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Primary CareIPSEDINCT06678906

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

A study testing Intervention arm in people with Primary Care, run by University Hospital, Grenoble at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Care
What is being tested?
Intervention arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteFrance
Study dates
May 2025to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas PINSAULT, Professor contact

+33 45 70 413 17

nicolas.pinsault@univ-grenoble-alpes.fr

Isabelle BOUDRY, PhD contact

+33 47 67 66 645

iboudry@chu-grenoble.fr

France1 site

  • Pr Nicolas PINSAULT

    Saint-Martin-d'Hères, 38400

    Nicolas PINSAULT, Professor, nicolas.pinsault@univ-grenoble-alpes.fr

    Isabelle BOUDRY, PhD, +33 47 67 66 645, iboudry@chu-grenoble.fr

Other trials in France

About this study

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.

Read the 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.

Conditions
Primary Care
Being tested
Intervention arm
Keywords
Physical inactivity, Sedendary behavior, Innovative personalized support by physiotherapist, Ambulatory primary care, Healthcare pathway
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention armBehavioural

    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.

Study groups in NCT06678906
Study groupRoleWhat they receive
Control armNo interventionControl group will receive standard information about physical activity and sedentary lifestyle.
Intervention armExperimentalAll 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.
Receives: Behavioral: Intervention arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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

    Measured: 6 months

Secondary outcomes (11)

  1. Describe the evolution of patients' physical activity and sedentary behavior levels at 6 months (for behavior change) and 12 months (for behavior maintenance).

    ONAPS-PAQ questionnaire score

    Measured: 12 months

  2. Quantify the evolution of patients' physical activity and sedentary behavior levels at 6 months (for behavior change) and 12 months (for behavior maintenance).

    7-day accelerometry measurement

    Measured: 12 months

  3. Explore the relationship between patient characteristics and changes (at 6 months) and maintenance (at 12 months) of physical activityand sedentary behavior levels.

    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

    Measured: 12 months

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

    MAPS questionnaire score

    Measured: 12 monts

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

    Basic Psychological Needs Scale score

    Measured: 12 monts

  6. Describe the self-efficacy perceived competence scale for engaging in a personalized physical activity program at 6 months and at 12 months.

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

    Measured: 12 monts

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

    Score obtained at perceived vitality and energy scale

    Measured: 12 monts

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

    Score obtained at the self-esteem scale

    Measured: 12 monts

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

    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.

    Measured: 12 months

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

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

    Measured: 12 months

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

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study startMay 2025 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
Cluster randomization will be conducted according to the "stepped wedge" design.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678906
Sponsor's protocol ID
38RC23.031
Acronym
IPSEDI
Status last verified
Feb 2025
First submitted
14 Oct 2024
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 41239336

Questions about this trial

What is this clinical trial studying?

A study testing Intervention arm in people with Primary Care, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolas PINSAULT, Professor (+33 45 70 413 17, nicolas.pinsault@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06678906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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