Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04927871
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-02-15
Brief Title:
Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela
Sponsor:
Foundation for Public Health and Epidemiological Research of Venezuela
Organization:
Foundation for Public Health and Epidemiological Research of Venezuela
Study Overview
Official Title:
Hybridized Three Steps HITS Intervention to Prevent Diabetes in Venezuela HITS Diabetes With Prevention An EVESCAM Lifestyle Intervention Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HITS
Brief 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 157 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 kcalday 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 TDRMNTDPP will double the weight loss of those that only receive DPP
Detailed Description:
In Venezuela mortality for cardiovascular disease CVD was responsible for 305 of all deaths increasing by 83 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 300 to 341 metabolic syndrome from 357 to 422 diabetes from 80 to 123 and prediabetes from 144 to 349 Prediabetes increased 242 in a decade from 24 to 7 million of adults estimating that 17 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 23 in the standard care group p 0001 none developed T2D compared with 6 of the crude cumulative incidence of T2D in the standard care group p00515 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 157 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 kcalday 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 107 04 kg and 835 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 TDRMNTDPP 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 714 specificity 654 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 50 kg standard deviation 49 compared with only DPP mean 24 kg standard deviation 19 Using a Beta error of 02 and an Alpha error of 001 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 11 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 US 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 adults population in Venezuela 2 Identification of the topic or researchclinical 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 eg 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 kcalday 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
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 kcalday 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 107 04 kg and 835 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 TDRMNTDPP 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 714 specificity 654 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 50 kg standard deviation 49 compared with only DPP mean 24 kg standard deviation 19 Using a Beta error of 02 and an Alpha error of 001 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 11 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 US 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 adults population in Venezuela 2 Identification of the topic or researchclinical 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 eg 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 kcalday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None