Table 5 SPIRIT flow diagram of schedule of enrolment, interventions, and assessments in PREVED study
Enrolment | Post-allocation | Close-out | |||||
|---|---|---|---|---|---|---|---|
Timepoint | Baseline | t0 | t+1M | t+2M | t+4M | t+14M | |
Home visit 1 | Home visit 2 | Childbirth | Home visit 3 | ||||
Leaflet | Workshops | ||||||
Enrolment: | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Interventions: | |||||||
Group 1 Control group | X | ||||||
Group 2 Intervention group in neutral location | X | X | |||||
Group3 Intervention group in contextualized location | X | X | |||||
ASSESSMENTS: | |||||||
Q1 Sociodemographic questionnaire + consumption habits | X | X | X | ||||
Q2 Psychosocial questionnaire | X | X | X | ||||
Collection of urine samples | X | X | X | X | |||
Colostrum samples | X | ||||||