NCT06365723 · University of Minnesota
Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Lake Forest, Illinois
- Winfield, Illinois
- Minneapolis, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations