Summary of the trial
At enrolment | Randomisation | After allocation | |||||
---|---|---|---|---|---|---|---|
Time point | Start | Week 6 | Week 12 | Week 13 | Week 18 | Week 24 | |
Enrolment | |||||||
Eligibility screen | + | ||||||
Informed consent | + | ||||||
Maturity stage (the criteria of Tanner) | + | + | + | ||||
Randomisation | + | ||||||
Product dispensation | + | + | |||||
Interventions (week 0–week 12) | + | + | + | ||||
Follow-up (week 13–week 24) | + | + | + | ||||
Assessments | |||||||
Anthropometry | + | + | + | + | + | + | |
Body composition (DXA measurement) | + | + | |||||
3-day food record | + | + | + | ||||
Dietitian's assessment | + | + | + | ||||
Physical activity assessment | + | + | |||||
Lipids and fasting plasma glucose | + | + | + | ||||
Blood pressure measurement | + | + | + | + | + | ||
Return of unused study products | + | + | |||||
Adverse events | + | + | + |
DXA, dual-energy X-ray absorption.