Nurture by Nature Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorIna Olmer Specht
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The kindergarten should geographically be located within or near by a social housing area or serve children from such an area.
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nature-base intervention
BehavioralThe 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.
Treatment groups
127 Participants
are divided into 2 treatment groupsGroup A: Nature-based interventionExperimental treatment 1 intervention
Group B: The control comparator groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
At baseline and at study week 14 (end-of-trial)Secondary outcomes
1
Recruitment rate
Recruitment rate, defined as the proportion of children who are enrolled as participants (numerator, n) out of all those who are eligible and attending the pre-existing kindergarten groups (denominator, N). A rate of 65% or higher will give a green signal, 30-64% will give an amber signal, while less than 30% will give a red signal.
Time frame
Study week 12
Fidelity
Fidelity is defined as adherence to the intervention protocol measured by the proportion of weeks with at least three nature-based activities/outings. Weeks with national holydays will not be included. A proportion of 75% or higher will give a green signal, 50-74% will give an amber signal, while less than 50% will give a red signal. A weekly checklist of frequency and duration of nature-based activities will be filled in by the kindergarten personnel.
Time frame
At baseline and at study week 14 (end-of-trial)Other outcomes
1
Exploratory feasibility outcome - compleation of questionnairs
\- The proportion of parents that complete all questionnaires required at baseline and at end-of-trial.
Time frame
At baseline and at study week 14 (end-of-trial)2
Explorative feasibility outcome - children willing to give hair samples
\- The proportion of children willing to give hair samples for hair cortisol measurements at both baseline and follow-up.
Time frame
At baseline and at study week 14 (end-of-trial)3
Exploaratory feasibility outcome - children willing to wear actigraph
The proportion of children willing to wear an actigraphy measuring physical activity and sleep, assessed as the proportion of children willing to wear and return the MotionWatch 8 after both baseline and mid-trial.
Time frame
Baseline and at 7-weeks of intervention (mid-trial)4
Explorative (clinical) Outcomes - SDQ, Potential primary outcome of a future cluster randomised trial
Child mental well-being will be measured by the validated Strength and Difficulties Questionnaire (SDQ) at baseline and end-of-trial. The SDQ parent version for 4-10-year-old will be used. SDQ has 25-items and screen for child prosocial behavior and emotional and behavioral problems. For each question, the parents are asked to consider the child's behavior over the past 6 months by the following answer categories: Not True, Somewhat True or Certainly True. In the end-of-trial questionnaire, the follow-up version of the SDQ which includes not only the same 25 items, but also two additional follow-up questions for use after an intervention will be used. To increase the chance of detecting change, the follow-up versions of the SDQ ask about 'the last month', as opposed to baseline questionnaire which refers to the past 6 months. A higher score coresponds to more difficulties.
Time frame
At baseline and at study week 14 (end-of-trial)Sponsors and contacts
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Ina Olmer Specht
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
Source ClinicalTrials.gov