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. Author manuscript; available in PMC: 2014 Nov 1.
Published in final edited form as: Contemp Clin Trials. 2013 Aug 17;36(2):10.1016/j.cct.2013.08.004. doi: 10.1016/j.cct.2013.08.004

Table 3.

Data collection scheme for primary and secondary outcome measures

Baseline 12 Weeks 60 Weeks

PRIMARY OUTCOME VARIABLES

  Body size and composition (adiposity) X X X
    Weight, body mass index, waist circumference, percent body fat and lean mass

  Cardiac Structure X X X
    Echocardiogram (left ventricular end diastolic diameter)

  Functional Status X X X
    Cardiopulmonary exercise test & 6-minute walk test

SECONDARY OUTCOME VARIABLES

  Lipid Profiles X X X
    Total cholesterol, triglycerides, LDL-C, HDL-C

  Glycemic Control and insulin resistance X X X
    HbAlc, Fasting blood sugar, Homeostasis Model Assessment

  QOL Measurement X X X
    Minnesota Living with Heart Failure Questionnaire

ADDITIONAL VARIABLES

  Sociodemographic Characteristics X
    Sociodemographic Form

  Clinical History X
    Clinical History/Co-Morbidity Form

  Biochemical analyses X X X
    BNP, serum creatinine, serum albumin, CRP