| | |
Study Period
|
---|
|
Staff member
|
Pre-study screening/consent
|
Baseline
|
Allocation
|
Post-allocation
|
---|
Time point
| | |
Week -3
|
Week 0
|
Week 1
|
Week 8
|
Week 24
|
---|
ENROLMENT
| |
Eligibility screen
|
Interviewer
|
X
| | | | | |
Informed consent
|
Interviewer
|
X
| | | | | |
Allocation
|
Study Coordinator
| | |
X
| | | |
INTERVENTIONS
| |
Shape-up
|
Interviewer
| | | | | | |
Usual care
|
Interviewer
| | | | | | |
ASSESSMENTS
| |
Socio-demographic data
|
Interviewer
| |
X
| | | | |
EORTC-QLQ-C30
|
Interviewer
| |
X
| | |
X
|
X
|
EORTC-QLQ-EN34
|
Interviewer
| |
X
| | |
X
|
X
|
Dietary assessment
|
Interviewer
| |
X
| | |
X
|
X
|
Physical activity
|
Interviewer
| |
X
| | |
X
|
X
|
Weight
|
Interviewer
| |
X
| | |
X
|
X
|
Height
|
Interviewer
| |
X
| | | | |
Body composition
|
Interviewer
| |
X
| | |
X
|
X
|
Waist circumference
|
Interviewer
| |
X
| | |
X
|
X
|
Hand-grip strength
|
Interviewer
| |
X
| | |
X
|
X
|
Blood pressure
|
Interviewer
| |
X
| | |
X
|
X
|
Shape Up evaluation
|
Interviewer
| | | | |
X
2
|
X
2
|
Control group input
|
Interviewer
| | | | | |
X3
|
Qualitative interviews
|
Interviewer
| | | | |
X
|
X
|
Health care resource use
|
Interviewer
| | | | | |
X
|
EQ5D-3 L
|
Interviewer
| |
X
| | |
X
|
X
|
Serious adverse report form
|
Study Coordinator
|
As needed throughout the protocol
|
-
1Closeout for the control group will be at week 40 after receiving the intervention
-
2Only the intervention group
-
3Only in the control group