Stress, PsychologicalPhase 1NCT06056375
Biological and Behavioral Outcomes of Community Nature Walks
A Phase 1 study testing Reclaiming Nature Intervention in people with Stress, Psychological and Telomere Shortening, run by Charlotte Tate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Telomere Shortening, Stress Reaction
- What is being tested?
- Reclaiming Nature Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnant women (and other gender identities who are pregnant)
- prisoners
- cognitively impaired
Trial locations and contacts
1 site in 1 country.
Leticia Marquez-Magana, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
San Francisco State University
San Francisco, California, 94132
Charlotte Tate, Ph.D., 415-338-2267, ctate2@sfsu.edu
Leticia Marquez-Magana, Ph.D., marquez@sfsu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological, Telomere Shortening, Stress Reaction
- Being tested
- Reclaiming Nature Intervention
- Medical subject headings
- Stress, Psychological, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reclaiming Nature InterventionBehavioural
The purpose of the community intervention is to prevent health disparities in Black, Latinx, Pilipinx, and Pacific Islander communities of San Francisco, California.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | Other | Waitlist control; all participants receive the treatment but are in a control condition prior to the treatment Receives: Behavioral: Reclaiming Nature Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Telomere Length
Relative Telomere Length in the name of the outcome measure.
Measured: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Secondary outcomes (3)
Hair cortisol concentration
Hair cortisol concentration in the name of the outcome measure.
Measured: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Self-reported stress (extent of)
Cohen Stress Scale (Likert-type self-reported measurement) in the name of the outcome measure.
Measured: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Positive mood (extent of)
Positive And Negative Affect Scale International version (PANAS-I) (Likert-type self-reported measurement)
Measured: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Feb 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Waitlist control design
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charlotte Tate
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor-investigator, Charlotte Tate, San Francisco State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056375
- Sponsor's protocol ID
- X21-013
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Anti-Racist Healing in Nature to Protect Telomeres of Transitional Age BIPOC for Health Equity
- ClinicalTrials.gov ID
- NCT06056375
- Acronym / sponsor ID
- X21-013
- Conditions
- Stress, Psychological, Telomere Shortening, Stress Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charlotte TateUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Waitlist control design
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | Other | Behavioral: Reclaiming Nature InterventionWaitlist control; all participants receive the treatment but are in a control condition prior to the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnant women (and other gender identities who are pregnant)
- prisoners
- cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reclaiming Nature InterventionThe purpose of the community intervention is to prevent health disparities in Black, Latinx, Pilipinx, and Pacific Islander communities of San Francisco, California. | Behavioural | Waitlist Control |
Primary outcome
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.
3 secondary outcomes
Hair cortisol concentration
Time frame: 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
Positive mood (extent of)
Time frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Marquez-Magana, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reclaiming Nature Intervention in people with Stress, Psychological and Telomere Shortening, run by Charlotte Tate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Tate, Ph.D. ((415) 338-2267, ctate2@sfsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Telomere Length (time frame: Baseline (pre-intervention), during intervention, immediate post-intervention, 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.