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

NCT05310526 | Completed

• 1 other identifier: Implementa-MAC
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Brazilian cardioprotective diet prescription rate

  Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)

  6 months

• 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 Outcomes (7)

• Implementing the extra dietaty guidelines

  6 months

• Professionals' understanding of the Brazilian cardioprotective diet

  right after intervention and 6 months after intervenions.

• Patients' understanding of the Brazilian cardioprotective diet

  right after intervention and 6 months after intervenions.

• Patients' adherence to dietary guidelines

  right after intervention and 6 months after intervenions.

• Participants' weight

  right after intervention and 6 months after intervenions.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Training Group

Control Group

NO INTERVENTION

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

Interventions

Training Group OTHER

Training for prescribing the Brazilian cardioprotective diet

Intervention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Prefeitura Municipal de Foz do Iguaçu

Foz do Iguaçu, Brazil

Location

MeSH Terms

Conditions

Obesity; Hypertension; Diabetes Mellitus; Dyslipidemias

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-Randomized Trial

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 5, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 19, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

BR (1)