Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Northwestern University | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this randomized crossover trial is to compare the differences in psychological and physiological effects of walking in two different outdoor environments (urban/suburban commercial environments vs. urban/suburban nature areas/preserves) in adults with prediabetes. The main questions it aims to answer are:
As this is a crossover trial, participants will serve as their own controls. Researchers will compare both the psychological and physiological effects walking in the two types of outdoor environments.
Participants will:
Approximately 92 million U.S. adults (~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, the investigators are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nature-based Walking then Built-environment/Commercial Walking | Experimental | People with prediabetes randomized to six weeks of nature-based walking followed by a five week washout, and then six weeks of built-environment/commercial-based walking |
|
| Built-environment/Commercial Walking then Nature-based Walking | Experimental | People with prediabetes randomized to six weeks of built-environment/commercial-based walking followed by a five week washout, and then six weeks of nature-based walking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nature-based Walking | Behavioral | All participants will be asked to walk three to five times per week for 30-50 minutes per walk, totaling 150 min/week, at moderate intensity over a 6-week period in a designated nature-based, or 'green', urban environment. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Anxiety | An Ecological Momentary Assessment of anxiety (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk. | Before and after each of the four assessment walks, which occur in weeks 4, 7, 15, and 18 (weeks 3 and 6 of each 6-week walking intervention). |
| Perceived stress assessment | Perceived stress will be measured using an Ecological Momentary Assessment of stress (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk. | Before and after each of the four assessment walks, which occur in weeks 4, 7, 15, and 18 (weeks 3 and 6 of each 6-week walking intervention). |
| Mood assessment | Mood will be evaluated using an Ecological Momentary Assessment of mood (i.e.. sadness, happiness, relaxation, mental energy, and physical energy) will be assessed pre/post each assessment walk (rating level on a 0-10 point Likert scale). | Before and after each of the four assessment walks, which occur in weeks 4, 7, 15, and 18 (weeks 3 and 6 of each 6-week walking intervention). |
| Restorativeness | Assessing the restorativeness of the walked environment (using the perceived restorativeness scale) after each of the four assessment walks. | Assessment given after each of the four assessment walks, which occur in weeks 4, 7, 15, and 18 (weeks 3 and 6 of each 6-week walking intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Heart Rate variability | Heart rate variability (HRV) will be measured before, during (within steady-state walking), and after each of the four assessment walks. We will use the Zephyr BioHarness and associated BioModule to complete these measurements. The a priori metric for analysis is the HRV during the walk between minutes 10 and 30. | Before, during, and after each of the four assessment walks, which occur in weeks 4, 7, 15, and 18 (weeks 3 and 6 of each 6-week walking intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Heart Rate Variability | Resting Heart rate variability (HRV) will be measured at the Baseline and Follow-up visits for each of the two study conditions (Weeks 1, 7, 12, and 18). We will use the Zephyr BioHarness and associated BioModule to complete these measurements. | At each of the four clinic visits which occur before and after each of the 6-week walking interventions (i.e. study weeks 1, 7, 12 and 18). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Rydell, MPH | Contact | 612-437-6126 | rydel004@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Pereira, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake Forest Hospital | Recruiting | Lake Forest | Illinois | 60045 | United States |
Not provided
| Label | URL |
|---|---|
| Study website for more information and contacts. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a randomized crossover trial with a 5-week washout period.
Not provided
Not provided
Not provided
| Built-environment/Commercial Walking | Behavioral | All participants will be asked to walk three to five times per week for 30-50 minutes per walk, totaling 150 min/week, at moderate intensity over a 6-week period in a designated built-environment/commercial, or 'Gray', urban environment. |
|
| Salivary cortisol levels | Saliva will be collected using the passive drool collection method at the following daily times: (1) immediately upon waking; (2) 30-45 minutes after waking; and (3) 14 hours after waking. Sampling times allow for calculation of the cortisol awakening response and diurnal decline in cortisol, metrics well correlated with health outcomes. Salivary cortisol will be assayed using validated ELISA assays | Within 7 days of each of the four clinic visits which occur before and after each of the 6-week walking interventions (i.e. study weeks 1, 7, 12 and 18). |
| Ambient Particulate Matter | Ambient Particulate Matter will be assessed using the AirBeam3, a palm-sized air quality instrument that measures PM1, PM2.5, PM10, temperature, and relative humidity. It will be worn during each of the four assessment walks, measuring air-quality in real time as the participant is out on their walk. | During each of the four assessment walks, which occur in weeks 4, 7, 15, and 18 (weeks 3 and 6 of each 6-week walking intervention). |
| CMD risk | CMD risk score will be computed as the average of the z-scores comprised of systolic blood pressure, and fasting blood glucose, insulin, triglycerides, and HDL-cholesterol (reverse scored). | At each of the four clinic visits which occur before and after each of the 6-week walking interventions (i.e. study weeks 1, 7, 12 and 18). |
| Anxiety | Anxiety will be assessed at each of the four clinical visits (occurring before and after each of the 6-week walking interventions) using the PROMIS Anxiety 8a. | At each of the four clinic visits which occur before and after each of the 6-week walking interventions (i.e. study weeks 1, 7, 12 and 18). |
| CMD-Risk Mediation | The extent to which physiological, psychological, and air pollution measures mediate the differential impact of Green versus Grey walking on CMD-risk using regression-based mediation models. | Throughout the study, up to 18 weeks. |
| Stress | Stress will be assessed at each of the four clinical visits (occurring before and after each of the 6-week walking interventions) using the Perceived Stress Scale, a 5-point scale measure (0-4), where a higher score indicated higher stress. | At each of the four clinic visits which occur before and after each of the 6-week walking interventions (i.e. study weeks 1, 7, 12 and 18). |
| Affect | Affect will be assessed at each of the four clinical visits (occurring before and after each of the 6-week walking interventions) using the PROMIS Affect 15a. | At each of the four clinic visits which occur before and after each of the 6-week walking interventions (i.e. study weeks 1, 7, 12 and 18). |
| Central DuPage Hospital | Recruiting | Winfield | Illinois | 60190 | United States |
|
| Epidemiological Clinical Research Center | Recruiting | Minneapolis | Minnesota | 55415 | United States |
|
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000076624 | Built Environment |
| ID | Term |
|---|---|
| D004779 | Environment Design |
| D004777 | Environment |
| D004778 | Environment and Public Health |
Not provided
Not provided