TY  - JOUR
AU  - Cunningham, Adam C
AU  - Prentice, Carley
AU  - Peven, Kimberly
AU  - Wickham, Aidan
AU  - Bamford, Ryan
AU  - Radovic, Tara
AU  - Klepchukova, Anna
AU  - Fomina, Maria
AU  - Cunningham, Katja
AU  - Hill, Sarah
AU  - Hantsoo, Liisa
AU  - Payne, Jennifer
AU  - Zhaunova, Liudmila
AU  - Ponzo, Sonia
PY  - 2024
DA  - 2024/5/2
TI  - Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial
JO  - JMIR Mhealth Uhealth
SP  - e54124
VL  - 12
KW  - digital health
KW  - health literacy
KW  - menstrual cycle
KW  - period tracking app
KW  - women’s health
KW  - PMS
KW  - PMDD
KW  - tracking
KW  - app
KW  - application
KW  - tracking app
KW  - tracking application
KW  - menstrual
KW  - women
KW  - efficacy
KW  - general health
KW  - wellbeing
KW  - randomized controlled trial
KW  - awareness
KW  - symptoms
KW  - manage
KW  - management
KW  - premenstrual
KW  - premenstrual syndrome
KW  - premenstrual dysphoric disorder
KW  - reproductive
KW  - reproductive health
KW  - health management
KW  - communication
KW  - pregnancy
KW  - quality of life
KW  - productivity
KW  - education
KW  - functionality
AB  - Background: Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one’s own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. Objective: The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. Methods: We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). Results: The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=–7.08; t115=–5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=–0.61; t311=–2.73, P=.007), and fear of unplanned pregnancies (D̄=–0.22; t311=–2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=–1.67; t144=–2.49, P=.01). Conclusions: These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. Trial Registration: OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq 
SN  - 2291-5222
UR  - https://mhealth.jmir.org/2024/1/e54124
UR  - https://doi.org/10.2196/54124
UR  - http://www.ncbi.nlm.nih.gov/pubmed/38696773
DO  - 10.2196/54124
ID  - info:doi/10.2196/54124
ER  -