The Effect of an App-Based Intervention on Cycle Irregularities
Summary description of the study
Cycle disorders are common among premenopausal women and are usually attributed to hormonal causes. Conditions affecting the ovaries such as Polycystic Ovary Syndrome, thyroid diseases, disorders of the pituitary gland, as well as stress, excessive exercise, and eating disorders can be causative factors. Once the cause of the cycle disorder is identified, it can usually be treated hormonally or with other medications. Due to side effects, hormonal therapies are occasionally interrupted, making alternative methods necessary in these cases. Studies have shown that consistent lifestyle modifications in terms of dietary adjustments, physical activity, weight changes, and mindfulness can lead to the regulation of the female cycle. As access to medical information and mobile apps is facilitated by the use of smartphones today, this could positively contribute to lifestyle modification in cases of cycle disorders. However, there are currently no studies on mobile apps that offer programs to change lifestyle in cases of cycle disorders. NALU Health Sàrl has developed the NALU Cycle Flow App as a supportive measure for women with cycle disorders. This app includes texts, audios, and videos designed to support lifestyle changes. In our research project, we want to investigate whether the use of this app can lead to an improvement in cycle disorders. Furthermore, we aim to find out whether it is reasonable to use this app as a supportive measure in the context of cycle disorders in the future. For this purpose, we will compare a group of women with cycle disorders who use the app-based measures with a control group that does not. Participants will be randomly assigned to the groups.
(BASEC)
Intervention under investigation
The intervention being studied is the NALU Cycle Flow App, a lifestyle app designed to help women with irregular cycles regulate their cycles. This app offers a 10-week program consisting of various modules made up of videos, audios, and texts.
The app includes information about the menstrual cycle, lifestyle and mindset changes, as well as nutritional advice including recipes, physical exercises, and mindfulness exercises. Additionally, the app features a cycle and symptom diary. Furthermore, it provides access to a WhatsApp group for women with cycle disorders and monthly group meetings and Q&A sessions moderated by a certified health coach.
(BASEC)
Disease under investigation
Cycle irregularities, Polycystic Ovary Syndrome, hypothalamic amenorrhea, hyperprolactinemia, hypothyroidism
(BASEC)
- Premenopausal women aged 18 and older - Women with cycle disorders (oligomenorrhea or secondary amenorrhea) who initially refuse hormonal therapy - Ownership of a smartphone (BASEC)
Exclusion criteria
- Primary amenorrhea - Anatomical/organic causes of amenorrhea (e.g., Asherman syndrome, Mayer-Rokitansky-Küster-Hauser syndrome) - Perimenopause - Hormonal therapy - Current fertility treatment - Breastfeeding, pregnancy, postmenopause - Osteopenia, osteoporosis - Malignant disease - Medications or drugs that cause hyperprolactinemia (antipsychotics, antidepressants, opioids, etc.) - Simultaneous participation in other intervention studies (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselspital Bern, repräsentiert durch Prof. M.D. Mueller, Frauenklinik
(BASEC)
Contact
Contact Person Switzerland
Marietta Gulz
+41764497111
marietta.gulz@clutterinsel.chFrauenklinik Inselspital Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
30.07.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A mobile application as supportive treatment of menstrual cycle irregularities. A randomized controlled trial. Short title: SYNC –Trial (Supporting Your Natural Cycle) (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
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Type of trial
not available
Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available