The Effect of an App-Based Intervention on Cycle Irregularities
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Bern
(BASEC)
Sponsor
Inselspital Bern, repräsentiert durch Prof. M.D. Mueller, Frauenklinik
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Marietta Gulz
+41764497111
marietta.gulz@clutterinsel.chFrauenklinik Inselspital Bern
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.07.2025
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
A mobile application as supportive treatment of menstrual cycle irregularities. A randomized controlled trial. Short title: SYNC –Trial (Supporting Your Natural Cycle) (BASEC)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar