Clinical trial NCT06678906: Physical Inactivity and Sedentary Behavior: Screening and Intervention in Ambulatory Primary Care
Official title: Physical Inactivity and Sedentary Behavior: Screening and Intervention in Ambulatory Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Care
Keywords: Physical inactivity
Sedendary behavior
Innovative personalized support by physiotherapist
Ambulatory primary care
Healthcare pathway
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Center - University Hospital Grenoble
name: Department of Physiotherapy - Grenoble Alpes University - TIMC LAboratory (UMR-UGA-CNRS-5525)
First posted: 2024-11-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster randomization will be conducted according to the "stepped wedge" design.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluate the 6-month effectiveness of an individualized intervention by a physiotherapist, on physical activity and sedentary behavior in adult patients without chronic diseases
timeFrame: 6 months
Secondary outcomes:
measure: Describe the evolution of patients' physical activity and sedentary behavior levels at 6 months (for behavior change) and 12 months (for behavior maintenance).
timeFrame: 12 months
measure: Quantify the evolution of patients' physical activity and sedentary behavior levels at 6 months (for behavior change) and 12 months (for behavior maintenance).
timeFrame: 12 months
measure: Explore the relationship between patient characteristics and changes (at 6 months) and maintenance (at 12 months) of physical activityand sedentary behavior levels.
timeFrame: 12 months
measure: Describe the quality of motivation initially (Month 0), at 6 months, and at 12 months.
timeFrame: 12 monts
measure: Describe the satisfaction of basic psychological needs at 6 months, and at 12 months.
timeFrame: 12 monts
measure: Describe the self-efficacy perceived competence scale for engaging in a personalized physical activity program at 6 months and at 12 months.
timeFrame: 12 monts
measure: Describe the perceived level of vitality and energy initially (M0), at 6 months, and at 12 months.
timeFrame: 12 monts
measure: Describe the self-esteem initially (M0), at 6 months, and at 12 months.
timeFrame: 12 monts
measure: Describe at M6 and M12 the strategies, barriers, and facilitators to patients' behavior change.
timeFrame: 12 months
measure: Study the relationship between ONAPS-PAQ results and 7-day actimetry in this population category (inactive and/or sedentary).
timeFrame: 12 months
measure: Identify perceived barriers and facilitators to implementation in primary care at 12 months among different stakeholders (general practitioners, physiotherapists, patients).
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Martin d'Hères
country: France
facility: Pr Nicolas PINSAULT
Study officials:
affiliation: Physiotherapy department - Grenoble Alpes University
name: Nicolas PINSAULT, Professor
role: PRINCIPAL_INVESTIGATOR
References: