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NCT Number: NCT07765797

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

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.

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Key information

Conditions

Atheroscleroses Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Geriatric Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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 contact

Emeline Muller

CONTACT

[email protected]

0561778707

MULLER

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scale development phase

Other

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

Beta testing phase

Other

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

Validation Phase

Other

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

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.

    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.

Secondary 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 inclusion

  2. 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

  3. 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

  4. Comparison of the ProChange scale with pre-existing scales

    Time frame: 3 months after the inclusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason SHOURICK, MD

CONTACT

[email protected]

05 61 14 56 23 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ProChange

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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