Informazioni generali
  • Categoria della malattia Malattie endocrinologiche (non cancro) , Malattie nutrizionali e metaboliche (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Berna
    (BASEC)
  • Responsabile dello studio Marietta Gulz marietta.gulz@insel.ch (BASEC)
  • Fonte dati BASEC: Importato da 30.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 30.07.2025 16:20
HumRes67118 | SNCTP000006516 | BASEC2025-D0012

The Effect of an App-Based Intervention on Cycle Irregularities

  • Categoria della malattia Malattie endocrinologiche (non cancro) , Malattie nutrizionali e metaboliche (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Berna
    (BASEC)
  • Responsabile dello studio Marietta Gulz marietta.gulz@insel.ch (BASEC)
  • Fonte dati BASEC: Importato da 30.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 30.07.2025 16:20

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

Cycle irregularities, Polycystic Ovary Syndrome, hypothalamic amenorrhea, hyperprolactinemia, hypothyroidism

(BASEC)

Criteri di partecipazione
- Premenopausal women aged 18 and older - Women with cycle disorders (oligomenorrhea or secondary amenorrhea) who initially refuse hormonal therapy - Ownership of a smartphone (BASEC)

Criteri di esclusione
- 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)

Luogo dello studio

Berna

(BASEC)

non disponibile

Sponsor

Inselspital Bern, repräsentiert durch Prof. M.D. Mueller, Frauenklinik

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Marietta Gulz

+41764497111

marietta.gulz@insel.ch

Frauenklinik Inselspital Bern

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Berna

(BASEC)

Data di approvazione del comitato etico

30.07.2025

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
A mobile application as supportive treatment of menstrual cycle irregularities. A randomized controlled trial. Short title: SYNC –Trial (Supporting Your Natural Cycle) (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile