Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2023-03-15
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Brazilian Diabetes Prevention Program Group
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.
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 Group
Diet prescription for weight loss
Diet
Hypocaloric diet prescription
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Beneficência Portuguesa de São Paulo
OTHER
Responsible Party
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Locations
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Hospital Universitário Professor Edgard Santos - HUPES
Salvador, Estado de Bahia, Brazil
Hospital de Clínicas de Goiania
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
Countries
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Other Identifiers
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PROVEN-Dia
Identifier Type: -
Identifier Source: org_study_id
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