PreDiabetes
Conditions
Keywords
Diabetes Prevention Program, Community-supported agriculture
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 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.
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.
Interventions
BEHAVIORALDiabetes Prevention Program (DPP)
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.
BEHAVIORALCommunity-Supported Agriculture (CSA)
Provides weekly and culturally appropriate fresh produce for 10 weeks.
BEHAVIORALCommunity Health Worker support (CHW)
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.
Sponsors
NYU Langone Health
American Diabetes Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Body Weight | Baseline, Month 3 | Weight measured in pounds (lbs) via a standardized weight scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Illness Perceptions score | Baseline, Month 3 | 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. |
| Change in Perceived Stress Score | Baseline, Month 3 | 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. |
| Change in Depressive Symptoms Score | Baseline, Month 3 | 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. |
| Change in Digital Literacy Score | Baseline, Month 3 | 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. |
| Change in Starting the Conversation (STC) Diet Scale Score | Baseline, Month 3 | 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. |
| Change in International Physical Activity Questionnaire (IPAQ) Short-Version Score | Baseline, Month 3 | 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. |
| Change in San Francisco Chinese Food Security Module Score | Baseline, Month 3 | 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. |
| Change in SDOH Score | Baseline, Month 3 | 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. |
| Change in Weight Efficacy Lifestyle Questionnaire (WEL) Score | Baseline, Month 3 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLu Hu, PhD
NYU Langone Medical Center
Outcome results
None listed