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

Overview

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.

Interventions

• Behavioral Operative 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 minim

Primary outcome measures

• Change in baseline HbA1C at 4 months [Time frame: From baseline to 4 months]
• Change in baseline HbA1C at 8 months [Time frame: From baseline to 8 months]
• Change in baseline HbA1C at 12 months [Time frame: From baseline to 12 months]
• Change in diabetic retinopathy and baseline diabetic kidney disease at 12 months [Time frame: From baseline to 12 months]

Secondary outcome measures (9)

• Change in basal body mass index at 4 months [Time frame: From baseline to 4 months]
• Change in basal body mass index at 8 months [Time frame: From baseline to 8 months]
• Change in basal body mass index at 12 months [Time frame: From baseline to 12 months]
• Change in basal metabolic control at 4 months [Time frame: From baseline to 4 months]
• Change in basal metabolic control at 8 months [Time frame: From baseline to 8 months]
• Change in basal metabolic control at 12 months [Time frame: From baseline to 12 months]
• Change in baseline blood pressure at 4 months [Time frame: From baseline to 4 months]
• Change in baseline blood pressure at 8 months [Time frame: From baseline to 8 months]
• Change in baseline blood pressure at 12 months [Time frame: From baseline to 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 2 centers

• Hospital de Clinicas de Porto Alegre — Porto Alegre
• Universidade Federal do Rio Grande do Sul — Porto Alegre

Publications

• 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

Identifiers

NCT: NCT05598203 · 20220238

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