Design of a school-based randomized trial to reduce smoking among 13 to 15-year olds, the X:IT study.

BACKGROUND: Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%. METHODS/DESIGN: The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%). DISCUSSION: The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77415416.

Developing and Evaluating a Data-Driven and Systems Approach to Health Promotion Among Vocational Students: Protocol for the Data Health Study.

BACKGROUND: Vocational school students exhibit significant risk behaviors in terms of poor diet, frequent use of nicotine products, inadequate fruit and vegetable intake, low levels of physical activity, and poor mental health. This makes vocational students vulnerable to the development of noncommunicable diseases. Therefore, effective health promotion programs targeting vocational students are required. OBJECTIVE: The Danish study "Data-driven and Systems Approach to Health Promotion Among Vocational Students" (Data Health) aims to develop, implement, and evaluate a systems approach to support vocational schools, municipalities, and local communities in implementing locally relevant health promotion actions among and for vocational students. This paper describes the Data Health program and how implementation and preliminary effectiveness will be evaluated. METHODS: The Data Health program offers an iterative 5-step process to develop changes in the systems that shape health behavior and well-being among vocational students. The program will be implemented and evaluated in 8 Danish vocational schools in 4 municipalities. The implementation of the process and actions will be explored using a systems-based evaluation design that assesses contextual differences and the mechanisms through which the program leads to changes in the systems. Preliminary effectiveness at the individual level (students' self-reported health behavior and well-being) and organizational level (school organizational readiness reported by school staff) will be assessed using a quasi-experimental design, and cross-sectional data will be collected at all 8 schools simultaneously 4 times during the 2-year study period. RESULTS: This study was launched in 2021, and data collection is expected to be completed in June 2024. The first results are expected to be submitted for publication in January 2024. CONCLUSIONS: We expect that the Data Health study will make significant contributions to complex intervention research by contributing to the paucity of research studies that have used systems approaches in school settings. The study will also provide evidence of successful elements for systems change and effectiveness to determine whether a national scale-up can be recommended. TRIAL REGISTRATION: ClinicalTrials.gov NCT05308459; https://clinicaltrials.gov/study/NCT05308459. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52571.

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes.

OBJECTIVE: To design an appealing time-restricted eating (TRE) intervention by exploring behavioral and social mechanisms to improve TRE adoption and maintenance among people with type 2 diabetes (T2D) and overweight. Time-restricted eating is an intermittent fasting regimen suggested to improve glycemic control and body weight. METHODS: Intervention development combined coherence theory and empirical data (workshops and semistructured interviews with the target group, their relatives, and health care professionals [HCPs]). Abductive analysis was applied. RESULTS: The analysis suggested designing the TRE intervention in 2 phases: a short period with strict TRE, followed by a longer period focusing on adapting TRE to individual needs with support from HCPs, relatives, and peers. To reinforce TRE motivation and maintenance, HCPs should adopt a whole-person approach that focuses on participants' previous experiences. CONCLUSIONS AND IMPLICATIONS: Important intervention elements to promote TRE adoption and maintenance are suggested to include a 2-phase design and support from professionals, family, and peers.

Health Literacy is Associated with Health Behaviors in Students from Vocational Education and Training Schools: A Danish Population-Based Survey.

Health literacy has been identified as an important and changeable intermediary determinant of health equity. Vocational education and training (VET) schools are a relevant setting for health behavior interventions seeking to diminish health inequities because many VET students come from low socio-economic status backgrounds. This study examines VET students' health literacy and its association with health behavior based on a cross-sectional survey among 6119 students from 58 VET schools in Denmark in 2019. Two scales from the Health Literacy Questionnaire was used to assess domains of health literacy. Data were analyzed using Anova and logistic regression. The study population consisted of 43.4% female, and mean age was 24.2 years (range 15.8-64.0). The health literacy domain 'Actively managing my health' mean was 2.51, SD 0.66, and 'Appraisal of health information' mean was 2.37, SD 0.65. For both domains, being female, older age, attending the VET educational program Care-health-pedagogy, and higher self-rated health were associated with higher scale scores. In the adjusted analyses, lower scale scores were associated with less frequent breakfast, daily smoking, high-risk alcohol behavior and moderate-to-low physical activity. Our results show that low health literacy is associated with unhealthy behaviors in this population. Our results support and inform health literacy research and practice in educational institutions and services.