Integrating Cultural Aspects Into Diabetes Education
INCLUDE
INCLUDE: INtegrating CuLtUral Aspects Into Diabetes Education
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2025
CompletedMarch 9, 2026
March 1, 2026
2 years
August 5, 2022
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage Change in Body Weight
Weight measured in pounds (lbs) via Bluetooth-enabled smart-scale.
Baseline, Month 3
Percentage Change in Body Weight
Weight measured in pounds (lbs) via Bluetooth-enabled smart-scale.
Month 3, Month 6
Secondary Outcomes (8)
Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score
Baseline, Month 3
Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score
Month 3, Month 6
Change in Starting the Conversation (STC) Diet Scale Score
Baseline, Month 3
Change in Starting the Conversation (STC) Diet Scale Score
Month 3, Month 6
Change in International Physical Activity Questionnaire (IPAQ) Short-Version Score
Baseline, Month 3
- +3 more secondary outcomes
Study Arms (2)
INCLUDE
EXPERIMENTALParticipants 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.
CONTROL
NO INTERVENTIONParticipants will receive the standard of usual care.
Interventions
Video-based intervention to prevent or delay Type 2 Diabetes. Includes both educational and social cognitive theory (SCT)-based behavioral content. Each video lasts about 5 minutes in duration.
Provides weekly and culturally appropriate fresh produce and in-language education on nutrition, healthy cooking demonstrations, and culturally tailored recipes for participants. Enables participants to socialize with other Chinese immigrants in the program as a way to enhance social cohesion and support.
Eligibility Criteria
You may qualify if:
- Participants must:
- self-identify as a Chinese immigrant or Chinese American;
- be between 18-70 years old,
- have a medical diagnosis of prediabetes or have a prediabetes risk test score of greater or equal to 5;
- Body Mass Index (BMI) \>= 23 kg/m2,
- be willing to receive brief videos regarding diabetes prevention, and 6) possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
You may not qualify if:
- Individuals will be excluded from participation if they meet any of the following:
- unable or unwilling to provide informed consent;
- unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
- unwilling to accept randomization assignment;
- are pregnant, plan to become pregnant in the next 6 months, or become pregnant during the study, or
- are breastfeeding (e.g., they may have potential dietary restrictions).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Diabetes Associationcollaborator
- NYU Langone Healthlead
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Related Publications (1)
Hu L, Lin NF, Shi Y, Cao J, Sevick MA, Li H, Beasley JM, Levy N, Tamura K, Xu X, Jiang Y, Ong I, Yang X, Bai Y, Su L, Chan SW, Yi SS. The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 19;13:e65455. doi: 10.2196/65455.
PMID: 39560984DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lu Hu, PhD
NYU Langone Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 9, 2022
Study Start
April 30, 2023
Primary Completion
May 7, 2025
Study Completion
May 7, 2025
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lu.hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Lu Hu (lu.hu@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.