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

Not Applicable

Recruiting

• Conditions: PreDiabetes
• Interventions: Behavioral: Green Walk; Behavioral: Gray Walk

• Registration Number: NCT06365723
• Lead Sponsor: University of Minnesota

Brief Summary

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, we 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-15
• Status Verified: 2024-06
• Study Start: 2024-06-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• 25-64 years old.
• Classified as overweight or obese with BMI 20.0-39.9 kg/m2.
• 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 the Modifiable Activity Questionnaire.
• 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 (<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

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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 ≥40.
• 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) or taking medications to control arrhythmias
• 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)
• Current tobacco or nicotine users, or those who have quit within the last six months
• Excessive alcohol (on average>1 drinks/day for women &>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
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Green Walking then Gray Walking	Green Walk	Prediabetics randomized to Green walk first then Gray walk.
Green Walking then Gray Walking	Gray Walk	Prediabetics randomized to Green walk first then Gray walk.
Gray Walking then Green Walking	Green Walk	Prediabetics randomized to Gray walk first then Green walk.
Gray Walking then Green Walking	Gray Walk	Prediabetics randomized to Gray walk first then Green walk.

Primary Outcome Measures

Name	Time	Method
Perceived stress assessment	baseline and 6 weeks	Perceived stress will be measured using Cohen's Perceived Stress Scale 10 (PSS 10). An Ecological Momentary Assessment of stress (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.
Measure of Anxiety	baseline and 6 weeks	An Ecological Momentary Assessment of anxiety (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.
Mood assessment	baseline and 6 weeks	Mood will be evaluated with the validated 20-item Positive and Negative Affect Schedule. An Ecological Momentary Assessment of mood (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.

Secondary Outcome Measures

Name	Time	Method
CMD risk	through study completion, up to 18 weeks	CMD risk score will be computed as the average of the z-scores comprised of systolic blood pressure, and fasting blood glucose, insulin, triglycerides, HDL-cholesterol (reverse scored), and waist circumference
Heart Rate variability	through study completion, up to 18 weeks	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) as well as before, during, and after each of the four assessment walks. We will use the Zephyr BioHarness and associated BioModule to complete these measurements.
Black Carbon levels	through study completion, up to 18 weeks	Black carbon will be assessed using the AirBeam3
Salivary cortisol levels	through study completion, up to 18 weeks	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
Ambient Particulate Matter	through study completion, up to 18 weeks	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.
State and Trait anxiety	through study completion, up to 18 weeks	State and Trait anxiety will be assessed with the State-Trait Anxiety Inventory (STAI) at each of the pre/post clinical visits.

Trial Locations

Locations (2)

Epidemiological Clinical Research Center; 🇺🇸 Minneapolis, Minnesota, United States

Lake Forest Hospital; 🇺🇸 Lake Forest, Illinois, United States