Table 1.
Schedule of study visits, assessment and procedures
Screening phone call | Enrolment and baseline (Visit 1) |
Allocation | Intervention (Visit 2) |
Accompanied shop (Visit 3) |
Followup (Visit 4) |
|
---|---|---|---|---|---|---|
Time point (weeks from baseline) | −1 | 0 | 2 | 2–3 | 4–9 | 9–10 |
Responsibility | Central research team | Central research team | Independent researcher | Healthcare professional | Central research team | Central research team |
STUDY PROCEDURES | ||||||
Eligibility assessment | ✓ | |||||
Informed consent | ✓ | |||||
Baseline assessment including: | ✓ | |||||
Blood pressure | ✓ | |||||
Height and weight | ✓ | |||||
Medical history and medications | ✓ | |||||
Shopping and diet questionnaire | ✓ | |||||
Instruction on baseline run-in data collection | ✓ | |||||
Urine sample collection | ✓ (+ up to 2 weeks) | |||||
Randomisation | ✓ | |||||
Intervention delivery | ✓ | |||||
Accompanied shop and interview | ✓ | |||||
Follow-up outcome measures including: | ✓ | |||||
Blood pressure | ✓ | |||||
Medical history and medication review | ✓ | |||||
Intervention acceptability questionnaire | ✓ | |||||
Urine sample collection |
✓ ✓ (+ up to 7 days) |