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Official title Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial
ClinicalTrials.gov ID: NCT06365723
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 64
You may be able to join if
- 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...
- 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"...
You likely can't join if
- Individuals \ 64: younger individuals may have not yet reached physiological maturity and in whom PreD prevalence is low; older individuals are more...
- BMI \<20 or ≥42.
- Individuals with an HbA1c level \ 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.
See the full eligibility 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...
- 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...
- 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
- Individuals \ 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 \ 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 treatment clinical trial.
- Previous randomization in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Lake Forest, Illinois, United States
- Winfield, Illinois, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lake Forest, Illinois, United States; Winfield, Illinois, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.