Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia)

Beneficência Portuguesa de São Paulo

Status: Completed

Conditions: Prediabetic State; PreDiabetes

Treatments: Behavioral: Brazilian Diabetes Prevention Program; Behavioral: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05689658

PROVEN-Dia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

  1. Diagnosis of prediabetes or
  2. Fasting blood glucose between 100-125mg/dl or blood glucose 2h after oral glucose tolerance test between 140 and 199mg/dl or HbA1c between 5.7 and 6.4% (maximum test date: last 3 months) or
  3. Previously diagnosed with gestational diabetes or
  4. 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 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 ml of blood)
• Presence of illnesses that could seriously reduce your life expectancy or your ability to 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 the primary outcome of this research, such as diet quality and physical activity level
• Pregnant and lactating women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Brazilian Diabetes Prevention Program Group

Experimental group

Description:

The program will be based on the American Diabetes Prevention Program (DPP), whose published results are used as a reference for prediabetic care patients in the Brazilian Diabetes Guideline. In order to reach the weight loss goal estimated at 0.5 to 1 Kg per week and 150 minutes of moderate physical activity per week, the program will offer individual and group visits, qualitative guidelines for improving diet, lifestyle and self-care.

Treatment:

Behavioral: Brazilian Diabetes Prevention Program

Diet Group

Active Comparator group

Description:

Diet prescription for weight loss

Treatment:

Behavioral: Diet