Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial

Table 1 Study assessments

Assessments	Instrument	Visits
Assessments	Instrument	Baseline	6-month	12-month	24-month
Total, HDL, LDL and VLDL cholesterol, triglycerides, estradiol, insulin, glucose and C-reactive protein	Blood test	√	√		√
Height^a, weight, waist and hip circumference, body mass index, waist-to-hip ratio	Calibrated scales, stadiometer, tape measure	√	√	√	√
Body composition (including total body water (TBW), body cell mass (BCM), extracellular water (ECW), fat-free mass (FFM), fat mass (FM) and percentage fat mass (% FM)	Bioelectrical impedance vector analysis (BIVA) (Nutrilab device, AKERN Srl – Italy)	√	√	√	√
Dietary target	24 hr recalls and/or food diary	√^b	√
Steps	Pedometer-like device	√^b	√
Diet	Food Frequency Questionnaire (FFQ)	√	√		√
Quality of life	Functional Assessment of Cancer Therapy- Breast (FACT-B)	√	√		√
Mood	State-Trait Anxiety Inventory (STAI)	√	√		√
Physical activity	International Physical Activity Questionnaire (IPAQ)	√	√		√

^aHeight will be assessed only at baseline
^b24 hr recalls and/or food diary and the pedometer-like device will be used during the intervention to monitor individualized goals

ISSN: 1745-6215