Hassan Saria, Sobers Natasha, Paul-Charles Joanne, Herbert Joseph, Dharamraj Kavita, Cruz Elsie, Garcia Enid, Fredericks Lyna, Desai Mayur M, Roy Shireen, Williams Sharon, Linnander Erika, Crusto Cindy, Horowitz Carol R, Arniella Guedy, Cattamanchi Adithya, Adams Oswald P, Nunez-Smith Marcella
Yale School of Medicine, New Haven, CT, USA.
Emory University School of Medicine, Emory Rollins School of Public Health, Atlanta, GA, USA.
Contemp Clin Trials Commun. 2021 Mar 11;22:100750. doi: 10.1016/j.conctc.2021.100750. eCollection 2021 Jun.
Globally, several diabetes prevention interventions have been shown to be cost-effective, yet they have had limited adaptation, implementation, and evaluation in the Caribbean and among Caribbean-descent individuals, where the burden of type 2 diabetes is high. We report on the protocol for the Lifestyle Intervention with Metformin Escalation (LIME) study - an evidence-based diabetes prevention intervention to reduce the incidence of diabetes among Caribbean-descent individuals with prediabetes.
LIME is a hybrid type-I effectiveness-implementation quasi-experimental study taking place in 4 clinical sites in Barbados, Trinidad, the U.S. Virgin Islands, and Puerto Rico. LIME targets individuals who self-identify as Caribbean or Caribbean-descent and have high-risk prediabetes with a hemoglobin A1c (HbA1c) between 6 and 6.4%. Eligible participants in the intervention arm are enrolled in a six-week lifestyle modification workshop. Six months later, individuals who have not lost at least 5% of their bodyweight or continue to have an HbA1c of 6% or higher are prescribed metformin medication. In total, participants are followed for one year. The primary effectiveness outcome is proportion of individuals who lower their HbA1c below 6%.
LIME is a unique diabetes prevention intervention for Caribbean and Caribbean-descent individuals. LIME utilizes a tailored lifestyle change curriculum, incorporates appropriate metformin prescribing when lifestyle change alone is insufficient, targets the highest-risk individuals with prediabetes, and is based in a clinical setting to ensure sustainability.
在全球范围内，多项糖尿病预防干预措施已被证明具有成本效益，但在加勒比地区以及有加勒比血统的人群中，这些措施的适应性、实施和评估却很有限，而在这些地区，2型糖尿病的负担很重。我们报告了“二甲双胍逐步升级生活方式干预（LIME）研究”的方案——这是一项基于证据的糖尿病预防干预措施，旨在降低有糖尿病前期的加勒比血统人群中糖尿病的发病率。
LIME是一项混合型的I类有效性-实施准实验研究，在巴巴多斯、特立尼达、美属维尔京群岛和波多黎各的4个临床地点开展。LIME的目标人群是自我认定为加勒比人或有加勒比血统、且患有高危糖尿病前期（糖化血红蛋白[HbA1c]在6%至6.4%之间）的个体。干预组中符合条件的参与者参加为期六周的生活方式改善工作坊。六个月后，体重未减轻至少5%或糖化血红蛋白仍在6%或更高水平的个体将被处方二甲双胍药物。参与者总共被随访一年。主要有效性结局是糖化血红蛋白降至6%以下的个体比例。
LIME是针对加勒比人和有加勒比血统人群的独特糖尿病预防干预措施。LIME采用量身定制的生活方式改变课程，在单纯生活方式改变不足时纳入适当的二甲双胍处方，针对糖尿病前期风险最高的个体，并且以临床环境为基础以确保可持续性。
