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

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Conditions

PreDiabetesHeart Rate Variability (HRV)Stress and AnxietyStress Biomarkerswalking interventionbuilt environmentoutdoor environmentstressurban

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-06
Study Completion:2028-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06365723

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 25-64 years old.
  2. * 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.
  3. * 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.
  4. * Currently engaged in ≤100 min/week of moderate to vigorous exercise -confirmed via a 7-day activity recall.
  5. * 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.
  6. * Stable weight over the last 3 months (less than 10% change).
  7. * Not currently pregnant, planning to become pregnant, or currently breastfeeding.
  8. * Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
  9. * Must own a smartphone and be willing and able to download the Garmin Connect app
  10. * Ability to speak and understand English.
  11. * Any level of income
  12. * Any race/ethnicity
  1. * 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.
  2. * BMI \<20 or ≥42.
  3. * Individuals with an HbA1c level \<5.7% or \>6.4%.
  4. * Currently engaged in \>100 min/wk of PA.
  5. * Individuals with contraindications to exercise participation as indicated by the PAR-Q.
  6. * A self-reported physical/mental disability that would prevent them from being able to adhere to the intervention.
  7. * Past or current diagnosis of Diabetes (Type 1, 1.5 or 2) or use of diabetic medications (e.g. medications to control blood sugar)
  8. * Any history of a cardiovascular disease event (e.g. heart attack, ablation, pacemaker, stroke)
  9. * Current treatment for cancer or heart disease (lipid and hypertensive medications acceptable but will be tracked closely).
  10. * 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)
  11. * The use of any medication that significantly interferes with the autonomic nervous system
  12. * Current tobacco or nicotine users, or those who have quit within the last six months
  13. * 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).
  14. * Unstable weight over the last three months (\>10% change).
  15. * 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
  16. * Currently within one-year postpartum, currently pregnant, or planning to become pregnant during the study period.
  17. * Currently breastfeeding.
  18. * Unwilling to comply with study randomization procedures.
  19. * Unwilling to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
  20. * Current participation in another interventional clinical trial.
  21. * Previous randomization in this study.

Contacts and Locations

Study Contact

Sarah Rydell, MPH
CONTACT
612-437-6126
rydel004@umn.edu

Principal Investigator

Mark Pereira, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
Epidemiological Clinical Research Center
Minneapolis, Minnesota, 55415
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Mark Pereira, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-06
Study Completion Date2028-11-30

Study Record Updates

Study Start Date2024-06-06
Study Completion Date2028-11-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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