- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07746791
Advancing Female University Students' Health Through Mobile Technology in Ethiopia (EMPOWER)
Advancing Female University Students Sexual and Reproductive Health, Nutrition, and Psychosocial Well-being Through Mobile Technology Interventions in Ethiopia
Background: Female university students in Ethiopia experience a high burden of sexual and reproductive health, nutrition, and psychosocial problems, exacerbated by limited access to essential health services and support. Mobile technology provides an opportunity to deliver accessible, evidence-based health interventions.
Objective: To evaluate the effectiveness of a mobile technology-based intervention in improving SRH, nutrition, and psychosocial well-being among female university students in Ethiopia.
Methods: A concurrent mixed-methods study will be conducted among first-year female university students. Baseline quantitative and qualitative assessments will identify needs, barriers, and facilitators. A randomized controlled trial will evaluate a comprehensive mobile health education intervention delivered monthly. Quantitative data will be analysed using descriptive and inferential statistics, while qualitative data will undergo thematic analysis.
Expected Outcomes: Improved sexual and reproductive health, dietary practices, and psychosocial well-being among female university students.
Duration and Budget: The project will be implemented over the proposed study period with a total budget of 1,208,564 Ethiopian birr.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeshalem M Demilew, PhD
- Phone Number: +251954342535
- Email: yeshalem_mulugeta@yahoo.com
Study Contact Backup
- Name: Elenie A Mengesha, PhD
- Phone Number: +251918772775
Study Locations
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Amhara
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Bahir Dar, Amhara, Ethiopia, 79
- Bahir Dar University
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Contact:
- Yeshalem Mulugeta Demilew
- Phone Number: 0918783819
- Email: yeshalem_mulugeta@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Regular undergraduate female university student will be included in the study.
- First year female students will be included in the study.
Exclusion Criteria:
• Students who have no mobile phone will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: M-health intervention
The intervention will address key components of adolescent health, including appropriate and responsible digital technology use, the fundamentals of sexual and reproductive health (SRH), adolescent nutrition, psychosocial well-being, health-related risk factors, and preventive measures.
Intervention content will be developed in a concise and age-appropriate format and delivered monthly via mobile technology over a period of three consecutive years.
Following each message, feedback will be collected from participating students to assess message receipt, exposure, and whether the content has been read.
This process will also facilitate monitoring of students' engagement with the intervention throughout the study period.
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Behavioural change intervention will be provided through mobile application to improve sexual and reproductive health, nutrition, psychosocial, and appropriate digital use.The intervention packages or contents of the intervention will be developed based on the survey finding.
Content of the intervention will include appropriate digital use, the basics of SRH, adolescent nutrition, psychosocial wellbeing, risk factors, and prevention measures.
Nutrition messages will include nutrient requirements, the benefits of a healthy diet, the dietary habits of adolescents, the adverse consequences of junk food consumption, short- and long-term consequences of taking unhealthy diet.
Possible solutions to improve dietary intake.
A simple message about detailed description of the contents of the intervention will be delivered monthly through mobile technology for three consecutive years.
Feedback will be collected from students after delivery of message to make sure whether students read or not.
Other Names:
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Active Comparator: Routine education
Control group will receive education provided by universities clinics and gender office.
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Students in the control group will receive message provided through gender office.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sexual and reproductive health
Time Frame: Baseline assessment will be done from August 1-September 30, 2026 (8 weeks) and endline assessment will be done from April to May2028 (8 weeks) .
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Sexual and reproductive health will be the primary outcomes and will be assessed using questionnaires.
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Baseline assessment will be done from August 1-September 30, 2026 (8 weeks) and endline assessment will be done from April to May2028 (8 weeks) .
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Psychosocial well-being
Time Frame: Baseline assessment will be done from August 1-September 30, 2026 (8 weeks) and endline assessment will be done from April to May2028(8 weeks) .
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Psychosocial well-being will be the primary outcomes of this studyand will be assessed using questionnaires.
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Baseline assessment will be done from August 1-September 30, 2026 (8 weeks) and endline assessment will be done from April to May2028(8 weeks) .
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Dietary intake
Time Frame: Baseline assessment will be done from August 1-September 30, 2026 (8 weeks) and endline assessment will be done from April to May 2028 (8 weeks).
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Dietary intake will be the primary outcome and will be measured using food frequency questionnaire.
Students who have a higher score for healthy foods will be considered as having appropriate dietary practice, otherwise not.
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Baseline assessment will be done from August 1-September 30, 2026 (8 weeks) and endline assessment will be done from April to May 2028 (8 weeks).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Admassu TW, Wolde YT, Kaba M. Ethiopia has a long way to go meeting adolescent and youth sexual reproductive health needs. Reprod Health. 2022 Jun 13;19(Suppl 1):130. doi: 10.1186/s12978-022-01445-3.
- Kassa GM, Degu G, Yitayew M, Misganaw W, Muche M, Demelash T, Mesele M, Ayehu M. Risky Sexual Behaviors and Associated Factors among Jiga High School and Preparatory School Students, Amhara Region, Ethiopia. Int Sch Res Notices. 2016 Jun 15;2016:4315729. doi: 10.1155/2016/4315729. eCollection 2016.
- Ejtahed HS, Mardi P, Hejrani B, Mahdavi FS, Ghoreshi B, Gohari K, Heidari-Beni M, Qorbani M. Association between junk food consumption and mental health problems in adults: a systematic review and meta-analysis. BMC Psychiatry. 2024 Jun 12;24(1):438. doi: 10.1186/s12888-024-05889-8.
- Hilger J, Loerbroks A, Diehl K. Eating behaviour of university students in Germany: Dietary intake, barriers to healthy eating and changes in eating behaviour since the time of matriculation. Appetite. 2017 Feb 1;109:100-107. doi: 10.1016/j.appet.2016.11.016. Epub 2016 Nov 15.
- Habte A, Dessu S. The uptake of key elements of sexual and reproductive health services and its predictors among rural adolescents in Southern Ethiopia, 2020: application of a Poisson regression analysis. Reprod Health. 2023 Jan 12;20(1):15. doi: 10.1186/s12978-023-01562-7.
- Abrha K, Worku A, Lerebo W, Berhane Y. Sexting and high sexual risk-taking behaviours among school youth in northern Ethiopia: estimating using prevalence ratio. BMJ Sex Reprod Health. 2019 Apr 27:bmjsrh-2018-200085. doi: 10.1136/bmjsrh-2018-200085. Online ahead of print.
- Muntean N, Kereta W, Mitchell KR. Addressing the Sexual and Reproductive Health Needs of Young People in Ethiopia: An Analysis of the Current Situation. Afr J Reprod Health. 2015 Sep;19(3):87-99.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- School of Public health, BDU
- BDU/20/2025 (Other Identifier: Bahir Dar University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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