Basketball for Prediabetes

(DPPHoops Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Diabetes, ESRD, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the efficacy of adapting the National Diabetes Prevention Program (NDPP) to include recreational sports in effort to increase physical activity (PA) and promote lifestyle changes that can help reduce the risk of developing Type 2 Diabetes Mellitus. The hypothesis is that both the traditional NDPP and the NDPP+ Basketball will be considered feasible. The primary outcome is to assess whether the intervention (NDPP+BB) compared to the standard of care (NDPP only) will result in greater weight loss, lower A1c, and increased engagement in physical activity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment NDPP + Basketball (BB) for prediabetes?

Research shows that physical activity, like playing basketball, is beneficial for people with prediabetes by helping maintain a healthy weight and reducing the risk of developing diabetes. The National Diabetes Prevention Program (NDPP) is a well-established program that helps prevent diabetes through lifestyle changes, including increased physical activity. ^{1 2 3 4 5}

Is playing basketball safe for people with prediabetes?

Exercise, including activities like basketball, is generally considered safe and beneficial for people with prediabetes. It can help with weight management, improve self-image, and reduce risks related to high blood pressure and cholesterol. However, it's important to monitor and adjust any medical treatments as needed. ^{3 6 7 8 9}

How does the Basketball for Prediabetes treatment differ from other treatments for prediabetes?

The Basketball for Prediabetes treatment is unique because it combines the National Diabetes Prevention Program (NDPP) with basketball, offering a novel approach that integrates physical activity with behavioral change strategies. This combination aims to make the program more engaging and effective in preventing the progression to type 2 diabetes by incorporating a team sport that may increase motivation and adherence. ^{3 6 10 11 12}

Eligibility Criteria

This trial is for adults aged 18-44 with a BMI of 25 or higher who have prediabetes (HbA1c levels between 5.7 to 6.4%). Participants should be able to walk and jump unassisted, not exercise more than 300 minutes per week, and must not have been in another lifestyle program recently. Those with Type 1 Diabetes, serious heart conditions, recent cancer treatment, or other major health issues can't join.

Inclusion Criteria

BMI >= 25 kg/m2

Ability to read in English and provide informed consent

I can jump in place.

Exclusion Criteria

I have Type 1 Diabetes.

I have Type 2 Diabetes.

I have congestive heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the NDPP program with or without basketball sessions over 12 months

12 months

Weekly virtual and in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NDPP + Basketball (BB)
• NDPP Standard of Care SOC

Trial Overview The study tests if adding basketball to the National Diabetes Prevention Program (NDPP) helps people lose more weight, lower their A1c levels (a blood sugar marker), and become more active compared to the standard NDPP alone. Participants will either follow the regular NDPP or do it plus play recreational basketball.

Participant Groups

Group I: NDPP + Basketball (BB) Experimental Treatment 1 Intervention

Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches along with virtual fitness sessions and in-person basketball sessions. During Months 1-4, participants will attend a 60-minute virtually facilitated session of the NDPP curriculum, followed by a 30-minute virtual fitness session. During that same week, participants will meet in person, for a 90-minute BB session. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks and there will no longer be a 30-minute online fitness session succeeding the session. During this same four-month period, 60-minute, in-person BB sessions will be held weekly. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session and bi-weekly 60-minute in-person BB sessions. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Group II: NDPP Standard of Care SOC Active Control 1 Intervention

Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches. During Months 1-4 participants will attend a 60-minute virtually facilitated session of the NDPP curriculum. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Findings from Research

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]

The digital Diabetes Prevention Program (d-DPP) significantly improved HbA1c levels and body weight among participants with prediabetes, showing a reduction in HbA1c by 0.08% and a weight loss of 5.5% compared to standard care.

Participants in the d-DPP were more likely to achieve clinically significant weight loss (43% vs 21%) and transition from prediabetes to normal HbA1c levels (58% vs 48%), indicating its effectiveness in preventing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Digital Diabetes Prevention Program: An RCT. Katula, JA., Dressler, EV., Kittel, CA., et al.[2022]

The pilot program successfully delivered the National Diabetes Prevention Program (NDPP) content to prediabetic patients through a mobile device, indicating that digital platforms can be effective for health interventions.

Patient and staff feedback suggested positive engagement with the virtual health coach, highlighting the potential for mobile health solutions to support diabetes prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings of the Delivery of the National Diabetes Prevention Program via a Mobile Application. Tiase, VL., Licata, M., Fleck, EM.[2018]

Regular physical exercise can help individuals with Insulin-Dependent Diabetes Mellitus (IDDM) achieve better body weight management, improve self-image, and reduce cardiovascular risk factors, although its impact on long-term blood sugar control is still debated.

To safely participate in athletic activities, IDDM patients need to understand their metabolic responses to exercise and may require careful monitoring and adjustments to their insulin doses and nutrition plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes mellitus and exercise. Landry, GL., Allen, DB.[2006]

The NHS Diabetes Prevention Programme (NDPP) significantly reduced the conversion rate from nondiabetic hyperglycaemia (NDH) to type 2 diabetes mellitus (T2DM), with a hazard ratio of 0.80, indicating a 20% lower risk for those referred to the program compared to those not referred.

In a cohort study of 18,470 patients referred to the NDPP, the probability of not converting to T2DM at 36 months was 87.3% for those referred, compared to 84.6% for those not referred, suggesting the program is effective in preventing diabetes in at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Referral to the NHS Diabetes Prevention Programme and conversion from nondiabetic hyperglycaemia to type 2 diabetes mellitus in England: A matched cohort analysis. Ravindrarajah, R., Sutton, M., Reeves, D., et al.[2023]

In a study of 92 prediabetic patients followed for three years, 76.08% remained in the prediabetic range, while only 16.4% reverted to normal blood sugar levels, indicating that many patients did not improve significantly despite interventions.

The use of metformin, a common medication for managing blood sugar, did not show a significant benefit in helping patients regress to a normal glycemic state, suggesting that more research is needed to explore effective interventions for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review. Alateeq, MA., Aljohani, M., Kinani, SS., et al.[2020]

References

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

Diabetes mellitus in sports. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA) in Prediabetes: A Multisite Randomized Controlled Trial. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Effects of physical activity goal attainment on engagement and outcomes in the National Diabetes Prevention Program. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a Digital Diabetes Prevention Program: An RCT. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary Findings of the Delivery of the National Diabetes Prevention Program via a Mobile Application. [2018]

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

Retention and outcomes of National Diabetes Prevention Program enrollees and non-enrollees with prediabetes: The University of Michigan experience. [2023]

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

Diabetes mellitus and exercise. [2006]

9. Canada pubmed.ncbi.nlm.nih.gov

Short Message Service Text Message Support for Weight Loss in Patients With Prediabetes: Pragmatic Trial. [2020]

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

Referral to the NHS Diabetes Prevention Programme and conversion from nondiabetic hyperglycaemia to type 2 diabetes mellitus in England: A matched cohort analysis. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Metabolic Changes After a 24-Week Soccer-Based Adaptation of the Diabetes Prevention Program in Hispanic Males: A One-Arm Pilot Clinical Trial. [2023]

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

The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review. [2020]