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BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study (Implementa-MAC)

Primary Purpose

Obesity, Hypertension, Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Training Group
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prefeitura Municipal de Foz do IguaçuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Distribution of the Brazilian cardioprotective diet manual to primary health care 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. Audit feedback

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

Outcomes

Primary Outcome Measures

Brazilian cardioprotective diet prescription rate
Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)
food intake of 400g of vegetables per day
Eficacy Primary Outcome - number of patients that achieve the goal of eating 400g of vegetable/day

Secondary Outcome Measures

Implementing the extra dietaty guidelines
rate of eligible individuals who received extra dietaty guidelines
Professionals' understanding of the Brazilian cardioprotective diet
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
Patients' understanding of the Brazilian cardioprotective diet
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
Patients' adherence to dietary guidelines
Diet Quality index
Patients' adherence to dietary guidelines
rate of adherence to the Brazilian cardioprotective diet
Patients' adherence to dietary guidelines
Vigitel dietary indicators
Patients' adherence to dietary guidelines
Vigitel dietary indicators (400g/d fruits and vegetables and ulptraprocessed foods)
Participants' weight
wheight in kg
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

Full Information

First Posted
March 16, 2022
Last Updated
January 13, 2023
Sponsor
Hospital do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT05310526
Brief Title
BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Acronym
Implementa-MAC
Official Title
Implementation of the Brazilian Cardioprotective Diet in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertension, Diabetes, Dyslipidemias

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-Randomized Trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
960 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Distribution of the Brazilian cardioprotective diet manual to primary health care 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. Audit feedback
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Distribution of the Brazilian cardioprotective diet manual to primary health care professionals
Intervention Type
Other
Intervention Name(s)
Training Group
Intervention Description
Training for prescribing the Brazilian cardioprotective diet
Primary Outcome Measure Information:
Title
Brazilian cardioprotective diet prescription rate
Description
Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)
Time Frame
6 months
Title
food intake of 400g of vegetables per day
Description
Eficacy Primary Outcome - number of patients that achieve the goal of eating 400g of vegetable/day
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Implementing the extra dietaty guidelines
Description
rate of eligible individuals who received extra dietaty guidelines
Time Frame
6 months
Title
Professionals' understanding of the Brazilian cardioprotective diet
Description
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
Time Frame
before randomization, right after intervention, 3 months and 6 months after intervenions.
Title
Patients' understanding of the Brazilian cardioprotective diet
Description
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
Time Frame
3 months and 6 months after intervenions.
Title
Patients' adherence to dietary guidelines
Description
Diet Quality index
Time Frame
3 months and 6 months after intervenions.
Title
Patients' adherence to dietary guidelines
Description
rate of adherence to the Brazilian cardioprotective diet
Time Frame
3 months and 6 months after intervenions.
Title
Patients' adherence to dietary guidelines
Description
Vigitel dietary indicators
Time Frame
3 months and 6 months after intervenions.
Title
Patients' adherence to dietary guidelines
Description
Vigitel dietary indicators (400g/d fruits and vegetables and ulptraprocessed foods)
Time Frame
3 months and 6 months after intervenions.
Title
Participants' weight
Description
wheight in kg
Time Frame
right after intervention, 3 months and 6 months after intervenions.
Title
Barriers and facilitators identified in the implementation of the Brasilian Cardioprotective diet in health facilities (situational diagnosis).
Description
Qualitative metodology: Focus groups with stakeholdrs and professionals involved in the implementation processo to identify barriers and facilitators perceived by them
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Prefeitura Municipal de Foz do Iguaçu
City
Foz do Iguaçu
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Bersch-Ferreira, PhD
Phone
+5511988295600
Email
angelacbferreira@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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