Clinical trial NCT05492916: Integrating Cultural Aspects Into Diabetes Education
Official title: INCLUDE: INtegrating CuLtUral Aspects Into Diabetes Education
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PreDiabetes
Keywords: Diabetes Prevention Program
Community-supported agriculture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2022-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Chinese immigrants 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 immigrants, 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 immigrant 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 immigrants 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 LEP Chinese immigrants, 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 immigrants. 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 immigrants. 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 immigrants. 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 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 LEP immigrant and minority groups.

Eligibility criteria: Inclusion Criteria:

Participants must:

1. self-identify as a Chinese immigrant or Chinese American;
2. be between 18-70 years old,
3. have a medical diagnosis of prediabetes or have a prediabetes risk test score of greater or equal to 5;
4. Body Mass Index (BMI) \>= 23 kg/m2,
5. 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.

Exclusion Criteria:

Individuals will be excluded from participation if they meet any of the following:

1. unable or unwilling to provide informed consent;
2. unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
3. unwilling to accept randomization assignment;
4. are pregnant, plan to become pregnant in the next 6 months, or become pregnant during the study, or
5. are breastfeeding (e.g., they may have potential dietary restrictions).

Primary outcomes:
measure: Percentage Change in Body Weight
timeFrame: Baseline, Month 3
measure: Percentage Change in Body Weight
timeFrame: Month 3, Month 6
Secondary outcomes:
measure: Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score
timeFrame: Baseline, Month 3
measure: Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score
timeFrame: Month 3, Month 6
measure: Change in Starting the Conversation (STC) Diet Scale Score
timeFrame: Baseline, Month 3
measure: Change in Starting the Conversation (STC) Diet Scale Score
timeFrame: Month 3, Month 6
measure: Change in International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Baseline, Month 3
measure: Change in International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Month 3, Month 6
measure: Change in San Francisco Chinese Food Security Module Score
timeFrame: Baseline, Month 3
measure: Change in San Francisco Chinese Food Security Module Score
timeFrame: Month 3, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Lu Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: