About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Factorial
Treatments tested in this trial
educational workshop on nutrition + additional intervention on UPF tool and how to use it
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Proportion (%) of participants with at least 1-point improvement in the WCRF score
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.
Secondary outcomes
Consumption of UPF
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)
Difference in the score of Open Food Facts application use
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)
Difference of median for each behavioral determinants
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)
Association between the difference in UPF consumption score
The association between the difference in UPF consumption score between baseline and 12 weeks and behavioral determinants (see SO.3)
Other outcomes
Qualitative assessments of participants' interview
Qualitative assessments of participants' interview
Sponsors and contacts
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