- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02623855
Stay Healthy In Nature Everyday: Family Nature Outings in a Low Income Population (SHINE)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Oakland, California, United States, 94609
- UCSF Benioff Children's Hospital Oakland Primary Care Clinic
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Park prescription
Park prescription, pedometry.
|
Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.
Participants will record their daily pedometry.
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Experimental: Park prescription and family outings
Park prescription, pedometry, case management and 3 weekly family outings.
|
Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.
Participants will record their daily pedometry.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Change in Stress
Time Frame: 1 month
|
measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Park Visits Per Week
Time Frame: 1 month
|
Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.
|
1 month
|
Change in Minutes of Moderate Physical Activity Per Day
Time Frame: 3 months
|
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
|
Change in Cortisol Level in Parents
Time Frame: 3 months
|
Salivary cortisol from parents
|
3 months
|
Change in Minutes of Moderate Physical Activity Per Day
Time Frame: 1 month
|
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
|
Change in Cortisol Level in Parents
Time Frame: 1 month
|
Salivary cortisol from parents
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1 month
|
Change in Park Visits Per Week
Time Frame: 3 month
|
Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.
|
3 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nooshin Razani, MD, MPH, UCSF Benioff Children's Hospital Oakland
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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