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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Proportion (%) of participants with at least 1-point improvement in the WCRF score [Срок оценки: Week 12]

Вторичные конечные точки (5)

• Consumption of UPF [Срок оценки: week 12]
• Difference in the score of Open Food Facts application use [Срок оценки: week 12]
• Difference of median for each behavioral determinants [Срок оценки: week 12]
• Association between the difference in UPF consumption score [Срок оценки: week 12]
• factors associated [Срок оценки: week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 3 центра

• Institut Sainte Catherine — Avignon
• Eugène Marquis — Rennes
• Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT07436312 · 2025-A00688-41 · 2025/4135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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