The Boost study: design of a school- and community-based randomised trial to promote fruit and vegetable consumption among teenagers

BACKGROUND: The aim of the Boost study was to produce a persistent increase in fruit and vegetable consumption among 13-year-olds. This paper describes the development, implementation and evaluation of a school-and community-based, multi-component intervention guided by theory, evidence, and best practice. METHODS/DESIGN: We used the Intervention Mapping protocol to guide the development of the intervention. Programme activities combined environmental and educational strategies and focused on increasing access to fruit and vegetables in three settings: School: Daily provision of free fruit and vegetables; a pleasant eating environment; classroom curricular activities; individually computer tailored messages; one-day-workshop for teachers. Families: school meeting; guided child-parent activities; newsletters. Local community: guided visits in grocery stores and local area as part of classroom curriculum; information sheets to sports-and youth clubs. The Boost study employed a cluster-randomised controlled study design and applied simple two-stage cluster sampling: A random sample of 10 municipalities followed by a random sample of 4 schools within each municipality (N = 40 schools). Schools were randomised into a total of 20 intervention-and 20 control schools. We included all year 7 pupils except those from school classes with special needs. Timeline: Baseline survey: August 2010. Delivery of intervention: September 2010-May 2011. First follow-up survey: May/June 2011. Second follow-up survey: May/June 2012. Primary outcome measures: Daily mean intake of fruit and vegetables and habitual fruit and vegetable intake measured by validated 24-hour recall-and food frequency questionnaires. Secondary outcome measures: determinants of fruit and vegetable intake, positive side-effects and unintended adverse effects. Implementation was monitored by thorough process evaluation. DISCUSSION: The baseline data file included 2,156 adolescents (95%). There was baseline equivalence between intervention-and control groups for sociodemographics, primary outcomes, and availability at home, school and sports-and youth clubs. Significantly larger proportions of pupils in the control group had parents born in Denmark. The study will provide insights into effective strategies to increase fruit and vegetable intake among teenagers. The study will gain knowledge on implementation processes, intervention effects in population subgroups with low intake, and opportunities for including local communities in interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11666034

Effect of specialised versus generalised outpatient treatment for bipolar disorder:The CAG Bipolar trial-study protocol for a randomised controlled trial

INTRODUCTION: Despite current available treatment patients with bipolar disorder often experience relapses and decreased overall functioning. Furthermore, patients with bipolar disorder are often not treated medically or psychologically according to guidelines and recommendations. A Clinical Academic Group is a new treatment initiative bringing together clinical services, research, education and training to offer care and treatment that is based on reliable evidence backed up by research. The present Clinical Academic Group for bipolar disorder (the CAG Bipolar) randomised controlled trial (RCT) aims for the first time to investigate whether specialised outpatient treatment in CAG Bipolar versus generalised community-based treatment improves patient outcomes and clinician’s satisfaction with care in patients with bipolar disorder. METHODS AND ANALYSIS: The CAG Bipolar trial is a pragmatic randomised controlled parallel-group trial undertaken in the Capital Region of Denmark covering a catchment area of 1.85 million people. Patients with bipolar disorder are invited to participate as part of their outpatient treatment in the Mental Health Services. The included patients will be randomised to (1) specialised outpatient treatment in the CAG Bipolar (intervention group) or (2) generalised community-based outpatient treatment (control group). The trial started 13 January 2020 and has currently included more than 600 patients. The outcomes are (1) psychiatric hospitalisations and cumulated number and duration of psychiatric hospitalisations (primary), and (2) self-rated depressive symptoms, self-rated manic symptoms, quality of life, perceived stress, satisfaction with care, use of medication and the clinicians’ satisfaction with their care (secondary). A total of 1000 patients with bipolar disorder will be included. ETHICS AND DISSEMINATION: The CAG Bipolar RCT is funded by the Capital Region of Denmark and ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248). Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets. TRIAL REGISTRATION NUMBER: NCT04229875