Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial

Abstract

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.

Keywords: PMDD; PMS; app; application; awareness; communication; digital health; education; efficacy; functionality; general health; health literacy; health management; manage; management; menstrual; menstrual cycle; period tracking app; pregnancy; premenstrual; premenstrual dysphoric disorder; premenstrual syndrome; productivity; quality of life; randomized controlled trial; reproductive; reproductive health; symptoms; tracking; tracking app; tracking application; wellbeing; women; women’s health.

Figure 1

Example of the Flo user interface including the main screen, tiles linking to educational content, cycle day information, and the symptom logging interface.

Figure 2

Participant flow diagram through trial 1 (cycle tracking) and trial 2 (premenstrual syndrome or premenstrual dysphoric disorder) intention-to-treat analysis. IG: intervention group; CG: control group; PSST: Premenstrual Screening Tool.

Figure 3

Estimated mean health literacy scores and 95% CIs from Mixed Models for Repeated Measures analysis at screening and end of intervention for the (A) intention-to-treat trial 1 (cycle tracking) and (B) intention-to-treat trial 2 (PMS or PMDD). PMDD: premenstrual dysphoric disorder; PMS: premenstrual syndrome.

Figure 4

Estimated mean self-reported menstrual health awareness scores and 95% CIs from ITT MMRM analysis at baseline and 12 weeks after baseline for trial 1 (cycle tracking).

Figure 5

Estimated mean general health and well-being scores and 95% CIs from intention-to-treat Mixed Models for Repeated Measures approach analysis at screening, 6 weeks, and 12 weeks after baseline for trial 1 (cycle tracking).

Figure 6

Intention-to-treat Mixed Models for Repeated Measures estimated mean Premenstrual Screening Tool scores at each timepoint for intention-to-treat trial 2 (premenstrual syndrome or premenstrual syndrome).