BACKGROUND: Promotion of physical activity (PA) is a key strategy to prevent non-communicable diseases. However, evidence on the effectiveness of community-wide interventions (CWIs) for promoting PA is limited. PURPOSE: To evaluate the effectiveness of a 3-year CWI for promoting PA in middle-aged and older adults compared with usual public health services. This study is an extension to an original 1-year investigation study. DESIGN: Cluster randomized controlled trial with community as unit of randomization and individual as unit of analysis. SETTING/PARTICIPANTS: 12 communities in Unnan, Japan were randomly allocated to the intervention (9) or the control (3). Additionally intervention communities were randomly allocated to aerobic activity promotion (group A), flexibility and muscle-strengthening activities promotion (group FM), or aerobic, flexibility, and muscle-strengthening activities promotion (group AFM), each consisting of three communities. Randomly-sampled 4,414 residents aged 40 to 79 years responded to the baseline survey (74%), and were analyzed in 2013 to 2014. INTERVENTION: A 3-year CWI based on social marketing, to promote PA from 2009 to 2012. MAIN OUTCOME MEASURES: The primary outcome was a change in regular aerobic, flexibility, and/or muscle-strengthening activities, defined by (1) engaging in 150 mins/week or more of walking, (2) engaging in daily flexibility activity, or (3) engaging 2 or more days/week in muscle-strengthening activities, evaluated at the individual level. Secondary outcomes were changes in specific types of PA and musculoskeletal pain. Outcomes were measured at baseline and at 1 and 3 years (2009, 2010, and 2012). RESULTS: The CWI did not significantly increase the proportion of adults who reached recommended levels of aerobic, flexibility, and/or muscle-strengthening activities (adjusted change difference 1.6% (95% CI -3.5 to 6.6)). In the subgroup analysis, compared to the controls, adults doing flexibility activity daily significantly increased in group FM (6.3% (95% CI 1.9 to 10.7)). In group A and AFM for PA outcomes and in all groups for pain outcomes, there was no significant change compared to controls. CONCLUSIONS: The CWI did not achieve significant increase in the proportion of adults who reached recommended PA levels. However, it might be effective in promoting flexibility activity in middle-aged and older Japanese. TRIAL REGISTRATION: UMIN-CTR UMIN000002683.

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