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

February 5, 2025 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Control group will receive standard information about physical activity and sedentary lifestyle.
Experimental: Intervention arm
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
Time Frame: 12 months
7-day accelerometry measurement
12 months
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
12 months
Describe the quality of motivation initially (Month 0), at 6 months, and at 12 months.
Time Frame: 12 monts
MAPS questionnaire score
12 monts
Describe the satisfaction of basic psychological needs at 6 months, and at 12 months.
Time Frame: 12 monts
Basic Psychological Needs Scale score
12 monts
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
12 monts
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
12 monts
Describe the self-esteem initially (M0), at 6 months, and at 12 months.
Time Frame: 12 monts
Score obtained at the self-esteem scale
12 monts
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.
12 months
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
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

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

Investigators

  • Principal Investigator: Nicolas PINSAULT, Professor, Physiotherapy department - Grenoble Alpes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC23.031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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