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

Hospital de Clinicas de Porto Alegre

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Operative group of nutrition education

Study type: Interventional

Funder types: Other

Identifiers

NCT05598203

20220238

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Operative group of nutrition education

Control (usual treatment)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Operative group of nutrition education