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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02623855
Other study ID # 2015-042
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date January 2017

Study information

Verified date November 2020
Source UCSF Benioff Children's Hospital Oakland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date January 2017
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Enrolled in a weight loss program, unable to be physically active, unable to give informed consent, unable to follow up for study duration.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Family outings
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 prescription
Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.
Device:
Pedometry
Participants will record their daily pedometry.
Behavioral:
Case Management
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.

Locations

Country Name City State
United States UCSF Benioff Children's Hospital Oakland Primary Care Clinic Oakland California

Sponsors (4)

Lead Sponsor Collaborator
UCSF Benioff Children's Hospital Oakland East Bay Regional Park District, National Recreation and Park Association, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Primary Change in Stress measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40. 1 month
Secondary Change in Park Visits Per Week Self-reported number of park visits in the last week, measured at 0, 1, and 3 months. 1 month
Secondary 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.
3 months
Secondary Change in Cortisol Level in Parents Salivary cortisol from parents 3 months
Secondary 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.
1 month
Secondary Change in Cortisol Level in Parents Salivary cortisol from parents 1 month
Secondary Change in Park Visits Per Week Self-reported number of park visits in the last week, measured at 0, 1, and 3 months. 3 month
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