Brazilian Diabetes Prevention Program: Pilot Study

PreDiabetes Clinical Trial

— PROVEN-Dia  

Official title:

Brazilian Diabetes Prevention Program: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689658
• Other study ID #: PROVEN-Dia
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Beneficência Portuguesa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 31, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Brazilian Diabetes Prevention Program
A Program structured in 7 visits (in group and individual) to guide the improvement of diet quality, self-care, and practice of physical activity
• Diet
Hypocaloric diet prescription

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Goiania	Goiânia	Goias
Brazil	Universidade Federal do Tocantins	Palmas	Tocantins
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Universitário Professor Edgard Santos - HUPES	Salvador	Bahia
Brazil	Universidade Federal de Viçosa	Viçosa	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Beneficência Portuguesa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of diet	to compare mean score of Brazilian Cardioprotective Nutritional Program dietary index (BALANCE DI) between groups. the index has a score from 0 to 40, with a high score indicating adherence to a healthy diet (BALANCE).	3 months
Primary	Minutes of Moderate Physical activity	to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups	3 months
Secondary	Implementation Barriers and Facilitators	Identification of Barriers and Facilitators of Program implementation from a qualitative analysis approach. This is not a score on a scale. For the qualitative data, thematic content analysis will be performed with the transcription of the focus groups. This analysis will serve to describe and understand perceptions, interpretations and beliefs from the perspective of managers and professionals about the intervention. The thematic nuclei will be defined a posteriori according to the references of models and implementation frameworks also used for the realization of the focus groups	3 months
Secondary	Moderate or vigorous physical activity (according to IPAQ-short)	to compare proportion of individuals who perform at the end of the follow-up moderate or vigorous physical activity	3 months
Secondary	Cardioprotective diet adherence	to compare adherence to a healthy and cardioprotective diet based on the Cardiovascular Health Diet Index (CHDI) between groups. The CHDI had 11 components and a total score ranging from 0 to 110 points. the higher the score, the greater adherence to a healthy and cardioprotective diet	3 months
Secondary	Global DNA Methylation	participants' global DNA methylation using the RRBS method (Reduced Representation Bisulfite Sequencing).	Baseline and 3 months
Secondary	weight	to compare mean weight (kg) between groups	3 months
Secondary	HbA1c	to compare mean HbA1c(%) between groups	3 months
Secondary	Glycemia	to compare mean Glycemia (mg/dL) between groups	3 months