A randomised controlled trial to test the efficacy of an m-health delivered physical activity and sleep intervention to improve sleep quality in middle-aged adults: The Refresh Study Protocol.

Introduction: Poor sleep health is common and has a substantial negative health impact. Physical activity has been shown to improve sleep health. Many sleep interventions do not explicitly target physical activity, potentially limiting changes in activity and also sleep. Few intervention target those with poor sleep health but without a diagnosed disorder. This study aims to examine the efficacy of a combined physical activity and sleep intervention to improve sleep quality in middle-aged adults and its effect on physical activity, depression and quality of life.

Methods: A three-arm randomised trial with a three-month primary time-point, will be conducted. Adults (N = 275) aged 40-65 years, who report physical inactivity and poor sleep quality, will be randomly allocated to either a combined Physical Activity and Sleep Health, a Sleep Health-Only or a Wait List Control group. The multi-component m-health intervention will be delivered using a smartphone/tablet "app", supplemented with email and SMS. Participants will use the app to access educational material, set goals, self-monitor and receive feedback about behaviours. Assessments will be conducted at baseline, three-month primary time-point and six-month follow-up. Generalized linear models using an ANCOVA (baseline-adjusted) approach, will be used to identify between-group differences in sleep quality, following an intention-to-treat principle.

Discussion: This study will determine whether the addition of a physical activity intervention enhances the effectiveness of a sleep intervention to improve sleep quality, relative to a sleep-only intervention, in physically inactive middle-aged adults who report poor sleep health, but without a sleep disorder.