Diabetes, Dyslipidemias, Hypertension, Obesity
Conditions
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.
Interventions
OTHERTraining Group
Training for prescribing the Brazilian cardioprotective diet
Sponsors
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Cluster-Randomized Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brazilian cardioprotective diet prescription rate | 6 months | Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription) |
| food intake of 400g of vegetables per day | 6 months | Eficacy Primary Outcome - number of patients that achieve the goal of eating 400g of vegetable/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' understanding of the Brazilian cardioprotective diet | right after intervention and 6 months after intervenions. | standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge) |
| Patients' adherence to dietary guidelines | right after intervention and 6 months after intervenions. | Vigitel dietary indicators |
| Implementing the extra dietaty guidelines | 6 months | rate of eligible individuals who received extra dietaty guidelines |
| Barriers and facilitators identified in the implementation of the Brasilian Cardioprotective diet in health facilities (situational diagnosis). | 6 months | Qualitative metodology: Focus groups with stakeholdrs and professionals involved in the implementation processo to identify barriers and facilitators perceived by them |
| Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component) | right after intervention and 6 months after intervenions. | standardized questionnaire. Dichotomus result (Agree/Disagree with the incorporation) |
| Participants' weight | right after intervention and 6 months after intervenions. | wheight in kg |
| Professionals' understanding of the Brazilian cardioprotective diet | right after intervention and 6 months after intervenions. | standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge) |
Countries
Brazil
Outcome results
None listed