Marcela D. Radtke , Wei-Ting Chen , Lan Xiao , Patricia Rodriguez Espinosa , Marcela Orizaga , Tainayah Thomas , Elizabeth Venditti , Amy L. Yaroch , Kenia Zepada , Lisa G. Rosas , June Tester
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Sustainable, effective interventions aimed at improving food insecurity and diabetes management for Latinx populations are needed.</div></div><div><h3>Methods</h3><div>This hybrid type 1 trial evaluates the effectiveness of a multi-level intervention that includes a medically supportive food and behavioral lifestyle program on the primary outcome of Hemoglobin A1c (HbA1c) at 6 months. Latinx adults (<em>n</em> = 355) with type 2 diabetes (HbA1c of 6.0–12.0 %), overweight/obesity (BMI > 25 kg/m<sup>2</sup>), and self-reported risk of food insecurity will be randomized 1:1 to intervention (12 weekly deliveries of vegetables, fruits, and whole-grain foods + culturally-modified behavioral lifestyle program) versus control (food deliveries after a 6-month delay). Outcome asessments will occur at 0, 6 and 12 months, and include HbA1c, dietary intake, psychosocial health outcomes, and diabetes-related stressors. In addition, food insecurity and the impact of the intervention on up to two household members will be measured. Qualitative interviews with patients, healthcare providers, and community partners will be conducted in accordance with Reach, Effectivenes, Adoption, Implementation, and Maintenence (RE-AIM) framework to identify barriers and best practices for future dissemination.</div></div><div><h3>Conclusions</h3><div>The ADELANTE trial will provide novel insight to the effectiveness of a multi-level intervention on diabetes-related outcomes in Latinx adults. The mixed-method approach will also identity the reach of this ‘Food is Medicine’ intervention on additional household members to inform diabetes prevention efforts.</div><div>Clinical Trial Registration: <span><span>NCT05228860</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107699"},"PeriodicalIF":2.0000,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Addressing diabetes by elevating access to nutrition (ADELANTE) - A multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes: A randomized controlled trial\",\"authors\":\"Marcela D. Radtke , Wei-Ting Chen , Lan Xiao , Patricia Rodriguez Espinosa , Marcela Orizaga , Tainayah Thomas , Elizabeth Venditti , Amy L. Yaroch , Kenia Zepada , Lisa G. Rosas , June Tester\",\"doi\":\"10.1016/j.cct.2024.107699\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Latinx adults are disproportionately impacted by the interrelated challenges of food insecurity and nutrition sensitive chronic diseases. Food and nutrition insecurity can exacerbate the development and progression of chronic diseases, such as diabetes. Sustainable, effective interventions aimed at improving food insecurity and diabetes management for Latinx populations are needed.</div></div><div><h3>Methods</h3><div>This hybrid type 1 trial evaluates the effectiveness of a multi-level intervention that includes a medically supportive food and behavioral lifestyle program on the primary outcome of Hemoglobin A1c (HbA1c) at 6 months. Latinx adults (<em>n</em> = 355) with type 2 diabetes (HbA1c of 6.0–12.0 %), overweight/obesity (BMI > 25 kg/m<sup>2</sup>), and self-reported risk of food insecurity will be randomized 1:1 to intervention (12 weekly deliveries of vegetables, fruits, and whole-grain foods + culturally-modified behavioral lifestyle program) versus control (food deliveries after a 6-month delay). Outcome asessments will occur at 0, 6 and 12 months, and include HbA1c, dietary intake, psychosocial health outcomes, and diabetes-related stressors. In addition, food insecurity and the impact of the intervention on up to two household members will be measured. Qualitative interviews with patients, healthcare providers, and community partners will be conducted in accordance with Reach, Effectivenes, Adoption, Implementation, and Maintenence (RE-AIM) framework to identify barriers and best practices for future dissemination.</div></div><div><h3>Conclusions</h3><div>The ADELANTE trial will provide novel insight to the effectiveness of a multi-level intervention on diabetes-related outcomes in Latinx adults. 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Addressing diabetes by elevating access to nutrition (ADELANTE) - A multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes: A randomized controlled trial
Background
Latinx adults are disproportionately impacted by the interrelated challenges of food insecurity and nutrition sensitive chronic diseases. Food and nutrition insecurity can exacerbate the development and progression of chronic diseases, such as diabetes. Sustainable, effective interventions aimed at improving food insecurity and diabetes management for Latinx populations are needed.
Methods
This hybrid type 1 trial evaluates the effectiveness of a multi-level intervention that includes a medically supportive food and behavioral lifestyle program on the primary outcome of Hemoglobin A1c (HbA1c) at 6 months. Latinx adults (n = 355) with type 2 diabetes (HbA1c of 6.0–12.0 %), overweight/obesity (BMI > 25 kg/m2), and self-reported risk of food insecurity will be randomized 1:1 to intervention (12 weekly deliveries of vegetables, fruits, and whole-grain foods + culturally-modified behavioral lifestyle program) versus control (food deliveries after a 6-month delay). Outcome asessments will occur at 0, 6 and 12 months, and include HbA1c, dietary intake, psychosocial health outcomes, and diabetes-related stressors. In addition, food insecurity and the impact of the intervention on up to two household members will be measured. Qualitative interviews with patients, healthcare providers, and community partners will be conducted in accordance with Reach, Effectivenes, Adoption, Implementation, and Maintenence (RE-AIM) framework to identify barriers and best practices for future dissemination.
Conclusions
The ADELANTE trial will provide novel insight to the effectiveness of a multi-level intervention on diabetes-related outcomes in Latinx adults. The mixed-method approach will also identity the reach of this ‘Food is Medicine’ intervention on additional household members to inform diabetes prevention efforts.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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