Trial name | Healthy Beginnings36(RCT) | Nourish37(RCT) | The Melbourne InFANT Program38(cluster RCT) | POI NZ39(2×2 Factorial RCT) |
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Registration number | ACTRN12607000168459 | ACTRN12608000056392 | ISRCTN81847050 | NCT00892983 |
Funding source | NHMRC | NHMRC | NHMRC | HRC New Zealand |
Number randomised | N = 667 first time mothers | N = 698 first time mothers | N = 559 first time mothers | N = 400 first time mothers |
Baseline data | Antenatal | Infant aged 4-6 months | Infant aged 3 months | Antenatal |
Primary outcome | Child weight and height at 24 months | Child weight and height at 24 months | Child weight and height at 18 months | Child weight and height at 24 months |
Usual care | Wk1 child health nurse home visit Self access to child health clinics | Self directed access to child health clinics | Access to 10 scheduled child health clinic visits | First 4 wks midwife home visits; Well Child (Plunkett) nurse: 8 visits in 5 yrs |
Intervention mode | Home visits; 8 visits over 2 years (antenatal, 1, 3, 5, 9, 12, 18, 24 months); maternal advice | Two education peer support modules (6 fortnightly sessions each) commencing when infant 4-7 months and again at 13-16 months at community health venues | Six 2 hour sessions delivered at 3 monthly intervals within pre-existing mothers groups, commencing at 3 months (3, 6, 9, 12, 15 and 18 months) | 3 groups: sleep (home visits at 3 wks, 4 months); healthy eating and activity (mix of 7 home visits and group based sessions at 1 wk + 3, 4, 7, 9, 12, 18 months) or both |
Intervention content (in addition to usual care) | Sustaining breastfeeding; Timely solid food introduction; Responsive to child cues of hunger & satiety; Healthy child food intake; Reduced TV viewing; Promote active play; The "how" of child feeding (e.g. managing food fussiness) | Neutral repeated exposure to a variety of foods; Responsive to child cues of hunger & satiety; Healthy child food intake; Reduced TV viewing; Promote authoritative parenting style; The "how" of child feeding (e.g. managing food fussiness) | Responsive to child cues of hunger & satiety; Healthy child food intake; Reduced TV viewing; Promote active play; The "how" of child feeding (e.g. managing food fussiness) | Sustaining breastfeeding; Timely solid food introduction; Responsive to child cues of hunger & satiety; Healthy child food intake; Reduced TV viewing; Promote active play; The "how" of child feeding (e.g. managing food fussiness); Developing good sleep habits |
Control group | Usual care plus written home safety/tobacco prevention information at f/up sessions plus three mail outs | Usual care plus quarterly newsletter on general child health messages excluding sleep, food and activity | Usual care plus quarterly newsletter on general child health messages excluding sleep, food and activity | Usual care |