Diabetes Mellitus, Type 2NCT05598203
Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes
A study testing Operative group of nutrition education in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
Every year there is an increase in people with diabetes all over the world. Because it is a disease associated with several comorbidities and is increasing, there is a need for more effective treatments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Operative group of nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesBrazil
- Study dates
- 6 Sep 2022to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with a previous diagnosis of type 2 diabetes mellitus
Who cannot join
- Patients with other types of diabetes
- With HbA1C within the therapeutic target or with values greater than 12%
- Severe neuropathy
- Chronic kidney disease [glomerular filtration rate <30mL/min/1.73m²]
- Life expectancy <6 months
- Chemical dependence/alcoholism or use of antipsychotics
Show all 12Show fewer
- Autoimmune disease or chronic steroid use
- Gastroparesis
- Pregnant or lactating women
- Patients who have had an Episode of Acute Coronary Syndrome (ACS) in the last 60 days
- Wheelchair users
- Cognitive, neurological or psychiatric condition
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
Jussara C De Almeida, PhD, +555133598410, jcalmeida@hcpa.edu.br
- Recruiting
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035003
Jussara C De Almeida, PhD, +555133598410, jcalmeida@hcpa.edu.br
About this study
Official title: Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial
Every year there is an increase in people with diabetes all over the world. Because it is a disease associated with several comorbidities and is increasing, there is a need for more effective treatments. Lifestyle changes combined with medication are the best strategies for the treatment and reduction of comorbidities. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes. A randomized clinical trial will be conducted with adult patients with a previous diagnosis of type 2 diabetes. Patients will be divided into two groups (intervention: nutritional education added the usual care; and control: usual care). The outcomes analyzed will be: glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations.
Read the detailed description
The estimate of patients with diabetes increases every year and for their treatment, a change in lifestyle is essential, so there is a need to seek strategies that increase patient adherence in the long term. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes.
An open randomized clinical trial will be performed. Patients = patients with type 2 DM; Intervention = food (nutritional) education based on operative groups added the usual care; Control = usual care; Outcome/Outcomes = glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations. In order to detect a mean difference of 0.59 in HbA1c between patients randomized to the intervention (patient-centered group) and those in the control group (traditional education intervention), with a standard deviation of 1.39%, a type I error of 5%, and a type II error of 20%, a total of 88 patients in each group were deemed necessary (1:1 ratio at randomization, n= 176). Considering a dropout rate of 30% over the long term (12 months), it will be essential to include a total of 252 participants.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Operative group of nutrition education
- Keywords
- Glycated Hemoglobin A, Food and Nutrition Education, Feeding Behavior, Diabetes Complications, Body Mass Index, Lipids, Blood Pressure, Outcome Assessment, Health Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Feeding Behavior, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative group of nutrition educationBehavioural
The intervention will be carried out with operational nutritional education groups. Four meetings will be held, each meeting lasting one hour, weekly or fortnightly (according to the availability of the patient). The following foods proposed foods: Meeting 1 = education on classification labels and proposed foods proposed foods (education on classification labels and substitution of Brazilian foods), in this guide meeting the proposal is processed or ultra-processed by an in natura food or minimally processed; Meeting 2 = assembly of the healthy dish (food portions, food index and glycemic load, food clothes), the proposal in this meeting is the assembly of the complete dish in the meals eaten throughout the day; and Encounter 3 = hunger and satiety (aiming to increase the perception of hunger and satiety signals), encounter as a task to be accomplished; Encounter 4 = strengthening change, barriers and difficulties in maintaining habits based on the transtheoretical model of change.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive four group meetings in addition to the usual care, specifically in the form of operative groups. Participants in these groups will actively participate in the sessions and will be given tasks to complete at home. There will be four sessions, which can be held weekly, fortnightly or monthly, depending on the availability of participants. Each participant will attend each meeting only once. These sessions, lasting one hour, will take place at the Hospital de Clínicas de Porto Alegre and approximately 20 participants will be invited to each group.
Topics covered in these sessions will include:
1. "Let's go shopping" = purchasing food through NOVA classification and nutritional labeling and food labels
2. "Healthy Plate" = Diabetes Plate Method.
