Physical Inactivity and Sedentary Behavior: Screening and Intervention in Ambulatory Primary Care

Overview

Physical inactivity and sedentary behaviors are among the leading modifiable risk factors for chronic diseases. In France, despite the national Sport Health strategy, awareness campaigns physical inactivity and sedentary behavior worsened between 2005 and 2015. Primary healthcare professionals, including general practitioners and physiotherapists already involved in tertiary prevention, can act for primary and secondary prevention.

Detailed description

In this study, we hypothesize that an innovative care pathway based on opportunistic screening by general practitioners to assess levels of physical activity and sedentary behavior, and an individualized intervention by a physiotherapist effectively supports behavioral changes towards increased physical activity and reduced sedentary behavior at 6 months in inactive adults without chronic conditions.

This multicenter study, employing an innovative stepped-wedge cluster methodology, will enable healthcare professionals from all included multidisciplinary health centers to enhance their skills in supporting health behavior changes.

For all patients, participation in the study should lead to an increased awareness of the risks associated with physical inactivity and sedentary behaviors.

Interventions

• Behavioral Intervention arm
  All patients in the intervention group will benefit from the standard information phase on physical activity and sedentary behavior, as well as personalized support for behavior change in the form of a serious game and remote coaching.

Primary outcome measures

• Evaluate the 6-month effectiveness of an individualized intervention by a physiotherapist, on physical activity and sedentary behavior in adult patients without chronic diseases [Time frame: 6 months]

Secondary outcome measures (11)

• Describe the evolution of patients' physical activity and sedentary behavior levels at 6 months (for behavior change) and 12 months (for behavior maintenance). [Time frame: 12 months]
• Quantify the evolution of patients' physical activity and sedentary behavior levels at 6 months (for behavior change) and 12 months (for behavior maintenance). [Time frame: 12 months]
• Explore the relationship between patient characteristics and changes (at 6 months) and maintenance (at 12 months) of physical activityand sedentary behavior levels. [Time frame: 12 months]
• Describe the quality of motivation initially (Month 0), at 6 months, and at 12 months. [Time frame: 12 monts]
• Describe the satisfaction of basic psychological needs at 6 months, and at 12 months. [Time frame: 12 monts]
• Describe the self-efficacy perceived competence scale for engaging in a personalized physical activity program at 6 months and at 12 months. [Time frame: 12 monts]
• Describe the perceived level of vitality and energy initially (M0), at 6 months, and at 12 months. [Time frame: 12 monts]
• Describe the self-esteem initially (M0), at 6 months, and at 12 months. [Time frame: 12 monts]
• Describe at M6 and M12 the strategies, barriers, and facilitators to patients' behavior change. [Time frame: 12 months]
• Study the relationship between ONAPS-PAQ results and 7-day actimetry in this population category (inactive and/or sedentary). [Time frame: 12 months]
• Identify perceived barriers and facilitators to implementation in primary care at 12 months among different stakeholders (general practitioners, physiotherapists, patients). [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• Adult patients
• Not benefiting from Long-Term Illness coverage
• Followed in primary outpatient care by one of the participating centers
• Patients identified as "inactive" by the ONAPS-PAQ questionnaire during an appointment with a general practitioner in the partner Multi-Professional Health Centers, whether sedentary or not
• Patient having signed informed consent to participate in the study
• Patients who understand and speak French
• Persons affiliated with a social security scheme or beneficiaries of a similar scheme
• Patients classified as "inactive" (< 600 MET.min/week) after 7-day actimetry analysis

Exclusion criteria

• Patient receiving follow-up for another reason with physiotherapists participating in the protocol
• Persons referred to in articles L1121-5 to L1121-8 of the Public Health Code
• Patient participating in another interventional research study with an exclusion period still ongoing at pre-inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Pr Nicolas PINSAULT — Saint-Martin-d'Hères

Publications

• Pinsault N, Rey S, Druart L, Guizon AH, Debru R, Roustit M, Pison C. Physical inactivity and sedentary behaviours: screening and intervention in primary care, a prospective, multicentre, cluster-randomised, controlled, stepped-wedge study. BMC Public Health. 2025 Nov 14;25(1):3951. doi: 10.1186/s12889-025-25410-4. PMID 41239336

Identifiers

NCT: NCT06678906 · 38RC23.031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