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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07765797
Acronym
ProChange
Enrollment
290
Registered
2026-08-14
Start date
2026-09-01
Completion date
2028-06-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheroscleroses, Geriatric

Keywords

prevention, gériatrics, risk factors

Brief summary

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.

Interventions

OTHERScale development phase

Questionnaire administered to patients to develop the scale's items and group them into subscales.

OTHERBeta testing phase

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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.3 months after the inclusionDevelopment 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.

Secondary

MeasureTime frameDescription
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 action3 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.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 intervention3 months after the inclusion
Comparison of the ProChange scale with pre-existing scales3 months after the inclusionComparison 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.

Countries

France

Contacts

CONTACTJason SHOURICK, MD
shourick.j@chu-toulouse.fr05 61 14 56 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026