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

Trial Summary

What is the purpose of this trial?

The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas.

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 data supports the effectiveness of the treatment for prediabetes?

Research shows that delivering the National Diabetes Prevention Program (NDPP) through Zoom in rural areas can be effective, with 44% of participants achieving significant weight loss. Additionally, digital and remote delivery methods of the NDPP have shown positive outcomes in weight loss and physical activity, indicating that these methods can be effective for prediabetes management. ^{1 2 3 4 5}

How does the Zoom Group Video and Self-Directed treatment for prediabetes differ from other treatments?

The Zoom Group Video and Self-Directed treatment for prediabetes is unique because it offers flexibility in delivery, allowing participants to engage in the program remotely through video conferencing or at their own pace online. This approach can increase accessibility, especially for those in rural areas, and has shown potential for effective weight loss and lifestyle changes similar to traditional in-person programs. ^{3 4 6 7 8}

Research Team

Anna M Gorczyca, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Patient-Centered Goal-Setting in the National Diabetes Prevention Program: A Pilot Study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Delivering the National Diabetes Prevention Program: Assessment of Outcomes in In-Person and Virtual Organizations. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Comparative Effectiveness for the Delivery of the National Diabetes Prevention Program through Cooperative Extension in Rural Communities. [2022]

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

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

6. Canada pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. [2021]

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

A Review of Technology-Assisted Interventions for Diabetes Prevention. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Telehealth delivery of the diabetes prevention program to rural communities. [2022]