BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study (Implementa-MAC)

Hospital do Coracao

Status: Completed

Conditions: Hypertension; Diabetes; Dyslipidemias; Obesity

Treatments: Other: Training Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05310526

Implementa-MAC

Details and patient eligibility

About

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.

Enrollment: 786 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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786 participants in 2 patient groups

Intervention Group

Experimental group

Description:

1. Distribution of the Brazilian cardioprotective diet manual to primary health care 2. Training to prescribe the cardioprotective Brazilian diet. the training consists of 5 face-to-face modules lasting 4 hours each, in addition to a virtual module and group exercises. 3. Audit feedback

Treatment:

Other: Training Group

Control Group

No Intervention group

Description:

Distribution of the Brazilian cardioprotective diet manual to primary health care professionals