Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomiz… (NCT06365723) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial
United States216 participantsStarted 2024-06-06
Plain-language 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.
Who can participate
Age range
25 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure of Anxiety
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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).