NCT06678906

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2025Jan 2027

First Submitted

Initial submission to the registry

October 14, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

October 14, 2024

Last Update Submit

February 5, 2025

Conditions

Primary Care

Keywords

Physical inactivitySedendary behaviorInnovative personalized support by physiotherapistAmbulatory primary careHealthcare pathway

Outcome Measures

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

    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

    6 months

Secondary Outcomes (11)

  • 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

  • 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

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

    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

  • +6 more secondary outcomes

Study Arms (2)

Control arm

NO INTERVENTION

Control group will receive standard information about physical activity and sedentary lifestyle.

Intervention arm

EXPERIMENTAL

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.

Behavioral: Intervention arm

Interventions

Intervention armBEHAVIORAL

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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pr Nicolas PINSAULT

Saint-Martin-d'Hères, 38400, France

Location

Related Publications (1)

  • 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: 41239336DERIVED

Related Links

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nicolas PINSAULT, Professor

    Physiotherapy department - Grenoble Alpes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas PINSAULT, Professor

CONTACT

+33 45 70 413 17nicolas.pinsault@univ-grenoble-alpes.fr

Isabelle BOUDRY, PhD

CONTACT

+33 47 67 66 645iboudry@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
As a result, all centers will include patients both before (control period) and after the implementation of the intervention (experimental period). The timing of the intervention implementation (training period) for each center will be randomized among 4 training periods distributed throughout the study, with two centers per training period
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Cluster randomization will be conducted according to the "stepped wedge" design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

November 7, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations

FR(1)