Biological and Behavioral Outcomes of Community Nature Walks
Primary Purpose
Stress, Psychological, Telomere Shortening, Stress Reaction
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Reclaiming Nature Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Stress, Psychological
Eligibility Criteria
Inclusion critieria: 18 years or older able to commit to a 9-month Nature Intervention (6-month walks; 3-month chosen nature activity) spoken languages: English, Spanish, or Tagalog able-bodied as in must be able to walk. Exclusion criteria: pregnant women (and other gender identities who are pregnant) prisoners cognitively impaired
Sites / Locations
- San Francisco State UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Waitlist Control
Arm Description
Waitlist control; all participants receive the treatment but are in a control condition prior to the treatment
Outcomes
Primary Outcome Measures
Relative Telomere Length
Relative Telomere Length in the name of the outcome measure.
Secondary Outcome Measures
Hair cortisol concentration
Hair cortisol concentration in the name of the outcome measure.
Self-reported stress (extent of)
Cohen Stress Scale (Likert-type self-reported measurement) in the name of the outcome measure.
Positive mood (extent of)
Positive And Negative Affect Scale International version (PANAS-I) (Likert-type self-reported measurement)
Full Information
NCT ID
NCT06056375
First Posted
September 14, 2023
Last Updated
September 20, 2023
Sponsor
Charlotte Tate
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT06056375
Brief Title
Biological and Behavioral Outcomes of Community Nature Walks
Official Title
Examining Anti-Racist Healing in Nature to Protect Telomeres of Transitional Age BIPOC for Health Equity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Charlotte Tate
Collaborators
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (Black, Latinx, Pilipinx, and Pacific Islander) as a preventative intervention for health disparities found in these communities. The intervention is comprised of two phases. The first consists of community nature walks in a pristine redwood forest for six months. This is followed by chosen nature activities with family and/or friends for three months. The investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. The use of these measures is in alignment with the National Institute of Minority Health and Health Disparities (NIMHD) Research Framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.
Detailed Description
The investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (Black, Latinx, Pilipinx, and Pacific Islander) as a preventative intervention for health disparities found in these communities. The intervention is comprised of two phases. The first consists of community nature walks in a pristine redwood forest for six months. This is followed by chosen nature activities with family and/or friends for three months. The investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. The use of these measures is in alignment with the National Institute of Minority Health and Health Disparities (NIMHD) Research Framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Telomere Shortening, Stress Reaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Waitlist control design
Masking
None (Open Label)
Masking Description
Since the study is a waitlisted control, all participants are aware of which condition they are in at any time.
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
Waitlist control; all participants receive the treatment but are in a control condition prior to the treatment
Intervention Type
Behavioral
Intervention Name(s)
Reclaiming Nature Intervention
Intervention Description
The purpose of the community intervention is to prevent health disparities in Black, Latinx, Pilipinx, and Pacific Islander communities of San Francisco, California.
Primary Outcome Measure Information:
Title
Relative Telomere Length
Description
Relative Telomere Length in the name of the outcome measure.
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Secondary Outcome Measure Information:
Title
Hair cortisol concentration
Description
Hair cortisol concentration in the name of the outcome measure.
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Title
Self-reported stress (extent of)
Description
Cohen Stress Scale (Likert-type self-reported measurement) in the name of the outcome measure.
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Title
Positive mood (extent of)
Description
Positive And Negative Affect Scale International version (PANAS-I) (Likert-type self-reported measurement)
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Other Pre-specified Outcome Measures:
Title
Steps (number of)
Description
total number of steps per day, assessed by Apple's Health Application on phones in the name of the outcome measure.
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Title
Heart rate (average of beats per minute over days)
Description
average beats per minute over days assessed by rate hear application on phones
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Title
Sleep quality (extent of)
Description
14-item Sleep Questionnaire (Likert-type self-reported measurement)
Time Frame
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion critieria:
18 years or older
able to commit to a 9-month Nature Intervention (6-month walks; 3-month chosen nature activity)
spoken languages: English, Spanish, or Tagalog
able-bodied as in must be able to walk.
Exclusion criteria:
pregnant women (and other gender identities who are pregnant)
prisoners
cognitively impaired
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Tate, Ph.D.
Phone
(415) 338-2267
Email
ctate2@sfsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leticia Marquez-Magana, Ph.D.
Email
marquez@sfsu.edu
Facility Information:
Facility Name
San Francisco State University
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Tate, Ph.D.
Phone
415-338-2267
Email
ctate2@sfsu.edu
First Name & Middle Initial & Last Name & Degree
Leticia Marquez-Magana, Ph.D.
Email
marquez@sfsu.edu
12. IPD Sharing Statement
Learn more about this trial
Biological and Behavioral Outcomes of Community Nature Walks
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