Activity | Recruitment for the trial and follow-up of those not entering the trial | Clinical trial | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
 | Pregnancy | Perinatal period | Post-pregnancy period (weeks) | |||||||||
 | Recruitment | Telephone contact | Trial preparation | Baseline measures | Follow-upa | All women entering the trial | ||||||
Post-randomization follow-up (months) | ||||||||||||
 | Gestational weeks 20–40 | Pregnancy to 30 days postpartum | 4–104 | 8–104 | Up to 260 | 0 | 0–6 | 6–12 | 12–24 | 24–36 | 36–48 | 48–60 |
Consents | x | Â | Â | x | Â | Â | Â | Â | Â | Â | Â | Â |
Entry | x | x | x | Â | Â | Trial randomization | Â | Â | Â | Â | Â | Â |
Interviews/exams/chart reviews | x | Â | Â | x | Â | x | Â | x | x | x | x | x |
Phone contacts | Â | x | x | Â | x | Â | Â | Â | Â | Â | Â | Â |
Baseline and follow-up measurements | Â | Â | Â | x | Â | Â | Â | x | x | x | x | x |
Material distributions | Breastfeeding folder 1; Pregnancy to postpartum booklet | Mail at birth: Breastfeeding folder 2 | Â | Project folder | Â | Preventing diabetes booklet | Â | Â | Â | Â | Â | Â |
 |  |  |  |  |  | Intervention group | ||||||
Motivational interviews | Â | Â | Â | Â | Â | x | x | x | x | Â | Â | Â |
Phone sessions | Â | Â | Â | Â | Â | Â | x | x | x | x | x | x |
SMS texting | Â | Â | Â | Â | Â | Â | x | x | x | x | x | x |
Group sessions | Â | Â | Â | Â | Â | Â | As needed | |||||
Social events | Â | Â | Â | Â | Â | Â | As needed | |||||
Mailings | Â | Â | Â | Â | Â | Â | As needed |