LonelinessNCT04913363

The Emotional, Physical and Cognitive Benefits of Purposeful Green Space Activities on Seniors

A study testing Green space in people with Loneliness and Social Isolation, run by University of Virginia 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

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Loneliness, Social Isolation, Mood
What is being tested?: Green space
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 17 Jun 2021to 17 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Over 65 years
A JABA center user
Can walk unassisted for 20 minutes
Willing to comply with COVID-19 regulations

Who cannot join

Under 65 years
Never used a JABA center
unable to walk unassisted for 20 minutes.
Unwilling to comply with COVID-19 regulations

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22903

Other trials in United States

About this study

This project explores if various nature based activities can lead to acute improvements in emotional, physical and cognitive health outcomes and encouraging senior center (JABA) service users to return to a safe environment. The activities the investigators will use include walking in nature, engaging in physical planting and cerebral, citizen science based activities.

Read the detailed description

This study builds on the previous experimental work and expands it to focus on older adults in the Charlottesville area. The study objective is to understand the impact of different types of activities in green settings on physical and mental health outcomes in older adults at JABA centers using a repeated measures, crossover design in 20 participants.

There are three activity sessions in this project; walking (contemplative), planting (physical) and citizen science (cerebral). The walking condition will be a short green walk (10-15 minutes). The planting session will be run by JABA staff and a Master Gardener and will allow participants an opportunity to be outdoors and plant and tend to plants. The citizen science session will be run by JABA staff and a consultant and will rely less on physical exertion but rather focus on understanding green space at a more academic level. All sessions will be outdoors and will follow COVID-19 guidelines in place at the time of testing.

Outcome Measures The investigators will use various measures to assess the impact of green activity on emotional, physical and cognitive health outcomes, including;

Loneliness; measured by the UCLA Loneliness Scale, a 3-item scale that captures feelings of loneliness.
Belonging; measured by the General Belonging Scale (GBS), a 12-item scale capturing social acceptance/inclusion and social rejection/exclusion.
Acute Mood; pre and post measures of mood will be taken using the UWIST Mood Adjective Checklist (MACL), an acute measure of hedonic tone, stress and arousal.
Restoration; Psychological restorative qualities of the setting measured by the Perceived Restorativeness Scale, a three point scale determining the restorative quality of activity spaces.
Physical Activity_OMNIT; In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIT Perceived Exertion scale (tiredness), to understand how physically tired the activities made them.
Physical Activity_OMNIH; In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIH Perceived Exertion scale (exertion), to understand how much perceived physical effort participants put in.
Accelerometer; the investigators will use accelerometers to measure participant movement throughout the activities to correlate with physical activity measures.

All outcome measures will be scored and subsequently analysed using a one-way ANOVA to determine if experimental condition leads to any statistically significant difference between outcome scores. The investigators will look for correlations between outcome measures in order to establish relationships between variables.

The investigators will also send a short survey to a number of JABA service users (n=30) to understand mood, wellbeing and current barriers to returning to their local JABA center. This survey will include the UCLA Loneliness Scale, the GBS, mood and physical activity measures included above, as well as broader questions assessing their experience of the lockdown and their needs for safe return to the center.

Participants will be sent consent information in advance and have an opportunity to talk to the research time prior to attending their first session. For all conditions, participants would meet at a pre-determined location near their local JABA center and taken to the activity site directly. Participants will complete the short surveys, listed above, both pre and post their activity. All activities will last around 20 minutes. Participants will return for two consecutive weeks to undertake the alternative activities to which they originally completed.

Activities Participants will undertake three activities, on separate days, throughout this project.

Walking; this contemplative activity will see users taken to a local green space area near their center and encouraged to walk around the space. It is anticipated that walks will last around 15-20 minutes.
Planting; this physical activity will see users, lead by a local Master Gardener, engage with planting vegetables/fruit in raised beds. Not only will this allow users a chance to engage physically with nature, but it is anticipated that the grown produce will be used for center users.
Citizen Science; this cerebral activity sees users engage with local green spaces, under the instruction of a citizen scientist, to learn about the intricacies of the space. This may include lichen counts (or similar) where the main outcome is learning based.

