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

NCT06365723 | Recruiting DMC

• 1 other identifier: SPH-2023-32410
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

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.

Conditions

PreDiabetes; Heart Rate Variability (HRV); Stress and Anxiety; Stress Biomarkers

Keywords

walking intervention; built environment; outdoor environment; prediabetes; stress; urban

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  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 (4)

• Walking Heart Rate variability

  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

  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

  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

  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 (5)

• Resting Heart Rate Variability

  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

  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

  Throughout the study, up to 18 weeks.

Study Arms (2)

Nature-based Walking then Built-environment/Commercial Walking

EXPERIMENTAL

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

Built-environment/Commercial Walking then Nature-based Walking

EXPERIMENTAL

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

Interventions

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 then Nature-based Walking; Nature-based Walking then Built-environment/Commercial Walking

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.

Built-environment/Commercial Walking then Nature-based Walking; Nature-based Walking then Built-environment/Commercial Walking

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Northwestern University: collaborator

Study Sites (3)

Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

RECRUITING

Central DuPage Hospital

Winfield, Illinois, 60190, United States

RECRUITING

Epidemiological Clinical Research Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Related Links

• Study website for more information and contacts.

MeSH Terms

Conditions

Prediabetic State; Anxiety Disorders

Interventions

Built Environment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Environment Design; Environment; Environment and Public Health

Study Officials

• Mark Pereira, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Rydell, MPH

CONTACT

612-437-6126; rydel004@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized crossover trial with a 5-week washout period.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 15, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)