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Environmental ExposureNCT04642235

Nature and Well-Being Project

A study testing Nature Nook, Nature Coach and Nature Nook + Nature Coach in people with Environmental Exposure and Health Behavior, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators pilot test two intervention strategies to increase green space use- place-based and person-based, as well as evaluate the dose-response relationship between green space use and health. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nature Nook, Nature Coach and Nature Nook + Nature Coach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
12 Apr 2021to 23 Aug 2022
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Live in one of the 8 target neighborhoods identified
  • Have a smartphone
  • Able to understand and respond to an oral interview in English.

Who cannot join

  • Unwilling to go outside
  • Not ambulatory

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania, Department of Emergency Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

The investigators pilot test two intervention strategies to increase green space use- place-based and person-based, as well as evaluate the dose-response relationship between green space use and health.

Read the detailed description

Neighborhood conditions can positively impact mental health and wellbeing. Green space has been cited as a potential buffer between inequitable neighborhood conditions and poor health. However, there is limited evidence how to increase exposure to green space and how much exposure is needed to produce benefit. Place-based and person-based interventions offer contrasting approaches to improving the impact of the environment on health. The environment influences people as they traverse the spaces between home, work, and recreation, in ways that can be healthy or harmful. Place-based approaches directly change the environment to encourage healthy behaviors, and potentially have broad population impact. Alternatively, person-based approaches directly target individuals' behavior and may be more feasible. To our knowledge, no studies combine both approaches into a single intervention, which may be more effective over either alone.

The broad objectives of this proposal are to pilot test two intervention strategies to increase green space use- place-based and person-based, as well as evaluate the dose-response relationship between green space use and health. Our place-based intervention, Nature Nooks, builds on our prior greening treatment by adding new features to encourage use - a path and benches to invite people into the space and instillation on large corner lots to maximize visibility. The investigators develop our person-based intervention, Nature Coach, as a novel adoption of an analogous, established patient navigator concept in healthcare.

Being tested
Nature Nook, Nature Coach, Nature Nook + Nature Coach
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nature NookOther

    The Nature Nook intervention will take place on lots that already have the standard greening intervention. In addition, design elements will be added such as a simple path and benches to explicitly invite people into the space. An additional difference is the exclusive use of larger, corner lots, rather than smaller mid-block spaces, to maximize visibility.

  • Nature CoachBehavioural

    The Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback.

    Home visit. During the 1-hour home visit, the coach will (a) provide education about the health benefits of nature, (b) identify nearby nature targets for the participant to visit, (c) complete a pre-commitment contract based on individualized weekly nature goals, and (d) brainstorm barriers and solutions to reaching the goals.

    Personalized weekly text messages. Texts will serve as reminders of goals set with the Nature Coach, as well as encouragement to meet the goals. The context of text messages with change slightly based on individual participants, the goals they set, and the barriers they identify.

    Goal feedback- At the end of each week, participants will receive a progression badge via text message that shows the amount of days and time they spent in nature, and how this matched up to the goal set with the Nature Coach.

  • Nature Nook + Nature CoachOther

    The combined intervention will involve the installation of Nature Nooks to blighted vacant lots followed by the delivery of the Nature Coach intervention to people living in the immediate surrounding blocks. The intervention will be tailored to explicitly direct participants to use the Nature Nook.

Study groups in NCT04642235
Study groupRoleWhat they receive
Nature NookExperimentalNature Nook builds on our prior work with a standard vacant lot greening intervention involving: removing trash, grading the land, planting new grass and trees, installing a low wooden perimeter fence, and regular maintenance. This greening intervention was designed as a blight removal strategy. People in this arm receive no intervention.
Receives: Other: Nature Nook
Nature CoachExperimentalThe Nature Coach intervention, developed in a prior study (NCT04146025), will be delivered to people in their homes. Participants will live in the blocks immediately surrounding the study vacant lots randomized to this arm. The lots in this arm receive no intervention.
Receives: Behavioral: Nature Coach
Nature Nook + Nature CoachExperimentalThis is a combined arm: a place-based intervention (Nature Nook) and a person-based intervention (Nature Coach).
Receives: Other: Nature Nook + Nature Coach
ControlNo interventionThe study lots randomly selected for this arm, as well as the participants living near them, receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Green Space Use

    This will measured using GPS data to see the amount of time spent in green space.

    Measured: 12 months

Secondary outcomes (3)

  1. Mental health and well-being: CES-D

    This will be measured using the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D scale is a brief 20-item self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. A score of 16 points or more is considered depressed.

    Measured: 12 months

  2. Mental health and well-being: PSS-10

    The Perceived Stress Scale-10(PSS-10) is a self-report instrument consisting of 10 items to assess stress perception, with the time frame being during the last month. Each of the items on the PSS-10 are rated on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Four positively stated items (item 4, 5, 7, and 8) are reversely scored (0 = very often, 1 = fairy often, 2 = sometimes, 3 = almost never, 4 = never). The sum of the 10 items represents the total score, with higher scores representing higher levels of perceived stress.

    Measured: 12 months

  3. Mental health and well-being: WHO-5

    The WHO-5 Well-Being Index is a questionnaire that measures current mental well-being, with the time frame being the previous two weeks. This is five items rated on 6-point Likert scale (All of the time, Most of the time, More than half the time, Less than half the time, Some of the time, At no time). The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start12 Apr 2021
  3. Primary completion23 Aug 2022
  4. Study completion23 Aug 2022

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642235
Sponsor's protocol ID
842575
Status last verified
Aug 2022
First submitted
13 Nov 2020
Last updated
1 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nature Nook, Nature Coach and Nature Nook + Nature Coach in people with Environmental Exposure and Health Behavior, run by University of Pennsylvania 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 2 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: finished, as of the sponsor's last update on 1 Sep 2022. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Green Space Use (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642235.

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 1 Sep 2022.

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