3. "Hunger and satiety" = signs of hunger and satiety and eating mindfully Receives: Behavioral: Operative group of nutrition education |
| Control (usual treatment) | Active comparator | In the usual care provided, there will be a consultation with a dietitian every four months. This consultation will involve nutritional counseling, where up to five combinations of lifestyle changes will be agreed upon with the participant. The combinations will be tailored to individual needs and align with diabetes recommendations, emphasizing increased consumption of natural foods, organizing meals according to the Diabetes Plate method, and promoting a reduction in sedentary time. Subsequent visits will reassess the combinations of lifestyle changes, addressing barriers and motivations identified during the counseling process.
Patients will not be encouraged to implement caloric restrictions, but they will be motivated to adopt healthy eating patterns in accordance with the recommendations of the American Diabetes Association and the Sociedade Brasileira de Diabetes. Receives: Behavioral: Operative group of nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline HbA1C at 4 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Measured: From baseline to 4 months
Change in baseline HbA1C at 8 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Measured: From baseline to 8 months
Change in baseline HbA1C at 12 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Measured: From baseline to 12 months
Change in diabetic retinopathy and baseline diabetic kidney disease at 12 months
Diabetes kidney disease and diabetic retinopathy will be collected from patients' electronic medical records at baseline and at the end of the study (12 months).
Measured: From baseline to 12 months
Secondary outcomes (9)
Change in basal body mass index at 4 months
Anthropometric measurements will be used to assess nutritional status and will include weight (with light clothes and without shoes) and height. For such measurements, an anthropometric scale and a fixed wall stadiometer will be used. BMI will be calculated from the formula weight (kg)/height2) and will be considered healthy weight (therapeutic target) when <25 kg/m2 for adults and <27 kg/m2 for the elderly.
Measured: From baseline to 4 months
Change in basal body mass index at 8 months
Anthropometric measurements will be used to assess nutritional status and will include weight (with light clothes and without shoes) and height. For such measurements, an anthropometric scale and a fixed wall stadiometer will be used. BMI will be calculated from the formula weight (kg)/height2) and will be considered healthy weight (therapeutic target) when <25 kg/m2 for adults and <27 kg/m2 for the elderly.
Measured: From baseline to 8 months
Change in basal body mass index at 12 months
Anthropometric measurements will be used to assess nutritional status and will include weight (with light clothes and without shoes) and height. For such measurements, an anthropometric scale and a fixed wall stadiometer will be used. BMI will be calculated from the formula weight (kg)/height2) and will be considered healthy weight (therapeutic target) when <25 kg/m2 for adults and <27 kg/m2 for the elderly.
Measured: From baseline to 12 months
Change in basal metabolic control at 4 months
The analyzes will be carried out at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre and will comprise: fasting plasma glucose (measured by the enzymatic glucose-peroxidase method - Biodiagnostic Kit), total cholesterol (colorimetric enzymatic method), HDL cholesterol (colorimetric reaction enzyme analysis, methods described by Farish and modified Fletcher) and serum triglycerides (colorimetric enzymatic method using a commercial kit, as described by McGowan). LDL cholesterol will be calculated using the Friedewald formula for patients with serum triglycerides below 400 mg/dL. The patient will be instructed to fast for 12 hours. Fasting glucose values between 80 - 130 mg/dL, HbA1c <7%, LDL-cholesterol <100 mg/dL and triglycerides <150 mg/dL will be considered within the recommended therapeutic target. Patients with HbA1c <7.0% (adults) and <7.5% (elderly) will be considered with good glycemic control.
Measured: From baseline to 4 months
Change in basal metabolic control at 8 months
The analyzes will be carried out at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre and will comprise: fasting plasma glucose (measured by the enzymatic glucose-peroxidase method - Biodiagnostic Kit), total cholesterol (colorimetric enzymatic method), HDL cholesterol (colorimetric reaction enzyme analysis, methods described by Farish and modified Fletcher) and serum triglycerides (colorimetric enzymatic method using a commercial kit, as described by McGowan). LDL cholesterol will be calculated using the Friedewald formula for patients with serum triglycerides below 400 mg/dL. The patient will be instructed to fast for 12 hours. Fasting glucose values between 80 - 130 mg/dL, HbA1c <7%, LDL-cholesterol <100 mg/dL and triglycerides <150 mg/dL will be considered within the recommended therapeutic target. Patients with HbA1c <7.0% (adults) and <7.5% (elderly) will be considered with good glycemic control.
