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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital de Clinicas de Porto Alegre

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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]

Trial design

Design model

Parallel

Treatments tested in this trial

  • Operative group of nutrition education

    Behavioral

    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.

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Control (usual treatment)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline to 4 months
2

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.

Time frame
From baseline to 8 months
3

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.

Time frame
From baseline to 12 months
4

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).

Time frame
From baseline to 12 months

Secondary outcomes

1

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.

Time frame
From baseline to 4 months
2

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.

Time frame
From baseline to 8 months
3

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.

Time frame
From baseline to 12 months
4

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.

Time frame
From baseline to 4 months

Other outcomes

1

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.

Time frame
From baseline to 4 months
2

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.

Time frame
From baseline to 8 months
3

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.

Time frame
From baseline to 12 months
4

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.

Time frame
From baseline to 4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.