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PreDiabetesINCLUDENCT05492916

Integrating Cultural Aspects Into Diabetes Education

A study testing Diabetes Prevention Program (DPP), Community-Supported Agriculture (CSA) and Community Health Worker support (CHW) in people with PreDiabetes, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Americans at risk of developing T2D in NYC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PreDiabetes
What is being tested?
Diabetes Prevention Program (DPP), Community-Supported Agriculture (CSA) and Community Health Worker support (CHW)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
30 Apr 2023to 7 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: INCLUDE: 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 INCLUDE) intervention compared with a wait-list control group (hereafter CONTROL) on diabetes prevention among Chinese Americans at risk of developing T2D in NYC. Participants will be randomized with equal allocation to one of the two groups. The INCLUDE group will receive 2-3 culturally tailored DPP brief video/week for 12 weeks delivered via WeChat. They will also have access to a 10-week 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 and gift cards with a value equal to the 10-week CSA program. 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.

Read the detailed description

Chinese Americans are the second largest immigrant group in the U.S., who suffer disproportionately high type 2 diabetes (T2D) burden and have poor diabetes outcomes. The Diabetes Prevention Program (DPP) is an evidence-based intervention to prevent or delay T2D. However, many social determinants of health (SDOH) barriers limit the access of DPP to underserved Chinese Americans, including high rates of LEP, poverty, lack of health insurance, and poor access to care. Furthermore, there is a significant shortage of cultural- and linguistic-concordant providers to deliver DPP. Given the high T2D burden and rapid growth in the Chinese American population, there is an urgent need for research to make DPP accessible to this minority group. High social media use (e.g., WeChat) in Chinese Americans suggests a promising mechanism for enhancing access to DPP. Yet, this mobile health (mHealth) intervention alone is likely insufficient to address many SDOH barriers reported by low-income and LEP Chinese Americans, including food insecurity, and lack of access to fruits and vegetables. Community-supported agriculture (CSA) has been demonstrated to be an effective way to improve food security in White populations, and may help to address food access issues in LEP Chinese Americans. Guided by the NIMHD Research Framework, the investigators argue that a mHealth DPP intervention (individual level) that is supplemented with a culturally appropriate CSA (community level) with complementary nutrition/produce preparation education is a novel model for enhancing access to DPP and addressing SDOH barriers in LEP Chinese Americans. The investigators' pilot work demonstrates the feasibility, acceptability, and potential efficacy of WeChat-delivered educational videos targeting T2D management, and Co-I Dr. Stella Yi's pilot study has found high feasibility of the CSA model in LEP Chinese Americans. Building upon these pilot data, the investigators will adapt their current T2D management intervention to include video content relevant to DPP and combine it with a CSA model. The goal of this study is to examine the efficacy of the video-based DPP+CSA (hereafter INCLUDE) intervention compared with a wait-list control group (hereafter CONTROL) on diabetes prevention among Chinese Americans at risk of developing T2D in NYC. Participants will be randomized with equal allocation to one of the two groups. The INCLUDE group will receive 2-3 culturally tailored DPP brief video/week for 12 weeks delivered via WeChat. They will also have access to a 10-week 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 and gift cards with a value equal to the 10-week CSA program. 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 LEP immigrant and minority groups.

Conditions
PreDiabetes
Being tested
Diabetes Prevention Program (DPP), Community-Supported Agriculture (CSA), Community Health Worker support (CHW)
Keywords
Diabetes Prevention Program, Community-supported agriculture
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Prevention Program (DPP)Behavioural

    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.

  • Community-Supported Agriculture (CSA)Behavioural

    Provides weekly and culturally appropriate fresh produce for 10 weeks.

  • Community Health Worker support (CHW)Behavioural

    CHWs will call participants every other week to review key video content, help with goal setting and problem solving, and assess and address SDOH barriers.