Conditions: Loneliness, Social Isolation, Mood, Well Aging, Physical Activity, Mobility Limitation
Being tested: Green space
Medical subject headings: Social Isolation, Motor Activity, Mobility Limitation

What participants receive

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

Green spaceOther
Green space in which activities take place

Study groups in NCT04913363
Study group	Role	What they receive
Walking	Experimental	This contemplative activity will see users taken to a local green space area near their center and encouraged to walk around the space. It is anticipated walks will last around 15-20 minutes. Receives: Other: Green space
Citizen Science	Experimental	This cerebral activity sees users engage with local green spaces, under the instruction of a citizen scientist, to learn about the intricacies of the space. This may include lichen counts (or similar) where the main outcome is learning based. Receives: Other: Green space
Planting	Experimental	This physical activity will see users, lead by a local Master Gardener, engage with planting vegetables/fruit in raised beds. Not only will this allow users a chance to engage physically with nature, but it is anticipated that the grown produce will be used for center users. Receives: Other: Green space

What is being measured

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

Loneliness (Time 1)
Loneliness was measured by the University of California, Los Angeles (UCLA) Loneliness Scale, a 3-item scale that captures feelings of loneliness. Scores range from 3 to 9 with higher scores indicating higher levels of perceived loneliness
Measured: Pre activity
Loneliness (Time 2)
Loneliness was measured by the University of California, Los Angeles (UCLA) Loneliness Scale, a 3-item scale that captures feelings of loneliness. Scores range from 3 to 9 with higher scores indicating higher levels of perceived loneliness
Measured: Post activity (20 minutes after pre-activity measure)
Social Isolation (Time 1)
Social Isolation was measured by the General Belonging Scale (GBS), a 12-item scale capturing social acceptance/inclusion and social rejection/exclusion. Scores will range from 12 to 84, with higher scores indicating higher levels of perceived belonging.
Measured: Pre activity
Social Isolation (Time 2)
Social Isolation was measured by the General Belonging Scale (GBS), a 12-item scale capturing social acceptance/inclusion and social rejection/exclusion. Scores will range from 12 to 84, with higher scores indicating higher levels of perceived belonging.
Measured: Post activity (20 minutes after pre-activity measure)
Mood_hedonic Tone (Time 1)
Pre measures of mood (hedonic tone) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of hedonic tone. The subscale will range from 4 to 16, with higher scores indicating higher valence.
Measured: Pre activity
Mood_hedonic Tone (Time 2)
Post measures of (hedonic tone) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of hedonic tone. The subscale will range from 4 to 16, with higher scores indicating higher valence.
Measured: Post activity (20 minutes after pre-activity measure)
Well Aging_ Using Perceived Restorativeness Scale
Psychological restorative qualities of the setting was measured by the Perceived Restorativeness Scale, a three point scale determining the restorative quality of activity spaces. Scores range from 4 to 28, with higher scores indicating higher levels of perceived restoration.
Measured: Post activity (20 minutes after pre-activity measure). This measure is a post-condition measure only that measures restoration as a result of the condition. This cannot be done before exposure to the condition.
Physical Activity_OMNIT
In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIT Perceived Exertion scale (tiredness), to understand how physically tired the activities made them. Lower scores indicate the tasks are easy; higher scores indicate the tasks are hard.
Measured: Post activity (20 minutes after pre-activity measure). OMNIT is administered post-activity ONLY.
Physical Activity_OMNIH
In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIH Perceived Exertion scale (exertion), to understand how much perceived physical effort participants put in. Lower scores indicate the tasks are easy; higher scores indicate the tasks are hard.
Measured: Post activity (20 minutes after pre-activity measure). OMNIH is administered post-activity ONLY.
Mood_Stress (Time 1)
Pre measures of mood (stress) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of stress. The subscale will range from 4 to 16, with higher scores indicating higher stress.
Measured: Pre activity
Mood_Stress (Time 2)
Post measures of mood (stress) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of stress. The subscale will range from 4 to 16, with higher scores indicating higher stress.
Measured: Post activity (20 minutes after pre-activity measure)
Mood_arousal (Time 1)
Pre measures of mood (arousal) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of arousal. The subscale will range from 4 to 16, with higher scores indicating higher arousal.
Measured: Pre activity
Mood_arousal (Time 2)
Post measures of mood (arousal) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of arousal. The subscale will range from 4 to 16, with higher scores indicating higher arousal.
Measured: Post activity (20 minutes after pre-activity measure)

