Depression Clinical Trial
Official title:
Nature and Health: How Does Lifestyle and Environment Affect Health and Wellness
NCT number | NCT06001697 |
Other study ID # | 72478 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 18, 2023 |
Est. completion date | December 2024 |
The purpose of this study is to examine if and how implementing nature prescriptions can increase time in nature and improve health to yield an actionable understanding of the nature-health connection. It aims to explore how public green spaces can be better used to improve individual and community health. Finally, this study aims to advance science by conducting a randomized controlled trial to improve understanding of the linkages between time in nature and human health.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 65 Years |
Eligibility | Inclusion Criteria: - Participants must be a patient of the AHN Forbes Family Medicine clinic. - Participants must have one or more chronic conditions, or significant lifestyle risks as identified by their healthcare provider. - Participants must be between 13-65 years old. - Participants must be willing and able to provide informed consent to participate - Participants under 18 must be willing and able to assent for themselves and obtain parental consent. - Participants must be willing to comply with all study procedures for the duration of the study. - Participants must reside in the greater Pittsburgh area for the duration of 6-month study. - Participants must have a smartphone that is capable of running the Urban Mind App and connecting to the Garmin wearable device (iPhone 6 and newer as well as most Android phones). - Minors who participate must have their own smartphone. - Participants must have their own email address to register with the Urban Mind App and the Garmin App. - Only one participant from a household may enroll in the study. - Participants must be able to comprehend written English (questionnaires will be provided to participants in English). - Participants may not be an employee of Forbes Family Medicine clinic Exclusion Criteria: - None, must meet all inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | Forbes Family Medicine/AHN Research Institute | Monroeville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Richard King Mellon Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nature Exposure Scale II (NES-II) | Assess each participant's exposure to nature in everyday life. The Nature Exposure Scale II uses a 5-point likert scale for each item. Higher score means greater exposure to nature. The total score is an average of all the items included. | Baseline and 6-months | |
Secondary | CDC Health related quality of life - 14 (CDC-HRQOL-14) | The Health related quality of life scale rates an individual's perceived physical and mental health over time. The main outcome score is the unhealthy days index, computed by adding a respondent's physically and mentally unhealthy days. Score goes from 0-30 where higher is worse. | Baseline and 6-months | |
Secondary | Brief-Pittsburgh Sleep Quality Index (B-PSQI) | Brief-Pittsburgh Sleep Quality Index assesses an individuals perceived sleep quality. The questionnaires contains 6 items and the total score ranges from 0-15 where higher scores indicate worse sleep. | Baseline and 6-months | |
Secondary | Perceived Stress Scale (PSS-10) | The Perceived Stress Scale is a measure of an individuals perceived stress levels. 10-items with scoring from 0-4 were higher is higher levels of perceived stress (worse). Total score is obtained by summing across all items. | Baseline and 6-months | |
Secondary | International Physical Activity Questionnaire Short form (IPAQ-S) | The International Physical Activity Questionnaire - Short Form rates an individuals physical activity levels and types of exercise. The questionnaire consists of 7 items that measures days physically active as well as duration. Scores will calculated as categorical low/medium/high where higher is more active (1-3). And continuous by calculating metabolic equivalent of task (MET) minutes for a week MET-minutes/week where higher is better. 0-10000 | Baseline and 6-months | |
Secondary | Patient Health Questionnaire (PHQ-8/PHQ-A) | The Patient Health Questionnaire is a scale for measuring depression in adults. The scale has 8 items and the scores ranges from 0-3. The total score ranges from 0-24 where higher is more depression (worse). The Patient Health Questionnaire - Adolescence measures depression in teens (PHQ-A). The scale consists of 9 items and scores from 0-3 and a total score of 27. Where higher scores is worse (more depression). | Baseline and 6-months | |
Secondary | General Anxiety Disorder (GAD-7) | The General Anxiety Disorder questionnaire is a scale for measuring levels of anxiety in individuals. The scale has 7 items and each items is scored 0-3 where the total score ranges from 0-21 where higher is worse (more anxiety). | Baseline and 6-months | |
Secondary | Step count | Daily step count measured through the Garmin Vivosmart 5. Steps measured is day can range from 0 to unlimited where higher steps is considered better (more physical activity). Total steps will be averaged by days to calculate an average steps per days. | From study start until study end (6 months) | |
Secondary | Green view index | Individuals nature exposure level measured through their GPS trajectories and Google Street View (GSV) images. Higher scores is better (more green space exposure). | From study start until study end (6 months) | |
Secondary | Urban Mind mental health assessment | Scores of the mental health assessment taken every 72-hours. The Urban Mind mental health assessment consists of one question which rates mental health from 1-5 where higher is better (poor/fair/good/very good/excellent). The total score will be the average score per day. | From study start until study end (6 months) | |
Secondary | Urban Mind physical health assessment | Scores of the physical health assessment taken every 72-hours. The Urban Mind physical health assessment consists of one question which rates physical health from 1-5 where higher is better (poor/fair/good/very good/excellent). The total score will be the average score per day. | From study start until study end (6 months) | |
Secondary | Urban Mind physical activity assessment | Scores of the physical activity assessment taken every 72-hours. The Urban Mind physical activity assessment consists of one question which rates physical activity in minutes by increments where higher is better (None/<10/10-30/30-60/60-120/>120. The categories are converted into likert scale scores 1-6 and the total score is the average score. | From study start until study end (6 months) | |
Secondary | Urban Mind nature exposure assessment | Scores of the nature exposure assessment taken every 72-hours. The Urban Mind nature exposure assessment consists of one question which rates nature exposure in minutes by increments where higher is better (None/<10/10-30/30-60/60-120/>120. The categories are converted into likest scale scores 1-6 and the total score is the average score. | From study start until study end (6 months) |
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