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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04913363
Other study ID # HSR210100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 17, 2021
Est. completion date November 17, 2022

Study information

Verified date November 2022
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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; In addition to the arousal measure of the MACL, the investigators will use the 10 point scale of the OMNI Perceived Exertion scale, to understand how physically exerted participants feel between activities. To understand baseline physical activity, the investigators use the international physical activity questionnaire (IPAQ) to compare between studies. - 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. 1. 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. 2. 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. 3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date November 17, 2022
Est. primary completion date November 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Over 65 years - A JABA center user - Can walk unassisted for 20 minutes - Willing to comply with COVID-19 regulations Exclusion Criteria: - Under 65 years - Never used a JABA center - unable to walk unassisted for 20 minutes. - Unwilling to comply with COVID-19 regulations

Study Design


Intervention

Other:
Green space
Green space in which activities take place

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Loneliness (Time 1) 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 Pre activity
Primary Loneliness (Time 2) 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 Post activity (20 minutes after pre-activity measure)
Primary Social Isolation (Time 1) 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. Pre activity
Primary Social Isolation (Time 2) 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. Post activity (20 minutes after pre-activity measure)
Primary Mood (Time 1) pre and post measures of mood will be taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an acute measure of hedonic tone, stress and arousal. Each subscale will range from 4 to 12, with higher scores indicating higher valence, stress and arousal, respectively. Pre activity
Primary Mood (Time 2) pre and post measures of mood will be taken using the University of Wales Institute of Science and Technology (UWIST) Mood Adjective Checklist (MACL), an acute measure of hedonic tone, stress and arousal. Each subscale will range from 4 to 12, with higher scores indicating higher valence, stress and arousal, respectively. Post activity (20 minutes after pre-activity measure)
Primary Well Aging (Time 1) Psychological restorative qualities of the setting 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. Pre activity
Primary Well Aging (Time 2) Psychological restorative qualities of the setting 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. Post activity (20 minutes after pre-activity measure)
Primary Physical Activity (Time 1) In addition to the arousal measure of the MACL, the investigators will use the 10 point scale of the OMNI Perceived Exertion scale, to understand how physically exerted participants feel between activities. To understand baseline physical activity, the investigators will use the international physical activity questionnaire (IPAQ) to compare between studies. For the OMNI, scores range from 1 to 11 with higher scores indicating increased ease of the task and tiredness, respectively. For the IPAQ, this is a composite of multiple scores that depend on participant minutes exercising; final scores however determine low, medium and high levels of exertion. Pre activity
Primary Physical Activity (Time 2) In addition to the arousal measure of the MACL, the investigators will use the 10 point scale of the OMNI Perceived Exertion scale, to understand how physically exerted participants feel between activities. To understand baseline physical activity, the investigators will use the international physical activity questionnaire (IPAQ) to compare between studies. For the OMNI, scores range from 1 to 11 with higher scores indicating increased ease of the task and tiredness, respectively. For the IPAQ, this is a composite of multiple scores that depend on participant minutes exercising; final scores however determine low, medium and high levels of exertion. Post activity (20 minutes after pre-activity measure)
Secondary Mobility Limitation we will use accelerometers to measure participant movement throughout the activities to correlate with physical activity measures. Throughout activity (measure taken for 20 minutes)
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