Secondary outcomes (1)

Mobility Limitation
Mobility Limitation was determined using accelerometers to measure participant movement throughout the activities to correlate with physical activity measures.
Measured: Throughout activity (measure taken for 20 minutes)

Timeline

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

17 Jun 202117 Nov 2022

First posted4 Jun 2021
Study start17 Jun 2021
Primary completion17 Nov 2022
Study completion17 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LonelinessStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
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 N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Model description: The study was designed in a single group, where participants will be complete the interventions (green space activities) in this order: Citizen Science, Walking, Planting. However, participants may or may not show up on the day of an activity. i.e. participants may skip one or more interventions, even though that was not the intent of the study design.
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04913363
Sponsor's protocol ID: HSR210100
Other IDs: UL1TR003015
Status last verified: Oct 2024
First submitted: 10 May 2021
Last updated: 10 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Loneliness trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Emotional, Physical and Cognitive Benefits of Purposeful Green Space Activities on Seniors
ClinicalTrials.gov ID: NCT04913363
Acronym / sponsor ID: HSR210100
Conditions: Loneliness, Social Isolation, Mood, Well Aging, Physical Activity, Mobility Limitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 17 Jun 2021 (actual)
Primary completion: 17 Nov 2022 (actual)
Study completion: 17 Nov 2022 (actual)
First posted: 4 Jun 2021 (actual)
Results: Posted 10 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Outcome Measures The investigators will use various measures to assess the impact of green activity on emotional, physical and cognitive health outcomes, including;

Loneliness; measured by the UCLA Loneliness Scale, a 3-item scale that captures feelings of loneliness.
Belonging; measured by the General Belonging Scale (GBS), a 12-item scale capturing social acceptance/inclusion and social rejection/exclusion.
Acute Mood; pre and post measures of mood will be taken using the UWIST Mood Adjective Checklist (MACL), an acute measure of hedonic tone, stress and arousal.
Restoration; Psychological restorative qualities of the setting measured by the Perceived Restorativeness Scale, a three point scale determining the restorative quality of activity spaces.
Physical Activity_OMNIT; In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIT Perceived Exertion scale (tiredness), to understand how physically tired the activities made them.
Physical Activity_OMNIH; In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIH Perceived Exertion scale (exertion), to understand how much perceived physical effort participants put in.
Accelerometer; the investigators will use accelerometers to measure participant movement throughout the activities to correlate with physical activity measures.

Activities Participants will undertake three activities, on separate days, throughout this project.

Walking; this contemplative activity will see users taken to a local green space area near their center and encouraged to walk around the space. It is anticipated that walks will last around 15-20 minutes.
Planting; this physical activity will see users, lead by a local Master Gardener, engage with planting vegetables/fruit in raised beds. Not only will this allow users a chance to engage physically with nature, but it is anticipated that the grown produce will be used for center users.
Citizen Science; this cerebral activity sees users engage with local green spaces, under the instruction of a citizen scientist, to learn about the intricacies of the space. This may include lichen counts (or similar) where the main outcome is learning based.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: The study was designed in a single group, where participants will be complete the interventions (green space activities) in this order: Citizen Science, Walking, Planting. However, participants may or may not show up on the day of an activity. i.e. participants may skip one or more interventions, even though that was not the intent of the study design.

