Набор по приглашению NCT07419503

010Fit'R - Healthy Lifestyle Interventions for Children With Overweight

Без фазы С лечением Overweight Children

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: 010 Fit'R intervention.
Кому может быть актуально: Состояния в реестре: Overweight, Children. Базовые параметры: 4 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: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight

Обзор

Overweight is a leading risk factor for non-communicable diseases. In the Netherlands, about 11% of children aged 4-12 years are overweight. The causes of childhood overweight are multifaceted, involving (epi)genetic, environmental, socioeconomic, and behavioral factors. The societal consequences are far-reaching, including lower academic performance, reduced quality of life and a greater risk of developing obesity in adulthood. Lifestyle interventions with diet and physical activity components have been shown to effectively reduce childhood overweight. The "010 Fit'R - Rotterdam approach for children with overweight" targets children between 4 and 12 years old and their parents. The program consists of multicomponent interventions addressing various lifestyle aspects, such as physical activity, nutrition, motor skills and healthy behaviours aiming to foster sustainable lifestyle changes. Providers were invited by the municipality of Rotterdam to develop interventions within the policy framework of 010 Fit'R. 12 providers were selected by the municipality based on the selection criteria (quality of the program; experience with the activities and target group; demonstrable connection with the area; connection with the target group; recruitment strategy; costs) and distributed over different neighbourhoods. This study evaluates the healthy lifestyle interventions involved in 010 Fit'R in terms of effectiveness and implementation outcomes. Quantitative data includes self-reported questionnaires, administrative data, a motor skill performance assessment and height and weight measurements to determine Body Mass Index (BMI). Data will be collected through self-reported questionnaires filled in by the parents of children who participate in 010 Fit'R. Additionally, children will be assessed on motor skills by providers of healthy lifestyle interventions involved in 010 Fit'R. Moreover, weight and height will be measured by the provider following standardized procedures. The parental questionnaire, motor skills and BMI will be assessed pre and post intervention. Administrative data includes data reported by providers on implementation outcomes, for example, data regarding enrolment and retention. Qualitative data includes documentary evidence of each healthy lifestyle intervention involved in 010 Fit'R to assess 'effective components' of interventions. In addition, two workshops with providers and/or practitioners of interventions will be held to map the context, working elements and outcomes. Focus groups (FGs) and semi-structured interviews are used to gather information from parents, children and providers and/or practitioners regarding implementation outcomes.

Вмешательства

Поведенческое 010 Fit'R intervention
Within the policy framework of 010 Fit'R, 12 different healthy lifestyle interventions will be implemented for children with overweight. Children participate in one of the 12 interventions. All interventions consist of at least one physical activity each week and encouraging a healthy lifestyle in children, individually or in groups, and advising children and their parents on nutrition, exercise, motor skills, and sustainable behavioral change.

Первичные конечные точки

PROMIS - assessed by a questionnaire [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]

Вторичные конечные точки (6)

BMI - assessed by physical measurement [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]
Motor skills - assessed by physical measurement [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]
Nutrition - assessed by a questionnaire [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]
Physical activity - assessed by a questionnaire [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]
Sleep behaviour - assessed by a questionnaire [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]
Screen time - assessed by a questionnaire [Срок оценки: Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)]

Критерии участия

Providers of the interventions will recruite children (4-12 years old) with overweight to participate in their intervention. All children (and their parents) participating in the interventions are invited to participate in the evaluation research study.

Критерии включения

Child participates in the 010Fit'R program and is between 4 and 12 years old (at the start of recruitment)
Parents of children participating in the 010 Fit'R program
Provider (e.g. participate in interview) is actively involved in promoting, implementing or conducting a healthy lifestyle intervention funded by 010Fit'R

All participants should be able to comprehend provided information to make an informed decision for participation and should provide consent for participating. In case of children the parent(s) consent, as well as the child when 12 years old.