Group Video vs Self-Directed Methods for Prediabetes

(RAD Trial)

Overseen By Annie Rice, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Pregnancy, Physical inactivity, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which method better helps adults in rural areas manage prediabetes: group video sessions (Zoom Group Video) or self-directed programs (Self Directed). The researchers seek to identify the most effective approach and understand the challenges or supports that influence the success of these programs. Suitable participants typically have a body mass index (BMI) over 25 and have recently been diagnosed with prediabetes, possibly through a blood test or previous pregnancy-related diabetes. Participants must be able to travel for meetings and speak English.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance prediabetes management in rural communities.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you are taking FDA-approved weight loss medications, you would not be eligible to participate.

What prior data suggests that these delivery methods are safe for prediabetic adults?

Research has shown that both the Zoom Group Video and Self-Directed methods for the National Diabetes Prevention Program (NDPP) are safe for participants.

For the Zoom Group Video method, studies indicate it is effective and easy to use. Adults who joined the program through Zoom found it simple to follow. These studies reported no major side effects, suggesting it is well-tolerated.

The Self-Directed NDPP has undergone thorough research and helps participants reduce their risk of developing type 2 diabetes by making lifestyle changes. Like the Zoom method, this approach is also safe, with no major side effects reported.

Both methods focus on lifestyle changes and are designed to be safe and supportive for people aiming to prevent diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways of empowering people with prediabetes through lifestyle changes. Unlike traditional methods that often require in-person classes or one-on-one sessions, this trial tests the effectiveness of a Group Video Diabetes Prevention Program using Zoom, offering a flexible and accessible approach. Additionally, the self-directed program allows participants to manage their health on their own schedule, potentially increasing adherence and engagement. By comparing these methods, researchers hope to discover more effective and convenient strategies for preventing diabetes, which could make a significant difference in managing the condition globally.

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

This trial will compare two methods of delivering the National Diabetes Prevention Program (NDPP): group video sessions and self-directed methods. Research has shown that the NDPP effectively lowers the risk of developing type 2 diabetes, regardless of delivery method. Participants in the group video arm, using platforms like Zoom, demonstrated positive changes, such as weight loss and improved blood sugar levels. Meanwhile, the self-directed arm allows participants to follow the program independently. Studies suggest that digital methods, like Zoom, are particularly beneficial for adults in rural areas at risk for type 2 diabetes. Overall, adhering to the program leads to positive outcomes, whether through video calls or self-directed efforts. ^{6 7 8 9 10}

Who Is on the Research Team?

Anna M Gorczyca, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for adults in rural areas with prediabetes, which means they have blood test results showing slightly elevated sugar levels or a previous diagnosis of gestational diabetes. Participants must be over 18, have a BMI ≥25 (or ≥23 if Asian), and speak English. They should be able to attend group video meetings and travel to the study site for orientation and testing.

Inclusion Criteria

Available to attend pre-specified meeting time of GV for their respective KSRE location

Medically stable as deemed by primary care provider consent

Blood test results in the pre diabetic range within the last year (HbA1C = 5.7%-6.4% or fasting plasma glucose= 100-125 mg/dl or 2-hr. plasma glucose following a 75-gm glucose load = 140-199 mg/dL) or have previous diagnosis of gestational diabetes or a positive screening for pre diabetes based on CDC pre diabetes risk test

Exclusion Criteria

Primary care provider stating that patient should not participate

Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)

I am taking weight loss medications approved by the FDA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the group video or self-directed Diabetes Prevention Program for 12 months

12 months

Monthly virtual or self-directed sessions

Follow-up

Participants are monitored for weight, physical activity, and HbA1c changes

4 weeks

1 visit (in-person) for final assessments

What Are the Treatments Tested in This Trial?

Interventions

• Self Directed
• Zoom Group Video

Trial Overview The trial is comparing two ways of delivering the National Diabetes Prevention Program: through group videos on Zoom or self-directed learning. It aims to see which method works better for preventing diabetes in rural communities.

How Is the Trial Designed?

Group I: Group Video Diabetes Prevention Program Experimental Treatment 1 Intervention

Participants randomized to the group video DPP for 12-months.

Group II: Self Directed Diabetes Prevention Program Active Control 1 Intervention

Participants randomized to the self directed DPP for 12-months.

Self Directed is already approved in United States for the following indications:

Approved in United States as National Diabetes Prevention Program for:

• Prediabetes
• Type 2 Diabetes Prevention

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Kansas State University

Collaborator

Trials

39

Recruited

13,400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A study of 333,715 participants in the National Diabetes Prevention Program showed that in-person delivery resulted in the highest attendance and weight loss, with an average weight loss of 4.4%, compared to 2.6% for online participants.