Study groups in NCT05492916
Study groupRoleWhat they receive
INCLUDEExperimentalParticipants will receive 2-3 Diabetes Prevention Program (DPP) videos per week for 12 weeks. Additionally, community health workers (CHWs) will call participants every other week to review key video content, help with goal setting and problem solving, and assess and address social determinants of health (SDOH) barriers. Participants will also receive fresh produce from the 10-week community-supported agriculture (CSA) program.
Receives: Behavioral: Diabetes Prevention Program (DPP); Behavioral: Community-Supported Agriculture (CSA); Behavioral: Community Health Worker support (CHW)
CONTROLNo interventionParticipants will receive the standard of usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Body Weight

    Weight measured in pounds (lbs) via a standardized weight scale.

    Measured: Baseline, Month 3

  2. Percentage Change in Body Weight

    Weight measured in pounds (lbs) via a standardized weight scale.

    Measured: Month 3, Month 6

Secondary outcomes (18)
  1. Change in Starting the Conversation (STC) Diet Scale Score

    8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more healthful dietary behaviors. A decrease in scores indicates healthful dietary behaviors increased during the observation period.

    Measured: Baseline, Month 3

  2. Change in Starting the Conversation (STC) Diet Scale Score

    8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more healthful dietary behaviors. A decrease in scores indicates healthful dietary behaviors increased during the observation period.

    Measured: Month 3, Month 6

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

    7-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity.

    Scores are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity. An increase in scores indicates weekly levels of physical activity increased during the observation period.

    Measured: Baseline, Month 3

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

    7-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity.

    Scores are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity. An increase in scores indicates weekly levels of physical activity increased during the observation period.

    Measured: Month 3, Month 6

  5. Change in San Francisco Chinese Food Security Module Score

    18-item self-assessment measuring food access and insecurity among Chinese immigrants. Responses of "yes," "often," "sometimes," "almost every month," and "some months but not every month" are coded as affirmative. Food Security Status Levels are assigned based on the total number of affirmative responses.

    Households with children: 0-2 affirmative responses = "Food Secure"; 3-7 = "Food Insecure without Hunger"; 8-12 = "Food Insecure with Hunger, Moderate"; 13-18 = "Food Insecure with Hunger, Severe."

    Households without children: 0-2 affirmative responses = "Food Secure"; 3-5 = "Food Insecure without Hunger"; 6-8 = "Food Insecure with Hunger, Moderate"; 9-10 = "Food Insecure with Hunger, Severe."

    A decrease in the number of affirmative responses indicates food security status improved during the observation period.

    Measured: Baseline, Month 3

  6. Change in San Francisco Chinese Food Security Module Score

    18-item self-assessment measuring food access and insecurity among Chinese immigrants. Responses of "yes," "often," "sometimes," "almost every month," and "some months but not every month" are coded as affirmative. Food Security Status Levels are assigned based on the total number of affirmative responses.

    Households with children: 0-2 affirmative responses = "Food Secure"; 3-7 = "Food Insecure without Hunger"; 8-12 = "Food Insecure with Hunger, Moderate"; 13-18 = "Food Insecure with Hunger, Severe."

    Households without children: 0-2 affirmative responses = "Food Secure"; 3-5 = "Food Insecure without Hunger"; 6-8 = "Food Insecure with Hunger, Moderate"; 9-10 = "Food Insecure with Hunger, Severe."

    A decrease in the number of affirmative responses indicates food security status improved during the observation period.

    Measured: Month 3, Month 6

  7. Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score

    20-item participant self-report of confidence level in resisting desire to eat. Assessed via 10-point Likert scale ranging from 0 (not confident) to 9 (very confident). Scores range from 0-180; higher scores indicate higher confidence level in resisting desire to eat. An increase in scores indicates confidence levels in resisting desire to eat increased during the observation period.

    Measured: Baseline, Month 3

  8. Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score

    20-item participant self-report of confidence level in resisting desire to eat. Assessed via 10-point Likert scale ranging from 0 (not confident) to 9 (very confident). Scores range from 0-180; higher scores indicate higher confidence level in resisting desire to eat. An increase in scores indicates confidence levels in resisting desire to eat increased during the observation period.

    Measured: Month 3, Month 6

  9. Change in SDOH Score

    The 14-item SDOH questionnaire assessed core health-related social needs and barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.

    Measured: Baseline, Month 3

  10. Change in SDOH Score

    The 14-item SDOH questionnaire assessed core health-related social needs and barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.

