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

Obesity Clinical Trial

— Implementa-MAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310526
• Other study ID #: Implementa-MAC
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: December 2023
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 786
• Est. completion date: December 19, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Dyslipidemias
• Hypertension
• Obesity

Intervention

Other:
• Training Group
Training for prescribing the Brazilian cardioprotective diet

Locations

Country	Name	City	State
Brazil	Prefeitura Municipal de Foz do Iguaçu	Foz do Iguaçu

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brazilian cardioprotective diet prescription rate	Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)	6 months
Primary	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	Implementing the extra dietaty guidelines	rate of eligible individuals who received extra dietaty guidelines	6 months
Secondary	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.
Secondary	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.
Secondary	Patients' adherence to dietary guidelines	Vigitel dietary indicators	right after intervention and 6 months after intervenions.
Secondary	Participants' weight	wheight in kg	right after intervention and 6 months after intervenions.
Secondary	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
Secondary	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.