Brazilian Diabetes Prevention Program: Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brazilian Diabetes Prevention Program: Pilot Study

Conditions
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PreDiabetes, Prediabetic State

Intervention / Treatment
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* Behavioral: Brazilian Diabetes Prevention Program
* Behavioral: Diet


Participation Criteria
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Eligibility Criteria
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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 glucose tolerance test between 140 and 199mg/dl or HbA1c between 5.7 and 6.4% (maximum test 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brazilian Diabetes Prevention Program Group<br>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. | Behavioral: Brazilian Diabetes Prevention Program<br>* A Program structured in 7 visits (in group and individual) to guide the improvement of diet quality, self-care, and practice of physical activity<br>|
| Active Comparator: Diet Group<br>Diet prescription for weight loss | Behavioral: Diet<br>* Hypocaloric diet prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Global DNA Methylation | participants' global DNA methylation using the RRBS method (Reduced Representation Bisulfite Sequencing). | Baseline | 
| weight | to compare mean weight (kg) between groups | 3 months | 
| HbA1c | to compare mean HbA1c(%) between groups | 3 months | 
| Glycemia | to compare mean Glycemia (mg/dL) between groups | 3 months |