Development and Validation of a Scale of Propensity for Change in Chronic Disease Prevention
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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),
Disqualifiers
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.
Trial population
Patients benefiting from a personalized prevention program in the context of geriatrics or cardiovascular diseases.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Scale development phase
Other interventionQuestionnaire administered to patients to develop the scale's items and group them into subscales.
Beta testing phase
Other interventionThe scale will be administered to the patient in the form of a questionnaire for the testing phase.
Validation phase
Other interventionThe scale will be administered to patients in the form of questionnaires for the validation phase.
Treatment groups
290 Participants
are divided into 1 treatment groupGroup A: Patients benefiting from a personalized prevention initiative3 interventions
Trial outcomes
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.
Time frame
3 months after the inclusionSecondary outcomes
1
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 inclusion2
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 inclusion3
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 inclusion4
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: