Clinical trial NCT05310526: BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Official title: Implementation of the Brazilian Cardioprotective Diet in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Diabetes
Dyslipidemias
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 786
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brazilian cardioprotective diet prescription rate
timeFrame: 6 months
measure: food intake of 400g of vegetables per day
timeFrame: 6 months
Secondary outcomes:
measure: Implementing the extra dietaty guidelines
timeFrame: 6 months
measure: Professionals' understanding of the Brazilian cardioprotective diet
timeFrame: right after intervention and 6 months after intervenions.
measure: Patients' understanding of the Brazilian cardioprotective diet
timeFrame: right after intervention and 6 months after intervenions.
measure: Patients' adherence to dietary guidelines
timeFrame: right after intervention and 6 months after intervenions.
measure: Participants' weight
timeFrame: right after intervention and 6 months after intervenions.
measure: Barriers and facilitators identified in the implementation of the Brasilian Cardioprotective diet in health facilities (situational diagnosis).
timeFrame: 6 months
measure: Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component)
timeFrame: right after intervention and 6 months after intervenions.
Other outcomes:
Locations:
city: Foz do Iguaçu
country: Brazil
facility: Prefeitura Municipal de Foz do Iguaçu
Study officials:
References: