Hybridized Three Steps (HITS) Intervention to Prevent Diabetes in Venezuela: HITS Diabetes With Prevention, An EVESCAM Lifestyle Intervention Study

In Venezuela, mortality for cardiovascular disease (CVD) was responsible for 30.5% of all deaths, increasing by 8.3% since 2007 to 2017. The prevalence of cardiometabolic risk factors in the country is also increasing. The investigators led two cross-sectional surveys in Venezuela, the VEMSOLS, evaluating 1320 adults between 2006 to 2010, and the EVESCAM, a national representative sample of 3420 adults, from 2014 to 20178, and the change of cardiometabolic risk factors prevalence was hypertension from 30.0% to 34.1%, metabolic syndrome from 35.7% to 42.2%, diabetes from 8.0% to 12.3%, and prediabetes from 14.4% to 34.9%. Prediabetes increased 242% in a decade, from 2.4 to 7 million of adults, estimating that 1.7 million of adults could advance to type 2 diabetes (T2D) in the next 3 to 5 years The American Diabetes Association recommends implementing the Diabetes Prevention Program (DPP) in subjects with prediabetes. This program aims weight reduction increasing physical activity and healthy eating. In controlled settings, DPP has consistently proved to reduce T2D incidence by 58%, with long term benefits. However, to translate this effectiveness to primary care settings is a major challenge. In Latin America, two studies on T2D prevention were done at the same time, funded by an International Diabetes Federation (IDF) initiative, with contradictory results. In Venezuela, Florez et al. implemented a Randomized Controlled Trial (RCT) using the US-DPP version, with a multidisciplinary team, on 140 adults with prediabetes and overweight, to receive standard care vs. lifestyle intervention (LSI), during two-years. LSI group lost more than 10% of basal weight compared with 2.3% in the standard care group (p< 0.001), none developed T2D compared with 6% of the crude cumulative incidence of T2D in the standard care group (p<0.05)15, and lipid profile and cardiovascular health score also improved. Contrarily, in Colombia, Barengo et al implemented the Finnish Diabetes Prevention Study (DPS) in primary health care centers, provided by specialists in physical activity and nutritionists on 772 adults with prediabetes, randomly assigned to LSI vs. standard care during two-years. Metabolic components, reversion to normoglycemia and T2D incidence were similar between groups. A meta-analysis of 36 pragmatic clinical trials of diabetes prevention programs in primary care settings showed a reduction in T2D incidence by 26%, less than half than the original studies (58%). In these studies LSI only showed a pooled mean weight loss 1.57 kg higher than standard care, demonstrating the large difficulties to reduce the weight of participants at community levels.

The team is leading in Venezuela a transculturalization process incorporating multiple validated components to significantly improve the effectiveness of preventive medicine initiatives for T2D, and by extension, positively impact T2D incidence, prevalence, quality of life, and health care costs.

To prevent T2D effectively, LSI programs need to induce weight loss. In the DPP, weight reduction was the main predictor of a lower incidence of T2D, each kilogram lost was related with 16% lower incidence. Total diet replacement (TDR) with low-energy liquid-diet or solid diet (825-853 kcal/day) is an effective strategy to reduce weight. In the PREVIEW study, 2224 participants with prediabetes and obesity received a low energy diet during 8-week and presented a mean weight loss of 10.7 ± 0.4 kg, and 83.5% achieved the target of ≥8% weight reduction, and expected incidence of T2D at three-year was only 4%, independent on the intervention used post-weight-loss. However, the effectiveness of intervention including an initial rapid weight loss in primary care levels in Venezuela is ignored. In order to improve the effectiveness of T2D prevention programs the following objectives are proposed:

1. To compare the weight loss achieved with two LSI programs in a community health center of Venezuela: a) A hybrid LSI including rapid weight loss with total diet replacement (TDR), followed by medical nutrition therapy (MNT), and the DPP protocol, vs b) only the DPP.
2. To compare the change of cardiometabolic risk factors between groups.
3. To evaluate the implementation process.

The hypothesis is: after six months of intervention, subjects receiving a hybridized LSI (TDR+MNT+DPP) will double the weight loss of those that only receive DPP (This is based on the pilot study - see below). If this outcome is achieved, it will have an enormous impact in the way that the DPP should be provided in the primary health care systems in developing countries, increasing the effectiveness of weight reduction, and in consequence, improving cardiovascular health.