Trial Outcomes & Findings for Stay Healthy In Nature Everyday: Family Nature Outings in a Low Income Population (NCT NCT02623855)
NCT ID: NCT02623855
Last Updated: 2020-11-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
3 months
Results posted on
2020-11-30
Participant Flow
Participant milestones
| Measure |
Park Prescription
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 and Family Outings
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
100
|
|
Overall Study
COMPLETED
|
46
|
84
|
|
Overall Study
NOT COMPLETED
|
10
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stay Healthy In Nature Everyday: Family Nature Outings in a Low Income Population
Baseline characteristics by cohort
| Measure |
Park Prescription
n=56 Participants
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 and Family Outings
n=100 Participants
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
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
39 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Latino White
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
4 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (Native American, Middle Eastern, API)
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsmeasured 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.
Outcome measures
| Measure |
Park Prescription
n=23 Participants
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 and Family Outings
n=42 Participants
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.
|
|---|---|---|
|
Change in Stress
|
-1.48 units on a scale
Interval -4.55 to 1.6
|
-1.83 units on a scale
Interval -3.42 to -0.25
|
PRIMARY outcome
Timeframe: 1 monthmeasured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.
Outcome measures
| Measure |
Park Prescription
n=21 Participants
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 and Family Outings
n=39 Participants
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.
|
|---|---|---|
|
Change in Stress
|
-2.81 units on a scale
Interval -6.51 to 0.89
|
-1.90 units on a scale
Interval -3.7 to -0.89
|
SECONDARY outcome
Timeframe: 1 monthSelf-reported number of park visits in the last week, measured at 0, 1, and 3 months.
Outcome measures
| Measure |
Park Prescription
n=23 Participants
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 and Family Outings
n=42 Participants
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.
|
|---|---|---|
|
Change in Park Visits Per Week
|
1.81 park visits/week
Interval 0.82 to 2.8
|
1.08 park visits/week
Interval 0.24 to 1.92
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Park Prescription
n=78 Participants
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 and Family Outings
n=78 Participants
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.
|
|---|---|---|
|
Change in Minutes of Moderate Physical Activity Per Day
|
33.91 minutes/day
Interval 8.2 to 59.62
|
18.58 minutes/day
Interval 3.75 to 33.42
|
SECONDARY outcome
Timeframe: 3 monthsSalivary cortisol from parents
Outcome measures
| Measure |
Park Prescription
n=17 Participants
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 and Family Outings
n=35 Participants
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.
|
|---|---|---|
|
Change in Cortisol Level in Parents
|
-0.01 ug/dL
Interval -0.04 to 0.03
|
0.01 ug/dL
Interval -0.07 to 0.09
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 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.
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.
Outcome measures
| Measure |
Park Prescription
n=18 Participants
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 and Family Outings
n=38 Participants
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.
|
|---|---|---|
|
Change in Minutes of Moderate Physical Activity Per Day
|
20.72 minutes/day
Interval -4.96 to 46.41
|
30.76 minutes/day
Interval 8.28 to 53.25
|
SECONDARY outcome
Timeframe: 1 monthSalivary cortisol from parents
Outcome measures
| Measure |
Park Prescription
n=17 Participants
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 and Family Outings
n=35 Participants
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.
|
|---|---|---|
|
Change in Cortisol Level in Parents
|
-0.01 ug/dL
Interval -0.04 to 0.03
|
0.01 ug/dL
Interval -0.07 to 0.09
|
SECONDARY outcome
Timeframe: 3 monthSelf-reported number of park visits in the last week, measured at 0, 1, and 3 months.
Outcome measures
| Measure |
Park Prescription
n=23 Participants
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 and Family Outings
n=42 Participants
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.
|
|---|---|---|
|
Change in Park Visits Per Week
|
-1.48 park visits/week
Interval -4.55 to 1.6
|
-1.83 park visits/week
Interval -3.42 to -0.25
|
Adverse Events
Park Prescription
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Park Prescription and Family Outings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nooshin Razani, Principal Investigator
UCSF Benioff Children's Hospital Oaland
Phone: 415-428-3129
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place