Walking Environments for Prediabetes

Recruiting at 2 trial locations

Overseen By Sarah Rydell, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Diabetic medications, Arrhythmia medications

Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether walking in nature (Green Walk) or in urban settings (Gray Walk) more effectively reduces stress and anxiety in people with prediabetes, a condition where blood sugar levels are higher than normal but not yet diabetes. Participants will walk for 150 minutes each week in both environments over different six-week periods. Individuals diagnosed with prediabetes in the past year, who are not very active, and have stable weight might be suitable for this study. As an unphased trial, the study offers a unique opportunity to explore personal health benefits from different walking environments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who have changed medications affecting study outcomes in the last 3 months or plan to change them. If you are on medications for lipids, blood pressure, anxiety, or depression, they will be tracked closely.

What prior data suggests that these walking environments are safe for people with prediabetes?

Research has shown that walking in natural (green) or urban (gray) areas is generally safe for people with prediabetes. Studies have found that walking in these environments provides both mental and physical benefits without major negative effects, indicating it is well-tolerated.

Walking in nature can reduce stress and improve mood, which benefits overall health and usually doesn't cause any problems. Similarly, walking in urban areas offers advantages. The city environment can encourage physical activity, which is important for managing prediabetes.

In summary, evidence supports that walking, whether in nature or city settings, is a safe and effective way to improve health for those with prediabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Walking Environments for Prediabetes trial because it compares the impact of walking in nature-based environments to walking in commercial, built environments on prediabetes. Unlike traditional treatments for prediabetes that focus on medication and dietary changes, this trial explores how the setting of physical activity might influence health outcomes. The unique aspect here is the focus on the environment as a potential factor in managing prediabetes, which could open up new, accessible, and natural ways to improve health. The trial aims to uncover whether the calming effects of nature might enhance the benefits of exercise beyond what's achieved in urban settings.

What evidence suggests that this trial's walking environments could be effective for prediabetes?

Research shows that walking can greatly improve health for people with prediabetes. Studies have found that regular walking, especially brisk walking for at least 150 minutes a week, can lower the risk of developing diabetes by 58% over a few years. This trial will compare two walking environments: nature-based walking and built-environment/commercial walking. Walking in nature, such as parks or forests, can lift mood and reduce stress and anxiety more than walking in city areas. Participants who have walked regularly have seen lower blood sugar levels and a decrease in their HbA1c, a measure of blood sugar control, by an average of 0.50%. Overall, walking anywhere can be a simple and effective way to manage prediabetes and improve overall well-being. ^{1 3 6 7 8}

Who Is on the Research Team?

Mark Pereira, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults aged 25-64 with prediabetes, classified as overweight or obese (BMI 20.0-39.9), who exercise less than 100 minutes per week and have stable weight for the last three months can join this trial. They must not be pregnant or breastfeeding, willing to keep their diet and exercise habits except for study requirements, own a smartphone, and pass a health questionnaire.

Inclusion Criteria

No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)

Stable weight over the last 3 months (<10% change)

Willing to maintain current dietary and exercise habits as per the study exercise protocol

Exclusion Criteria

Currently engaged in more than 100 min/week of physical activity

Self-reported physical/mental disability that would prevent adherence to the intervention

My BMI is either below 20 or 40 and above.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of anxiety, mood, heart rate variability, and other biomarkers are taken

1 week

1 visit (in-person)

Treatment

Participants engage in walking sessions in both Green and Gray environments in a randomized crossover design

6 weeks

Multiple visits (in-person) for assessment walks

Follow-up

Participants are monitored for changes in anxiety, mood, heart rate variability, and other biomarkers

12 weeks

Follow-up visits at weeks 7, 12, and 18

What Are the Treatments Tested in This Trial?

Interventions

• Gray Walk
• Green Walk

Trial Overview

The trial is testing the effects of walking in different environments on adults with prediabetes by comparing walks in urban green spaces ('Green Walk') versus built-up city areas ('Gray Walk'). It aims to see which setting might better reduce stress and improve health indicators like heart rate variability.

How Is the Trial Designed?

Group I: Nature-based Walking then Built-environment/Commercial Walking Experimental Treatment 2 Interventions

People with prediabetes randomized to six weeks of nature-based walking followed by a five week washout, and then six weeks of built-environment/commercial-based walking

Group II: Built-environment/Commercial Walking then Nature-based Walking Experimental Treatment 2 Interventions

People with prediabetes randomized to six weeks of built-environment/commercial-based walking followed by a five week washout, and then six weeks of nature-based walking

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Prediabetes, characterized by impaired fasting glucose or glucose tolerance, is linked to a higher risk of metabolic syndrome and cardiovascular issues, highlighting the importance of early intervention.

Effective management of prediabetes includes weight loss and regular physical activity, with certain medications also being recommended to help prevent the progression to Type 2 diabetes and cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes. Rosolová, H.[2022]

A systematic review of 47 studies involving over 8000 individuals with prediabetes or diabetes found that while there are some risks associated with increased physical activity, such as musculoskeletal injuries and hypoglycemia, the overall prevalence of severe adverse events is low.

The review supports that increased physical activity is generally safe for individuals with prediabetes and diabetes, and it led to the development of a new risk assessment algorithm to help guide safe exercise practices for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: diabetes mellitus and related comorbidities. Riddell, MC., Burr, J.[2022]

In a study of 50,593 participants, increased residential greenness was linked to a significant reduction in the risk of prediabetes and diabetes, with stronger effects observed in rural areas compared to urban areas.

