Chronic DiseaseCliniCAPNCT06616064
Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting
A study testing personalised feedback and brief motivational, routine lifestyle advice and questionnaire CliniCAP in people with Chronic Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
Chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. These diseases are responsible for 74% of deaths worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- personalised feedback and brief motivational, routine lifestyle advice and questionnaire CliniCAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Treated for a stabilised chronic disease OR person treated for localised cancer, after the end of heavy treatment during the follow-up period within 5 years of the date of diagnosis of the cancer.
- Contactable by telephone
- Affiliated to a social security scheme
- Having signed a free, informed and written consent.
Who cannot join
- Requiring psychiatric assessment
- Suffering from eating disorders
- Undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year)
- Suffering from a life-threatening condition within 5 years
- Suffering from a disabling condition (reduced activity with major restrictions)
- Unable to read
- Taking part in another psycho-behavioural nutritional intervention study
- Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declaratory), breast-feeding woman and minor).
Trial locations and contacts
1 site in 1 country.
About this study
Chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. These diseases are responsible for 74% of deaths worldwide. Despite the frequency with which practitioners witness these bad habits in their patients, little time is devoted to lifestyle advice during medical visits, and even less to using effective techniques to discuss their behaviour. Yet medical and paramedical consultations could be an essential educational opportunity to promote a healthy lifestyle. But advice is often limited during medical check-ups, due to a lack of time and suitable tools, and is often focused on a particular risk factor. To date, there is no procedure for screening and behavioural intervention to deal with harmful lifestyle habits in patients.
- Conditions
- Chronic Disease
- Being tested
- personalised feedback and brief motivational, routine lifestyle advice, questionnaire CliniCAP
- Keywords
- brief intervention of lifestyle advice
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalised feedback and brief motivationalBehavioural
personalised feedback and brief motivational
routine lifestyle adviceOther
routine lifestyle advice
questionnaire CliniCAPOther
questionnaire CliniCAP
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: personalised feedback and brief motivational; Other: routine lifestyle advice; Other: questionnaire CliniCAP |
| Control | Other | Not described Receives: Other: routine lifestyle advice; Other: questionnaire CliniCAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of green criteria on application feedback
The green criterioa corresponds to good compliance with health recommendations.
Measured: between Day 0 and Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start21 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Moirand, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616064
- Sponsor's protocol ID
- 35RC23_9738_CliniCAP
- Other IDs
- 2024-A01631-46
- Acronym
- CliniCAP
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting
- ClinicalTrials.gov ID
- NCT06616064
- Acronym / sponsor ID
- CliniCAP / 35RC23_9738_CliniCAP
- Conditions
- Chronic Disease
- Keywords
- brief intervention of lifestyle advice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Sep 2024 (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.
Chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. These diseases are responsible for 74% of deaths worldwide. Despite the frequency with which practitioners witness these bad habits in their patients, little time is devoted to lifestyle advice during medical visits, and even less to using effective techniques to discuss their behaviour. Yet medical and paramedical consultations could be an essential educational opportunity to promote a healthy lifestyle. But advice is often limited during medical check-ups, due to a lack of time and suitable tools, and is often focused on a particular risk factor. To date, there is no procedure for screening and behavioural intervention to deal with harmful lifestyle habits in patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: personalised feedback and brief motivational, Other: routine lifestyle advice, Other: questionnaire CliniCAP |
| Control | Other | Other: routine lifestyle advice, Other: questionnaire CliniCAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Treated for a stabilised chronic disease OR person treated for localised cancer, after the end of heavy treatment during the follow-up period within 5 years of the date of diagnosis of the cancer.
- Contactable by telephone
- Affiliated to a social security scheme
- Having signed a free, informed and written consent.
Key exclusion criteria (8 listed)
- Requiring psychiatric assessment
- Suffering from eating disorders
- Undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year)
- Suffering from a life-threatening condition within 5 years
- Suffering from a disabling condition (reduced activity with major restrictions)
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 |
|---|---|---|
| personalised feedback and brief motivationalpersonalised feedback and brief motivational | Behavioural | Experimental |
| routine lifestyle adviceroutine lifestyle advice | Other | Control, Experimental |
| questionnaire CliniCAPquestionnaire CliniCAP | Other | Control, Experimental |
Primary outcome
Number of green criteria on application feedback
Time frame: between Day 0 and Month 1
The green criterioa corresponds to good compliance with health recommendations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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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. This study is not recruiting at the moment.
Romain Moirand principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalised feedback and brief motivational, routine lifestyle advice and questionnaire CliniCAP in people with Chronic Disease, run by Rennes University Hospital 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 May 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of green criteria on application feedback (time frame: between Day 0 and Month 1). 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 21 May 2025.