Adherence to a healthy dietary pattern is part of the self-care of patients with type 2 diabetes mellitus (T2DM), and may contribute substantially to therapeutic target goals and to a better quality of life as well. However, not all nutritional recommendations aimed at these patients are easily applicable in clinical practice. The primary objective of the study is to evaluate the effectiveness of a nutritional strategy for glycemic control in patients with T2DM users of a Public Health System after 6 months of follow-up. As secondary objectives, we will evaluate the impact of the proposed strategy on self-care and on the quality of life of the patients. In this randomized multicenter open-label randomized trial, 370 patients \>30 years old with T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who have not received or received nutritional counseling for at least 06 months will be enrolled. Patients allocated to the control group will receive individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes. Nutritional counseling in the intervention group will be performed based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance will be based on feasible goals built together (patient and nutritionist), and no diet will be prescribed for intervention group. In both groups, patients will receive glymeters for residential self-monitoring of glycemic levels. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and blood pressure will be also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
370
Counseling based on dietary goals and mindfulness techniques.
Dietary prescription according to guidelines.
Universidade Federal de Juiz de Fora
Governador Valadares, Brazil
Universidade Federal de Lavras
Lavras, Brazil
Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul
Porto Alegre, Brazil
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Brazil
Instituto Estadual de Cardiologia Aloysio de Castro
Rio de Janeiro, Brazil
Universidade Federal da Bahia
Salvador, Brazil
Hospital do Coracao
São Paulo, Brazil
Universidade Federal de Viçosa
Viçosa, Brazil
HbA1C
Glycated hemoglobin, in %
Time frame: 6 months
GC
Glycemic control, defined as either having HbA1C \> 7% at baseline and achieving HbA1C ≤ 7% after follow-up or having HbA1C \< 7% at baseline and reducing anti-diabetic drugs after follow-up.
Time frame: 6 months
FG
Fasting glucose, in mg/dL
Time frame: 6 months
SBP
Systolic blood pressure, in mmHg
Time frame: 6 months
DBP
Diastolic blood pressure, in mmHg
Time frame: 6 months
HDL-c
HDL cholesterol, in mg/dL
Time frame: 6 months
LDL-c
LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula
Time frame: 6 months
TC
Total cholesterol, in md/dL
Time frame: 6 months
TG
Serum triglycerides, in mg/dL
Time frame: 6 months
Castelli Index I
Castelli Index I, obtained by the mathematical formula TC/HDL-c
Time frame: 6 months
VLDL-c
VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5
Time frame: 6 months
NHDL
Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c
Time frame: 6 months
Castelli Index II
Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c
Time frame: 6 months
BW
Body weight, in kg
Time frame: 6 months
WC
Waist circumference, in cm
Time frame: 6 months
BMI
Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height\*height)
Time frame: 6 months
Cr
Creatinine, in mg/dL
Time frame: 6 months
GFR
Glomerular filtration rate, in ml/min/1.73m2
Time frame: 6 months
Sodium (s)
Serum sodium, in mEq/L
Time frame: 6 months
Sodium (u)
Urinary sodium, in mEq/L
Time frame: 6 months
Potassium (s)
Serum potassium, in mEq/L
Time frame: 6 months
Potassium (u)
Urinary potassium, in mEq/L
Time frame: 6 months
ALB
Albuminuria, in mg/g
Time frame: 6 months
B-PAID
Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale. The scale consists of 20 questions; it uses a score from 0 to 100, in which the maximum score is configured as greater suffering. The possible response options are divided on a 5-point Likert scale, ranging from: "Not a problem=0", "Small problem=1", "Moderate problem=2", "Almost serious problem=3", "Serious problem=4". A cut-off point equal or greater 40 indicates a high degree of emotional distress.
Time frame: 6 months
DSCA
Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities. The questionnaire has six domains and 15 items for assessment of the diabetes self-care; it is based on the number of days per week in which the respondent has a given behavior, with each item scoring from 0 to 7 points (i.e. 0 is the least desirable situation and 7 is the most desirable one). At least five days for each self-care activity is considered adequate.
Time frame: 6 months
DQ
Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)
Time frame: 6 months
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