Study protocol of the Healthy High School study: a school-based intervention to improve well-being among high school students in Denmark.

Background: The prevalence of low well-being, perceived stress and unhealthy behaviours is high among high school students, but few interventions have addressed these problems. The aim of this paper is to present a study protocol of a cluster randomised controlled trial evaluating the Healthy High School (HHS) intervention programme. The intervention programme is designed to improve well-being (primary outcome) by preventing 1) stress and promoting 2) sleep, 3) sense of community, 4) physical activity (PA) and 5) regular and healthy meals among high school students in Denmark.

Methods: The development of the HHS study was guided by the Intervention Mapping protocol. The intervention comprises four components: 1) a teaching material, 2) a smartphone app, 3) a catalogue focusing on environmental changes, and 4) a peer-led innovation workshop aiming at inspiring students to initiate and participate in various movement activities. The HHS study employs a cluster-randomised controlled trial design. Thirty-one high schools across Denmark were randomly allocated to intervention (16 schools) or control (15 schools) groups. The study included all first-year students (~ 16 years of age) (n = 5976 students). Timeline: Intervention: August 2016 - June 2017. Collection of questionnaire data: Baseline (August 2016), 1st follow-up (May 2017) and 2nd follow-up (April 2018). All students were invited to participate in a monthly sub-study about perceived stress using text messages for data collection (September 2016 - June 2017). PA was objectively assessed among a sub-sample of students using accelerometers (Axivity, AX3) in August 2016 and May 2017.

Primary Outcome Measures: Student well-being measured by the Cantril Ladder and the five item World Health Organisation Well-being Index (individual level outcomes).

Secondary Outcome Measures: Stress (10-item Perceived Stress Scale), sleep (quantity and quality), PA (hours of moderate-to-vigorous PA per week, hours of daily sedentary time and average daily PA), meal habits (daily intake of breakfast, lunch, snacks and water), and strong sense of community in class and at school, respectively (individual level outcomes). The study encompasses process and effect evaluation as well as health economic analyses.

Trial Registration: ISRCTN ISRCTN43284296, 28 April 2017, retrospectively registered.