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Table 4 Data collection plan

From: Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial

Variables

Procedures

Baseline visit

Follow-up week 4

Follow-up week 8

Follow-up week 12

Final assessment week 16

Demographic data (sex, age, ethnicity, marital status); medical history; smoking and alcohol consumption; socioeconomic and educational status.

Questionnaire

x

    

Current medications in use

Questionnaire

x

x

x

x

x

Nutritional assessment and counseling

• Nutrient intake

• Energy intake

• Healthy patterns and food groups

• Diet quality

• Diet adherence

24-h dietary recalls and questionnaire

x

x

x

x

x

FFQ

x

   

x

DICA Br counseling

x

x

x

x

x

mAHEI

x

   

x

BALANCE Index

x

   

x

Physical activity levels

IPAQ

x

   

X

Anthropometric assessmenta (body weight, body height, BMI, waist circumference, hip circumference, waist to hip ratio, waist to height ratio)

 

x

x

x

x

x

Biochemical data

• Lipid profileb (TC, HDL-c, LDL-c, NHDL-c, TG, VLDL-c, Castelli indexes I and II, TG/HDL-c);

• Glycemic profilec (FG, FI, HbA1c, HOMA-IR);

• Kidney functiond (Cr, eGRF).

Blood samples

x

   

x

  1. FFQ food frequency questionnaire, DICA Br DIeta CArdioprotetora Brasileira, mAHEI modified Alternative Healthy Eating Index, BALANCE Brazilian Cardioprotective Nutritional Program, IPAQ International Physical Activity Questionnaire, BMI body mass index, TC total cholesterol, HDL-c high-density lipoprotein cholesterol, LDL-c low-density lipoprotein cholesterol, NHDL-c non-HDL cholesterol, TG fasting triglycerides, VLDL-c very low-density lipoprotein cholesterol, TG/HDL-c ratio between TG and HDL-c, FG fasting glucose, FI fasting insulin, HbA1c glycated hemoglobin, HOMA-IR homeostasis model assessment-insulin resistance, Cr serum creatinine, eGRF estimated glomerular filtration rate
  2. aGeneral obesity defined as BMI ≥ 30 kg/m2 [32]; abdominal obesity defined as waist circumference ≥ 94 cm (men) and ≥ 80 cm (women), waist to hip ratio > 0.90 (men) and > 0.85 (women) [33], and/or waist to height ratio > 0.5 (both sexes) [34]
  3. bVLDL-c calculated via formula TG/5; LDL-c calculated via Martin’s formula (LDL-c = TC-HDL-c –TG/X, where X ranges from 3.1 to 11.9 considering TG ≥ 400 mg/dl) [35]; NHDL-c calculated via formula TC – HDL-c; Castelli 1 index calculated via formula TC/HDL-c; Castelli II index calculated via formula LDL-c/HDL-c; TG/HDL-c ratio calculated by dividing TG for HDL-c
  4. cHOMA-IR calculated via formula FG (mmol) × FI (UI/mL) ÷ 22.5
  5. deGRF (in mL/min/1.73 m2) calculated via formula GRF = 175 × [Cr−1.154] × [age−0.203] × [0.742, if women] × [1.210, if afro descendant]) [36]
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Trials

ISSN: 1745-6215