Regardless of the delivery mode, participants who stayed in the program longer achieved better outcomes, with those attending at least 22 sessions exceeding the program's weight loss goal of 5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering the National Diabetes Prevention Program: Assessment of Outcomes in In-Person and Virtual Organizations. Ely, EK., Ng, BP., Cannon, MJ.[2023]

The National Diabetes Prevention Program (NDPP) delivered via Zoom by Cooperative Extension personnel showed promising results, with 44% of participants achieving a weight loss of 5% or more, compared to only 7% in the Facebook group.

Both delivery methods had similar attendance and retention rates, indicating that remote group formats can effectively engage rural residents with prediabetes in lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Comparative Effectiveness for the Delivery of the National Diabetes Prevention Program through Cooperative Extension in Rural Communities. Gorczyca, AM., Washburn, RA., Smith, P., et al.[2022]

Supplemental text messaging (SMS4PreDM) was appealing to participants, particularly younger individuals and those from underserved populations, but it did not significantly enhance attendance or weight loss outcomes in the in-person National Diabetes Prevention Program (NDPP).

The study involved 488 participants over a year, comparing those who received in-person NDPP classes with and without the SMS4PreDM support, highlighting the need for further research to find effective strategies for improving NDPP outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. Ritchie, ND., Gutiérrez-Raghunath, S., Durfee, MJ., et al.[2021]

Participants in the Diabetes Prevention Program (DPP) who received the intervention through telehealth had similar rates of participation and weight loss compared to those attending on-site, indicating that telehealth is an effective alternative for delivering this program.

From 2008 to 2015, 894 participants were enrolled, with no significant differences in attendance or weight loss outcomes between the two groups, suggesting that telehealth can effectively increase access to DPP, especially in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth delivery of the diabetes prevention program to rural communities. Vadheim, LM., Patch, K., Brokaw, SM., 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 NDPP-Flex program, which allows participants to set flexible and personalized goals, resulted in a significant reduction in glycated hemoglobin (HbA1c) levels compared to the standard NDPP, indicating better blood sugar control.

While retention rates, physical activity, and weight loss were similar between NDPP-Flex and standard NDPP, NDPP-Flex participants were four times more likely to achieve normoglycemia, suggesting that a patient-centered approach may enhance diabetes management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Goal-Setting in the National Diabetes Prevention Program: A Pilot Study. Ritchie, ND., Sauder, KA., Kaufmann, PG., et al.[2022]

Technology-assisted diabetes prevention programs (DPP), including mobile text messaging, apps, and telehealth, have shown potential for clinically meaningful weight loss and cost-effectiveness in preventing type 2 diabetes.

These interventions can be widely distributed and sustained, making them accessible options for individuals at risk for diabetes, although further research is needed to identify the most effective combination of features for these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Technology-Assisted Interventions for Diabetes Prevention. Grock, S., Ku, JH., Kim, J., et al.[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]

Citations

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Assessing the Fit of a Digitally Delivered National Diabetes ... This qualitative study aimed to examine the fit of the National DPP delivered digitally using Zoom or Facebook to rural living adults at risk for type 2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06252038

NCT06252038 | Rural Alliance for Diabetes Prevention The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self ...

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Diabetes prevention program outcomes by in-person ... A two-group, pre–post study design compared National Diabetes Prevention Program outcomes based on in-person delivery (2018–2020 pre-COVID-19 ...

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Feasibility and Comparative Effectiveness for the Delivery ... This pilot trial demonstrated the potential feasibility and effectiveness of the NDPP delivered by CE personnel in a group remote format (Zoom) to adults with ...

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(PDF) Delivering the National Diabetes Prevention Program In summary, if participants stay in the program, most have positive program outcomes regardless of delivery mode; they have some outcome ...

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Diabetes Prevention Program (DPP) - NIDDK After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

7. cdc.gov cdc.gov/diabetes-prevention/index.html

National Diabetes Prevention Program The National Diabetes Prevention Program is building a nationwide network for its lifestyle change program, which is proven to cut type 2 diabetes risk in half.

8. coveragetoolkit.org coveragetoolkit.org/about-national-dpp/ndpp-overview/

National Diabetes Prevention Program Overview The National DPP lifestyle change program is an evidence-based program focused on helping participants make positive lifestyle changes such as ...

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Virtual Diabetes Prevention Program Tailored to Increase ... The primary aim of the project is to assess the effect of Power-Up versus NDPP on weight loss among men with prediabetes. The secondary aim is ...

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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 ...