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

Обзор

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.

Подробное описание

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, the investigators 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.

Вмешательства

• Поведенческое Nature-based Walking
  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.
• Поведенческое Built-environment/Commercial Walking
  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.

Первичные конечные точки

• Measure of Anxiety [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Вторичные конечные точки (4)

• Walking Heart Rate variability [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 3 центра

• Lake Forest Hospital — Lake Forest
• Central DuPage Hospital — Winfield
• Epidemiological Clinical Research Center — Minneapolis

Идентификаторы

NCT: NCT06365723 · SPH-2023-32410

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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