Measured: From baseline to 8 months
Change in basal metabolic control at 12 months
The analyzes will be carried out at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre and will comprise: fasting plasma glucose (measured by the enzymatic glucose-peroxidase method - Biodiagnostic Kit), total cholesterol (colorimetric enzymatic method), HDL cholesterol (colorimetric reaction enzyme analysis, methods described by Farish and modified Fletcher) and serum triglycerides (colorimetric enzymatic method using a commercial kit, as described by McGowan). LDL cholesterol will be calculated using the Friedewald formula for patients with serum triglycerides below 400 mg/dL. The patient will be instructed to fast for 12 hours. Fasting glucose values between 80 - 130 mg/dL, HbA1c <7%, LDL-cholesterol <100 mg/dL and triglycerides <150 mg/dL will be considered within the recommended therapeutic target. Patients with HbA1c <7.0% (adults) and <7.5% (elderly) will be considered with good glycemic control.
Measured: From baseline to 12 months
Change in baseline blood pressure at 4 months
Three blood pressure measurements will be performed with a Digital Blood Pressure Monitor Omron sphygmomanometer model HEM-705CP, with an interval of one minute, with the patient sitting down after five minutes of rest, using a cuff of the appropriate size for the arm diameter.
Measured: From baseline to 4 months
Change in baseline blood pressure at 8 months
Three blood pressure measurements will be performed with a Digital Blood Pressure Monitor Omron sphygmomanometer model HEM-705CP, with an interval of one minute, with the patient sitting down after five minutes of rest, using a cuff of the appropriate size for the arm diameter.
Measured: From baseline to 8 months
Change in baseline blood pressure at 12 months
Three blood pressure measurements will be performed with a Digital Blood Pressure Monitor Omron sphygmomanometer model HEM-705CP, with an interval of one minute, with the patient sitting down after five minutes of rest, using a cuff of the appropriate size for the arm diameter.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start6 Sep 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each group will be exposed to only one of the factors, diabetes education operative groups added usual individual counseling; or usual individual counseling.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jussara C De Almeida, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598203
- Sponsor's protocol ID
- 20220238
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Busanello A, Menezes VM, Koller OG, Volz Andreia A, de Almeida JC. Effect of group-based nutritional education combined with individual standard care for outpatients with type 2 diabetes: study protocol for a randomized clinical trial 1. Trials. 2025 Mar 6;26(1):78. doi: 10.1186/s13063-025-08720-1.
PubMed 40050966
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05598203
- Acronym / sponsor ID
- 20220238
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Glycated Hemoglobin A, Food and Nutrition Education, Feeding Behavior, Diabetes Complications, Body Mass Index, Lipids, Blood Pressure, Outcome Assessment, Health Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 28 Oct 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.
Every year there is an increase in people with diabetes all over the world. Because it is a disease associated with several comorbidities and is increasing, there is a need for more effective treatments. Lifestyle changes combined with medication are the best strategies for the treatment and reduction of comorbidities. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes. A randomized clinical trial will be conducted with adult patients with a previous diagnosis of type 2 diabetes. Patients will be divided into two groups (intervention: nutritional education added the usual care; and control: usual care). The outcomes analyzed will be: glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations.
Detailed description
The estimate of patients with diabetes increases every year and for their treatment, a change in lifestyle is essential, so there is a need to seek strategies that increase patient adherence in the long term. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes.
