Breast Cancer, Colon Cancer, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Lynch Syndrome, Pancreas Cancer
Conditions
Brief summary
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
BEHAVIORALeducational 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.
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
2 cohorts: intervention group (educational workshop on nutrition + additional intervention on UPF tool and how to use it) and control group (educational workshop on nutrition only).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion (%) of participants with at least 1-point improvement in the WCRF score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of UPF | 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) |
| Difference in the score of Open Food Facts application use | 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) |
| Difference of median for each behavioral determinants | 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) |
| Association between the difference in UPF consumption score | week 12 | The association between the difference in UPF consumption score between baseline and 12 weeks and behavioral determinants (see SO.3) |
| factors associated | 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) |
Countries
France
Contacts
CONTACTBruno Raynard, MD
CONTACTAdeline Salasc, Pharm D
STUDY_CHAIRBruno Raynard, MD
Gustave Roussy, Villejuif, France
Outcome results
None listed