Nurture by Nature Feasibility Study

NCT07780123 | Not Yet Recruiting

• 1 other identifier: 1990001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nature, Human; Pediatric ALL; Well-Being, Psychological

Outcome Measures

Primary Outcomes (1)

• Completion of end-of-trial assessment, SDQ

  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.

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

Secondary Outcomes (2)

• Recruitment rate

  Study week 1

• Fidelity

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

Other Outcomes (16)

• Exploratory feasibility outcome - compleation of questionnairs

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

• Explorative feasibility outcome - children willing to give hair samples

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

• Exploaratory feasibility outcome - children willing to wear actigraph

  Baseline and at 7-weeks of intervention (mid-trial)

Study Arms (2)

Nature-based intervention

EXPERIMENTAL

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

Behavioral: Nature-base intervention

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.

Interventions

Nature-base intervention BEHAVIORAL

The intervention is a 14-week nature-based program delivered during winter and designed to increase children's engagement with nature through play and learning activities. It is integrated into existing kindergarten routines and delivered by kindergarten staff, requiring minimal organizational changes. Staff will attend a workshop and receive training from a nature educator before implementation. Children in the intervention group will engage in nature-based activities at least 3 days per week for 3.5 months. Activities will primarily take place in natural areas within walking or cycling distance of the kindergarten, although occasional visits to nearby forests or beaches may be arranged using public transportation. The intervention details has been made through a co-design process.

Nature-based intervention

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ina Olmer Specht: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital, The Parker Institute

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psychological Well-Being

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Ina O Specht, PhD

CONTACT

004538163083; ina.olmer.specht@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior researcher

Model Details: Cluster RCT

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (1)