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

NCT07765797 | Not Yet Recruiting

• 2 other identifiers: RC31/24/0573ID-RCB
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Atheroscleroses; Geriatric

Keywords

prevention; gériatrics; risk factors

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after the inclusion

Secondary Outcomes (4)

• 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

  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.

  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

  3 months after the inclusion

• Comparison of the ProChange scale with pre-existing scales

  3 months after the inclusion

Study Arms (1)

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; Other: Beta testing phase; Other: Validation phase

Interventions

Scale development phase OTHER

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

Patients benefiting from a personalized prevention initiative

Beta testing phase OTHER

The scale will be administered to the patient in the form of a questionnaire for the testing phase.

Patients benefiting from a personalized prevention initiative

Validation phase OTHER

The scale will be administered to patients in the form of questionnaires for the validation phase.

Patients benefiting from a personalized prevention initiative

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service d'Epidémiologie Clinique et de Santé Publique CHU de Toulouse, Pôle Santé Publique et Médecine Sociale Faculté de Médecine, 37 allées Jules Guesde

Toulouse, Oui, 31000, France

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jason SHOURICK, MD

CONTACT

05 61 14 56 23; shourick.j@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)