Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 4
- 主要终点
- Change in baseline HbA1C at 4 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a previous diagnosis of type 2 diabetes mellitus
排除标准
- •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
研究组 & 干预措施
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:
- "Let's go shopping" = purchasing food through NOVA classification and nutritional labeling and food labels
- "Healthy Plate" = Diabetes Plate Method.
- "Hunger and satiety" = signs of hunger and satiety and eating mindfully
干预措施: Operative group of nutrition education (Behavioral)
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.
干预措施: Operative group of nutrition education (Behavioral)
结局指标
主要结局
Change in baseline HbA1C at 4 months
时间窗: From baseline to 4 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Change in diabetic retinopathy and baseline diabetic kidney disease at 12 months
时间窗: From baseline to 12 months
Diabetes kidney disease and diabetic retinopathy will be collected from patients' electronic medical records at baseline and at the end of the study (12 months).
Change in baseline HbA1C at 12 months
时间窗: From baseline to 12 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
Change in baseline HbA1C at 8 months
时间窗: From baseline to 8 months
The Glycated Hemoglobin test (high precision chromatography on a Merck-Hitachi 9100 device with reference values of 4.8-6.0%) will be performed at the Clinical Pathology Laboratory of the Hospital de Clínicas de Porto Alegre (HCPA) by means of blood sample. The patient will be instructed to fast for 12 hours.
次要结局
- Change in basal body mass index at 8 months(From baseline to 8 months)
- Change in basal body mass index at 4 months(From baseline to 4 months)
- Change in basal body mass index at 12 months(From baseline to 12 months)
- Change in basal metabolic control at 4 months(From baseline to 4 months)
- Change in basal metabolic control at 8 months(From baseline to 8 months)
- Change in baseline blood pressure at 4 months(From baseline to 4 months)
- Change in baseline blood pressure at 8 months(From baseline to 8 months)
- Change in basal metabolic control at 12 months(From baseline to 12 months)
- Change in baseline blood pressure at 12 months(From baseline to 12 months)