The protective effects of greenness against diabetes were partly mediated by factors such as air pollution, physical activity, and body mass index, highlighting the importance of environmental factors in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rural-urban disparities in the associations of residential greenness with diabetes and prediabetes among adults in southeastern China. Yu, W., Li, X., Zhong, W., et al.[2023]

Exposure to green spaces is associated with a reduced risk of developing type 2 diabetes mellitus (T2DM) and obesity, as well as increased physical activity levels, based on a systematic review of 19 studies.

The review suggests that access to green spaces in urban areas can play a significant role in moderating the onset of T2DM by promoting healthier lifestyles and reducing obesity rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green Space Exposure Association with Type 2 Diabetes Mellitus, Physical Activity, and Obesity: A Systematic Review. De la Fuente, F., Saldías, MA., Cubillos, C., et al.[2021]

Notifying individuals of their prediabetes status led to significant improvements in fasting plasma glucose and weight loss over 18 months, suggesting that awareness can motivate lifestyle changes.

Participants with prediabetes reported better dietary and exercise habits compared to a control group, indicating that self-directed lifestyle modifications may be a key factor in improving glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness of Prediabetes Status and Subsequent Health Behavior, Body Weight, and Blood Glucose Levels. Owei, I., Umekwe, N., Ceesay, F., et al.[2022]

In a study of 1,317 US adults, those in the highest tertile of physical activity had a lower prevalence of pre-diabetes (PD) compared to those in the lowest tertile, suggesting that higher physical activity may be protective against PD.

However, when adjusting for age and body mass index (BMI), the association between physical activity and pre-diabetes prevalence was no longer significant, indicating that age and BMI may confound the relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and pre-diabetes-an unacknowledged mid-life crisis: findings from NHANES 2003-2006. Farni, K., Shoham, DA., Cao, G., et al.[2021]

A 12-month home-based physical activity counseling (PAC) intervention for older adults with prediabetes did not significantly improve glycemic measures like insulin resistance or HbA1c compared to usual care, despite both groups showing a small decline in fasting blood glucose levels.

The PAC intervention successfully increased endurance physical activity levels among participants, indicating that while it may enhance physical activity, it does not translate into improved glycemic control in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus. Morey, MC., Pieper, CF., Edelman, DE., et al.[2022]

Prediabetes is a significant health concern that increases the risk of developing type 2 diabetes (T2DM) and associated complications, but it can be effectively managed through lifestyle changes and medications.

Various treatments, including lifestyle interventions, medications like metformin and GLP-1 receptor agonists, and even bariatric surgery, have been shown to prevent or delay the progression from prediabetes to T2DM, highlighting the importance of individualized management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating prediabetes: why and how should we do it? Braga, T., Kraemer-Aguiar, LG., Docherty, NG., et al.[2019]

The ADAPT program significantly increased daily physical activity among patients with prediabetes, with participants in the intervention group walking an average of 1418 more steps per day compared to a decrease of 598 steps in the control group over 6 months.

While there was a trend towards weight loss in the intervention group (-1.0 lbs) compared to the control group (-3.0 lbs), there was no significant change in glycemic control, indicating that while physical activity improved, further strategies may be needed to impact weight and blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of technology-assisted goal setting to improve physical activity among primary care patients with prediabetes. Mann, DM., Palmisano, J., Lin, JJ.[2023]

A telephone support program significantly improved participants' progression to healthier eating habits in adults with prediabetes, with an odds ratio of 1.31 compared to a control group after one year.

The program also led to decreased fasting plasma glucose levels specifically in participants who were in the contemplation stage of change, indicating targeted benefits for those considering lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of telephone support programme using telemonitoring on stage of change towards healthy eating and active exercise in people with prediabetes. Sakane, N., Oshima, Y., Kotani, K., et al.[2022]

In a study of 352 adults participating in the Diabetes Prevention Program (DPP), baseline patient activation did not predict attendance or uptake of the program, indicating that initial engagement levels may not influence participation.

However, attending the DPP was linked to a significant increase in patient activation scores, suggesting that the program not only helps with weight loss and health improvements but also empowers participants to take a more active role in their health decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Prevention Program attendance is associated with improved patient activation: Results from the Prediabetes Informed Decisions and Education (PRIDE) study. Skrine Jeffers, K., Castellon-Lopez, Y., Grotts, J., et al.[2020]

In a study involving 30 prediabetic volunteers using Fitbit activity trackers, changes in physical activity variability were more closely associated with improvements in health markers like lipid levels and body composition than the total step count.

The findings suggest that healthcare providers should focus on the variability of physical activity over time, rather than just the total number of steps, to better assess and promote health in prediabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Evaluation Using Activity Trackers for Type 2 Diabetes Prevention in Patients with Prediabetes. Bliudzius, A., Svaikeviciene, K., Puronaite, R., et al.[2022]

Clinicians recognize the importance of prediabetes screening and diagnosis, with 93.7% acknowledging it as a significant health issue, yet only 45.2% are familiar with the National Diabetes Prevention Program (DPP).

Despite high screening rates (75.9%) for diabetes among eligible patients, only 50.7% of those diagnosed with prediabetes had their condition documented, and no patients were referred to a DPP, indicating a gap in the implementation of lifestyle change programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. Keck, JW., Thomas, AR., Hieronymus, L., et al.[2020]

A community-based diabetes prevention program successfully enrolled 213 individuals with prediabetes, achieving a high completion rate of 95%, and demonstrated significant improvements in weight, waist circumference, and physical activity after 6 months.

The program showed effective diabetes risk reduction, but future efforts are needed to enhance physician referrals and participant engagement, as well as to explore digital expansion to reach more individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of the Reach and Effectiveness of a Diabetes Prevention Behaviour Change Program Situated in a Community Site. Bean, C., Dineen, T., Locke, SR., et al.[2021]

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