NCT07746791

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress1%
Aug 2026Jun 2028

First Submitted

Initial submission to the registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 28, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

Dietary intakeSRHEthiopiaPsychosocial wellbeing

Outcome Measures

Primary Outcomes (3)

  • Dietary intake

    Dietary intake will be the primary outcome and will be measured using food frequency questionnaire.

    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).

  • Sexual and reproductive health

    Sexual and reproductive health will be the primary outcomes and will be assessed using questionnaires.

    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) .

  • Psychosocial well-being

    Psychosocial well-being will be the primary outcomes of this studyand will be assessed using questionnaires.

    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) .

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention group

Behavioral: Behavioural change intervention will be provided through mobile application

Control

ACTIVE COMPARATOR

Control group

Behavioral: Routine care

Interventions

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.

Also known as: Group one
Intervention arm
Routine careBEHAVIORAL

Students in the control group will receive message provided through gender office.

Control

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Regular undergraduate female university student will be included in the study.
  • First year female students will be included in the study.

You may not qualify if:

  • Students who have no mobile phone will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahir Dar University

Bahir Dar, Amhara, 79, Ethiopia

Location

Related Publications (7)

  • 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.

MeSH Terms

Conditions

Coitus

Interventions

One-Carbon Group Transferases

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

TransferasesEnzymesEnzymes and Coenzymes

Central Study Contacts

Yeshalem M Demilew, PhD

CONTACT

Elenie A Mengesha, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A two-arm parallel cluster randomized controlled trial will be conducted to assess the effect of mobile technology interventions on enhancing sexual and reproductive health, nutrition, and psychosocial Well-being among Female University Students in Ethiopia.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 5, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

For security purpose

Locations