BACKGROUND: Step-count monitors (pedometers, body-worn trackers and smartphone applications) can increase walking, helping to tackle physical inactivity. We aimed to assess the effect of step-count monitors on physical activity (PA) in randomised controlled trials (RCTs) amongst community-dwelling adults; including longer-term effects, differences between step-count monitors, and between intervention components. METHODS: Systematic literature searches in seven databases identified RCTs in healthy adults, or those at risk of disease, published between January 2000 to April 2020. Two reviewers independently selected studies, extracted data and assessed risk of bias. Outcome was mean differences (MD) with 95% confidence intervals (CI) in steps at follow-up between treatment and control groups. Our preferred outcome measure was from studies with follow-up steps adjusted for baseline steps (change studies); but we also included studies reporting follow-up differences only (end-point studies). Multivariate-meta-analysis used random-effect estimates at different time-points for change studies only. Meta-regression compared effects of different step-count monitors and intervention components amongst all studies at <= 4 months. RESULTS: Of 12,491 records identified, 70 RCTs (at generally low risk of bias) were included, with 57 trials (16,355 participants) included in meta-analyses: 32 provided change from baseline data; 25 provided end-point only. Multivariate meta-analysis of the 32 change studies demonstrated step-counts favoured intervention groups: MD of 1,126 steps/day 95%CI (787 to 1,466) at <= 4 months, 1,050 steps/day (602 to 1,498) at 6 months, 464 steps/day (301 to 626) at 1 year, 121 steps/day (-64 to 306) at 2 years and 434 steps/day (191 to 676) at 3 to 4 years. Meta-regression of the 57 trials at <= 4 months demonstrated in mutually-adjusted analyses that: end-point were similar to change studies (+257 steps/day (-417 to 931)); body-worn trackers/smartphone applications were less effective than pedometers (-834 steps/day (-1542 to -126)); and interventions providing additional counselling/incentives were not better than those without (-812 steps/day (-1,503 to -122)). CONCLUSIONS: Step-count monitoring leads to short and long-term step-count increases, with no evidence that either body-worn trackers/smartphone applications, or additional counselling/incentives offer further benefit over simpler pedometer-based interventions. Simple step-count monitoring interventions should be prioritised to address the public health physical inactivity challenge. SYSTEMATIC REVIEW REGISTRATION: PROSPERO number CRD42017075810.

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