Arm	Type	Receives
Walking	Experimental	Other: Green spaceThis contemplative activity will see users taken to a local green space area near their center and encouraged to walk around the space. It is anticipated walks will last around 15-20 minutes.
Citizen Science	Experimental	Other: Green spaceThis cerebral activity sees users engage with local green spaces, under the instruction of a citizen scientist, to learn about the intricacies of the space. This may include lichen counts (or similar) where the main outcome is learning based.
Planting	Experimental	Other: Green spaceThis physical activity will see users, lead by a local Master Gardener, engage with planting vegetables/fruit in raised beds. Not only will this allow users a chance to engage physically with nature, but it is anticipated that the grown produce will be used for center users.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Over 65 years
A JABA center user
Can walk unassisted for 20 minutes
Willing to comply with COVID-19 regulations

Key exclusion criteria (4 listed)

Under 65 years
Never used a JABA center
unable to walk unassisted for 20 minutes.
Unwilling to comply with COVID-19 regulations

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
Green spaceGreen space in which activities take place	Other	Citizen Science, Planting, Walking

Primary outcome

Loneliness (Time 1)
Time frame: Pre activity
Loneliness was measured by the University of California, Los Angeles (UCLA) Loneliness Scale, a 3-item scale that captures feelings of loneliness. Scores range from 3 to 9 with higher scores indicating higher levels of perceived loneliness
Loneliness (Time 2)
Time frame: Post activity (20 minutes after pre-activity measure)
Loneliness was measured by the University of California, Los Angeles (UCLA) Loneliness Scale, a 3-item scale that captures feelings of loneliness. Scores range from 3 to 9 with higher scores indicating higher levels of perceived loneliness
Social Isolation (Time 1)
Time frame: Pre activity
Social Isolation was measured by the General Belonging Scale (GBS), a 12-item scale capturing social acceptance/inclusion and social rejection/exclusion. Scores will range from 12 to 84, with higher scores indicating higher levels of perceived belonging.
Social Isolation (Time 2)
Time frame: Post activity (20 minutes after pre-activity measure)
Social Isolation was measured by the General Belonging Scale (GBS), a 12-item scale capturing social acceptance/inclusion and social rejection/exclusion. Scores will range from 12 to 84, with higher scores indicating higher levels of perceived belonging.
Mood_hedonic Tone (Time 1)
Time frame: Pre activity
Pre measures of mood (hedonic tone) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of hedonic tone. The subscale will range from 4 to 16, with higher scores indicating higher valence.
Mood_hedonic Tone (Time 2)
Time frame: Post activity (20 minutes after pre-activity measure)
Post measures of (hedonic tone) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of hedonic tone. The subscale will range from 4 to 16, with higher scores indicating higher valence.
Well Aging_ Using Perceived Restorativeness Scale
Time frame: Post activity (20 minutes after pre-activity measure). This measure is a post-condition measure only that measures restoration as a result of the condition. This cannot be done before exposure to the condition.
Psychological restorative qualities of the setting was measured by the Perceived Restorativeness Scale, a three point scale determining the restorative quality of activity spaces. Scores range from 4 to 28, with higher scores indicating higher levels of perceived restoration.
Physical Activity_OMNIT
Time frame: Post activity (20 minutes after pre-activity measure). OMNIT is administered post-activity ONLY.
In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIT Perceived Exertion scale (tiredness), to understand how physically tired the activities made them. Lower scores indicate the tasks are easy; higher scores indicate the tasks are hard.
Physical Activity_OMNIH
Time frame: Post activity (20 minutes after pre-activity measure). OMNIH is administered post-activity ONLY.
In addition to the arousal measure of the MACL, the investigators used the 11 point scale (from 0 to 10) of the OMNIH Perceived Exertion scale (exertion), to understand how much perceived physical effort participants put in. Lower scores indicate the tasks are easy; higher scores indicate the tasks are hard.
Mood_Stress (Time 1)
Time frame: Pre activity
Pre measures of mood (stress) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of stress. The subscale will range from 4 to 16, with higher scores indicating higher stress.
Mood_Stress (Time 2)
Time frame: Post activity (20 minutes after pre-activity measure)
Post measures of mood (stress) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of stress. The subscale will range from 4 to 16, with higher scores indicating higher stress.
Mood_arousal (Time 1)
Time frame: Pre activity
Pre measures of mood (arousal) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of arousal. The subscale will range from 4 to 16, with higher scores indicating higher arousal.
Mood_arousal (Time 2)
Time frame: Post activity (20 minutes after pre-activity measure)
Post measures of mood (arousal) was taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an average measure of arousal. The subscale will range from 4 to 16, with higher scores indicating higher arousal.

