Stress, PsychologicalSHINENCT02623855
Stay Healthy In Nature Everyday: Family Nature Outings in a Low Income Population
A study testing Family outings, Park prescription and Pedometry in people with Stress, Psychological and Social Isolation, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
The SHINE study is a randomized controlled study of the effect of a park-based family support group on multiple outcomes (including stress and physical activity) in a low income population. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Social Isolation, Physical Activity
- What is being tested?
- Family outings, Park prescription and Pedometry
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child must be 4 years and older, a patient in our clinic, physically able, available for follow up, able to answer questionnaire
- Caregiver must be 18 or older, legal guardian, physically able, able for follow up, able to answer questionnaire
Who cannot join
- Enrolled in a weight loss program, unable to be physically active, unable to give informed consent, unable to follow up for study duration.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital Oakland Primary Care Clinic
Oakland, California, 94609
About this study
Official title: Stay Healthy In Nature Everyday: a Randomized Controlled Trial of the Effect of Family Nature Outings on Stress and Physical Inactivity in a Low Income Population
The SHINE study is a randomized controlled study of the effect of a park-based family support group on multiple outcomes (including stress and physical activity) in a low income population.
Read the detailed description
Despite mounting evidence that nature matters for human health, we are not aware of any prospective intervention trials looking at the use of nature as a health intervention. Like other protective factors, such as the presence of a caring adult, safe play places, greater stimulation, the presence of green-space in a child's life has been empirically linked to greater resilience. Nature has been proposed as a buffer to stress through several pathways: by providing a space for friends and families to gather (thereby increasing social support and improving family relationships), by increasing opportunities for physical activity, and by improving cognition. Research to date suggests that participation in outdoor activities facilitates a sense of connectedness to place. This sense of attachment may also provide a form of social support. Families served by Children's Hospital Oakland Primary Care Clinic experience high levels of stress. As a safety-net clinic, the primary care clinic serves a diverse set of patients, with a common thread of poverty. The Stay Healthy In Nature program was developed to encourage stress management skills through play and physical activity in parks. The program uses a combination of facilitated and independent outings into local parks to encourage sustained behavior change and measurable health benefits.
- Conditions
- Stress, Psychological, Social Isolation, Physical Activity
- Being tested
- Family outings, Park prescription, Pedometry, Case Management
- Keywords
- Parks, Well-being, Stress, Physical Activity, Nature, Greenspace
- Medical subject headings
- Stress, Psychological, Social Isolation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family outingsBehavioural
Participants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff.
Park prescriptionBehavioural
Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.
PedometryDevice
Participants will record their daily pedometry.
Case ManagementBehavioural
Participants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Park prescription | Active comparator | Park prescription, pedometry. Receives: Behavioral: Park prescription; Device: Pedometry |
| Park prescription and family outings | Experimental | Park prescription, pedometry, case management and 3 weekly family outings. Receives: Behavioral: Family outings; Behavioral: Park prescription; Device: Pedometry; Behavioral: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress
measured through the Perceived Stress Score10 (PSS10) over 0, 1 and 3 months. The PSS10 is a ten item, validated instrument which ranges from 0-40. Each item on the instrument is summed to create a total score. Higher values correspond with higher stress.
Measured: 3 months
Change in Stress
measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.
Measured: 1 month
Secondary outcomes (6)
Change in Park Visits Per Week
Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.
Measured: 1 month
Change in Minutes of Moderate Physical Activity Per Day
Parents will report their physical activity in terms of minutes of moderate physical activity in the week before follow up at 0, 1, and 3 months out.
Pedometers were also given to participants. Of note, because of poor follow through with returning pedometer data, this variable was not analyzed in the study results.
Measured: 3 months
Change in Cortisol Level in Parents
Salivary cortisol from parents
Measured: 3 months
Change in Minutes of Moderate Physical Activity Per Day
Parents will report their physical activity in terms of minutes of moderate physical activity in the week before follow up at 0, 1months follow up.
Pedometers were also given to participants. Of note, because of poor follow through with returning pedometer data, this variable was not analyzed in the study results.
