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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brazilian Diabetes Prevention Program Group | Experimental | 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. |
|
| Diet Group | Active Comparator | Diet prescription for weight loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brazilian Diabetes Prevention Program | Behavioral | A Program structured in 7 visits (in group and individual) to guide the improvement of diet quality, self-care, and practice of physical activity |
| 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 |
| 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 |
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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)
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Professor Edgard Santos - HUPES | Salvador | Estado de Bahia | Brazil | |||
| Hospital de Clínicas de Goiania |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Diet | Behavioral | Hypocaloric diet prescription |
|
| 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 and 3 months |
| 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 |
| Goiânia |
| Goiás |
| Brazil |
| Universidade Federal de Viçosa | Viçosa | Minas Gerais | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Universidade Federal do Tocantins | Palmas | Tocantins | Brazil |
| D004700 | Endocrine System Diseases |