Study protocol for “Moving Bright, Eating Smart”– A phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors

Table 1 Outcome measures

	Measures	When
Primary outcome
PA target – general health	Accelerometer	0 M, 6 M, 12 M, 18 M, 24 M
PA target – cancer outcome	Accelerometer	0 M, 6 M, 12 M, 18 M, 24 M
Dietary target – red/processed meat	FFQ [30]	0 M, 6 M, 12 M, 18 M, 24 M
Dietary target – refined grain	FFQ [30]	0 M, 6 M, 12 M, 18 M, 24 M
Secondary outcome
Magnitude of PA change	Accelerometer	0 M, 6 M, 12 M, 18 M, 24 M
	GPAQ [31]
Magnitude of dietary change	FFQ [30]	0 M, 6 M, 12 M, 18 M, 24 M
Compliance	Intervention record; pedometer, food diary	6 M, 12 M
Measurement of theoretical constructs	Questionnaire	0 M, 6 M, 12 M, 18 M, 24 M
Facilitators and barriers of intervention	Questionnaire	6 M, 12 M
	Focus-group discussion	Towards end of intervention (last group meeting)
BMI, WHR	Calibrated scales, stadiometer; tape measure	0 M, 6 M, 12 M, 18 M, 24 M
Body and visceral fat	Bioelectrical impedance	0 M, 12 M, 24 M
Physical fitness	Six-minute ergometry	0 M, 12 M, 24 M
Quality of life	SF12 [32, 33], FACT [34]	0 M, 6 M, 12 M, 18 M, 24 M
Mood	HADS [35, 36], PSS [37]	0 M, 6 M, 12 M, 18 M, 24 M
Dietary deficiency – caloric and protein intake	FFQ [30]	0 M, 6 M, 12 M, 18 M, 24 M
Dietary associated anaemia	CBC by blood test	0 M, 6 M, 12 M, 18 M, 24 M
PA- associated injury	Direct questioning during phone call	Fortnightly during intervention, 6 M, 12 M

Abbreviations: M-months post-randomization, PA-physical activity, BMI-body mass index, WHR-waist-hip ratio, FFQ-food frequency questionnaire, GPAQ-global physical activity questionnaire, SF12-Short Form 12 item, FACT-Functional Assessment of Cancer Therapy, HADS-Hospital Anxiety and Depression Scale, PSS-Perceived Stress Scale, CBC-complete blood count.

ISSN: 1471-2458