Development and Validation of a Scale of Propensity for Change in Chronic Disease Prevention (ProChange)

August 10, 2026 updated by: University Hospital, Toulouse

Development and Validation of a Propensity-to-change Scale in the Field of Chronic Disease Prevention: the ProChange Scale

Modifiable risk factors are estimated to account for 70% of cardiovascular diseases, 40% of Alzheimer's-type dementias, and 50% of type 2 diabetes cases. Numerous trials have evaluated interventions aimed at modifying these risk factors, whether through the promotion of healthy lifestyle choices (diet, physical activity, etc.) or specific activities (cognitive training, etc.). However, these trials have yielded inconsistent or modest results, potentially due to a failure to adopt the recommended lifestyle changes. To better tailor prevention interventions, it is therefore essential to have scales available that measure the barriers to and facilitators of lifestyle change.

The aim of this study is to develop and validate a Patient-Reported Outcome Measure (PROM) to assess the barriers to and facilitators of change following participation in a prevention program. The scale will be structured into three sub-scales (capability, opportunity, and motivation), administered one month after the prevention activity, and will distinguish between the adoption of new habits and the abandonment of existing ones.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

290

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 Locations

  • France
    • Oui
      • Toulouse, Oui, France, 31000
        • Service d'Epidémiologie Clinique et de Santé Publique CHU de Toulouse, Pôle Santé Publique et Médecine Sociale Faculté de Médecine, 37 allées Jules Guesde
        • Contact:
        • Contact:

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients benefiting from a personalized prevention program in the context of geriatrics or cardiovascular diseases.

Description

Inclusion Criteria:

  • Participant receiving a personalized prevention intervention through the frailty assessment day-hospital program, the Atherosclerosis Detection and Prevention Center (CDPA), or the Salutance program,
  • Participant who has received prevention advice aimed at improving their health in at least one of the following two areas: nutrition or physical activity,
  • Participant aged 45 or older (we are targeting a middle-aged to older population, as this group is the primary target for cardiovascular prevention initiatives and efforts to prevent pathological aging),

Exclusion Criteria:

  • Participant unable to improve their lifestyle, according to the scales used in the study (participant with a maximum score on the ONAPS-PAQ scale and the food frequency score),
  • Participant without a postal or email address,
  • Participant with a life expectancy of less than 5 years.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients benefiting from a personalized prevention initiative
patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health
Other: Scale development phase
Questionnaire administered to patients to develop the scale's items and group them into subscales.
Other: Beta testing phase
The scale will be administered to the patient in the form of a questionnaire for the testing phase.
Other: Validation phase
The scale will be administered to patients in the form of questionnaires for the validation phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of the Prochange scale assessing barriers to and facilitators of lifestyle changes for the adoption of non-pharmacological strategies in the field of prevention.
Time Frame: 3 months after the inclusion
Development of a scale based on COSMIN criteria (COnsensus-based Standards for the selection of health Measurement INstruments), consisting of three subscales of 10 questions each.
3 months after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the area under the curve of the Prochange scale for the prediction of an improvement in lifestyle at 3 months after the initiation of a preventive action
Time Frame: 3 months after the inclusion
3 months after the inclusion
Comparison of the performance of the ProChange scale with that of pre-existing scales in predicting lifestyle change three months after the initiation of a prevention intervention.
Time Frame: 3 months after the inclusion
3 months after the inclusion
Evaluation of the correlation between the score obtained on the ProChange scale one month after the prevention intervention and the extent of lifestyle modification three months after the initiation of the prevention intervention
Time Frame: 3 months after the inclusion
3 months after the inclusion
Comparison of the ProChange scale with pre-existing scales
Time Frame: 3 months after the inclusion
Comparison of the ProChange scale with pre-existing scales in terms of the correlation between the score obtained on the scale one month after the prevention intervention and the extent of lifestyle change three months after the initiation of the prevention intervention.
3 months after the inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

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)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/24/0573
  • ID-RCB (Other Identifier: 2025-A02583-46)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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