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NCT Number: NCT06678906

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

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.

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Key information

Conditions

Primary Care Behavior Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention arm

Behavioral

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 outcomes

  1. 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

    • 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
    • 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

  1. 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

    ONAPS-PAQ questionnaire score

  2. 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

    7-day accelerometry measurement

  3. 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

    Degree of correlation between the socio-demographic categories (age, sex, socio-economic category, environment and place of residence, type and work hours) and 7-day accelerometry measurement

  4. Describe the quality of motivation initially (Month 0), at 6 months, and at 12 months.

    Time frame: 12 monts

    MAPS questionnaire score

  5. Describe the satisfaction of basic psychological needs at 6 months, and at 12 months.

    Time frame: 12 monts

    Basic Psychological Needs Scale score

  6. 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

    Score obtained at perceived competence scale for engaging in a personalized physical activity program

  7. Describe the perceived level of vitality and energy initially (M0), at 6 months, and at 12 months.

    Time frame: 12 monts

    Score obtained at perceived vitality and energy scale

  8. Describe the self-esteem initially (M0), at 6 months, and at 12 months.

    Time frame: 12 monts

    Score obtained at the self-esteem scale

  9. Describe at M6 and M12 the strategies, barriers, and facilitators to patients' behavior change.

    Time frame: 12 months

    Extraction of coaching verbatims coupled with a qualitative survey using semi-structured interviews on a sample of volunteer patients who may or may not have benefited from the intervention at 6 months and 12 months.

  10. Study the relationship between ONAPS-PAQ results and 7-day actimetry in this population category (inactive and/or sedentary).

    Time frame: 12 months

    Degree of correlation between categorizations obtained by energy expenditure from accelerometry and the ONAPS-PAQ questionnaire

  11. Identify perceived barriers and facilitators to implementation in primary care at 12 months among different stakeholders (general practitioners, physiotherapists, patients).

    Time frame: 12 months

    Score obtained on the scale of level of satisfaction and perception of the project's implementation in primary care by the various players: doctors, physiotherapists and patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle BOUDRY, PhD

CONTACT

[email protected]

+33 47 67 66 645

Nicolas PINSAULT, Professor

CONTACT

[email protected]

+33 45 70 413 17

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Center - University Hospital Grenoble
  • Department of Physiotherapy - Grenoble Alpes University - TIMC LAboratory (UMR-UGA-CNRS-5525)

Registry information

Acronym: IPSEDI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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