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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • educational workshop on nutrition + additional intervention on UPF tool and how to use it

    Behavioral

    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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 12

Secondary outcomes

1

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)

Time frame
week 12
2

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)

Time frame
week 12
3

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)

Time frame
week 12
4

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)

Time frame
week 12

Other outcomes

1

Qualitative assessments of participants' interview

Qualitative assessments of participants' interview

Time frame
week 36

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