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NCT Number: NCT06365723

Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial

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:

* Do psychological measures of stress, anxiety, and affect improve more in one type of outdoor environment over the other? * Do physiological measures of stress improve more in one type of outdoor environment over the other?

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:

* Walk 150-minutes per week for six weeks in each of the two outdoor conditions. * Visit the clinic four times, including before and after each six-week walking period. * Collect saliva samples immediately proceeding or following the four clinic visits. * Return to their pre-study level of physical activity for a 5-week washout period between each of the two walking interventions.

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Key information

Age range

25 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lake Forest Hospital, Lake Forest, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 25-64 years old.
  • Classified as overweight or obese with BMI 20.0-39.9 kg/m2 per self-report and a BMI of 20.0- 41.9 kg/m2 upon actual measure.
  • Documentation* of a PreD diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.49%271; OR a study screening lab value of HbA1C within the aforementioned range.
  • Currently engaged in ≤100 min/week of moderate to vigorous exercise -confirmed via a 7-day activity recall.
  • No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) -this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status. Answering "yes" to any one of these questions may require a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention. The participant would not be enrolled until this doctor's note is received.
  • Stable weight over the last 3 months (less than 10% change).
  • Not currently pregnant, planning to become pregnant, or currently breastfeeding.
  • Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
  • Must own a smartphone and be willing and able to download the Garmin Connect app
  • Ability to speak and understand English.
  • Any level of income
  • Any race/ethnicity

Exclusion criteria

  • Individuals <25 or >64: younger individuals may have not yet reached physiological maturity and in whom PreD prevalence is low; older individuals are more likely to have contraindications to PA and other comorbidities.
  • BMI <20 or ≥42.
  • Individuals with an HbA1c level <5.7% or >6.4%.
  • Currently engaged in >100 min/wk of PA.
  • Individuals with contraindications to exercise participation as indicated by the PAR-Q.
  • A self-reported physical/mental disability that would prevent them from being able to adhere to the intervention.
  • Past or current diagnosis of Diabetes (Type 1, 1.5 or 2) or use of diabetic medications (e.g. medications to control blood sugar)
  • Any history of a cardiovascular disease event (e.g. heart attack, ablation, pacemaker, stroke)
  • Current treatment for cancer or heart disease (lipid and hypertensive medications acceptable but will be tracked closely).
  • Any change within the last 3 months, or anticipated changes, of any medications that would affect study outcomes (e.g. medications for lipids, blood pressure, anxiety, depression)
  • The use of any medication that significantly interferes with the autonomic nervous system
  • Current tobacco or nicotine users, or those who have quit within the last six months
  • Excessive alcohol (on average>1 drinks/day for women and >2 drinks/day for men) or excessive recreational drug use (reported usage of once a week or more).
  • Unstable weight over the last three months (>10% change).
  • Those with major surgery planned or recent history of bariatric surgery (within last 2 years) or a history of other medical interventions that would interfere with study outcomes
  • Currently within one-year postpartum, currently pregnant, or planning to become pregnant during the study period.
  • Currently breastfeeding.
  • Unwilling to comply with study randomization procedures.
  • Unwilling to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
  • Current participation in another interventional clinical trial.
  • Previous randomization in this study.

Treatment and study plan

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.

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.

Primary outcomes

  1. Measure of Anxiety

    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).

    An Ecological Momentary Assessment of anxiety (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.

  2. Perceived stress assessment

    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 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.

  3. Mood assessment

    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 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).

  4. Restorativeness

    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).

    Assessing the restorativeness of the walked environment (using the perceived restorativeness scale) after each of the four assessment walks.

Secondary outcomes

  1. Walking Heart Rate variability

    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).

    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.

  2. Salivary cortisol levels

    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).

    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

  3. Ambient Particulate Matter

    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).

    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.

  4. CMD risk

    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 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).

Other outcomes

  1. Resting Heart Rate Variability

    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 (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.

  2. Anxiety

    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 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.

  3. CMD-Risk Mediation

    Time frame: Throughout the study, up to 18 weeks.

    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.

  4. 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).

    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.

  5. Affect

    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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Rydell, MPH

CONTACT

[email protected]

612-437-6126

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Northwestern University

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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