Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-64
SponsorUniversity of Minnesota
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Nature-based Walking
BehavioralAll 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
BehavioralAll 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.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: Nature-based Walking then Built-environment/Commercial WalkingExperimental treatment 2 interventions
Group B: Built-environment/Commercial Walking then Nature-based WalkingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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).2
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).3
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).4
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).Other outcomes
1
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).2
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).3
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.4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Minnesota
Lead sponsor
Northwestern University
Collaborator
Source ClinicalTrials.gov