Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela

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.

Conditions

• Obesity
• Overweight
• PreDiabetes
• Diabetes Mellitus, Type 2
• Risk Factor, Cardiovascular

Interventions

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.

BEHAVIORAL

Diabetes Prevention Program

The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 6-months.

Sponsors & Collaborators

• Foundation for Public Health and Epidemiological Research of Venezuela

  lead NETWORK

Principal Investigators

• Juan P Gonzalez-R, MD · Foundation for Public Health and Epidemiological Research of Venezuela

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-16

Primary Completion

2021-11-23

Completion

2022-01-15

Countries

• Venezuela

Study Locations