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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Operative group of nutrition education

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Operative group of nutrition education

Intervention Type 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.

Interventions

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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 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No