Clinical Research Directory

Intervention to Reduce Sedentary Behavior During School Recess Among Adolescents

This cluster randomized controlled trial evaluated the effectiveness of an 8-week, school-based behavioural intervention grounded in the Multi-Process Action Control (M-PAC) framework in promoting interruption of sedentary behaviour during school breaks among adolescents. Twelve primary and secondary schools in China, were recruited and randomly allocated (at the school level) to either an intervention group or a control group to minimise contamination and support pragmatic delivery within the school setting. Schools assigned to the intervention group implemented a multi-component programme comprising educational materials, teacher-delivered guidance, peer reminders, and health lectures, whereas control schools continued their usual routines without receiving intervention materials. The primary outcome was interruption of sedentary behaviour during school breaks assessed using self-reported measures. Secondary outcomes included physical activity levels, emotional and behavioural problems, executive function, and psychological factors related to behaviour regulation, such as motivation, planning, and habit. Findings from this trial are intended to inform the development and implementation of feasible, theory-informed school strategies to reduce sedentary behaviour during school breaks.

Reducing and Breaking up School-related Sedentary Behaviour Among Adolescents Using Co-creation

Adolescents spend the majority of the day sedentary, especially at school whilst sitting in class and at home when performing school-related tasks. As high levels of sedentary time are associated with adverse health effects, effective interventions are needed. To improve effectiveness, literature recommends a co-creative approach in which adolescents and other key stakeholders (such as teachers) are actively involved in the choice and development of intervention strategies. Therefore, this project aims to co-adapt a previously co-created intervention targeting adolescents' school-related sedentary behaviour. Further, the effect of this co-adapted intervention on adolescents' sedentary behaviour and related determinants, sleep, and mental wellbeing will be evaluated via a three-arm clustered controlled trial, including a co-adaptation intervention arm, a standard intervention arm (including schools that were not involved in co-adapting the intervention) and a control arm (continuing their curriculum as usual). By comparing these three arms, the investigators can evaluate the added value of co-creation compared to not involving adolescents or stakeholders in the development of an intervention. Lastly, the investigators will conduct a process evaluation of (1) the co-adaptation approach used to adapt the co-created intervention and (2) the implementation of both the co-adapted and standard interventions. Studies that evaluate co-created interventions are scarce. However, if such interventions prove to be more effective, this approach could be promising to change adolescents' health behaviour.

Effectiveness of the RISE Intervention

Study aim: Primarily, to investigate the effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent major adverse cardiovascular events (i.e., recurrent stroke or TIA, acute coronary events and cardiovascular death, MACE) after 1 year follow-up compared to standard care, and cost-effectiveness. For this aim, 376 persons are enrolled in the experimental group and 376 in the control group. Considering loss to follow up, it is expected that around 950-1000 patients need to be included during baseline measurement in total. Additionally, to determine the effectiveness of the RISE intervention on reducing sedentary behaviour after discharge from acute hospital care in community dwelling people with a first-ever stroke, who have a sedentary movement behavioural pattern (so called 'sedentary prolongers' and 'sedentary movers') in comparison to usual care, at the end of the intervention period (T1). For this aim, 59 persons are enrolled in the experimental group and 59 in the control group. Considering loss to follow up, it is expected that around 197 patients need to be included during baseline measurement in total. Who can participate? People aged over 18, who return home after acute care with a first-ever stroke, who are independent in walking with or without a walking aid, will be included in the RISE intervention study. What does the study involve? In this clinical randomized controlled trial, participants with first-ever stroke and a sedentary movement pattern will be included and randomly assigned to either the experimental group who will receive RISE intervention and usual care or the control group who will receive usual care. Primary and secondary outcome will be measured at baseline, post-treatment and six, nine and 12 months post-randomisation.

Click2Move Intervention to Reduce Home-office Workers' Sedentary Behaviour.

The goal of this clinical evaluate the effectiveness of the Ckick2Move Programme, a multicomponent digital-based intervention, to reduce sedentary behaviour among home-office workers, and the impact on employees physcial activity patterns, musculoskeletal risk and work-related outcomes (i.e., absenteeism, presenteeism, occupational fatigue and job satisfaction). The study will take place in four countries along Europe (Spain, Ireland, Netherlands, and Slovenia).