Increased Physical Activity and Stopping Evening Snacking for Prediabetes

Overseen By Lori Malone

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Hormone therapy

Disqualifiers: Diabetes, Chronic disease, Liver, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment of increased physical activity and stopping evening snacking for prediabetes?

Research shows that increasing physical activity, like taking more steps each day, can help lower the risk of developing type 2 diabetes in people with prediabetes. Combining exercise with healthy eating habits, such as stopping evening snacking, is effective in improving blood sugar control. ^{1 2 3 4 5}

Is it safe to increase physical activity and stop evening snacking for prediabetes?

Increasing physical activity is generally safe for people with prediabetes, though there may be some mild risks like muscle injuries or low blood sugar, especially if you're not used to exercising. Stopping evening snacking is also safe and can help manage blood sugar levels. ^{2 6 7 8 9}

How does the treatment of increased physical activity and stopping evening snacking for prediabetes differ from other treatments?

This treatment is unique because it focuses on lifestyle changes, specifically increasing daily physical activity to at least 10,000 steps and eliminating evening snacking, rather than relying on medication. These changes target the root causes of prediabetes, such as low physical activity and poor dietary habits, which are key drivers of high blood sugar levels. ^{2 4 10 11 12}

What is the purpose of this trial?

Non-healthy eating habits and a lack of exercise contribute to prediabetes and type 2 diabetes (T2D). Evening snacking is linked to abnormal weight gain in adults and healthy adolescents. Most adolescents do not get enough exercise. This study aims to look at the benefits of more exercise and stopping evening snacking in youth with prediabetes. The study lasts 8 weeks, and participants will be randomly assigned to either an intervention group or a standard of care group.

Research Team

Mustafa Tosur, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for young individuals with prediabetes, impaired glucose tolerance, or incretin hormone issues related to Polycystic Ovary Syndrome. Participants should be willing to increase their daily steps and stop snacking in the evening.

Inclusion Criteria

I have been diagnosed with prediabetes.

Inadequate physical activity

Engaging in frequent evening snacking

Exclusion Criteria

I have serious liver or kidney disease.

I am on hormone replacement therapy.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm perform ≥10,000 daily steps and omit evening snacking after 8:00 p.m. for 8 weeks

8 weeks

Standard of Care

Participants in the standard of care arm follow recommendations of their physician for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

2 weeks

Treatment Details

Interventions

• ≥10,000 daily steps and stopping evening snacking

Trial Overview The study tests if walking at least 10,000 steps on most days of the week and not eating snacks in the evening can improve metabolic health over an 8-week period compared to standard care.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Participants in the intervention arm will be asked to perform ≥10,000 daily steps (≥5 days/week) and omit evening snacking after 8:00 p.m.

Group II: Standard of Care Arm Active Control 1 Intervention

Participants in the standard of care arm will be asked to follow recommendations of their physician.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Findings from Research

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 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]

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]

Lifestyle modifications, including both diet and exercise, are effective in reducing the risk of developing type 2 diabetes (T2D) and improving blood sugar control in adults with prediabetes, even without significant weight loss.

The specific contributions of diet or exercise alone to glycemic control and weight loss in prediabetes remain unclear, indicating a need for further research to determine the most effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent and combined effect of diet and exercise in adults with prediabetes. Sénéchal, M., Slaght, J., Bharti, N., 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 94 participants (41 with normal glucose tolerance and 53 with impaired glucose tolerance), glycemic variability (GV) was found to be higher in individuals with impaired glucose tolerance, indicating a potential risk factor for diabetes.

The study revealed that higher overall carbohydrate and refined grain consumption worsened GV, while increased intake of whole grains and protein was associated with improved GV, suggesting dietary modifications could help manage glycemic fluctuations in those with impaired glucose tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. Dimova, R., Chakarova, N., Del Prato, S., et al.[2023]

References

1. 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]

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. New Zealand pubmed.ncbi.nlm.nih.gov

Independent and combined effect of diet and exercise in adults with prediabetes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Self-reported physical activity preferences in individuals with prediabetes. [2015]

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

Managing free-living hyperglycemia with exercise or interrupted sitting in type 2 diabetes. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Lifestyle Behaviors on Postprandial Hyperglycemia during Continuous Glucose Monitoring in Adult Males with Overweight/Obesity but without Diabetes. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

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

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

Optimal Number of Steps per Day to Prevent All-Cause Mortality in People With Prediabetes and Diabetes. [2022]

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

The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. [2023]

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

Lifestyle and medication interventions for the prevention or delay of type 2 diabetes mellitus in prediabetes: a systematic review of randomised controlled trials. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

The role of physical activity in the management of impaired glucose tolerance: a systematic review. [2022]