Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting (CliniCAP)

May 20, 2025 updated by: Rennes University Hospital
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes cedex 9, France, 35033
        • CHU Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. 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.
  3. Contactable by telephone
  4. Affiliated to a social security scheme
  5. Having signed a free, informed and written consent.

Exclusion Criteria:

  1. Requiring psychiatric assessment
  2. Suffering from eating disorders
  3. Undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year)
  4. Suffering from a life-threatening condition within 5 years
  5. Suffering from a disabling condition (reduced activity with major restrictions)
  6. Unable to read
  7. Taking part in another psycho-behavioural nutritional intervention study
  8. Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declaratory), breast-feeding woman and minor).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Behavioral: personalised feedback and brief motivational
personalised feedback and brief motivational
Other: routine lifestyle advice
routine lifestyle advice
Other: questionnaire CliniCAP
questionnaire CliniCAP
Other: Control
Other: routine lifestyle advice
routine lifestyle advice
Other: questionnaire CliniCAP
questionnaire CliniCAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between Day 0 and Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Romain Moirand, CHU Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC23_9738_CliniCAP
  • 2024-A01631-46 (Other Identifier: N°ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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