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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, month 6
Awards & highlights
INCLUDE Trial 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.Check my eligibility
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.See study design
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.
INCLUDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a smartphone or am willing to use one provided by the study.
Select...
I am between 18 and 70 years old.
Select...
I have been diagnosed with prediabetes or my risk score is 5 or higher.
INCLUDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3, month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage Change in Body Weight
Secondary outcome measures
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 moreINCLUDE 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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,485 Total Patients Enrolled
American Diabetes AssociationOTHER
138 Previous Clinical Trials
99,376 Total Patients Enrolled
Lu Hu, PhDPrincipal InvestigatorNYU Langone Medical Center
4 Previous Clinical Trials
700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to be randomly assigned to a treatment group.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.I am between 18 and 70 years old.I can fully participate in the study without issues related to sight or hearing.You have a BMI of 23 or higher.I have been diagnosed with prediabetes or my risk score is 5 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: INCLUDE
- Group 2: CONTROL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this trial open to individuals under 35 years of age?
"This clinical trial is enrolling individuals aged 18 and over, yet no older than 70 years of age."
Answered by AI
Is it feasible to join this medical experiment?
"This medical trial calls for 150 participants of Chinese descent between the ages 18-70, possessing a BMI of at least 23 kg/m2 and with a prediabetes diagnosis or risk score greater than 5. As well as being willing to view instructive videos on diabetes prevention via smartphone (or be able to use one provided by us)."
Answered by AI
Are there any vacancies remaining in this clinical investigation?
"As indicated on clinicaltrials.gov, this medical experiment is not presently enrolling individuals - it was initiated on February 1st 2023 and last modified on August 5th 2022. Nevertheless, 198 other trials are still searching for participants at present."
Answered by AI
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