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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether increasing physical activity and stopping evening snacking can help young people with prediabetes. The goal is to determine if taking at least 10,000 steps a day and avoiding snacks after 8:00 p.m. can improve health. Participants will either adopt these new habits or continue their usual care for 8 weeks. The trial seeks young people aged 12-18 who have prediabetes, snack often at night, and don't get enough exercise. As an unphased trial, it provides a unique opportunity to contribute to understanding lifestyle changes that may improve health in young people.

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 prior data suggests that increased physical activity and stopping evening snacking are safe for youth with prediabetes?

Studies have shown that walking more each day can improve health. Walking up to about 10,000 steps daily is linked to a lower risk of death and heart problems, even for those who aren't very active otherwise. Research also suggests that for every additional 1,000 steps taken, the risk of developing diabetes decreases by 2%.

More exercise, such as walking, can help control blood sugar levels, which is important for managing conditions like prediabetes. Regular aerobic exercise, like walking, aids in blood sugar control, while resistance exercises, using weights or body weight, improve how the body uses insulin, a hormone that helps control blood sugar.

Stopping evening snacking can also support healthy living by preventing weight gain. No specific safety concerns have been reported for simply increasing steps or stopping evening snacks. These lifestyle changes are generally considered safe for most people, including young individuals with prediabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a simple yet potentially powerful lifestyle intervention for prediabetes. Unlike traditional treatments that often involve medication to regulate blood sugar levels, this approach emphasizes behavioral changes: increasing physical activity to at least 10,000 steps a day and eliminating evening snacking. These methods aim to improve insulin sensitivity and reduce calorie intake without the need for pharmaceuticals, offering a natural, accessible way to manage prediabetes. This focus on lifestyle adjustments could provide a sustainable and side-effect-free alternative to more conventional treatments.

What evidence suggests that increased physical activity and stopping evening snacking might be effective for prediabetes?

This trial will evaluate the effects of increased physical activity and dietary changes on prediabetes. Participants in the intervention arm will perform at least 10,000 steps daily (on at least 5 days per week) and avoid evening snacking after 8:00 p.m. Research has shown that walking 10,000 steps a day can greatly improve health. Studies have found that for every additional 1,000 steps taken, the risk of diabetes drops by 2%. Walking this much daily is also linked to better heart health and a lower risk of diseases like dementia and cancer. Additionally, avoiding snacks after 8:00 p.m. can help control weight gain, a risk factor for prediabetes and type 2 diabetes. Together, these lifestyle changes may offer a promising way to improve health in young people with prediabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Mustafa Tosur, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Engaging in frequent evening snacking

Inadequate physical activity

Exclusion Criteria

Pregnancy

I have serious liver or kidney disease.

I am on hormone replacement therapy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06782906

Effect of Increased Physical Activity and Stopping Evening ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9013106/

Associations of steps per day and step intensity with the risk of ... There was a suggestive lower risk of diabetes with more steps/day– adults had a 2% lower risk per 1000 steps/day (HR = 0.98 (95% CI 0.95, 1.00)) ...

3. kumc.edu kumc.edu/about/news/news-archive/jama-study-ten-thousand-steps.html

10000 steps might really be the 'magic pill' everyone is ... Studies in JAMA show that walking 10,000 steps can improve cardiovascular health and reduce risks of both dementia and cancer better than any ...

4. journals.viamedica.pl journals.viamedica.pl/clinical_diabetology/article/view/101566

The Impact of Daily Step Counts on Diabetes Prevention ... Daily physical activity, which can be measured indirectly by the daily step count, has been shown to reduce overall morbidity and mortality from T2D.

5. foxnews.com foxnews.com/health/forget-10000-steps-research-reveals-real-number-you-need-better-health

Forget 10000 steps — research reveals the ... - Fox News They found that walking at least 7,000 steps a day was linked to improvement in eight major health outcomes, including heart disease, dementia ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35796565/

Optimal Number of Steps per Day to Prevent All-Cause ... Conclusions: Accumulating more steps per day up to ∼10,000 steps per day may lower the risk of all-cause mortality of adults with prediabetes ...

7. sph.unc.edu sph.unc.edu/sph-news/more-steps-per-day-tied-with-lower-diabetes-risk/

More steps per day tied with lower diabetes risk Our results suggest that there is a 2% lower risk of diabetes for every 1,000 steps taken.” “Many activity trackers nudge you upon reaching ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667036423000018

The importance of exercise for glycemic control in type 2 ... Habitual aerobic exercise helps manage blood glucose. Resistance exercise benefits insulin sensitivity in those with type 2 diabetes.

9. bmj.com bmj.com/company/newsroom/taking-9000-to-10000-steps-daily-may-counteract-the-risk-of-death-and-cardiovascular-disease-in-highly-sedentary-people/

Taking 10000 daily steps may counteract the risk of ... Increased daily step count linked to lower risk of death and CVD regardless of time spent sedentary. Every additional step up to around 10,000 steps per day ...