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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding basketball to a diabetes prevention program can help people with prediabetes lose more weight, lower their blood sugar levels, and increase their exercise. Participants will either follow the standard National Diabetes Prevention Program (NDPP) or one that includes basketball sessions. It suits individuals aged 18–44 with prediabetes who do not exercise much, are not part of another lifestyle program, and can walk and jump unaided. As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve health and fitness.

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 prior data suggests that this protocol is safe for participants?

Research has shown that the National Diabetes Prevention Program (NDPP) is generally safe and well-tolerated. The program promotes lifestyle changes, such as moderate weight loss and increased physical activity. Adding basketball to the program has shown promise, as it attracts more participants and leads to significant weight loss without major safety concerns.

Studies have found that participants in a similar basketball-focused program were more likely to lose a meaningful amount of weight and improve blood sugar levels. These studies reported no serious issues related to the basketball activities.

Overall, adding basketball to the NDPP is expected to be safe, as it includes supervised exercise and support from trained coaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adding basketball to the National Diabetes Prevention Program (NDPP) might help people with prediabetes. The unique feature of this approach is the combination of virtual NDPP sessions with regular, in-person basketball games, which adds a fun and engaging physical activity to the mix. This could potentially enhance motivation and adherence compared to the standard NDPP, which primarily focuses on virtual sessions without an integrated sports component. By incorporating a team sport, the trial aims to improve physical activity levels and potentially lead to better health outcomes for participants.

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

This trial will compare two approaches for people with prediabetes: the NDPP combined with basketball and the NDPP standard of care. Research has shown that adding basketball to the National Diabetes Prevention Program (NDPP) can benefit people with prediabetes. In one study, participants who played basketball were more likely to lose a significant amount of weight, with 43% achieving this compared to 21% who only followed the NDPP. Additionally, 58% of those in the basketball group moved from prediabetes to normal blood sugar levels. The NDPP alone has also been shown to aid in moderate weight loss and increased physical activity, reducing the risk of developing Type 2 Diabetes. Overall, combining the NDPP with basketball appears promising for improving health in people at risk of diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Not currently pregnant

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-glucose-intolerance-5-2021-85fcc

Basketball for Prediabetes (DPPHoops Trial) 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05066542/recreational-basketball-to-increase-participation-in-diabetes-prevention

Recreational Basketball to Increase Participation in ... The NDPP has successfully helped to reduce the rate of Type 2 Diabetes Mellitus (T2DM) through moderate weight loss and increased physical ...

3. withpower.com withpower.com/clinical-trials/for-prediabetes?page=3

Top Prediabetes Clinical Trials | Power 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, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7445538/

Current Perspectives on the Impact of the National ... Reports show a promising 4.2% mean weight loss for in-person NDPP classes and 4.3% weight loss for virtual programs. These are impressive ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0033062020301353

Physical fitness and activity changes after a 24-week ... Participants meeting the PA goals but not reaching the weight loss goals still showed a 44% reduction in T2DM incidence.8 Today, most NDPP offerings use a group ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05066542?tab=history&a=2

Record History | ver. 2: 2024-04-15 | NCT05066542 An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1282458/

The Diabetes Prevention Program (DPP) - PubMed Central These changes in lifestyle resulted in large changes in diabetes risk: 10.6% of the intervention group developed diabetes over 5 years compared with 28.6% of ...

8. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...