Status:
COMPLETED
BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Lead Sponsor:
Hospital do Coracao
Conditions:
Obesity
Hypertension
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This is an implementation type II hybrid study with randomisation in cluster, whose objective is to compare two strategies of implementation of the Brazilian cardioprotective diet guidelines in primar...
Eligibility Criteria
Inclusion
- Clusters Inclusion criteria: All Public Primary Care Units from both cities will be included. However, the Health services that encourage health professionals to use the Cardioprotective Food manual before randomization will be excluded.
- Participants (patients) Inclusion criteria:
- Individuals aged ≥20 years of either sex who have a previous medical diagnosis of at least one of the following conditions:
- Type 2 diabetes mellitus;
- Systemic arterial hypertension (Systolic blood pressure ≥140 mmHg or diastolic blood pressure greater than ≥90 mmHg or in drug treatment for hypertension);
- Isolated hypercholesterolemia: isolated increase in LDL-c (LDL-c ≥ 160 mg/dL).
- Isolated hypertriglyceridemia: isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL if the sample is obtained without fasting).
- Obesity or overweight (body mass index ≥25.0 kg/m2).
- Exclusion Criteria:
- Prior cardiovascular event (acute myocardial infarction, stroke, peripheral arterial disease);
- Psychiatric or neurocognitive condition that prevents understanding of guidelines (defined by the clinical judgment of the investigators);
- Life expectancy less than 6 months (example: metastatic malignant neoplasm) to be defined by the investigator's judgment;
- Pregnancy or lactation;
- Liver failure with a previous history of encephalopathy or anasarca;
- Chronic renal failure;
- Organ transplantation;
- Gastroplasty for less than a year;
- Impossibility of oral feeding.
- No access to internet or mobile phone.
Exclusion
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
786 Patients enrolled
Trial Details
Trial ID
NCT05310526
Start Date
November 1 2022
End Date
December 19 2023
Last Update
December 26 2023
Active Locations (1)
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1
Prefeitura Municipal de Foz do Iguaçu
Foz do Iguaçu, Brazil