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

NCT ID: NCT05310526

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 786 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-12-19

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.

Conditions

Obesity; Hypertension; Diabetes; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Intervention 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

Group Type: EXPERIMENTAL

Training Group

Intervention Type: OTHER

Training for prescribing the Brazilian cardioprotective diet

Control Group

Distribution of the Brazilian cardioprotective diet manual to primary health care professionals

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training Group

Training for prescribing the Brazilian cardioprotective diet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prefeitura Municipal de Foz do Iguaçu

Foz do Iguaçu, , Brazil

Countries

Brazil

Other Identifiers

Implementa-MAC

Identifier Type: -

Identifier Source: org_study_id