Brazilian Diabetes Prevention Program: Pilot Study

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Brazilian Diabetes Prevention Program

Diet

Clinical Study ID

NCT05689658

PROVEN-Dia

Ages 18-65
All Genders

Study Summary

To structure a Brazilian Diabetes Prevention Program based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS) and evaluating its effectiveness in a multicentric randomized clinical trial with 220 pre-diabetic patients and a follow up of 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Body mass index greater than or equal to 24kg/m2
Have one of the following criteria: (CDC criteria for participating in the DPP)

Diagnosis of prediabetes or
Fasting blood glucose between 100-125mg/dl or blood glucose 2h after oral glucosetolerance test between 140 and 199mg/dl or HbA1c between 5.7 and 6.4% (maximumtest date: last 3 months) or
Previously diagnosed with gestational diabetes or
High risk on the CDC prediabetes risk test

With Internet access
With personal cell phone access
No prior nutritional monitoring (6 months)
Live at least 60 minutes from the survey call center

Exclusion

Exclusion Criteria:

Diagnosis of Diabetes Mellitus
In secondary prevention for cardiovascular disease
HIV patient with detectable viral load (amount of virus greater than 40 copies per mlof blood)
Presence of illnesses that could seriously reduce your life expectancy or your abilityto participate in the study
Refuse to participate in the study (signing the Free and Informed Consent Form)
Participation in another Randomized Clinical Trial whose objective interferes with theprimary outcome of this research, such as diet quality and physical activity level
Pregnant and lactating women

Study Design

Brazilian Diabetes Prevention Program

March 15, 2023

October 31, 2023

Study Description

This is a multicentric randomized clinical study coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).

The study's objective is the Brazilian Diabetes Prevention Program development based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS).

The program will not include a multidisciplinary orientation, but the prescription will have a multi-professional vision. The objective is to bring the multi-team together to discuss different aspects of the same intervention, such as accessibility, motivation, contexts, and needs, so that the program, to be guided by the nutritionist, can also be recognized and supported by the other teammates.

Once the program is defined, the research teams from the collaborating centers will be trained and qualified. 220 individuals with pre-diabetes will be included in the study and followed for 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.

Connect with a study center

Hospital Universitário Professor Edgard Santos - HUPES
Salvador, Bahia
Brazil
Site Not Available
Hospital de Clínicas de Goiania
Goiânia, Goias
Brazil
Site Not Available
Universidade Federal de Viçosa
Viçosa, Minas Gerais
Brazil
Site Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul
Brazil
Site Not Available
Universidade Federal do Tocantins
Palmas, Tocantins
Brazil
Site Not Available

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