Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: educational workshop on nutrition + additional intervention on UPF tool and how to use it.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Pancreas Cancer, Colon Cancer, Lynch Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
The U-TRANS study was initiated by Gustave Roussy, which is its sponsor\*. It is part of the Interception Program and aims to reduce the consumption of ultra-processed foods in order to improve the overall quality of the diet among people at high risk of cancer (WCRF score ≤ 5, corresponding to low adherence to nutritional cancer prevention recommendations: eating a diet rich in whole grains, vegetables, fruit and fibre, and limiting ultra-processed foods, red meat, processed meats, sugary drinks and alcohol). It assesses the impact of a digital intervention (based on the use of the Open Food Facts app) as a complement to the nutritional education provided by the Interception program.
Detailed description
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.
Interventions
- Behavioral educational workshop on nutrition + additional intervention on UPF tool and how to use it
Participants with WCRF score at baseline ≤ 5 will be randomized at 1:1 ratio between intervention group (educational workshop on nutrition + additional intervention on UPF tool and how to use it) and control group (educational workshop on nutrition only). Impact will be assessed at 12 weeks with the WCRF questionnaire.
Primary outcome measures
- Proportion (%) of participants with at least 1-point improvement in the WCRF score [Time frame: Week 12]
Secondary outcome measures (5)
- Consumption of UPF [Time frame: week 12]
- Difference in the score of Open Food Facts application use [Time frame: week 12]
- Difference of median for each behavioral determinants [Time frame: week 12]
- Association between the difference in UPF consumption score [Time frame: week 12]
- factors associated [Time frame: week 12]
Eligibility criteria
Inclusion criteria
- Age > 18 years,
- Individuals at increased risk of different cancers as defined within the Interception program,
- With a baseline WCRF score ≤ 5 at entry in the Interception program,
- Agreeing to participate and who have given their written agreement for the study,
- Agreeing to fill in the questionnaires on the dedicated platform for the duration of the study,
- Participant have and accept to use their smartphone,
- All participants must understand spoken and written French language
Exclusion criteria
- Psychiatric disorders or cognitive impairments precluding participation,
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- Institut Sainte Catherine — Avignon
- Eugène Marquis — Rennes
- Gustave Roussy — Villejuif
Identifiers
NCT: NCT07436312 · 2025-A00688-41 · 2025/4135