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

NCT06616064 | Active Not Recruiting

• 2 other identifiers: 35RC23_9738_CliniCAP2024-A01631-46
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

brief intervention of lifestyle advice

Outcome Measures

Primary Outcomes (1)

• Number of green criteria on application feedback

  The green criterioa corresponds to good compliance with health recommendations.

  between Day 0 and Month 1

Study Arms (2)

Experimental

EXPERIMENTAL

Behavioral: personalised feedback and brief motivational; Other: routine lifestyle advice; Other: questionnaire CliniCAP

Control

OTHER

Other: routine lifestyle advice; Other: questionnaire CliniCAP

Interventions

personalised feedback and brief motivational BEHAVIORAL

personalised feedback and brief motivational

Experimental

routine lifestyle advice OTHER

routine lifestyle advice

Control; Experimental

questionnaire CliniCAP OTHER

questionnaire CliniCAP

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Romain Moirand

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: October 21, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2024-09

Locations

FR (1)