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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Nutritional Education Groups Added in the Usual Care of Outpatients With Type 2 Diabetes: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598203
• Other study ID #: 20220238
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: March 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Jussara C De Almeida, PhD
• Phone: +555133598410
• Email: jcalmeida[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: August 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Operative group of nutrition education
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in baseline eating behavior at 4 months	Eating behavior will be evaluated using the Intuitive Eating Scale-2 (IES-2), adapted to Portuguese. This scale, based on principles of intuitive eating, encompasses questions about food attitudes and has been designed to assess adherence to hunger and satiety signals. Food consumption will be estimated through the 24-hour dietary recalls Multiple-Pass Method. Additionally, the study will assess the frequency of consumption of sweets, sugary drinks, alcoholic beverages, fried foods, cooking oil, and added oil after preparation (specifying type and quantity per capita), as well as sausages, canned goods, preserves, industrialized seasonings, meat, and eggs.	From baseline to 4 months
Other	Change in baselineeating behavior at 8 months	Eating behavior will be evaluated using the Intuitive Eating Scale-2 (IES-2), adapted to Portuguese. This scale, based on principles of intuitive eating, encompasses questions about food attitudes and has been designed to assess adherence to hunger and satiety signals. Food consumption will be estimated through the 24-hour dietary recalls Multiple-Pass Method. Additionally, the study will assess the frequency of consumption of sweets, sugary drinks, alcoholic beverages, fried foods, cooking oil, and added oil after preparation (specifying type and quantity per capita), as well as sausages, canned goods, preserves, industrialized seasonings, meat, and eggs.	From baseline to 8 months
Other	Change in baseline eating behavior at 12 months	Eating behavior will be evaluated using the Intuitive Eating Scale-2 (IES-2), adapted to Portuguese. This scale, based on principles of intuitive eating, encompasses questions about food attitudes and has been designed to assess adherence to hunger and satiety signals. Food consumption will be estimated through the 24-hour dietary recalls Multiple-Pass Method. Additionally, the study will assess the frequency of consumption of sweets, sugary drinks, alcoholic beverages, fried foods, cooking oil, and added oil after preparation (specifying type and quantity per capita), as well as sausages, canned goods, preserves, industrialized seasonings, meat, and eggs.	From baseline to 12 months
Other	Change in baseline dynapenia obesity at 4 months	The SARC-F questionnaire (a simple tool for rapid sarcopenia diagnosis) will be administered by phone. Calf circumference will be measured at the point of greatest horizontal circumference, with the subject sitting, legs in a non-contracted position, and 20 cm apart. Handgrip strength will be assessed using a Hydraulic Hand Dynamometer (in the dominant hand), and the walking test will involve the patient walking a pre-marked distance of four meters (measured with the aid of a stopwatch). The cutoff points employed to identify low muscle strength will be <26 kg for men and <16 kg for women, with altered waist circumference defined as >102 for men and >88 for women. For dynapenic abdominal obesity, individuals with both low muscle strength and altered waist circumference will be considered.	From baseline to 4 months
Other	Change in baseline dynapenia obesity at 8 months	The SARC-F questionnaire (a simple tool for rapid sarcopenia diagnosis) will be administered by phone. Calf circumference will be measured at the point of greatest horizontal circumference, with the subject sitting, legs in a non-contracted position, and 20 cm apart. Handgrip strength will be assessed using a Hydraulic Hand Dynamometer (in the dominant hand), and the walking test will involve the patient walking a pre-marked distance of four meters (measured with the aid of a stopwatch). The cutoff points employed to identify low muscle strength will be <26 kg for men and <16 kg for women, with altered waist circumference defined as >102 for men and >88 for women. For dynapenic abdominal obesity, individuals with both low muscle strength and altered waist circumference will be considered.	From baseline to 8 months
Other	Change in baseline dynapenia obesity at 12 months	The SARC-F questionnaire (a simple tool for rapid sarcopenia diagnosis) will be administered by phone. Calf circumference will be measured at the point of greatest horizontal circumference, with the subject sitting, legs in a non-contracted position, and 20 cm apart. Handgrip strength will be assessed using a Hydraulic Hand Dynamometer (in the dominant hand), and the walking test will involve the patient walking a pre-marked distance of four meters (measured with the aid of a stopwatch). The cutoff points employed to identify low muscle strength will be <26 kg for men and <16 kg for women, with altered waist circumference defined as >102 for men and >88 for women. For dynapenic abdominal obesity, individuals with both low muscle strength and altered waist circumference will be considered.	From baseline to 12 months
Other	Change in baseline adherence to recommendations at 4 months	We will assess adherence to the nutritional combinations during each scheduled visit (at four, eight, and 12 months), as well as adherence to the Diabetes Plate Method. Additionally, the attendance of participants randomized to the intervention group will be monitored through their presence at the scheduled meetings, considering patients who attend at least two meetings. In the control group, assiduity will be evaluated based on return consultation attendance.	From baseline to 4 months
Other	Change in baseline adherence to recommendations at 8 months	We will assess adherence to the nutritional combinations during each scheduled visit (at four, eight, and 12 months), as well as adherence to the Diabetes Plate Method. Additionally, the attendance of participants randomized to the intervention group will be monitored through their presence at the scheduled meetings, considering patients who attend at least two meetings. In the control group, assiduity will be evaluated based on return consultation attendance.	From baseline to 8 months
Other	Change in baseline adherence to recommendations at 12 months	We will assess adherence to the nutritional combinations during each scheduled visit (at four, eight, and 12 months), as well as adherence to the Diabetes Plate Method. Additionally, the attendance of participants randomized to the intervention group will be monitored through their presence at the scheduled meetings, considering patients who attend at least two meetings. In the control group, assiduity will be evaluated based on return consultation attendance.	From baseline to 12 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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