Implementation of the Brazilian Cardioprotective Diet in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 786
- 试验地点
- 1
- 主要终点
- Brazilian cardioprotective diet prescription rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Brazilian cardioprotective diet prescription rate
时间窗: 6 months
Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)
food intake of 400g of vegetables per day
时间窗: 6 months
Eficacy Primary Outcome - number of patients that achieve the goal of eating 400g of vegetable/day
次要结局
- Professionals' understanding of the Brazilian cardioprotective diet(right after intervention and 6 months after intervenions.)
- Implementing the extra dietaty guidelines(6 months)
- Patients' understanding of the Brazilian cardioprotective diet(right after intervention and 6 months after intervenions.)
- Participants' weight(right after intervention and 6 months after intervenions.)
- Patients' adherence to dietary guidelines(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).(6 months)
- Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component)(right after intervention and 6 months after intervenions.)