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Clinical Trials/NCT06678906
NCT06678906
Not Yet Recruiting
N/A

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

University Hospital, Grenoble1 site in 1 country160 target enrollmentMay 2025
ConditionsPrimary Care

Overview

Phase
N/A
Intervention
Not specified
Conditions
Primary Care
Sponsor
University Hospital, Grenoble
Enrollment
160
Locations
1
Primary Endpoint
Evaluate the 6-month effectiveness of an individualized intervention by a physiotherapist, on physical activity and sedentary behavior in adult patients without chronic diseases
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2025
End Date
January 2027
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

1. Proportion of patients changing to a higher physical activity category, measured by actimetry, between inclusion and M6, defined as: from inactive to moderately active or very active 2. Proportion of patients changing to a lower sedentary behavior category, measured by actimetry, between inclusion and M6, defined as: from high sedentary behavior to moderate sedentary behavior or non-sedentary and from moderate sedentary behavior to non-sedentary

Secondary Outcomes

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

Study Sites (1)

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