An observational study in Atheroscleroses and Geriatric, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University Hospital, Toulouse · Observational
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.
Patients benefiting from a personalized prevention program in the context of geriatrics or cardiovascular diseases.
Exclusion Criteria:
patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health
Other: Scale development phase · Other: Beta testing phase · Other: Validation phase
Questionnaire administered to patients to develop the scale's items and group them into subscales.
The scale will be administered to the patient in the form of a questionnaire for the testing phase.
The scale will be administered to patients in the form of questionnaires for the validation phase.
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.
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.
Time frame: 3 months after the inclusion
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
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
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
Comparison of the ProChange scale with pre-existing scales
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.
Time frame: 3 months after the inclusion
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse