Implementa-MAC: BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group 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
Training for prescribing the Brazilian cardioprotective diet
|
| No Intervention: Control Group Distribution of the Brazilian cardioprotective diet manual to primary health care professionals |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Implementing the extra dietaty guidelines [6 months]
rate of eligible individuals who received extra dietaty guidelines
- Professionals' understanding of the Brazilian cardioprotective diet [before randomization, right after intervention, 3 months and 6 months after intervenions.]
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
- Patients' understanding of the Brazilian cardioprotective diet [3 months and 6 months after intervenions.]
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
- Patients' adherence to dietary guidelines [3 months and 6 months after intervenions.]
Diet Quality index
- Patients' adherence to dietary guidelines [3 months and 6 months after intervenions.]
rate of adherence to the Brazilian cardioprotective diet
- Patients' adherence to dietary guidelines [3 months and 6 months after intervenions.]
Vigitel dietary indicators
- Patients' adherence to dietary guidelines [3 months and 6 months after intervenions.]
Vigitel dietary indicators (400g/d fruits and vegetables and ulptraprocessed foods)
- Participants' weight [right after intervention, 3 months and 6 months after intervenions.]
wheight in kg
- 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
Eligibility Criteria
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:
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Individuals aged ≥20 years of either sex who have a previous medical diagnosis of at least one of the following conditions:
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Type 2 diabetes mellitus;
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Systemic arterial hypertension (Systolic blood pressure ≥140 mmHg or diastolic blood pressure greater than ≥90 mmHg or in drug treatment for hypertension);
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Isolated hypercholesterolemia: isolated increase in LDL-c (LDL-c ≥ 160 mg/dL).
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Isolated hypertriglyceridemia: isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL if the sample is obtained without fasting).
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Obesity or overweight (body mass index ≥25.0 kg/m2).
Exclusion Criteria:
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Prior cardiovascular event (acute myocardial infarction, stroke, peripheral arterial disease);
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Psychiatric or neurocognitive condition that prevents understanding of guidelines (defined by the clinical judgment of the investigators);
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Life expectancy less than 6 months (example: metastatic malignant neoplasm) to be defined by the investigator's judgment;
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Pregnancy or lactation;
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Liver failure with a previous history of encephalopathy or anasarca;
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Chronic renal failure;
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Organ transplantation;
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Gastroplasty for less than a year;
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Impossibility of oral feeding.
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No access to internet or mobile phone.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital do Coracao
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Implementa-MAC