Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents (MGA)

March 4, 2026 updated by: Dr. Robert A. de Leeuw, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial

The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Studies have shown that menstrual health-related quality of life is influenced mainly by pain, blood loss and school/work/leisure absenteeism. We hypothesize that using a mHealth intervention designed for adolescents will increase the self-awareness of an adolescent's menstrual health, including adequate healthcare-seeking. As a result, the intervention will increase menstrual health-related quality of life.

Postmenarchal adolescents aged between 12 and 22 years can be included in this study and will be randomised using 1:1 stratified randomisation in the intervention arm or control arm. Stratification factors are: age (<16 of ≥ 16 years old), use of hormonal anticonception (yes or no) and menstrual disturbance score (Period ImPact and Pain Assessment score <3 or ≥3).

Participants in the intervention arm will be asked to track their menstrual complaints in the mobile menstrual tracker and education application daily for at least three months. Participants in the control arm will not use the mobile menstrual tracker and education application for six months. Participants in the control arm also get access to the mobile menstrual tracker and education application six months after enrollment and after the primary outcome measurement at 6-months after enrollment.

The primary outcome measure is quality of life, using the PedsQL measured six months after enrollment. Secondary outcomes are school, work and leisure absenteeism, menstrual careseeking behavior, knowledge about menstrual complaints, the prevalence of suspected bleeding disorders, the prevalence of menstrual disturbance, the amount of menstrual blood loss, and societal costs.

All outcomes will be measured using online questionnaires send at 6, 12 and 24 months after enrollment.

Study Type

Interventional

Enrollment (Estimated)

874

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Dutch, English, Turkish or Moroccan-Arabic speaking
  • Post menarche
  • Access to a smartphone or tablet with iOS or Android operating system

Exclusion Criteria:

  • Amenorrhea
  • Pregnancy
  • No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.
  • Previously or currently under treatment by a health care provider for menstrual complaints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App group
Participants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application.
Other: Menstrual Tracker and Education Application
The intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health.
No Intervention: Waitlist group
Participants in the 'waitlist group' will not directly get access to the mobile menstrual tracker and education application. They will be put on a 'waitlist'. Six months after inclusion and after completing the 6-month questionnaire, participants will get access to the application and are free to install and use it if desired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Score
Time Frame: 6 months after enrollment
Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.
6 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual bleeding related quality of life
Time Frame: 6, 12, 24 months after enrollment
The menstrual bleeding related quality of life assessed with the (adolescent) Menstrual Bleeding Questionnaire. The adolescent (<18) or adult version of the questionnaire will be used as appropriate.
6, 12, 24 months after enrollment
Knowledge about menstrual health
Time Frame: 6, 12 and 24 months after enrollment
The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey.
6, 12 and 24 months after enrollment
School-, work-, and leisure absences
Time Frame: 6, 12 and 24 months after enrollment
The impact of menstrual complaints on school, work and leisure activities will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). Impact of menstrual complaints is also reported in the mobile menstrual tracker and education app.
6, 12 and 24 months after enrollment
Societal costs
Time Frame: 6, 12 and 24 months after enrollment
Societal costs including healthcare use and prodictivity loss will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ) and the iMTA Medical Consumption Questionnaire (iMCQ).
6, 12 and 24 months after enrollment
Quality of Life for cost-effectiveness calculation
Time Frame: 6, 12 and 24 months after enrollment
To calculate the cost-effectiveness of the intervention, the quality of life assessed with the 5-level EQ-5D (EQ-5D-5L) and EQ-5D-Y-5L as appropriate as a measure for effectiveness.
6, 12 and 24 months after enrollment
Participants' experience of effectiveness
Time Frame: 6, 12 and 24 months after enrollment
The effectiveness experienced by the participant is measured using the 1-item questionnaire Patient Global Impression of Change.
6, 12 and 24 months after enrollment
Dose of mobile menstrual tracking and education application
Time Frame: 6, 12 and 24 months
Logdata of the mobile menstrual tracking and education application will be used to calculate the dose of the intervention received.
6, 12 and 24 months
Menstrual disturbance
Time Frame: 6, 12 and 24 months after enrollment
The menstrual disturbance score assessed with the Period ImPact and Pain Assessment tool (PIPPA)
6, 12 and 24 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 16, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGA-studie
  • 10390032310035 (Other Grant/Funding Number: ZonMw)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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