Table 1.
Study schedule for data measurements.
|
|
Study period and time point (week) | ||||||||||||
|
|
|
Enrollment | Allocation | Treatment phase | Follow-up | ||||||||
|
|
|
–1 | 0 | 2 | 4 | 6 | 8 | 10 | 12 | 14 | 16 | ||
| Enrollment | |||||||||||||
|
|
Eligibility screen | ✓ |
|
|
|
|
|
|
|
|
|
||
|
|
Informed consent | ✓ |
|
|
|
|
|
|
|
|
|
||
|
|
Physical examination | ✓ |
|
|
|
|
|
|
|
|
|
||
|
|
Randomization |
|
✓ |
|
|
|
|
|
|
|
|
||
| Interventions | |||||||||||||
|
|
ACEa group (n=46) |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
|
|
Control group (n=46) |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Assessments | |||||||||||||
|
|
BWb | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
|
|
BMI | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
|
|
WCc | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
|
|
HCd |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
|
|
VASe of appetite |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Safety | |||||||||||||
|
|
AEf |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
||
aACE: acupoint catgut embedding.
bBW: body weight.
cWC: waist circumference.
dHC: hip circumference.
eVAS: visual analogue scale.
fAE: adverse event.