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DPP + CSA for Prediabetes (INCLUDE Trial)

N/A

Recruiting

Led By Lu Hu, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Possess a smartphone or, if they do not have one, be willing and able to use a study smartphone

Be between 18-70 years old

Must not have

Unwilling to accept randomization assignment

Unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3, month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether the video-based Diabetes Prevention Program, delivered through the social media platform WeChat, + Community-supported agriculture can prevent diabetes among Chinese immigrants with T2D in NYC.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves educational materials and dietary support rather than medication, typical drug side effects aren't expected. However, changes in diet or lifestyle as suggested by the program may cause temporary digestive adjustments or food sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 70 years old.

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I have been diagnosed with prediabetes or my risk score is 5 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I can fully participate in the study without issues related to sight or hearing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage Change in Body Weight

Secondary study objectives

Change in International Physical Activity Questionnaire (IPAQ) Short-Version Score

Change in San Francisco Chinese Food Security Module Score

Change in Starting the Conversation (STC) Diet Scale Score

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: INCLUDEExperimental Treatment2 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: CONTROLActive Control1 Intervention

Participants will receive the standard of usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes Prevention Program (DPP)

2012

N/A

~340

0 / 5Eligibility criteria met