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

NCT05598203 | Recruiting

• 1 other identifier: 20220238
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change in basal body mass index at 4 months

  From baseline to 4 months

• Change in basal body mass index at 8 months

  From baseline to 8 months

• Change in basal body mass index at 12 months

  From baseline to 12 months

• Change in basal metabolic control at 4 months

  From baseline to 4 months

• Change in basal metabolic control at 8 months

  From baseline to 8 months

Other Outcomes (9)

• Change in baseline eating behavior at 4 months

  From baseline to 4 months

• Change in baselineeating behavior at 8 months

  From baseline to 8 months

• Change in baseline eating behavior at 12 months

  From baseline to 12 months

Study Arms (2)

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

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.

Behavioral: Operative group of nutrition education

Interventions

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.

Control (usual treatment); Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients with a previous diagnosis of type 2 diabetes mellitus

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

RECRUITING

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 40050966 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Feeding Behavior; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior, Animal; Behavior

Study Officials

• Jussara C De Almeida, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussara C De Almeida, PhD

CONTACT

+555133598410; jcalmeida@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each group will be exposed to only one of the factors, diabetes education operative groups added usual individual counseling; or usual individual counseling.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 28, 2022
• Study Start: September 6, 2022
• Primary Completion: March 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

BR (2)