An interventional study of Nature-based Walking and Built-environment/Commercial Walking in PreDiabetes, Heart Rate Variability (HRV) and Stress and Anxiety, sponsored by University of Minnesota. Recruiting at 3 sites in United States. Open to participants aged 25 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's planned enrollment of 216 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →University of Minnesota is the lead sponsor of 1,185 studies on the registry; 196 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 92 (70%) have results posted.
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Exclusion Criteria:
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
Behavioral: Nature-based Walking · Behavioral: Built-environment/Commercial Walking
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
Behavioral: Nature-based Walking · Behavioral: Built-environment/Commercial Walking
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.
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
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.
Time frame: 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).
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
Time frame: 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.
Time frame: 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).
Time frame: 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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Plan to share: No
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