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临床试验/NCT07780123
NCT07780123招募中不适用

A Feasibility Study of a Cluster Randomized Controlled Trial of a Nature-based Intervention Enhancing Mental and Physical Well-being Among Kindergarten Children From Deprived Areas: Nurture by Nature

Ina Olmer Specht2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
127
试验地点
2
主要终点
Completion of end-of-trial assessment, SDQ

研究概览

简要总结

The goal of this feasibility cluster randomized trial is to determine whether a future large pragmatic cluster randomized controlled trial can be conducted to evaluate the effects of a nature-based intervention on children's mental and physical health. The intervention will be delivered in preschools located in or near public housing areas and compared with usual activities in similar preschools.

The main questions it aims to answer are:

  • Are parents willing to participate in follow-up assessment using the Strengths and Dif-ficulties Questionnaire (SDQ)?
  • Can participants be successfully recruited, and can the nature-based intervention be delivered as intended?
  • Is it possible to gather data on children's motor development, physical activity, sleep, absenteeism, and stress, and on stress and absenteeism among educators and parents?
  • Is the intervention safe and acceptable for children, parents, and educators?

Researchers will compare a 14-week nature-based intervention with usual preschool activities.

The nature-based intervention is based on the Danish Outdoor Council's Green Sprouts ("Grønne Spirer") programme and focuses on using nature for play and learning. The intervention is being developed together with educators and children and includes nature-based activities designed to support motor development, physical activity, and positive interactions between children.

Participants will:

  • Take part in either the nature-based intervention or usual preschool activities.
  • Complete questionnaires about child well-being, quality of life, and parental stress.
  • Participate in assessments of fine and gross motor skills.
  • Wear an activity monitor to measure physical activity and sleep.
  • Provide hair samples for measurement of stress-related hormones.
  • Take part in interviews and observations.

The study will include approximately 56 children aged 4 to 6 years, their parents, and approx-imately 15 educators.

The results will help determine whether the intervention can be implemented in preschools as currently designed and will inform the planning of a future large cluster-randomized controlled trial. No major risks are expected. Participants may experience minor discomfort when a small hair sample is collected for stress measurement.

详细描述

  1. Background A newly published report from 2024 highlights significant socioeconomic, geographical, and seasonal disparities in 1-15 years-old Danish children's access to outdoor environments. While the overall time spent outdoors has remained stable since 2018 (averaging 2 hours and 41 minutes on weekdays and 3 hours and 24 minutes on weekends), the distribution of this time has changed. Most children spend their weekdays outdoor time in structured settings such as schoolyards and playgrounds, whereas weekend visits to natural areas have increased, particularly among families from higher socioeconomic status (SES) and in the summer months.

The report reveals persistent socioeconomic and regional differences in how children engage with nature as also shown in other studies. Children in rural areas and smaller towns tend to spend more time outdoors overall, benefiting from the closer proximity to nature. In contrast, children in urban areas, particularly in the Capital Region and Region Zealand, use schoolyards, playgrounds, and urban parks, with fewer opportunities for spontaneous nature experiences. On weekends, however, urban families, particularly those from higher educational backgrounds, are more likely to travel to forests and beaches. Meanwhile, those parents with lower educational levels face greater barriers to nature access, including transportation limitations and fewer nearby green spaces. While their total outdoor time is comparable to other groups, they are significantly less likely to visit public natural areas, especially on weekdays.

Seasonal differences further impact children's outdoor activity, with outdoor activities more prevalent in summer months and higher engagement with nature compared to winter. It is important to highlight a crucial distinction between general outdoor activities which includes playgrounds, yards and streets, and direct engagement with natural environments, emphasising that while children may spend considerable time outdoors, they do not necessarily interact with nature. The Danish Outdoor Council [Friluftsrådet] stresses the unique benefits of nature exposure, extending beyond conventional outdoor play at playgrounds. The outdoor environment can be categorized into two groups, the green outdoor environment which includes nature, and the grey outdoor environment which includes streets and other outdoor environments which are not nature.

A recent Danish health report indicated that 5.2% of children with a mean age of 6.6 years assessed their overall well-being as low. Another Danish report among children aged 0-9 years stated that at least 16% of young children experience mental health issues or psychiatric diseases.

Exposure to green outdoor environments might promote emotional well-being, reduce stress, fostering social connectedness, support cognitive development and better sleep quality among children, all of which are crucial for learning abilities and daily functioning. Furthermore, regular outdoor activities in nature have been shown to reduce ADHD symptoms, improve concentration, and enhance executive functioning. Additionally, it is speculated that nature-connectedness, e.g. the feeling of being emotionally and psychologically part of the natural world, fosters stronger social bonds and greater emotional regulation, all of which contribute to children's psychological well-being. However, the evidence for these benefits among young children is still limited as only few studies have been conducted among this age group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A kindergarten cluster will be eligible for study participation if the cluster meets the following criteria:
  • The kindergarten should geographically be located within or near by a social housing area or serve children from such an area.
  • At least 11 children in the cluster, each:
  • aged 4-7 years due to the primary outcome cutoff age, and
  • have a parent who is able to understand and communicate in Danish, and
  • have consented to participate
  • Inclusion criteria of children and parents:
  • A child and parent will be eligible for study participation if they meet the following criteria:
  • the child is aged 4-7 years due to the primary outcome cutoff age, and
  • the parent is able to understand and communicate in Danish, and
  • have consented to participate
  • Inclusion criteria of kindergarten personnel:
  • Kindergarten personnel will be eligible for study participation if they meet the following criteria:
  • if they have >80% of their working hours in the eligible kindergarten cluster
  • have consented to participate

排除标准

  • A kindergarten cluster will not be eligible for the study if the cluster meets any of the following criteria:
  • the kindergarten is currently spending > two days per week in nature (green outdoor),
  • the kindergarten is already using the ''Green Sprouts'' program,
  • the kindergarten is exclusively for children with special needs All exclusion criteria are at cluster level. There are no individual exclusion criteria.

研究组 & 干预措施

The control comparator group

No Intervention

The usual activities clusters (the control comparator group) will follow usual practices which may include trips outside the kindergarten area as well as indoor and playground activities for 14 weeks.

Nature-based intervention

Experimental

Among the 5 enrolled kindergartens, 3 will be randomly assigned to the intervention arm.

干预措施: Nature-base intervention (Behavioral)

结局指标

主要结局

Completion of end-of-trial assessment, SDQ

时间窗: At baseline and at study week 14 (end-of-trial)

Completion of end-of-trial assessment, the response rate is measured by the proportion of parents who complete the Strength and Difficulties Questionnaire (SDQ) at the end-of-trial assessment as this is our putative primary outcome measure in a future CRCT. A response rate of 80% or higher completers will give a green signal, 60-79% will give an amber signal, while less than 60% will give a red signal.

次要结局

  • Recruitment rate(Study week 1)
  • Fidelity(At baseline and at study week 14 (end-of-trial))

研究者

发起方
Ina Olmer Specht
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ina Olmer Specht

Senior researcher

University Hospital Bispebjerg and Frederiksberg

研究点 (2)

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