NCT02623855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

November 24, 2015

Results QC Date

February 15, 2018

Last Update Submit

November 20, 2020

Conditions

Stress, PsychologicalSocial IsolationPhysical Activity

Keywords

ParksWell-beingStressPhysical ActivityNatureGreenspace

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change in Stress

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

    1 month

Secondary Outcomes (6)

  • Change in Park Visits Per Week

    1 month

  • Change in Minutes of Moderate Physical Activity Per Day

    3 months

  • Change in Cortisol Level in Parents

    3 months

  • Change in Minutes of Moderate Physical Activity Per Day

    1 month

  • Change in Cortisol Level in Parents

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Park prescription

ACTIVE COMPARATOR

Park prescription, pedometry.

Behavioral: Park prescriptionDevice: Pedometry

Park prescription and family outings

EXPERIMENTAL

Park prescription, pedometry, case management and 3 weekly family outings.

Behavioral: Family outingsBehavioral: Park prescriptionDevice: PedometryBehavioral: Case Management

Interventions

Family outingsBEHAVIORAL

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 and family outings
Park prescriptionBEHAVIORAL

Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.

Park prescriptionPark prescription and family outings
PedometryDEVICE

Participants will record their daily pedometry.

Park prescriptionPark prescription and family outings
Case ManagementBEHAVIORAL

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.

Park prescription and family outings

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Enrolled in a weight loss program, unable to be physically active, unable to give informed consent, unable to follow up for study duration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Benioff Children's Hospital Oakland Primary Care Clinic

Oakland, California, 94609, United States

Location

Related Publications (1)

  • 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.

    PMID: 29447248DERIVED

MeSH Terms

Conditions

Stress, PsychologicalSocial IsolationMotor Activity

Interventions

Case Management

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Dr. Nooshin Razani, Principal Investigator
Organization
UCSF Benioff Children's Hospital Oaland
nrazani@mail.cho.org
415-428-3129

Study Officials

  • Nooshin Razani, MD, MPH

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 8, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

November 30, 2020

Results First Posted

February 18, 2019

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)