ObesityImplementa-MACNCT05310526
BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
A study testing Training Group in people with Obesity and Hypertension, run by Hospital do Coracao at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity, Hypertension, Diabetes
- What is being tested?
- Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2022to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
Show all 10Show fewer
- Organ transplantation;
- Gastroplasty for less than a year;
- Impossibility of oral feeding.
- No access to internet or mobile phone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of the Brazilian Cardioprotective Diet 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.
- Conditions
- Obesity, Hypertension, Diabetes, Dyslipidemias
- Being tested
- Training Group
- Medical subject headings
- Obesity, Hypertension, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training GroupOther
Training for prescribing the Brazilian cardioprotective diet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Training Group |
| Control Group | No intervention | Distribution of the Brazilian cardioprotective diet manual to primary health care professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brazilian cardioprotective diet prescription rate
Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)
Measured: 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
Measured: 6 months
Secondary outcomes (7)
Implementing the extra dietaty guidelines
rate of eligible individuals who received extra dietaty guidelines
Measured: 6 months
Professionals' understanding of the Brazilian cardioprotective diet
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
Measured: right after intervention and 6 months after intervenions.
Patients' understanding of the Brazilian cardioprotective diet
standardized questionnaire. Continuous result (number of correct answers) and dichotomous (good knowledge / poor knowledge)
Measured: right after intervention and 6 months after intervenions.
Patients' adherence to dietary guidelines
Vigitel dietary indicators
Measured: right after intervention and 6 months after intervenions.
Participants' weight
wheight in kg
Measured: right after intervention and 6 months after intervenions.
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
Measured: 6 months
Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component)
standardized questionnaire. Dichotomus result (Agree/Disagree with the incorporation)
Measured: right after intervention and 6 months after intervenions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Nov 2022
- Primary completion30 Nov 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-Randomized Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310526
- Sponsor's protocol ID
- Implementa-MAC
- Acronym
- Implementa-MAC
- Status last verified
- Dec 2023
- First submitted
- 16 Mar 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Brazilian Cardioprotective Diet in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
- ClinicalTrials.gov ID
- NCT05310526
- Acronym / sponsor ID
- Implementa-MAC / Implementa-MAC
- Conditions
- Obesity, Hypertension, Diabetes, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Training Group1. 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 |
| Control Group | No intervention | –Distribution of the Brazilian cardioprotective diet manual to primary health care professionals |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training GroupTraining for prescribing the Brazilian cardioprotective diet | Other | Intervention Group |
Primary outcome
Brazilian cardioprotective diet prescription rate
Time frame: 6 months
Implementation Primary Outcome (rate of eligible individuals who received Brazilian cardioprotective diet prescription)
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
7 secondary outcomes
Implementing the extra dietaty guidelines
Time frame: 6 months
Professionals' understanding of the Brazilian cardioprotective diet
Time frame: right after intervention and 6 months after intervenions.
Patients' understanding of the Brazilian cardioprotective diet
Time frame: right after intervention and 6 months after intervenions.
Patients' adherence to dietary guidelines
Time frame: right after intervention and 6 months after intervenions.
Participants' weight
Time frame: right after intervention and 6 months after intervenions.
Barriers and facilitators identified in the implementation of the Brasilian Cardioprotective diet in health facilities (situational diagnosis).
Time frame: 6 months
Professionals' perception regarding the incorporation of MAC guidelines into practice (implementation component)
Time frame: right after intervention and 6 months after intervenions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Group in people with Obesity and Hypertension, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brazilian cardioprotective diet prescription rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.