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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

Locations
Other Locations
Brazil
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Universidade Federal do Rio Grande do Sul
RECRUITING
Porto Alegre
Contact Information
Primary
Jussara C De Almeida, PhD
jcalmeida@hcpa.edu.br
+555133598410
Time Frame
Start Date: 2022-09-06
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 252
Treatments
Experimental: Intervention
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
Active_comparator: Control (usual treatment)
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital de Clinicas de Porto Alegre

This content was sourced from clinicaltrials.gov