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NCT05689658
Brazilian Diabetes Prevention Program: Pilot Study
Conditions: PreDiabetes, Prediabetic State
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE3
Enrollment: 220
Sponsor: Beneficência Portuguesa de São Paulo
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.
Eligibility Criteria
Inclusion Criteria:Body mass index greater than or equal to 24kg/m2Have one of the following criteria: (CDC criteria for participating in the DPP)Diagnosis of prediabetes orFasting 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) orPreviously diagnosed with gestational diabetes orHigh risk on the CDC prediabetes risk testWith Internet accessWith personal cell phone accessNo prior nutritional monitoring (6 months)Live at least 60 minutes from the survey call centerExclusion Criteria:Diagnosis of Diabetes MellitusIn secondary prevention for cardiovascular diseaseHIV 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 studyRefuse 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 levelPregnant and lactating women
Source: ClinicalTrials.gov (NCT05689658). StuddyBuddy aggregates publicly available trial information.