    Measured: Month 3, Month 6

  11. Change in Illness Perceptions score

    Illness perceptions were measured using the 8-item Brief Illness Perception Questionnaire, adapted to assess participants' perceptions of prediabetes or risk for T2D. The instrument includes 8 scaled items rated from 0 to 10 that capture cognitive and emotional representations of diabetes or risk, including perceived consequences, timeline, personal control, treatment control, identity, illness coherence, concern, and emotional response. A ninth open-ended item asks participants to report perceived causes of their prediabetes or diabetes risk. Item scores were summed, ranging from 0 to 80, with higher scores indicating a more negative perception of prediabetes or diabetes risk. We expected the intervention to reduce Brief IPQ total scores, reflecting a shift toward a more manageable perception of diabetes risk.

    Measured: Baseline, Month 3

  12. Change in Illness Perceptions score

    Illness perceptions were measured using the 8-item Brief Illness Perception Questionnaire, adapted to assess participants' perceptions of prediabetes or risk for T2D. The instrument includes 8 scaled items rated from 0 to 10 that capture cognitive and emotional representations of diabetes or risk, including perceived consequences, timeline, personal control, treatment control, identity, illness coherence, concern, and emotional response. A ninth open-ended item asks participants to report perceived causes of their prediabetes or diabetes risk. Item scores were summed, ranging from 0 to 80, with higher scores indicating a more negative perception of prediabetes or diabetes risk. We expected the intervention to reduce Brief IPQ total scores, reflecting a shift toward a more manageable perception of diabetes risk.

    Measured: Month 3, Month 6

  13. Change in Perceived Stress Score

    Perceived stress was assessed using the 10-item Perceived Stress Scale, a widely used and validated measure of the extent to which individuals perceive situations in their lives as stressful, unpredictable, uncontrollable, and overwhelming. Items are rated on a 5-point scale from 0 ("never") to 4 ("very often"), yielding a total score ranging from 0 to 40. Higher scores indicate greater perceived stress.

    Measured: Baseline, Month 3

  14. Change in Perceived Stress Score

    Perceived stress was assessed using the 10-item Perceived Stress Scale, a widely used and validated measure of the extent to which individuals perceive situations in their lives as stressful, unpredictable, uncontrollable, and overwhelming. Items are rated on a 5-point scale from 0 ("never") to 4 ("very often"), yielding a total score ranging from 0 to 40. Higher scores indicate greater perceived stress.

    Measured: Month 3, Month 6

  15. Change in Depressive Symptoms Score

    Depressive symptoms were assessed using the Patient Health Questionnaire-2, a brief screening tool for patients with low literacy that measures the frequency of depressed mood and loss of interest or pleasure during the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 6. Higher scores indicate greater depressive symptom severity.

    Measured: Baseline, Month 3

  16. Change in Depressive Symptoms Score

    Depressive symptoms were assessed using the Patient Health Questionnaire-2, a brief screening tool for patients with low literacy that measures the frequency of depressed mood and loss of interest or pleasure during the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 6. Higher scores indicate greater depressive symptom severity.

    Measured: Month 3, Month 6

  17. Change in Digital Literacy Score

    Digital literacy was assessed using the 8-item eHealth Literacy Scale, a validated self-report measure of perceived ability to locate, evaluate, and apply health information from electronic sources. Each item is rated on a 5-point scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), yielding a total score from 8 to 40. Higher scores indicate better digital literacy.

    Measured: Baseline, Month 3

  18. Change in Digital Literacy Score

    Digital literacy was assessed using the 8-item eHealth Literacy Scale, a validated self-report measure of perceived ability to locate, evaluate, and apply health information from electronic sources. Each item is rated on a 5-point scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), yielding a total score from 8 to 40. Higher scores indicate better digital literacy.

    Measured: Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2022
  2. Study start30 Apr 2023
  3. Primary completion7 May 2025
  4. Study completion7 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492916
Sponsor's protocol ID
22-00783
Acronym
INCLUDE
Status last verified
Aug 2026
First submitted
5 Aug 2022
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39560984

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Prevention Program (DPP), Community-Supported Agriculture (CSA) and Community Health Worker support (CHW) in people with PreDiabetes, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Body Weight (time frame: Baseline, Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05492916, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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