TrialPath
Recruiting

Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer

NCT07436312 · Gustave Roussy, Cancer Campus, Grand Paris
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Impact of a Mixed Intervention Aiming to Decrease the Consumption of Ultra-processed Foods on the Global Diet Quality in Individuals at High Risk of Cancer
About this study
The consumption of ultra-processed foods (UPFs) has increased in our diet over the past 50 years. Their consumption is associated with poor nutritional profiles. In recent years, it has been associated with numerous pathologies, including obesity, diabetes, cardiovascular disease and, more recently, cancer. An improvement in people's nutritional profiles (measured in particular by the internationally recognized WCRF score) is associated with a lower risk of cancer, whether in the general population or in people at high risk of cancer. However, changing dietary habits is not easy, especially over the long term, due to its cultural, economic and social components. PO: To demonstrate whether an intervention aiming to decrease the consumption of UPF improves the global diet quality of individuals at high risk of different cancers. SO.1 To compare the magnitude of change in UPF consumption between the two arms (simple education versus intervention with the Open Food Facts application), using a validated food frequency questionnaire designed to capture UPF exposure (Canadian questionnaire that will be adapted to the French population). SO.2 To describe the change in frequency of use of the Open Food Facts application from baseline to 12 weeks in the intervention arm. SO.3 To assess the determinants of changes in UPF consumption behaviors before and after the intervention. SO.4 To identify factors associated with a greater improvement in global diet quality, a larger decrease in UPF consumption, and the observance of the UPF consumption including relevant clinical and demographic characteristics. EO.1 To evaluate participants' attitudes towards UPF and the Open Food Facts application and investigate the relationship between these attitudes, food literacy, and UPF consumption behaviors.
Eligibility criteria
Inclusion Criteria: 1. Age \> 18 years, 2. Individuals at increased risk of different cancers as defined within the Interception program, 3. With a baseline WCRF score ≤ 5 at entry in the Interception program, 4. Agreeing to participate and who have given their written agreement for the study, 5. Agreeing to fill in the questionnaires on the dedicated platform for the duration of the study, 6. Participant have and accept to use their smartphone, 7. All participants must understand spoken and written French language Exclusion Criteria: 1. Psychiatric disorders or cognitive impairments precluding participation, 2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Study design
Enrollment target: 170 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-04
Estimated completion: 2028-03
Last updated: 2026-05-08
Interventions
Behavioral: educational workshop on nutrition + additional intervention on UPF tool and how to use it
Primary outcomes
  • Proportion (%) of participants with at least 1-point improvement in the WCRF score (Week 12)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · other
Contacts & investigators
ContactBruno Raynard, MD · contact · bruno.raynard@gustaveroussy.fr · +33 (0) 1 42 11 42 11
ContactAdeline Salasc, Pharm D · contact · adeline.salasc@gustaveroussy.fr · +33 (0) 1 42 11 42 11
InvestigatorBruno Raynard, MD · study_chair, Gustave Roussy, Villejuif, France
All locations (3)
Institut Sainte CatherineNot Yet Recruiting
Avignon, France
Eugène MarquisRecruiting
Rennes, France
Gustave RoussyRecruiting
Villejuif, France
Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer · TrialPath