Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04927871 |
| Other study ID # |
FISPEVEN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2020 |
| Est. completion date |
January 15, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Foundation for Public Health and Epidemiological Research of Venezuela |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The American Diabetes Association recommends implementing the Diabetes Prevention Program
(DPP) in subjects with prediabetes. In the DPP, weight reduction was the main predictor of a
lower incidence of type 2 diabetes (T2D), each kilogram lost was related with 16% lower
incidence. However, the effectiveness of the DPP in primary care settings is lower than the
original study. A meta-analysis of 36 pragmatic clinical trials of DPP in primary care
settings showed a reduction in T2D incidence by 26%, less than half than the original study
(58%), with a pooled mean weight loss 1.57 kg higher than standard care, demonstrating the
large difficulties to reduce weight of participants at community levels. Total diet
replacement (TDR) with low-energy liquid-diet or solid diet (825-853 kcal/day) is an
effective strategy to reduce weight. The effectiveness of an intervention including initial
rapid weight loss before starting the DPP is ignored in primary care levels in Venezuela. We
aim: 1- To compare the weight loss achieved of two lifestyle intervention programs in a
community health center of Venezuela: a) A hybrid lifestyle including rapid weight loss with
total diet replacement (TDR), then medical nutrition therapy (MNT), and the DPP, VS b) only
the DPP; 2- To evaluate the change of cardiometabolic risk factors between groups; 3- To
evaluate the implementation process. Our hypothesis is: after six months of intervention,
subjects receiving a hybridized lifestyle (TDR+MNT+DPP) will double the weight loss of those
that only receive DPP.
Description:
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.
Approach Design: A pragmatic mix trial was designed with two groups a) subjects receiving a
hybridized LSI (TDR-MNT-DPP) and b) only DPP.
Sampling: Community members will be invited to a medical screening at the community health
care center. Those with high risk will be identified using the Latin America Finish Diabetes
Risk Score (LA-FINRISC). The LA-FINDRISC is a non-invasive tool that includes age, body mass
index (BMI), waist circumference, physical activity, daily consumption of fruits and
vegetables, history of hyperglycemia, history of antihypertensive drug treatment, and family
history of diabetes, assigning a score ranging from 0 to 26 points. In Venezuelan adults, 9
points are the best score (sensitivity 71.4% + specificity 65.4%) to detect subjects with
impaired glucose tolerance. Those with an LA-FINDRISC ≥ 10 points and having the inclusion
criteria will be invited to laboratory test and medical evaluation and those with laboratory
criteria will be invited to participate.
Sample Size: The formula to compare two mean was used. Based on preliminary results of the
pilot study, the aim was to detect a two-fold reduction of weight loss in the intensive group
(mean = 5.0 kg, standard deviation = 4.9) compared with only DPP (mean = 2.4 kg, standard
deviation = 1.9). Using a Beta error of 0.2 and an Alpha error of 0.01, the sample size
required for each group is 50, and assuming a 20% of the loss to follow up (based on the
pilot study), and a 30% additional to ensure representativeness of the sample and power, the
sample size will be incremented to 78 participants in each group, total sample size of 156
participants.
Randomization: Eligible participants will be randomly assigned to hybridized LSI or only DPP
with 1:1 allocation.
Implementation:
Diabetes Prevention Program: The DPP Group Lifestyle Balance (GLB) core curriculum content
modified from the original DPP is available online, in both English and Spanish. Despite the
intent of facilitating T2D care for the U.S. Hispanic population, the advantage of the
Spanish language version, and the robust and general recommendations in which the DPP GLB
program is based, this effort was not a true transculturalization process. Important
differences among various ethnocultural co-populations and environments were not addressed.
For example, in Venezuela, there are unique culinary customs: units of measure during food
preparation, types of whole foods in their natural form, and recipes with foods that are not
easily available. In addition, recommendations of physical activities must be feasible for a
certain population based on religious customs, social norms, the built environment, climate
and terrain, and socioeconomic constraints; even, there are food patterns and behaviors
regionally different in the same country.
The tDNA process was implemented in the following steps to undertake the transcultural
adaptation of the DPP content: 1) Identification target population: adult's population in
Venezuela. 2) Identification of the topic or research/clinical question: One out three adults
in Venezuela has prediabetes. Evidence-based solutions are required to reduce diabetes burden
in Venezuela. 3) Team of experts in the source (DPP) and target population (Venezuelan
culture): A group of Venezuelan experts composed by four diabetologists, one primary care
physician, and two community members trained and certificate by this team to provide T2D
prevention programs implemented the adaptive content of the DPP GLB program. 4)
Identification and resolution of cultural nodes using a framework: The DPP content was
organized with the Ecological Validity Model (EVM). Using an interactive process each
discrepancy between the content and cultural or local costumes were identified and modified
in base to the EVM framework (e.g. recipes were adapted to the current socio-economic moment
of the country). Finally, T2D prevention curriculum content was culturally adapted to
Venezuelan adults avoiding any incongruence with the original version. Healthy options, goal
settings, and problem-solving were consistent attributes of the culturally adapted program.
Details of this transcultural adaptation will be published soon. This content was used in the
pilot study.
Low-Energy Liquid-Diet (LELD): LELD, structured food reintroduction, and then a weight-loss
maintenance program have demonstrated being a feasible and acceptable strategy to lose and
maintain weight during 12 months. A "home-made" milk- and fruit-juice-based diet (811
kcal/day, 64 g protein, 132 g carbohydrate, 6 g fat) will be recommended. Recipes and
preparation techniques were transculturally adapted to the population using local available
low-cost foods in Venezuela. A pilot study assessing acceptability, appropriateness, and
feasibility of this LELD strategy in Venezuelan adults with obesity is ongoing.
