AtherosclerosesProChangeNCT07765797
Development and Validation of a Scale of Propensity for Change in Chronic Disease Prevention
An observational study of Atheroscleroses and Geriatric, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atheroscleroses, Geriatric
- What is being tested?
- Scale development phase, Beta testing phase and Validation phase
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients benefiting from a personalized prevention program in the context of geriatrics or cardiovascular diseases.
Who may be able to join
- 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),
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
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
Emeline Muller, 0561778707, muller.E@chu-toulouse.Fr
MULLER, muller.E@chu-toulouse.Fr
About this study
Official title: Development and Validation of a Propensity-to-change Scale in the Field of Chronic Disease Prevention: the ProChange Scale
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
- Being tested
- Scale development phase, Beta testing phase, Validation phase
- Keywords
- prevention, gériatrics, risk factors
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scale development phaseOther
Questionnaire administered to patients to develop the scale's items and group them into subscales.
Beta testing phaseOther
The scale will be administered to the patient in the form of a questionnaire for the testing phase.
Validation phaseOther
The scale will be administered to patients in the form of questionnaires for the validation phase.
| Study group | Role | What they receive |
|---|---|---|
| Patients benefiting from a personalized prevention initiative | patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health Receives: Other: Scale development phase; Other: Beta testing phase; Other: Validation phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 3 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765797
- Sponsor's protocol ID
- RC31/24/0573
- Other IDs
- ID-RCB
- Acronym
- ProChange
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Propensity-to-change Scale in the Field of Chronic Disease Prevention: the ProChange Scale
- ClinicalTrials.gov ID
- NCT07765797
- Acronym / sponsor ID
- ProChange / RC31/24/0573
- Conditions
- Atheroscleroses, Geriatric
- Keywords
- prevention, gériatrics, risk factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients benefiting from a personalized prevention initiative | – | Other: Scale development phase, Other: Beta testing phase, Other: Validation phasepatients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients benefiting from a personalized prevention program in the context of geriatrics or cardiovascular diseases.
Key inclusion criteria (3 listed)
- 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),
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scale development phaseQuestionnaire administered to patients to develop the scale's items and group them into subscales. | Other | Patients benefiting from a personalized prevention initiative |
| Beta testing phaseThe scale will be administered to the patient in the form of a questionnaire for the testing phase. | Other | Patients benefiting from a personalized prevention initiative |
| Validation phaseThe scale will be administered to patients in the form of questionnaires for the validation phase. | Other | Patients benefiting from a personalized prevention initiative |
Primary outcome
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.
Time frame: 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.
4 secondary outcomes
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
Time frame: 3 months after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atheroscleroses and Geriatric, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason SHOURICK, MD (05 61 14 56 23 ext. +33, shourick.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.