Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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, this study seeks to assess the effect of group nutrition education on metabolic control and diabetes complications compared to usual care. 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; and control: usual care). The outcomes analyzed will be: metabolic control, intuitive food scale, food consumption, body composition and chronic complications of diabetes (diabetic retinopathy and diabetic kidney disease).

Detailed Description
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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, this study seeks to evaluate the effect of food education with operative groups on metabolic control and diabetes complications in patients with type 2 DM when compared with the usual treatment offered in a specialized nutrition outpatient clinic. An open randomized clinical trial will be performed. Patients = patients with type 2 DM; Intervention = food (nutritional) education based on operative groups; Control = usual care; Outcome/Outcomes = metabolic control, intuitive eating scale, food consumption, body composition and chronic complications of diabetes (diabetic retinopathy and diabetes kidney disease). 116 patients will be needed in each group (1:1), considering a difference in glycated hemoglobin of 0.59 + 1.39% between patients in the intervention group when compared to the control observed in the literature, error Type I error of 5%, Type II error of 20% and a possible loss rate of 30%.

Official Title
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Effect of the Inclusion of Food Education Groups in the Usual Care of Patients With Type 2 Diabetes Treated at a Specialized Outpatient Clinic: Randomized Clinical Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Operative group of nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adult patients with a previous diagnosis of type 2 diabetes mellitus Exclusion Criteria: 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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each group will be exposed to only one of the factors, diabetes education operative groups or usual individual counseling.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention: The intervention will be carried out with operational nutritional education groups. Three meetings will be held, each meeting lasting one hour, weekly or fortnightly (according to the availability of the patient). The following foods 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. | Behavioral: Operative group of nutrition education<br>* The intervention will be carried out with operational nutritional education groups. Three meetings will be held, each meeting lasting one hour, weekly or fortnightly (according to the availability of the patient). The following foods 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.<br>|
| No Intervention: Control (usual treatment)<br>Patients will follow the usual follow-up offered at the HCPA nutrition and diabetes outpatient clinic: individual consultations every three or four months (three to four meetings a year). These consultations will be carried out in the form of nutritional counseling, where up to five combinations for dietary changes are agreed with the patient. In each service, after nutritional anamnesis, adherence to combinations for lifestyle changes is verified, as well as possible barriers and motivations to continue the counseling process. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | From baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to 12 months | 
| Change in baseline waist circumference at 4 months | The waist circumference measurement will be taken at the midpoint between the last rib and the iliac crest. For this measurement, an inelastic fiberglass measuring tape will be used. For classification, cutoff measurements < 94cm for men and <80cm for women will be used. | From baseline to 4 months | 
| Change in baseline waist circumference at 8 months | The waist circumference measurement will be taken at the midpoint between the last rib and the iliac crest. For this measurement, an inelastic fiberglass measuring tape will be used. For classification, cutoff measurements < 94cm for men and <80cm for women will be used. | From baseline to 8 months | 
| Change in baseline waist circumference at 12 months | The waist circumference measurement will be taken at the midpoint between the last rib and the iliac crest. For this measurement, an inelastic fiberglass measuring tape will be used. For classification, cutoff measurements < 94cm for men and <80cm for women will be used. | From baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycated Hemoglobin A, Food and Nutrition Education, Feeding Behavior