BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
- Conditions
- HypertensionDiabetesObesityDyslipidemias
- Interventions
- Other: Training Group
- Registration Number
- NCT05310526
- Lead Sponsor
- Hospital do Coracao
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 786
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Training Group 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Implementing the extra dietaty guidelines 6 months rate of eligible individuals who received extra dietaty guidelines
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)
Participants' weight right after intervention and 6 months after intervenions. wheight in kg
Patients' adherence to dietary guidelines right after intervention and 6 months after intervenions. Vigitel dietary indicators
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)
Trial Locations
- Locations (1)
Prefeitura Municipal de Foz do Iguaçu
🇧🇷Foz do Iguaçu, Brazil