Self-Efficacy among Adolescent Girls with Parental Involvement in Rural Bangladesh
Scientific Title:Acronym
Impact of mHealth Education with Parental Involvement on Nutritional Status, Preconception Health, and Self-Efficacy among Adolescent Girls
Region
| Asia(except Japan) |
Condition
Condition
Anaemia
Classification by specialty
| Obstetrics and Gynecology | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to implement mHealth education involving parental intervention for adolescent girls in rural Bangladesh and to evaluate its effectiveness.
Basic objectives2
Others
Basic objectives -Others
This study compares improvements in nutritional status, including iron and folate levels (the primary outcome measure), alongside preconception-related knowledge, attitudes, and practices (KAP) and self-efficacy (secondary outcome measures) between an intervention group receiving mHealth education and a control group not receiving mHealth education among adolescent girls in rural Bangladesh.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
A six-month mHealth education programme will be implemented, with changes in nutritional status (iron and folate levels) assessed before and after the intervention.
Key secondary outcomes
1. Implement mHealth education for six months and evaluate changes in preconception-related knowledge, attitudes, and practices (KAP) before and after the intervention.
2. Implement mHealth education for six months and evaluate changes in self-efficacy before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. At baseline and at the end of the three-month intervention period, health education campaigns will be conducted for research participants and their guardians. These campaigns, delivered within the school environment, will address 'nutrition' and 'reproductive and preconception health' using presentations and posters.
2. Community health workers will deliver a 24-week mHealth educational intervention to participants and their guardians (particularly mothers) via structured telephone calls and text messages.
3. Nutrition-related content will cover balanced diets, micronutrient-rich foods, iron and folate intake, and strategies for preventing nutritional deficiencies. Preconception content will address nutritional preparedness, healthy weight management, menstrual hygiene awareness, and prevention of early pregnancy-related risks. Reproductive health content addresses basic anatomy, menstrual hygiene, and the long-term impact of adolescent health on maternal outcomes. Healthy lifestyle content covers regular physical activity, adequate sleep, hydration, and reducing consumption of unhealthy foods. Enhancing self-efficacy involves promoting behavioural reinforcement through motivational messages and goal-setting strategies aligned with social cognitive theory.
Interventions/Control_2
Receive only the standard healthcare services provided in the local area. Following the final assessment, provide health education materials identical to those 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
| 14 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Adolescents aged 14 to 19 years who have been enrolled at the selected schools for this study for at least six months.
2. Individuals who have access to a mobile phone either personally or through their parents.
3. Individuals who live with their parents.
4. Individuals for whom written informed assent has been obtained from the participant and informed consent has been obtained from the parent or guardian.
Key exclusion criteria
1. Individuals planning to participate in other intervention studies related to nutrition or reproductive health
2. Individuals unable to participate in the data collection process due to serious illness
3. Pregnant individuals
4. Individuals with mental or physical symptoms
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Bilkis |
| Middle name | |
| Last name | Banu |
Organization
Independent University,Bangladesh
Division name
Department of Public Health
Zip code
1245
Address
Plot 16, Block B, Aftabuddin Ahmed Road, Bashundhara R/A, Dhaka 1245, Bangladesh
TEL
8801716245245
bilkis@iub.edu.bd
Public contact
Name of contact person
| 1st name | Bilkis |
| Middle name | |
| Last name | Banu |
Organization
Independent University,Bangladesh
Division name
Department of Public Health
Zip code
1245
Address
Plot 16, Block B, Aftabuddin Ahmed Road, Bashundhara R/A, Dhaka 1245, Bangladesh
TEL
8801716245245
Homepage URL
bilkis@iub.edu.bd
Sponsor or person
Institute
Independent University, Bangladesh
Institute
Department
Personal name
Bilkis Banu
Funding Source
Organization
HU SPRING Transdisciplinary Grant Program
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Independent University, Bangladesh
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent University,Bangladesh
Address
Plot 16, Block B, Aftabuddin Ahmed Road, Bashundhara R/A, Dhaka 1245, Bangladesh
Tel
8809612939393
info@iub.edu.bd
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-SPPH-NSR-ST:01
Org. issuing International ID_1
Independent University,Bangladesh
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 | 04 | Month | 30 | 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 | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | 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 | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069625