Measured: 1 month
Change in Cortisol Level in Parents
Salivary cortisol from parents
Measured: 1 month
Change in Park Visits Per Week
Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- East Bay Regional Park District, National Recreation and Park Association, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Nooshin Razani, MD, MPH, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623855
- Sponsor's protocol ID
- 2015-042
- Acronym
- SHINE
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2015
- Last updated
- 30 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Razani N, Morshed S, Kohn MA, Wells NM, Thompson D, Alqassari M, Agodi A, Rutherford GW. Effect of park prescriptions with and without group visits to parks on stress reduction in low-income parents: SHINE randomized trial. PLoS One. 2018 Feb 15;13(2):e0192921. doi: 10.1371/journal.pone.0192921. eCollection 2018.
PubMed 29447248
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stay Healthy In Nature Everyday: a Randomized Controlled Trial of the Effect of Family Nature Outings on Stress and Physical Inactivity in a Low Income Population
- ClinicalTrials.gov ID
- NCT02623855
- Acronym / sponsor ID
- SHINE / 2015-042
- Conditions
- Stress, Psychological, Social Isolation, Physical Activity
- Keywords
- Parks, Well-being, Stress, Physical Activity, Nature, Greenspace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- East Bay Regional Park District, National Recreation and Park Association, University of California, San Francisco
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SHINE study is a randomized controlled study of the effect of a park-based family support group on multiple outcomes (including stress and physical activity) in a low income population.
Detailed description
Despite mounting evidence that nature matters for human health, we are not aware of any prospective intervention trials looking at the use of nature as a health intervention. Like other protective factors, such as the presence of a caring adult, safe play places, greater stimulation, the presence of green-space in a child's life has been empirically linked to greater resilience. Nature has been proposed as a buffer to stress through several pathways: by providing a space for friends and families to gather (thereby increasing social support and improving family relationships), by increasing opportunities for physical activity, and by improving cognition. Research to date suggests that participation in outdoor activities facilitates a sense of connectedness to place. This sense of attachment may also provide a form of social support. Families served by Children's Hospital Oakland Primary Care Clinic experience high levels of stress. As a safety-net clinic, the primary care clinic serves a diverse set of patients, with a common thread of poverty. The Stay Healthy In Nature program was developed to encourage stress management skills through play and physical activity in parks. The program uses a combination of facilitated and independent outings into local parks to encourage sustained behavior change and measurable health benefits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Park prescription | Active comparator | Behavioral: Park prescription, Device: PedometryPark prescription, pedometry. |
| Park prescription and family outings | Experimental | Behavioral: Family outings, Behavioral: Park prescription, Device: Pedometry, Behavioral: Case ManagementPark prescription, pedometry, case management and 3 weekly family outings. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Child must be 4 years and older, a patient in our clinic, physically able, available for follow up, able to answer questionnaire
- Caregiver must be 18 or older, legal guardian, physically able, able for follow up, able to answer questionnaire
Key exclusion criteria (1 listed)
- Enrolled in a weight loss program, unable to be physically active, unable to give informed consent, unable to follow up for study duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family outingsParticipants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff. | Behavioural | Park prescription and family outings |
| Park prescriptionParticipants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. | Behavioural | Park prescription, Park prescription and family outings |
| PedometryParticipants will record their daily pedometry. | Device | Park prescription, Park prescription and family outings |
| Case ManagementParticipants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary. | Behavioural | Park prescription and family outings |
Primary outcome
Change in Stress
Time frame: 3 months
measured through the Perceived Stress Score10 (PSS10) over 0, 1 and 3 months. The PSS10 is a ten item, validated instrument which ranges from 0-40. Each item on the instrument is summed to create a total score. Higher values correspond with higher stress.
Change in Stress
Time frame: 1 month
measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.
6 secondary outcomes
Change in Park Visits Per Week
Time frame: 1 month
Change in Minutes of Moderate Physical Activity Per Day
Time frame: 3 months
Change in Cortisol Level in Parents
Time frame: 3 months
Change in Minutes of Moderate Physical Activity Per Day
Time frame: 1 month
Change in Cortisol Level in Parents
Time frame: 1 month
Change in Park Visits Per Week
Time frame: 3 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29447248Razani N, Morshed S, Kohn MA, Wells NM, Thompson D, Alqassari M, Agodi A, Rutherford GW. Effect of park prescriptions with and without group visits to parks on stress reduction in low-income parents: SHINE randomized trial. PLoS One. 2018 Feb 15;13(2):e0192921. doi: 10.1371/journal.pone.0192921. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nooshin Razani, MD, MPH principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family outings, Park prescription and Pedometry in people with Stress, Psychological and Social Isolation, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.