DPP + CSA for Prediabetes

(INCLUDE Trial)

Overseen By Lu Hu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Sensory impairments, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to examine the efficacy of the video-based Diabetes Prevention Program (DPP) + Community-supported agriculture (CSA) (hereafter INCLUDE) intervention compared with a wait-list control group (hereafter CONTROL) on diabetes prevention among Chinese immigrants with T2D in NYC. Participants will be randomized with equal allocation to one of the two groups. The INCLUDE group will receive one culturally tailored DPP brief video/week for 24 weeks delivered via WeChat. They will also have access to the CSA program that Co-I Dr. Stella Yi has built in existing and ongoing community-partnered work in Brooklyn Chinatown. The CONTROL group will continue to receive their usual care and, at the end of the study, they will receive DPP videos. Measurements will occur at baseline, 3, and 6 months. This study will provide critical information on whether it is efficacious to use an existing social media platform plus CSA support to enhance access to DPP. If the intervention is proven efficacious, this project can provide important data for future scaling of this intervention. This study may serve as a transformative new model to enhance access to culturally tailored diabetes education and promote health equity for underserved limited English proficiency (LEP) immigrant and minority groups.

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 seems focused on lifestyle changes rather than medication adjustments.

What data supports the effectiveness of the treatment DPP + CSA for Prediabetes?

The Diabetes Prevention Program (DPP) is a proven lifestyle change program that can reduce the risk of developing diabetes by 58% over three years. It has been successfully adapted for other conditions like non-alcoholic fatty liver disease, suggesting its potential effectiveness when combined with community-supported agriculture (CSA) for prediabetes. ^{1 2 3 4 5}

Is the Diabetes Prevention Program (DPP) safe for humans?

The Diabetes Prevention Program (DPP) has been evaluated in clinical trials and is considered safe for humans, as it focuses on lifestyle changes like diet and exercise to reduce the risk of developing diabetes. ^{1 2 3 6 7}

How is the Diabetes Prevention Program (DPP) treatment unique for prediabetes?

The Diabetes Prevention Program (DPP) is unique because it focuses on lifestyle changes, such as diet and exercise, to prevent or delay type 2 diabetes in people with prediabetes, rather than relying on medication. It has been shown to reduce the risk of developing diabetes by 58% over three years, making it a highly effective non-drug approach. ^{1 2 3 4 8}

Research Team

Lu Hu, PhD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

This trial is for Chinese immigrants or Chinese Americans aged 18-70 with prediabetes, a BMI of at least 23 kg/m2, and access to a smartphone. They must be willing to receive diabetes prevention videos. Excluded are those with significant sight/hearing issues, breastfeeding mothers, pregnant women or those planning pregnancy soon.

Inclusion Criteria

You are of Chinese immigrant or Chinese American background.

I am willing to watch videos about preventing diabetes.

I have a smartphone or am willing to use one provided by the study.

Exclusion Criteria

I am not willing to be randomly assigned to a treatment group.

Are pregnant, plan to become pregnant in the next 6 months, or become pregnant during the study

Unable or unwilling to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one culturally tailored DPP brief video per week for 24 weeks delivered via WeChat and access to the CSA program

24 weeks

Weekly virtual engagement via WeChat

Follow-up

Participants are monitored for changes in food security, physical activity, body weight, and dietary behaviors

3 months

Measurements at baseline, 3, and 6 months

Treatment Details

Interventions

• Community-Supported Agriculture (CSA)
• Diabetes Prevention Program (DPP)

Trial Overview The study tests if culturally tailored Diabetes Prevention Program (DPP) videos plus Community-Supported Agriculture (CSA) benefits can prevent diabetes in participants compared to usual care. One group receives weekly DPP videos via WeChat and CSA access; the control group gets standard care.

Participant Groups

Group I: INCLUDE Experimental Treatment 2 Interventions

Participants will receive one Diabetes Prevention Program (DPP) video per week for 24 weeks. Additionally, community health workers (CHWs) will help participants to join the community-supported agriculture (CSA) program and assess and address other social determinants of health (SDOH) barriers.

Group II: CONTROL Active Control 1 Intervention

Participants will receive the standard of usual care.

Diabetes Prevention Program (DPP) is already approved in United States for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Prediabetes
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Findings from Research

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

A randomized clinical trial involving 257 obese patients with metabolic syndrome showed that a group conference call (CC) intervention led to significantly greater weight loss (-5.6%) compared to individual calls (IC) (-1.8%) over 2 years, indicating that group support may enhance weight loss outcomes.

Participants in the CC group not only lost more weight but also continued to lose weight between the first and second year, while those in the IC group began to regain weight, highlighting the importance of ongoing support in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. Weinstock, RS., Trief, PM., Cibula, D., et al.[2022]

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.

The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]

The study involved 33 interviews with lifestyle coaches across 20 clinic sites, identifying six key factors that influence the successful implementation of the Diabetes Prevention Program (DPP) in large healthcare systems.

These factors include broader and institutional contexts, program provision, recruitment processes, characteristics of lifestyle coaches, and group dynamics, all of which are interconnected and can either facilitate or hinder the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. Halley, MC., Petersen, J., Nasrallah, C., et al.[2021]

The Diabetes Prevention Program (DPP) is a large clinical trial involving 3,234 participants aimed at evaluating interventions to prevent type 2 diabetes in individuals at high risk, with a diverse demographic including various ethnic backgrounds and age groups.

The study will assess the effectiveness of three treatment approaches: intensive lifestyle modification, standard care with metformin, and standard care with placebo, to determine their impact on delaying or preventing diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

A pilot study involving 92 participants showed that a group-based lifestyle intervention delivered by the YMCA led to a significant 6.0% reduction in body weight after 6 months, compared to only a 2.0% reduction in the control group.

The intervention also resulted in a notable decrease in total cholesterol levels, with a reduction of 22 mg/dL in the intervention group versus an increase of 6 mg/dL in controls, indicating the program's effectiveness in improving health markers associated with diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Ackermann, RT., Finch, EA., Brizendine, E., et al.[2022]

The Diabetes Prevention Program (DPP) effectively identified high-risk adults for type 2 diabetes, with 27% of participants showing impaired glucose tolerance and 13% having previously undiagnosed diabetes based on oral glucose tolerance tests (OGTT).

Fasting capillary glucose levels, along with age and BMI, significantly improved the screening process for high-risk individuals across various ethnic groups, suggesting it can enhance the efficiency of diabetes prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]

References

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

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]

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

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. [2023]

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

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. [2022]

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

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. [2019]

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

Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. [2021]

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

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. [2022]

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

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]