NCT05310526Completed
BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Implementation of the Brazilian Cardioprotective Diet in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Source: ClinicalTrials.gov · Last updated 26 Dec 2023
Brief summary (registry, in English)
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 primary health care in two Brazilian cities. All health professionals from the health units (clusters) randomized to the intervention group will receive training on the subject. The health professionals from the health units randomized to the control group will follow the usual activities, receiving only the printed guidelines, as usually done. After 6 months, the prescription rate of the Brazilian cardioprotective diet will be evaluated, as well as the quality of the diet of patients in both groups.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 786 (actual)
- First submitted
- 16 Mar 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Hospital do Coracao
- Diseases
- Obesity, High blood pressure, Type 2 diabetes
- NCT number
- NCT05310526
What you commit to
- Study type: Interventional
- Participants enrolled: 786
- From 1 Nov 2022 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior cardiovascular event (acute myocardial infarction, stroke, peripheral arterial disease);
- Liver failure with a previous history of encephalopathy or anasarca;
- Organ transplantation;
Other illness
- 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;
- Chronic renal failure;
Other
- Pregnancy or lactation;
- Gastroplasty for less than a year;
- Impossibility of oral feeding.
- No access to internet or mobile phone.
Criteria the registry did not label
- 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).
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prefeitura Municipal de Foz do Iguaçu Coordinator of this site? Confirm its status | Foz do Iguaçu | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.