Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela

NACompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

November 16, 2020

Primary Completion Date

November 23, 2021

Study Completion Date

January 15, 2022

Conditions
ObesityOverweightPreDiabetesDiabetes Mellitus, Type 2Risk 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.

Trial Locations (2)

1006

Maria M. Infante Garcia, Caracas

1060

FISPEVEN, Caracas

All Listed Sponsors
lead

Foundation for Public Health and Epidemiological Research of Venezuela

NETWORK

NCT04927871 - Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela | Biotech Hunter | Biotech Hunter