Walking Environments for Prediabetes

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of the treatment Gray Walk, Green Walk for prediabetes?

Research shows that lifestyle changes, like increasing physical activity, can help prevent prediabetes from progressing to diabetes. A study found that a program encouraging physical activity led to an increase in daily steps and a trend towards weight loss in people with prediabetes, suggesting that similar walking treatments could be effective. ^{1 2 3 4 5}

Is walking in different environments safe for people with prediabetes?

Increased physical activity, like walking, is generally safe for people with prediabetes, though there are some mild to severe risks such as muscle injuries or low blood sugar. However, these risks are low, and with proper precautions, walking can be a safe activity. ^{3 6 7 8 9}

How does the treatment 'Gray Walk, Green Walk' differ from other treatments for prediabetes?

The 'Gray Walk, Green Walk' treatment is unique because it focuses on modifying walking environments to encourage physical activity, which is a key factor in managing prediabetes. Unlike medications or dietary changes, this approach emphasizes the role of the environment in promoting regular physical activity to help prevent the progression to type 2 diabetes. ^{10 11 12 13 14}

What is the purpose of this trial?

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, we 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.

Research Team

Mark Pereira, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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)

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

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

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

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

Treatment Details

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.

Participant Groups

Group I: Green Walking then Gray Walking Experimental Treatment 2 Interventions

Prediabetics randomized to Green walk first then Gray walk.

Group II: Gray Walking then Green Walking Experimental Treatment 2 Interventions

Prediabetics randomized to Gray walk first then Green walk.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of technology-assisted goal setting to improve physical activity among primary care patients with prediabetes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

An Evaluation of the Reach and Effectiveness of a Diabetes Prevention Behaviour Change Program Situated in a Community Site. [2021]

4. England 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. [2022]

5. United States 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. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Rural-urban disparities in the associations of residential greenness with diabetes and prediabetes among adults in southeastern China. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Green Space Exposure Association with Type 2 Diabetes Mellitus, Physical Activity, and Obesity: A Systematic Review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Awareness of Prediabetes Status and Subsequent Health Behavior, Body Weight, and Blood Glucose Levels. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Treating prediabetes: why and how should we do it? [2019]

11. United States 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. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Physical activity and pre-diabetes-an unacknowledged mid-life crisis: findings from NHANES 2003-2006. [2021]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

Prediabetes. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity Evaluation Using Activity Trackers for Type 2 Diabetes Prevention in Patients with Prediabetes. [2022]