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Набор скоро начнётся NCT06933121

Empowering Healthy Lifestyle Behaviour Through Personalised Intervention Portfolios to Prevent and Control Obesity in Children - UEV Pilot Study

Без фазы С лечением Obesity and Obesity-related Medical Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Digital twin for personalized recommendations.
Кому может быть актуально
Состояния в реестре: Obesity and Obesity-related Medical Conditions. Базовые параметры: 5 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study is being performed under the European Consortium HealthyW8 that has the main objective of developing a digital tool for personalized recommendations for healthy lifestyle and prevention of obesity. This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on children (age 5 to 12 y) and parents. The main purpose is to study whether the healthy lifestyle recommender solution, reflecting a multi-portfolio intervention and developed within this project, is well accepted by the participants, has a decent adherence (i.e. user time of the app), and whether the overall design is well suited to the participants, in order that they will improve dietary habits. This study will be of longitudinal design without a control group.

Подробное описание

At present, numbers of persons with overweight and obesity continue to grow in most countries worldwide. Children and young adults are at risk for different reasons: in the case of children, dietary habits and lifestyle is starting to be developed and if, at this phase, children do not acquire healthy habits, it will be probable that they will have a higher potential to develop obesity and the associated co-morbidities. It is at this stage that food preferences develop. Moreover, children obesity is increasing and it is known that an obese or pre-obese children will have a higher propensity to be an obese adult. For young adults, the risks and concerns are different. Is in this period of life that most people starts an independent life, and consequently decide their food and lifestyle choices, with an increase in irregularity of meals and unhealthy food choices, together with changes in physical activity habits and social or individual pressures. It is essential to give them tools that will allow them to make healthy choices and to have healthy habits, since they will be the future adult population that will raise and inspire the next generation. As solutions to combat the trend toward increasing overweight and obesity are much in need, the present study aims to intervene with the developed healthy lifestyle recommender solution to address various factors known to constitute a risk for developing obesity, including socio-demographic aspects, psychological/behavioural ones, physical activity, dietary patterns, among other. Such a multi-dimensional portfolio approach is believed to be very much needed for the prevention of obesity and co-morbidities, and the personalization of the solution, as well as the nudging/gamification aspects will strive to ensure a high long-term adherence to the developed solution.

The primary objective of the study is to determine whether the developed healthy-lifestyle recommender solution can be successfully applied to the target population (children and their parents), and whether they adhere to using it frequently during the duration of the study.

This will be assessed by adherence time to the lifestyle recommender solution and questionnaires addressing the user-friendliness and limitation or problems encountered. Secondly, the investigators will study whether the assessment of endpoints required for the ensuing long-term study can be well assessed within the study and if despite the limited time of the intervention duration, the intervention will be able to improve some markers related to the risk of obesity and associated co-morbidities.

Вмешательства

  • Устройство Digital twin for personalized recommendations
    The intervention is the developed eHealth solution, i.e. the healthy lifestyle recommender system. It is based on a previously developed meal recommender system, but will be much extended, resulting in a multilevel portfolio intervention regarding: 1. Suggesting personalized meal recommendations, 2. Proposing physical activities tailored to the individuals' capabilities and preferences, 3. Measuring and considering emotional and psychological parameters, 4. Proposing additional healthy life-sty

Первичные конечные точки

  • Adherence to digital tool [Срок оценки: At the end of the study, after 3-month intervention.]
Вторичные конечные точки (4)
  • Changes in BMI [Срок оценки: 3-months]
  • Salivary biomarkers of stress [Срок оценки: 3-months]
  • Salivary biomarkers of physiology and metabolism [Срок оценки: 3-months]
  • Dietary habits [Срок оценки: At the beginning of the study]

Критерии участия

Критерии включения

  • Children (age 5-12 y) and, at least, one of their parents
  • To reside in Portugal (for logistic reasons)
  • To be overweight (BMI percentile > 85%)
  • Both boys and girls

Критерии исключения

  • To have manifest chronic diseases (e.g. cancer)
  • To be already in energy restriction or following a specific diet (on their own or advised by their physician)
  • To have eating behaviour pathologies

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06933121 · UEVHeightW8Children

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