An open randomized clinical trial will be performed. Patients = patients with type 2 DM; Intervention = food (nutritional) education based on operative groups added the usual care; Control = usual care; Outcome/Outcomes = glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations. In order to detect a mean difference of 0.59 in HbA1c between patients randomized to the intervention (patient-centered group) and those in the control group (traditional education intervention), with a standard deviation of 1.39%, a type I error of 5%, and a type II error of 20%, a total of 88 patients in each group were deemed necessary (1:1 ratio at randomization, n= 176). Considering a dropout rate of 30% over the long term (12 months), it will be essential to include a total of 252 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each group will be exposed to only one of the factors, diabetes education operative groups added usual individual counseling; or usual individual counseling.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Operative group of nutrition educationThe intervention group will receive four group meetings in addition to the usual care, specifically in the form of operative groups. Participants in these groups will actively participate in the sessions and will be given tasks to complete at home. There will be four sessions, which can be held weekly, fortnightly or monthly, depending on the availability of participants. Each participant will attend each meeting only once. These sessions, lasting one hour, will take place at the Hospital de Clínicas de Porto Alegre and approximately 20 participants will be invited to each group. Topics covered in these sessions will include: 1. "Let's go shopping" = purchasing food through NOVA classification and nutritional labeling and food labels 2. "Healthy Plate" = Diabetes Plate Method. 3. "Hunger and satiety" = signs of hunger and satiety and eating mindfully |
| Control (usual treatment) | Active comparator | Behavioral: Operative group of nutrition educationIn the usual care provided, there will be a consultation with a dietitian every four months. This consultation will involve nutritional counseling, where up to five combinations of lifestyle changes will be agreed upon with the participant. The combinations will be tailored to individual needs and align with diabetes recommendations, emphasizing increased consumption of natural foods, organizing meals according to the Diabetes Plate method, and promoting a reduction in sedentary time. Subsequent visits will reassess the combinations of lifestyle changes, addressing barriers and motivations identified during the counseling process. Patients will not be encouraged to implement caloric restrictions, but they will be motivated to adopt healthy eating patterns in accordance with the recommendations of the American Diabetes Association and the Sociedade Brasileira de Diabetes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with a previous diagnosis of type 2 diabetes mellitus
Key exclusion criteria (12 listed)
- Patients with other types of diabetes
- With HbA1C within the therapeutic target or with values greater than 12%
- Severe neuropathy
- Chronic kidney disease [glomerular filtration rate <30mL/min/1.73m²]
- Life expectancy <6 months
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 |
|---|---|---|
| Operative group of nutrition educationThe intervention will be carried out with operational nutritional education groups. Four meetings will be held, each meeting lasting one hour, weekly or fortnightly (according to the availability of the patient). The following foods proposed foods: Meeting 1 = education on classification labels and proposed foods proposed foods (education on classification labels and substitution of Brazilian foods), in this guide meeting the proposal is processed or ultra-processed by an in natura food or minimally processed; Meeting 2 = assembly of the healthy dish (food portions, food index and glycemic load, food clothes), the proposal in this meeting is the assembly of the complete dish in the meals eaten throughout the day; and Encounter 3 = hunger and satiety (aiming to increase the perception of hunger and satiety signals), encounter as a task to be accomplished; Encounter 4 = strengthening change, barriers and difficulties in maintaining habits based on the transtheoretical model of change. | Behavioural | Control (usual treatment), Intervention |
Primary outcome
Change in baseline HbA1C at 4 months
Time frame: From baseline to 4 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Change in baseline HbA1C at 8 months
Time frame: From baseline to 8 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Change in baseline HbA1C at 12 months
Time frame: From baseline to 12 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Change in diabetic retinopathy and baseline diabetic kidney disease at 12 months
Time frame: From baseline to 12 months
Diabetes kidney disease and diabetic retinopathy will be collected from patients' electronic medical records at baseline and at the end of the study (12 months).
9 secondary outcomes
Change in basal body mass index at 4 months
Time frame: From baseline to 4 months
Change in basal body mass index at 8 months
Time frame: From baseline to 8 months
Change in basal body mass index at 12 months
Time frame: From baseline to 12 months
Change in basal metabolic control at 4 months
Time frame: From baseline to 4 months
Change in basal metabolic control at 8 months
Time frame: From baseline to 8 months
Change in basal metabolic control at 12 months
Time frame: From baseline to 12 months
Change in baseline blood pressure at 4 months
Time frame: From baseline to 4 months
Change in baseline blood pressure at 8 months
Time frame: From baseline to 8 months
Change in baseline blood pressure at 12 months
Time frame: From baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 40050966Busanello A, Menezes VM, Koller OG, Volz Andreia A, de Almeida JC. Effect of group-based nutritional education combined with individual standard care for outpatients with type 2 diabetes: study protocol for a randomized clinical trial 1. Trials. 2025 Mar 6;26(1):78. doi: 10.1186/s13063-025-08720-1.
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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.
Jussara C De Almeida, PhD principal investigator
Federal University of Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative group of nutrition education in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 2 sites 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 1 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jussara C De Almeida, PhD (+555133598410, jcalmeida@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline HbA1C at 4 months (time frame: From baseline to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598203, which also lists 1 linked publication.
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 18 Mar 2025.