1 secondary outcome

Mobility Limitation
Time frame: Throughout activity (measure taken for 20 minutes)

Results and safety

Results posted to the registry on 10 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Citizen Science + Walking + Planting	12	12
Citizen Science + Walking	1	1
Citizen Science + Planting	1	1
Citizen Science	3	3
Walking	5	5
Planting	2	2

Primary outcome: Loneliness (Time 1)

Time frame: Pre activity. Mean (Standard Deviation). Unit: units on a scale

Measure	Citizen Science + Walking + Planting n = 12	Citizen Science + Walking n = 1	Citizen Science + Planting n = 1	Citizen Science n = 2	Walking n = 5	Planting n = 2
Value	4.08 (1.084)	5 (0)	3 (0)	3 (0)	3.6 (0.894)	3 (0)

Population analysed: Only 2 (of 3) participants from the Citizen Science group completed the UCLA scale.

Primary outcome: Loneliness (Time 2)

Time frame: Post activity (20 minutes after pre-activity measure). Mean (Standard Deviation). Unit: units on a scale

Measure	Citizen Science + Walking + Planting n = 12	Citizen Science + Walking n = 1	Citizen Science + Planting n = 1	Citizen Science n = 3	Walking n = 5	Planting n = 2
Value	4.25 (1.357)	5 (0)	3 (0)	4.33 (2.309)	3.4 (0.894)	3 (0)

Primary outcome: Social Isolation (Time 1)

Time frame: Pre activity. Mean (Standard Deviation). Unit: units on a scale

Measure	Citizen Science + Walking + Planting n = 12	Citizen Science + Walking n = 1	Citizen Science + Planting n = 1	Citizen Science n = 2	Walking n = 5	Planting n = 2
Value	71.42 (12.894)	56 (0)	83 (0)	74 (2.828)	70.4 (13.24)	79 (7.071)

Population analysed: Only 2 (of 3) participants from the Citizen Science group completed the GBS.

Primary outcome: Social Isolation (Time 2)

Time frame: Post activity (20 minutes after pre-activity measure). Mean (Standard Deviation). Unit: units on a scale

Measure	Citizen Science + Walking + Planting n = 12	Citizen Science + Walking n = 1	Citizen Science + Planting n = 1	Citizen Science n = 3	Walking n = 4	Planting n = 2
Value	72.18 (13.121)	51 (0)	84 (0)	65 (4.583)	67.75 (17.481)	79.5 (6.364)

Population analysed: Only 4 (of 5) participants from the Walking group completed the GBS measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Event Data were collected through study completion. Participants may be engaged in up to 3 study visits over 3 weeks. Each visit will be less than 1 hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Citizen Science + Walking + Planting	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Citizen Science + Walking	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Citizen Science + Planting	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Citizen Science	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Walking	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Planting	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Study was a pilot, using small samples without comparison groups (such as controls). In addition, the study was a one-off and was unable to explore longer-term studies exploring 'dose' of the activity e.g. longer duration of activity (min), frequency and seasonality effects. Data capture using objective measures (e.g. actual physical exertion rates using accelerometers/mobile health sensors) was unable to be carried out owing to Covid-19 restrictions on direct contact with participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Jenny Roe principal investigator

University of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Green space in people with Loneliness and Social Isolation, run by University of Virginia 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 4 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 10 Oct 2024. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Loneliness (Time 1) (time frame: Pre activity). The study lists 13 primary outcomes in all. 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 NCT04913363.

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 10 Oct 2024.