RecruitingNot ApplicableNCT05598203

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

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

Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

252 participants

Start Date

Sep 6, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Inclusion Criteria1

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

Exclusion Criteria12

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

Interventions

BEHAVIORALOperative 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.