Table 1.
Schedule for measurement, testing and assessment at baseline and follow-up visits
| Measures | Baseline | Follow-up |
|---|---|---|
| Anthropometric measures | ||
| Weight | X | X |
| Height | X | |
| BMI (kg/m2) | X | X |
| Waist circumference | X | X |
| Body composition (DXA) | X | X |
| Components of energy balance (antecedents to change in BMI) | ||
| Dietary intake (1-weekday and 1-weekend day) by a registered dietitian | X | X |
| Godin leisure time physical activity questionnaire | X | X |
| Physical activity data captured via accelerometry (3-day period) | X | X |
| Cardiorespiratory fitness (VO2 submax) | X | X |
| Tumour markers | ||
| Ki-67, I-R, VEGF, TNFα, NFκB, 4E-BP1, activated caspase-3 and p16 in paraffin-embedded tumours | X | X |
| p-Akt, p-GSK-3β, p-p70S6K, p-S6RP for fresh-frozen tumour | X* | X |
| Gene expression using multi array | ||
| Insulin (I-R), leptin (LEPR), VEGF (VEGFR) and TNF (FAS) in tumours | X | X |
| Insulin (I-R), leptin (LEPR), VEGF (VEGFR), TNF (FAS) and apoptosis regulator (Bcl-2) in PBMCs | X | X |
| Serum biomarkers | ||
| Insulin, leptin, estradiol, VEGF, TNFα, SHBG | X | X |
| Microbiome profiles | ||
| Saliva | X | X |
| Faeces | X | X |
| Quality of life | ||
| FACT-B (questionnaire) | X | X |
| Demographics/comorbidities | ||
| Demographics—race, age, educational level | X | |
| Medical history and medications | X | X |
| OARS comorbidity scale | X | X |
*Diagnostic specimens are optionally obtained after study enrolment.
BMI, body mass index; DXA, dual-energy X-ray absorptiometry; FACT-B, Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer; I-R, insulin receptor; LEPR, leptin receptor; NFκB, nuclear factor κ-light-chain-enhancer of activated B cells; OARS, Older American Resources and Services; PBMCs, peripheral blood mononuclear cells; SHBG, sex hormone-binding globulin; TNFα, tumour necrosis factor α; VEGF, vascular endothelial growth factor; VEGFR, vascular endothelial growth factor receptor.