Clinical trial NCT05598203: Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes
Official title: Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 252
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each group will be exposed to only one of the factors, diabetes education operative groups added usual individual counseling; or usual individual counseling.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline HbA1C at 4 months
timeFrame: From baseline to 4 months
measure: Change in baseline HbA1C at 8 months
timeFrame: From baseline to 8 months
measure: Change in baseline HbA1C at 12 months
timeFrame: From baseline to 12 months
measure: Change in diabetic retinopathy and baseline diabetic kidney disease at 12 months
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Change in basal body mass index at 4 months
timeFrame: From baseline to 4 months
measure: Change in basal body mass index at 8 months
timeFrame: From baseline to 8 months
measure: Change in basal body mass index at 12 months
timeFrame: From baseline to 12 months
measure: Change in basal metabolic control at 4 months
timeFrame: From baseline to 4 months
measure: Change in basal metabolic control at 8 months
timeFrame: From baseline to 8 months
measure: Change in basal metabolic control at 12 months
timeFrame: From baseline to 12 months
measure: Change in baseline blood pressure at 4 months
timeFrame: From baseline to 4 months
measure: Change in baseline blood pressure at 8 months
timeFrame: From baseline to 8 months
measure: Change in baseline blood pressure at 12 months
timeFrame: From baseline to 12 months
Other outcomes:
measure: Change in baseline eating behavior at 4 months
timeFrame: From baseline to 4 months
measure: Change in baselineeating behavior at 8 months
timeFrame: From baseline to 8 months
measure: Change in baseline eating behavior at 12 months
timeFrame: From baseline to 12 months
measure: Change in baseline dynapenia obesity at 4 months
timeFrame: From baseline to 4 months
measure: Change in baseline dynapenia obesity at 8 months
timeFrame: From baseline to 8 months
measure: Change in baseline dynapenia obesity at 12 months
timeFrame: From baseline to 12 months
measure: Change in baseline adherence to recommendations at 4 months
timeFrame: From baseline to 4 months
measure: Change in baseline adherence to recommendations at 8 months
timeFrame: From baseline to 8 months
measure: Change in baseline adherence to recommendations at 12 months
timeFrame: From baseline to 12 months
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Jussara C De Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References: