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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent diabetes in Chinese immigrants with prediabetes in NYC. Researchers will divide participants into two groups. One group will watch weekly diabetes prevention videos and join a community-supported agriculture (CSA) program to improve their health. The other group will continue their usual care and receive the videos after the trial. This trial suits Chinese immigrants diagnosed with prediabetes who have a smartphone and are open to watching short health videos. As an unphased trial, it offers participants the chance to contribute to innovative diabetes prevention strategies tailored to their community.

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 prior data suggests that this intervention is safe for diabetes prevention among Chinese immigrants?

Research has shown that the Diabetes Prevention Program (DPP) is safe and well-tolerated. Studies have found that this program, which emphasizes lifestyle changes, can reduce the risk of developing type 2 diabetes by 58% over three years. Reports of negative effects are absent, suggesting it is generally safe for participants.

The DPP promotes healthy lifestyle changes, such as improving diet and increasing exercise, which most people find manageable. The program also includes community-supported agriculture (CSA), providing participants with fresh produce to enhance their diet.

Reports of serious side effects from participating in the DPP or CSA are absent. These programs aim to improve health through everyday habits, indicating they are likely safe for most people to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines the Diabetes Prevention Program (DPP) with community-supported agriculture (CSA) to address prediabetes in a unique way. Unlike the standard care options, which often focus solely on medication or lifestyle changes like diet and exercise, this approach adds a community element by involving community health workers to help participants overcome social barriers and access fresh produce through the CSA program. This holistic strategy not only aims to improve individual health habits but also tackles broader social determinants of health, potentially offering a more comprehensive solution to prevent diabetes.

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

Research has shown that the Diabetes Prevention Program (DPP) effectively reduces the risk of developing type 2 diabetes. A major study found that the DPP Lifestyle Change Program lowered this risk by 58% over three years. Additionally, a follow-up study revealed that participants were still one-third less likely to develop diabetes even after ten years. Community-supported agriculture (CSA) programs have also significantly improved participants' diet quality. In this trial, one group of participants will receive the DPP along with support to join the CSA program. This combination is being explored because both have shown positive results individually in managing and preventing diabetes. ^{4 6 7 8 9}

Who Is on the Research Team?

Lu Hu, PhD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6893336/

Population Health Impact and Cost-Effectiveness of ... A recent randomized clinical trial found that a CSA was effective in improving diet quality for participants drawn from a federally qualified community health ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6874748/

Health Center–Based, Community-Supported Agriculture This RCT found that a subsidized CSA intervention significantly improved diet quality, compared with a “cash-benchmark” control condition. Further, it reduced ...

3. withpower.com withpower.com/trial/phase-prediabetic-state-1-2023-9c8bf

DPP + CSA for Prediabetes (INCLUDE Trial) 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404623003949

Diet Quality Outcomes of a Cooperative Extension ... This study provides valuable insight into the weight and DQ outcomes of the DPP when implemented as intended in the community setting of Extension.

5. trialx.com trialx.com/clinical-trials/listings/268606/integrating-cultural-aspects-into-diabetes-education/

Integrating Cultural Aspects Into Diabetes Education The goal of this study is to examine the efficacy of the video-based Diabetes Prevention Program (DPP) + Community-supported agriculture (CSA) (hereafter ...

6. 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.

7. niddk.nih.gov niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

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 ...

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

National Diabetes Prevention Program Overview The CDC DPRP standards require that at least 35% of a program's participants be diagnosed with prediabetes through blood testing (or have a ...

9. diabetesjournals.org diabetesjournals.org/care/article/46/2/e39/148317/The-National-Clinical-Care-Commission-Report-to

The National Clinical Care Commission Report to Congress In this article, we describe the recommendations of an NCCC subcommittee that focused primarily on prevention of type 2 diabetes in people with prediabetes.