Paul 2011.

Study characteristics
Methods	Study design: RCT Intervention period: 2 nurse home visits (2‐3 weeks post birth and at 4‐6 months post birth) Follow‐up period (post‐intervention): 1 year Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: mother–newborn dyads Unit of analysis: individual
Participants	N (control baseline) = 41 N (control follow‐up) = 30 N (intervention baseline) = 39 (soothe/sleep) N (intervention follow‐up) = 29 N (intervention baseline) = 38 (introduction of solids) N (intervention follow‐up) = 29 N (intervention baseline) = 42 (soothe/sleep and introduction of solids) N (intervention follow‐up) = 22 Setting (and number by study group): home‐based Recruitment: mother–newborn dyads intending to breastfeed were recruited from a maternity ward of a single, academic medical centre Percentage of eligible population enrolled: NR Mean age: intervention + control: 39 weeks gestation Sex: intervention + control: 51% female (completers)
Interventions	To promote healthy growth in the first year after birth – 2 interventions Soothe/Sleep” One home visit 2‐3 weeks post birth by nurse Designed to increase sleep duration in early infancy: At the first visit parents were taught “alternate strategies to feeding as an indiscriminate first response to infant distress” One‐on‐one instruction and demonstration was provided to teach 5 soothing techniques: swaddling side or stomach position while awake shushing swinging sucking In addition to training participants were given instructional handout and commercially produced video “The Happiest Baby on the block” Other instructions to parents: emphasize day/night environment difference respond to nocturnal awakenings with other soothing and care‐taking responses rather than feeding “Introduction of solids" T to teach parents about hunger and satiety cues and the appropriate time to start solids and how to use repeated exposure to overcome infant rejection: At the first visit parents were: instructed to delay the introduction of complementary foods until infant at least 4 months old and to avoid putting infant cereal into a bottle of breast or formula milk given instructional handout to recognise hunger and fullness cues asked to inform the research nurse when the child was ready to for solid food At the 2nd visit (4‐6 months post birth by nurse) parents: were taught the importance of repeated exposure to solid foods to improve acceptance of unfamiliar foods and the developmental signs for solid food readiness (such as good head control and sitting with support) received hands‐on demonstration on feeding their child pureed food and handouts on infant feeding including how to recognise hunger and fullness were instructed to begin pureed food when infant calm and alert, not crying or fussing. After 2nd home visit parents asked to feed infants 1/4 pureed vegetables at a similar time each day, for 6 consecutive days over 4 consecutive weeks Mothers were provided with the infant foods All participants (control and other intervention): 2 home visits, the first 2‐3 weeks after birth, the 2nd within 2 weeks of the 1st introduction of solid foods (between 4‐6 months of age of the infant) Content of the visits depended on which group randomised to Interventions delivered by research nurses Received standard infant parenting book with traditional advice on handling infant night awakenings Questions about general infant breast feeding and care answered Infants weighed and measured Diet intervention vs control
Outcomes	Outcome measures Primary outcome: weight for length percentile Secondary outcomes: sleep and feeding behaviour, conditional weight gain scores, adverse effects (growth) Process evaluation: NR
Implementation‐related factors	Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender; mother: race/ethnicity; SES (household income), education, marital status PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: reported (gaining insufficient weight) Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR
Notes	NCT00359242 Funding: this work was supported by grant DK72996 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and in part by a General Clinical Research Center grant from NIH (M01RR10732) and GCRC Construction Grant (C06RR016499) awarded to the Pennsylvania State University College of Medicine. Infant food jars were generously donated by Gerber. Additional support was received from the Penn State Children, Youth and Families Consortium and The Children’s Miracle Network. The mean birth weight for these participants was 3.33 kg, equivalent to the 45th percentile for birth weight for gestational age. “... We do not have adequate data to assess the extent to which parents’ implementation of the “Soothe/Sleep” intervention may have affected its impact.”
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation included stratification for maternal prepregnancy BMI with 2 groups, BMI < 25 and BMI ≥ 25. Mother–newborn dyads were randomised into 1/4 cells using a 2 × 2 design to receive both, 1, or no interventions delivered at 2 nurse home visits
Allocation concealment (selection bias)	Unclear risk	NR
Blinding (performance bias and detection bias) All outcomes	High risk	Assessors (research nurses) were unblinded
Incomplete outcome data (attrition bias) All outcomes	High risk	31% attrition in a relatively small trial, no significant difference between groups. Non‐completers significantly younger and less educated at baseline, and were more likely to be single, non‐white, and Medicaid‐insured.
Selective reporting (reporting bias)	High risk	Trial registration found. BMI was not listed in the trial registration report, but is listed in the outcome data of the trial report. Therefore this outcome is at high risk of bias.
Other bias	Low risk