Research AppraisalRandomised Controlled Trial

Determinants of dropout from lifestyle interventions for overweight polycystic ovary syndrome: An exploratory analysis of randomized controlled trial.

PloS oneXie, Min, Zhou, Siyu, Wu, Jing et al.DOI

Clinical Snapshot

45CEBM
Evidence: WeakRandomised Controlled Trial

PICO Framework

P — PopulationOverweight or insulin-resistant women with polycystic ovary syndrome (PCOS) aged 18–45 years
I — InterventionStructured lifestyle intervention program combined with cyclic progestin and metformin
C — ComparatorNo separate comparator arm for dropout analysis; completers versus dropouts within the same intervention cohort
O — OutcomesPrimary: dropout from the lifestyle intervention program within one year (defined as proactive withdrawal, missing two consecutive visits, or loss of contact >6 months). Secondary: baseline predictors of dropout, including physical activity level (PAL) measured by accelerometry

Bottom Line

This exploratory analysis of a single-arm lifestyle intervention for overweight women with PCOS identifies baseline physical activity level (PAL), measured objectively by accelerometry, as the strongest predictor of dropout over one year. The 61% dropout rate within the parent trial is alarming and itself represents a major threat to the validity of any efficacy conclusions from that study. The finding that lower baseline PAL predicts dropout is clinically plausible and actionable — women who are least physically active at baseline may require more intensive behavioural support to sustain engagement with lifestyle programs. However, the study is limited by its single-centre design, small sample size, absence of reported confidence intervals, and exploratory nature. The multivariable logistic regression model is at risk of overfitting given the event-to-variable ratio. Clinicians designing PCOS lifestyle programs should consider routine physical activity assessment at enrolment and proactively intensify support for sedentary women. These findings are hypothesis-generating and require prospective validation before formal incorporation into clinical guidelines. The 2023 International PCOS Guideline's emphasis on individualised lifestyle counselling is consistent with this study's conclusions.

Evidence: Weak

Key Findings

  • P Value: Not specified in the abstract for the primary predictor

  • Effect Size: Each 0.3-unit increase in baseline physical activity level (PAL) was associated with a 29.6% reduction in the likelihood of dropout

  • Primary Outcome: Dropout from the lifestyle intervention program within one year: 61.06% (n=69) of participants dropped out

  • Nnt Or Sensitivity: NNT not calculable from available data; odds ratio with confidence intervals not provided in abstract. The 29.6% relative risk reduction per 0.3-unit PAL increment is the primary effect estimate reported

  • Confidence Interval: Not reported in the abstract; full paper required for assessment

Clinical Application

Accelerometer-based PAL measurement is feasible in research settings but may not be routinely available in standard clinical practice. Consumer-grade wearable devices (e.g., Fitbit, Apple Watch) could serve as accessible proxies, though their validity for PAL measurement in this population requires evaluation. The recommendation to provide 'personalised support' to low-PAL women is clinically intuitive but operationally undefined in this paper. In Australia, PCOS affects approximately 8–13% of women of reproductive age and is a leading cause of anovulatory infertility. RACGP and the 2023 International Evidence-Based Guideline for the Assessment and Management of PCOS (developed with NHMRC support) strongly recommend lifestyle intervention as first-line management for overweight women with PCOS. Metformin is PBS-listed for type 2 diabetes but its use in PCOS is off-label in Australia, consistent with the study's protocol. The high dropout rate identified in this study is directly relevant to Australian general practitioners and gynaecologists designing PCOS lifestyle programs. Accelerometry is not routinely funded under Medicare for this indication. The finding supports consideration of physical activity assessment tools (including validated questionnaires or wearables) at enrolment into PCOS lifestyle programs, aligned with the RACGP's emphasis on personalised chronic disease management. Overweight or insulin-resistant women with PCOS aged 18–45 years being enrolled in structured lifestyle intervention programs, particularly in tertiary or specialist reproductive endocrinology settings

Abstract

OBJECTIVE: This exploratory analysis of a randomized controlled trial aimed to identify baseline predictors of dropout in overweight women with polycystic ovary syndrome (PCOS) participating in a lifestyle intervention program. METHODS: An exploratory analysis was conducted using data from a randomized controlled trial involving overweight or insulin-resistant women with PCOS aged 18-45. All participants received cyclic progestin, metformin, and a structured lifestyle intervention. Dropout was defined as proactive withdrawal, missing two consecutive visits, or loss of contact for more than six months. Univariate and adjusted multivariable logistic regression models were used to identify factors associated with dropout. RESULTS: Among the participants, 61.06% (n = 69) dropped out within one year. No significant differences were observed in baseline demographic, clinical, biochemical, psychological, or dietary characteristics between completers and dropouts. However, baseline physical activity level (PAL), objectively measured using an accelerometer, was identified as the strongest predictor of dropout. Each 0.3-unit increase in PAL was associated with a 29.6% reduction in the likelihood of dropout. CONCLUSION: Baseline PAL is strongly associated with the risk of dropout. Screening for PAL in women with PCOS is recommended, and those with lower PAL should receive personalized support in addition to lifestyle interventions to improve adherence and promote weight loss.

References

  1. 1.Xie, M., Zhou, S., Wu, J., Luo, X., Guo, Y., Qiao, L., & Zhang, J. (2026). Determinants of dropout from lifestyle interventions for overweight polycystic ovary syndrome: An exploratory analysis of randomized controlled trial. PLOS ONE. https://doi.org/10.1371/journal.pone.0351575
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