SHINE: Stay Healthy In Nature Everyday: Family Nature Outings in a Low Income Population

• Sponsor: UCSF Benioff Children's Hospital Oakland (Other)
• Overall Status: Completed
• CT.gov ID: NCT02623855
• Collaborator: East Bay Regional Park District (Other), National Recreation and Park Association (Other), University of California, San Francisco (Other)
• Enrollment: 156
• Location: 1
• Arms: 2
• Duration (Months): 18.1
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological; Social Isolation; Physical Activity	Behavioral: Family outings; Behavioral: Park prescription; Device: Pedometry; Behavioral: Case Management	N/A

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

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Park prescription Park prescription, pedometry.	Behavioral: 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.
Experimental: Park prescription and family outings Park prescription, pedometry, case management and 3 weekly family outings.	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.; Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Stress [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.

2. Change in Stress [1 month]

   measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.

Secondary Outcome Measures

1. Change in Park Visits Per Week [1 month]

   Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.

2. Change in Minutes of Moderate Physical Activity Per Day [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. Change in Cortisol Level in Parents [3 months]

   Salivary cortisol from parents

4. Change in Minutes of Moderate Physical Activity Per Day [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.

5. Change in Cortisol Level in Parents [1 month]

   Salivary cortisol from parents

6. Change in Park Visits Per Week [3 month]

   Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Benioff Children's Hospital Oakland Primary Care Clinic	Oakland	California	United States	94609

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Nooshin Razani, MD, MPH, UCSF Benioff Children's Hospital Oakland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCSF Benioff Children's Hospital Oakland
• ClinicalTrials.gov Identifier: NCT02623855
• Other Study ID Numbers: 2015-042
• First Posted: Dec 8, 2015
• Last Update Posted: Nov 30, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by UCSF Benioff Children's Hospital Oakland: Parks; Well-being; Stress; Physical Activity; Nature; Greenspace
• Additional relevant MeSH terms: Stress, Psychological

Study Results

Participant Flow

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Period Title: Overall Study
STARTED	56	100
COMPLETED	46	84
NOT COMPLETED	10	16

Baseline Characteristics

Arm/Group Title	Park Prescription	Park Prescription and Family Outings	Total
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.	Total of all reporting groups
Overall Participants	56	100	156
Age (Count of Participants)
<=18 years	28 50%	50 50%	78 50%
Between 18 and 65 years	28 50%	50 50%	78 50%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	34 60.7%	72 72%	106 67.9%
Male	22 39.3%	28 28%	50 32.1%
Race/Ethnicity, Customized (Count of Participants)
African-American	39 69.6%	59 59%	98 62.8%
Non-Latino White	1 1.8%	5 5%	6 3.8%
Latino	4 7.1%	21 21%	25 16%
Other (Native American, Middle Eastern, API)	12 21.4%	17 17%	29 18.6%
Region of Enrollment (Count of Participants)
United States	56 100%	100 100%	156 100%

Outcome Measures

1. Primary Outcome

Title	Change in Stress
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	23	42
Mean (95% Confidence Interval) [units on a scale]	-1.48	-1.83

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Park Prescription, Park Prescription and Family Outings
	Comments	The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.
	Type of Statistical Test	Superiority
	Comments	Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.
Statistical Test of Hypothesis	p-Value	0.6099
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change in Stress
Description	measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	21	39
Mean (95% Confidence Interval) [units on a scale]	-2.81	-1.90

3. Secondary Outcome

Title	Change in Park Visits Per Week
Description	Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	23	42
Mean (95% Confidence Interval) [park visits/week]	1.81	1.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Park Prescription, Park Prescription and Family Outings
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0085
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Change in Minutes of Moderate Physical Activity Per Day
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Minutes of moderate physical activity per average day in the week prior to follow up at 0, 1 and 3 months was measured. Below we list the mean within group change of minutes of moderate physical activity per day.

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	78	78
Mean (95% Confidence Interval) [minutes/day]	33.91	18.58

5. Secondary Outcome

Title	Change in Cortisol Level in Parents
Description	Salivary cortisol from parents
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	17	35
Mean (95% Confidence Interval) [ug/dL]	-0.01	0.01

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Park Prescription, Park Prescription and Family Outings
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1749
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Change in Minutes of Moderate Physical Activity Per Day
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Minutes of moderate physical activity per average day in the week prior to follow up at 0, 1 and 3 months was measured. Below we list the mean within group change of minutes of moderate physical activity per day.

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	18	38
Mean (95% Confidence Interval) [minutes/day]	20.72	30.76

7. Secondary Outcome

Title	Change in Cortisol Level in Parents
Description	Salivary cortisol from parents
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	17	35
Mean (95% Confidence Interval) [ug/dL]	-0.01	0.01

8. Secondary Outcome

Title	Change in Park Visits Per Week
Description	Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Park Prescription	Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.	Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
Measure Participants	23	42
Mean (95% Confidence Interval) [park visits/week]	-1.48	-1.83

Adverse Events

Arm/Group Title	Park Prescription		Park Prescription and Family Outings
Arm/Group Description	Park prescription, pedometry. Park prescription: Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature. Pedometry: Participants will record their daily pedometry.		Park prescription, pedometry, case management and 3 weekly family outings. 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. Pedometry: Participants will record their daily pedometry. 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.
All Cause Mortality
	Park Prescription		Park Prescription and Family Outings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/50 (0%)
Serious Adverse Events
	Park Prescription		Park Prescription and Family Outings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Park Prescription		Park Prescription and Family Outings
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.