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

NCT07765797 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Observational

Started

2026-09-01

Last updated

2026-08-14

Condition(s) studied

AtherosclerosesGeriatric

Investigational drug(s) / intervention(s)

Scale development phaseBeta testing phaseValidation phase

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

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

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

Study 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.

Eligibility

Sex

ALL

Min age

45 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

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 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.

Trial sites (1)

Facility	City	Region	Status
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

More University Hospital, Toulouse trials in France

Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity Recruiting

Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE) Recruiting

Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules Recruiting

Periodontal Microbiota of Patients Candidates for Bariatric Surgery With Body Mass Index Greater Than 30 Recruiting

Effects of an Intensive Rhythmic Dance Program on Learning Skills in Children With Cerebral Palsy Recruiting

Other trials for the same condition

Association Between Early Consultation by the Primary Care Physician After Hospitalization in Geriatric Medicine Department, and the Risk of Re-hospitalization at 1 and 3 Months Recruiting

Feasibility of Physical Activity in Older Adults With Haematological Malignancies: ACCES Study Active, not recruiting

Three-month Follow-up Analysis of Social Recommendations Issued by the Mobile Geriatric Team Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07765797 on ClinicalTrials.gov ↗ ← All trials in France