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Completed

NCT Number: NCT05310526

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training group

Other

Training for prescribing the Brazilian cardioprotective diet

Primary outcomes

  1. Brazilian cardioprotective diet prescription rate

    Time frame: 6 months

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

  2. food intake of 400g of vegetables per day

    Time frame: 6 months

    Eficacy Primary Outcome - number of patients that achieve the goal of eating 400g of vegetable/day

Secondary outcomes

  1. Implementing the extra dietaty guidelines

    Time frame: 6 months

    rate of eligible individuals who received extra dietaty guidelines

  2. Professionals' understanding of the Brazilian cardioprotective diet

    Time frame: right after intervention and 6 months after intervenions.

    standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)

  3. Patients' understanding of the Brazilian cardioprotective diet

    Time frame: right after intervention and 6 months after intervenions.

    standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)

  4. Patients' adherence to dietary guidelines

    Time frame: right after intervention and 6 months after intervenions.

    Vigitel dietary indicators

  5. Participants' weight

    Time frame: right after intervention and 6 months after intervenions.

    wheight in kg

  6. Barriers and facilitators identified in the implementation of the Brasilian Cardioprotective diet in health facilities (situational diagnosis).

    Time frame: 6 months

    Qualitative metodology: Focus groups with stakeholdrs and professionals involved in the implementation processo to identify barriers and facilitators perceived by them

  7. Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component)

    Time frame: right after intervention and 6 months after intervenions.

    standardized questionnaire. Dichotomus result (Agree/Disagree with the incorporation)

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Acronym: Implementa-MAC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2022
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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