Physical inactivity and sedentary behaviours: screening and intervention in primary care, a prospective, multicentre, cluster-randomised, controlled, stepped-wedge study.

backgroundPhysical inactivity and sedentary behaviours (PiA/SED) are among the major modifiable risk factors for chronic diseases. Behaviour change models for PA can shape personalised interventions leading to sustainable lifestyle changes. We hypothesise that screening for PiA/SED by a general practitioner, followed by a personalised intervention by a physiotherapist, could reduce PiA/SED in inactive adults.

methodsWe designed a prospective, multicentre, cluster-randomised, controlled, step-wedge study. Adult patients without chronic illnesses will be recruited in 8 multi-professional health centres. They will receive educational content on PiA/SED. During the intervention periods, patients will see a physiotherapist for a functional assessment, and an intervention aimed at improving PiA/SED using a serious game. Two follow-up appointments at months 2 and 4 (M2-4) are planned to maintain patient motivation. At M6, a 7-day actimetry will be performed, and at M6-12, questionnaires and semi-structured interviews will close the study. Two primary endpoints will be analysed using a pre-specified hierarchical sequential analysis: the proportion of patients changing PiA/SED at M6. Secondary objectives include: 1-describing changes in PiA/SED at M6 and M12, 2-exploring the link between patient characteristics and changes in PiA/SED, 3-describing participants' quality of motivation, satisfaction of basic psychological needs, feelings of self-efficacy, perceived levels of vitality and energy, and self-esteem, 4-describing the strategies, barriers and facilitators of behavioural changes, 5-studying the correlation between questionnaires measuring physical activity and actimetry, 6-identifying the perceived barriers and facilitators to implement this care pathway. Assuming that 10% of patients in the control period will improve their PA and that the intervention will increase it by 20%, 160 patients provides 82% power to observe a significant difference. DISCUSSION: This design will harmonise the skills of all professionals in the field of motivational support for PiA/SED and providing information about the risks associated with PiA/SED. Patients in the intervention group will also receive individual support for behaviour changes related to PiA/SED. Considering public health, this study will contribute to increase primary prevention by healthcare professionals. Finally, this study will assess the effectiveness, adherence, satisfaction of the stakeholders involved in this pathway allowing to consider its implementation in routine primary care. SPIRIT 2025 CHECKLIST OF ITEMS: see supplement files.

trial registrationClinicalTrials n° NCT06678906, https://clinconnect.io/trials/NCT06678906#about-company-tab , first registration October 14, 2024, Trial updated February 05, 2025.