NCT Number: NCT07436312
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Institut Sainte Catherine, Avignon, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 12
The primary endpoint is the proportion (%) of participants with at least 1-point improvement in the WCRF score (ranging from 0 to 7 , the higher the healthier) at 12 weeks compared to baseline, in the intervention arm versus the control arm.
Time frame: week 12
The difference in the decrease of the UPF consumption score (ranging from 0 to 6, the lower - the lower consumption) between the two arms at 12 weeks (see SO.1)
Time frame: week 12
The difference in the increase of the ordinal scale score (ranging from 0 to 6, the higher the healthier) of Open Food Facts application use between the two arms at 12 weeks (see SO.2)
Time frame: week 12
The difference in the evolution of the 10-point Likert scale between the two arms at 12 weeks for each behavioral determinants (Capability, Opportunity, and Motivation) (see SO.3)
Time frame: week 12
The association between the difference in UPF consumption score between baseline and 12 weeks and behavioral determinants (see SO.3)
Time frame: week 12
The factors associated with the difference between baseline and 12 weeks (1) in the WCRF score, (2) in the UPF consumption score, and (3) in the observance of the UPF consumption, as measured by the 4th question of the questionnaire preliminary to the UPF questionnaire (see SO.4)
Time frame: week 36
Qualitative assessments of participants' interview
Contact information is provided by the study sponsor or research team.
Adeline Salasc, Pharm D
CONTACT
Bruno Raynard, MD
CONTACT
Gustave Roussy, Cancer Campus, Grand Paris
Other
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
Acronym: U-TRANS
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