BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of the Brazilian Cardioprotective Diet in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study

Conditions
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Obesity, Hypertension, Diabetes, Dyslipidemias

Intervention / Treatment
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* Other: Training Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-Randomized Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Distribution of the Brazilian cardioprotective diet manual to primary health care 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. Audit feedback | Other: Training Group<br>* Training for prescribing the Brazilian cardioprotective diet<br>|
| No Intervention: Control Group<br>Distribution of the Brazilian cardioprotective diet manual to primary health care professionals | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brazilian cardioprotective diet prescription rate | Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription) | 6 months | 
| food intake of 400g of vegetables per day | Eficacy Primary Outcome - number of patients that achieve the goal of eating 400g of vegetable/day | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementing the extra dietaty guidelines | rate of eligible individuals who received extra dietaty guidelines | 6 months | 
| Professionals' understanding of the Brazilian cardioprotective diet | standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge) | right after intervention and 6 months after intervenions. | 
| Patients' understanding of the Brazilian cardioprotective diet | standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge) | right after intervention and 6 months after intervenions. | 
| Patients' adherence to dietary guidelines | Vigitel dietary indicators | right after intervention and 6 months after intervenions. | 
| Participants' weight | wheight in kg | right after intervention and 6 months after intervenions. | 
| Barriers and facilitators identified in the implementation of the Brasilian Cardioprotective diet in health facilities (situational diagnosis). | Qualitative metodology: Focus groups with stakeholdrs and professionals involved in the implementation processo to identify barriers and facilitators perceived by them | 6 months | 
| Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component) | standardized questionnaire. Dichotomus result (Agree/Disagree with the incorporation) | right after intervention and 6 months after intervenions. |