- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06056375
Biological and Behavioral Outcomes of Community Nature Walks
September 20, 2023 updated by: Charlotte Tate
Examining Anti-Racist Healing in Nature to Protect Telomeres of Transitional Age BIPOC for Health Equity
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charlotte Tate, Ph.D.
- Phone Number: (415) 338-2267
- Email: ctate2@sfsu.edu
Study Contact Backup
- Name: Leticia Marquez-Magana, Ph.D.
- Email: marquez@sfsu.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94132
- Recruiting
- San Francisco State University
-
Contact:
- Leticia Marquez-Magana, Ph.D.
- Email: marquez@sfsu.edu
-
Contact:
- Charlotte Tate, Ph.D.
- Phone Number: 415-338-2267
- Email: ctate2@sfsu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Waitlist Control
Waitlist control; all participants receive the treatment but are in a control condition prior to the treatment
|
The purpose of the community intervention is to prevent health disparities in Black, Latinx, Pilipinx, and Pacific Islander communities of San Francisco, California.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Telomere Length
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Relative Telomere Length in the name of the outcome measure.
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hair cortisol concentration
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Hair cortisol concentration in the name of the outcome measure.
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
|
Self-reported stress (extent of)
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Cohen Stress Scale (Likert-type self-reported measurement) in the name of the outcome measure.
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
|
Positive mood (extent of)
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Positive And Negative Affect Scale International version (PANAS-I) (Likert-type self-reported measurement)
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Steps (number of)
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
total number of steps per day, assessed by Apple's Health Application on phones in the name of the outcome measure.
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
|
Heart rate (average of beats per minute over days)
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
average beats per minute over days assessed by rate hear application on phones
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
|
Sleep quality (extent of)
Time Frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
14-item Sleep Questionnaire (Likert-type self-reported measurement)
|
Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
September 14, 2023
First Submitted That Met QC Criteria
September 20, 2023
First Posted (Actual)
September 28, 2023
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X21-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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