The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial
BackgroundType 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy....
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JMIR Publications
2024-11-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e65455 |
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| author | Lu Hu Nelson F Lin Yun Shi Jiepin Cao Mary Ann Sevick Huilin Li Jeannette M Beasley Natalie Levy Kosuke Tamura Xinyi Xu Yulin Jiang Iris Ong Ximin Yang Yujie Bai Liwen Su Sze Wan Chan Stella S Yi |
| author_facet | Lu Hu Nelson F Lin Yun Shi Jiepin Cao Mary Ann Sevick Huilin Li Jeannette M Beasley Natalie Levy Kosuke Tamura Xinyi Xu Yulin Jiang Iris Ong Ximin Yang Yujie Bai Liwen Su Sze Wan Chan Stella S Yi |
| author_sort | Lu Hu |
| collection | DOAJ |
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BackgroundType 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy.
ObjectiveThe goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media–based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted, community-supported agriculture program. Here, we report the protocol for the INCLUDE study.
MethodsINCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff to review video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine.
ResultsRecruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July 2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants for the second cohort as of July 2024.
ConclusionsThe INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes.
Trial RegistrationClinicalTrials.gov NCT05492916; https://clinicaltrials.gov/study/NCT05492916
International Registered Report Identifier (IRRID)DERR1-10.2196/65455 |
| format | Article |
| id | doaj-art-8f2aedb9811f4bfb9c0230fa6327a797 |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj-art-8f2aedb9811f4bfb9c0230fa6327a7972024-11-19T15:47:30ZengJMIR PublicationsJMIR Research Protocols1929-07482024-11-0113e6545510.2196/65455The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled TrialLu Huhttps://orcid.org/0000-0001-6465-6779Nelson F Linhttps://orcid.org/0009-0002-3371-0183Yun Shihttps://orcid.org/0000-0003-1936-072XJiepin Caohttps://orcid.org/0000-0002-0117-5756Mary Ann Sevickhttps://orcid.org/0000-0002-5482-7535Huilin Lihttps://orcid.org/0000-0002-8288-7068Jeannette M Beasleyhttps://orcid.org/0000-0002-9343-6895Natalie Levyhttps://orcid.org/0000-0003-2956-5876Kosuke Tamurahttps://orcid.org/0000-0002-4920-2856Xinyi Xuhttps://orcid.org/0009-0007-8758-1360Yulin Jianghttps://orcid.org/0009-0000-5323-6330Iris Onghttps://orcid.org/0009-0006-6908-8356Ximin Yanghttps://orcid.org/0009-0000-9227-2190Yujie Baihttps://orcid.org/0009-0004-1936-4020Liwen Suhttps://orcid.org/0009-0004-8201-0591Sze Wan Chanhttps://orcid.org/0000-0001-5230-7619Stella S Yihttps://orcid.org/0000-0002-9943-2609 BackgroundType 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy. ObjectiveThe goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media–based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted, community-supported agriculture program. Here, we report the protocol for the INCLUDE study. MethodsINCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff to review video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine. ResultsRecruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July 2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants for the second cohort as of July 2024. ConclusionsThe INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes. Trial RegistrationClinicalTrials.gov NCT05492916; https://clinicaltrials.gov/study/NCT05492916 International Registered Report Identifier (IRRID)DERR1-10.2196/65455https://www.researchprotocols.org/2024/1/e65455 |
| spellingShingle | Lu Hu Nelson F Lin Yun Shi Jiepin Cao Mary Ann Sevick Huilin Li Jeannette M Beasley Natalie Levy Kosuke Tamura Xinyi Xu Yulin Jiang Iris Ong Ximin Yang Yujie Bai Liwen Su Sze Wan Chan Stella S Yi The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial JMIR Research Protocols |
| title | The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial |
| title_full | The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial |
| title_fullStr | The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial |
| title_short | The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial |
| title_sort | integrating cultural aspects into diabetes education include study to prevent diabetes in chinese immigrants protocol for a randomized controlled trial |
| url | https://www.researchprotocols.org/2024/1/e65455 |
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