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Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela (HITS)

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ClinicalTrials.gov Identifier: NCT04927871
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Foundation for Public Health and Epidemiological Research of Venezuela

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 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.

Condition or disease Intervention/treatment Phase
Obesity Overweight PreDiabetes Diabetes Mellitus, Type 2 Risk Factor, Cardiovascular Behavioral: Total Diet Replacement (TDR) Behavioral: Medical Nutritional Therapy (MNT) Behavioral: Diabetes Prevention Program 4 months Behavioral: Diabetes Prevention Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hybridized Three Steps (HITS) Intervention to Prevent Diabetes in Venezuela: HITS Diabetes With Prevention, An EVESCAM Lifestyle Intervention Study
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 15, 2021

Arm Intervention/treatment
Experimental: Hybridized Lyfestile Intervention
The participants will receive three interventions including Total Diet Replacement, Medical Nutrition Therapy, and the Diabetes Prevention Program
Behavioral: Total Diet Replacement (TDR)
The nutritionist will provide a total diet replacement (TDR) with Low-Energy Liquid-Diet (LELD - 811 kcal/day, 64 g protein, 132 g carbohydrate, 6 g fat) and the food reintroduction for two months.

Behavioral: Medical Nutritional Therapy (MNT)
The nutritionist will provide Medical Nutritional Therapy (MNT) using the transcultural Diabetes Nutritional Algorithm (tDNA) Toolkit adapted for Venezuela for four months.

Behavioral: Diabetes Prevention Program 4 months
The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 4-months.

Active Comparator: Only Diabetes Prevention Program
The comparison group will receive only the Diabetes Prevention Program
Behavioral: Diabetes Prevention Program
The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 6-months.




Primary Outcome Measures :
  1. Change of weight in kilograms [ Time Frame: 6 months ]
    The difference of change of weight in kilograms between the arms of the intervention


Secondary Outcome Measures :
  1. Change in the points of Acceptance of the program assessed by a questionnaire using a Likert scale [ Time Frame: 6 months ]
    The level of acceptance of the program will be measured with a questionnaire. Each question will be scored using a Likert scale from 0 to 5 points, where 0 is the worse and 5 is the best result. The change in the points of each question will be compared between arms of intervention.

  2. Change in the points of Appropriateness of the core-curriculum assessed by a questionnaire using a Likert scale [ Time Frame: 6 months ]
    The level of appropriateness of the core-curriculum will be measured with a questionnaire. Each question will be scored using a Likert scale from 0 to 5 points, where 0 is the worse and 5 is the best result. The change in the points of each question will be compared between arms of intervention.

  3. Percentage of Attendance to the program [ Time Frame: 6 months ]
    The percentage of attendance to the program will be calculated as the number of sessions that the participant attended from the total number of sessions. The percentage will be compared between arms of the intervention.

  4. Percentage of Completion of the program. [ Time Frame: 6 months ]
    The completion percentage will be measured as the percentage of participants that finalized the program. The percentage will be compared between arms of intervention.



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults between 20 to 79 years years old
  • No personal history of type 2 diabetes
  • Body mass index ≥ 25 kg/m2
  • High risk for type 2 diabetes

Exclusion Criteria:

  • Chronic ischemic heart disease: acute myocardial infarction, stable angina, unstable angina.
  • Stroke.
  • Use of anticoagulants
  • Severe renal failure
  • Heart failure.
  • Cannot do moderate-intensity physical activity
  • Cannot attend most sessions
  • Pregnancy or plans of having during the next sixth months
  • Cancer or chemotherapy.
  • Use of medications that affect weight (e.g. levothyroxine, pregabalin, orlistat)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927871


Contacts
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Contact: Maria M Infante, MD +584125801131 mariainfante384@gmail.com
Contact: Juan P Gonzalez-R, MD +420735190316 juanpgonzalezr@hotmail.com

Locations
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Venezuela
Maria M. Infante Garcia Recruiting
Caracas, Chacao, Venezuela, 1006
Contact: Maritza Duran, MD       maritzamanueladaniela@gmail.com   
Contact: maria marulanda, MD       mariainesmarulanda@gmail.com   
FISPEVEN Recruiting
Caracas, Chacao, Venezuela, 1060
Contact: Maria M Infante, MD    +584125801131    mariainfante384@gmail.com   
Contact: Ramfis Nieto, MD    +13057933682    nietoramfis@gmail.com   
Principal Investigator: Juan P Gonzalez-R, MD         
Sponsors and Collaborators
Foundation for Public Health and Epidemiological Research of Venezuela
Investigators
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Principal Investigator: Juan P Gonzalez-R, MD Foundation for Public Health and Epidemiological Research of Venezuela
  Study Documents (Full-Text)

Documents provided by Foundation for Public Health and Epidemiological Research of Venezuela:
Study Protocol  [PDF] February 17, 2020

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Responsible Party: Foundation for Public Health and Epidemiological Research of Venezuela
ClinicalTrials.gov Identifier: NCT04927871    
Other Study ID Numbers: FISPEVEN
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight