Improvements in Daily Activity and Exercise in School Children: the ActChild Study

Обзор

The goal of this clinical trial is to assess the health-related effects of an exercise intervention in children aged 5-8 years. Main research questions: * Does a municipality-driven exercise intervention improve physical activity levels in children? * Does a municipality-driven exercise intervention improve sleep parameters in children? * Does a municipality-driven exercise intervention improve eating behaviors in children? * Does a municipality-driven exercise intervention improve quality of life in children? Study Design: Participants will be assigned to either: * Intervention group: Attend 1-2 weekly sessions of 45-60 minutes of child-friendly exercise for 1 year. * Control group: Receive no intervention. Data Collection: Participants will: * Complete questionnaires at baseline, and at 1-year, 3-year, and 5-year follow-ups. * Wear accelerometers for 7 consecutive days at baseline, and at 1-year, 3-year, and 5-year follow-ups.

Подробное описание

Introduction:

Being physically inactive is associated with increased risk of developing non-communicable, lifestyle diseases such as Type 2 Diabetes (T2D), overweight/obesity, coronary heart disease (CHD) and premature death. In Denmark it is estimated that physical inactivity is responsible for more than 6000 deaths and related costs of 5.3 billion Danish Kroner each year. Although not fully elucidated, an increase in physical inactivity among children has over the last 20-30 years been observed in parallel with an increase in childhood overweight and obesity.

Aim:

The overall aim of this study is to promote (increase and sustain) healthy physical activity behaviors in children aged 5-8 years. The investigators wish to investigate the effects of an exercise intervention on physical activity, sleep (e.g. quality and duration), eating behavior, quality of life and anthropometrics.

Design The project is a collaborative clinical trial investigating the implementation of supervised physical activity in school children in Aarhus Municipality.

Intervention Children aged 5-8 years from Aarhus municipality will be included in the study. Initially first-year students from selected schools will be recruited as a control group. After one year an intervention group will be formed out of first-year students from the same schools. The intervention group will be invited to participate in a supervised training intervention during after-school daycare time.

The supervised physical activity will be conducted by after-school childcare educators in the municipalities, who have years of experience in handling children. The childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions.

Parents/legal guardians and participants will be able to withdraw from the study at any time.

Feasibility Feasibility and sustainability form the foundation of this exercise intervention. The project is developed, evaluated, and implemented in close collaboration with Aarhus Municipality. The intervention is designed to be easily maintained and scalable for implementation beyond the research setting.

Вмешательства

• Поведенческое Exercise
  After-school childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions. The children will receive 1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year.

Первичные конечные точки

• Between group change in time spent in moderate to vigorous physical activity (MVPA) [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in total movement time [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in time spent in light physical activity (LPA) [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in time spent being sedentary [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in total sleep time (TST) [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in sleep efficiency (SE) [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in sleep onset latency (SOL) [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group change in wake after sleep onset (WASO) [Срок оценки: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]

Вторичные конечные точки (4)

• Between group change in eating behavior [Срок оценки: The CEBQ will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
• Between group changes in self-reported quality of life [Срок оценки: Questionnaires will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups.]
• Between group change in BMI-SDS [Срок оценки: From enrollment to the end of 5-year follow-up.]
• Baseline characteristics and data from school questionnaires [Срок оценки: From enrollment to the end of the 5-year follow-up.]

Критерии участия

Критерии включения

• Schoolchildren, 0.-1. Grade, 5-8 years of age,
• Resident in Aarhus Municipality

Критерии исключения

\- None

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Aarhus Municipality — Aarhus

Идентификаторы

NCT: NCT06791278 · ActChild

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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