NCT06365723 Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial
| NCT ID | NCT06365723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2024-06-06 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Mark Pereira, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06365723 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 64 Years, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06365723 currently recruiting?
Yes, NCT06365723 is actively recruiting participants. Contact the research team at rydel004@umn.edu for enrollment information.
Where is the NCT06365723 trial being conducted?
This trial is being conducted at Lake Forest, United States, Winfield, United States, Minneapolis, United States.
Who is sponsoring the NCT06365723 clinical trial?
NCT06365723 is sponsored by University of Minnesota. The principal investigator is Mark Pereira, PhD at University of Minnesota. The trial plans to enroll 216 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.