NCT07780123Toboroz
Nurture by Nature Feasibility Study
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 1.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 127 (tervezett)
- Első benyújtás
- 2026. aug. 12.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2027. máj. 1.
- Fő szponzor
- Ina Olmer Specht
- Betegségek
- Akut limfoid leukémia (ALL), Gyermekkori daganatok
- NCT-szám
- NCT07780123
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 127
- 2026. okt. 1. és az elsődleges befejezés (2027. máj. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Egyéb
- 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.
Kiket keres a vizsgálat
- 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
- 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
- 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
Életkor a regiszterben: 4 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Bispebjerg and Frederiksberg Hospital, The Parker Institute | Frederiksberg | Dánia | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.